News from Georgia Life Sciences

ArunA Bio Raises $13 Million in Common Stock Financing

Thu, 01 Aug 2019 02:25:41 GMT

-- Financing proceeds to advance ArunA Bio’s neural exosome therapies for neurodegenerative diseases and partnering activities --

-- ArunA Bio establishes an office in Research Triangle Park, NC --

Athens, GA; Research Triangle Park, NC - July 24, 2019—ArunA Bio, Inc., a leader in the development of neural exosomes for the treatment of neurodegenerative diseases, today announced the completion of a $13 million common stock financing. Proceeds from the financing will be used to support the continued development of ArunA Bio’s neural exosome delivery platform and pipeline of novel neural exosome therapies for the treatment of neurodegenerative diseases such as ALS and Huntington’s Disease, as well as stroke.

The financing included both existing and new private investors along with participation by several institutional investors including Eshelman Ventures and members of the Board of Directors and management.

“The level of interest and enthusiasm we encountered from investors during this financing effort and the fact that it was oversubscribed speak to the interest and excitement around the data we have generated and prospects for the use of our neural exosomes as therapeutics and a delivery vehicle for treating devastating neurodegenerative diseases,” said Dr. Mark A. Sirgo, Chief Executive Officer of ArunA Bio. “We appreciate the support of both existing and new investors and look forward to building shareholder value as we progress our neural exosome science towards meaningful products for patients.”

ArunA Bio plans to use the proceeds to further validate the ability of its proprietary neural exosomes to provide therapeutic benefits through their anti-inflammatory, neuroprotective and neuroregenerative properties, as well as deliver therapeutic payloads including siRNAs and antibodies across the blood brain barrier. Data from planned studies will support the submission of ArunA Bio’s first pre-IND (Investigational New Drug) package to the U.S. Food and Drug

Administration in the upcoming months. Additionally, funding will support key personnel hiring and further expansion of ArunA’s proprietary manufacturing capabilities to meet future regulatory requirements. The company is also looking to partner with pharmaceutical and biotech companies with a presence in the neurodegenerative disease space to develop the neural exosome platform.

ArunA Bio also announced that it has established an office in Research Triangle Park (“RTP”), North Carolina. RTP is one of the nation’s largest and fastest growing markets in life sciences with

over 550 companies employing over 40,000 people according to the North Carolina Biotechnology Center. The RTP area has also been very attractive from an investment standpoint, with the amount of new venture capital to life sciences of nearly $16 billion over a recent one- year period. ArunA Bio expects to increase its management presence in RTP and will continue its ongoing research and manufacturing activities in Athens, Georgia.

About ArunA Bio

ArunA Bio is harnessing the natural abilities of neural exosomes to cross the blood brain barrier and enhance the body’s anti-inflammatory, self-repair and protective mechanisms to treat a range of neurodegenerative disorders. ArunA Bio is also leveraging its proprietary exosomes and manufacturing platform to create synergistic therapies by enhancing exosomes with RNA, oligonucleotides, antibodies and small molecules. www.arunabio.com

Contact

George E. MacDougall 781-235-3060 gmacdougall@macbiocom.com

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of U.S. federal securities laws. Forward-looking statements express views of ArunA Bio regarding future plans and expectations. They include statements that include words such as “may,” “could,” “would,” “should,” “believe,” “expect,” “anticipate,” “plan,” “estimate,” “target,” “project,” “plan,” “intend” and similar words or expressions.

Forward-looking statements in this press release include, but are not limited to, statements regarding future operations, business strategy and past, present, or future values of the anticipated reserves, cash flows, income, costs, expenses, liabilities and profits, if any, of ArunA Bio. These statements are based on numerous assumptions and are subject to known and unknown risk and uncertainties. These assumptions may not materialize. Actual future results may vary materially from those expressed or implied in these forward-looking statements, and our business, financial condition and results of operations could be materially and adversely affected by numerous factors, including such known and unknown risks and uncertainties. As a result, forward-looking statements should be understood to be only predictions and statements of our current beliefs, they are not guarantees of performance.

07/24/2019

Freenome Closes $160 Million Series B Financing to Advance Its Multiomics Blood Testing Platform for Early Cancer Detection

Thu, 01 Aug 2019 02:26:33 GMT

Proceeds Will Fund Pivotal Validation Study of Company’s Blood-based Test for the Screening of Colorectal Cancer

Platform Has Potential for Use in Multiple Cancer Types and Enhanced Drug Development by Characterizing Tumor and Immune Signatures

July 24, 2019 09:00 AM Eastern Daylight Time

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Freenome, a biotechnology company that has pioneered the most comprehensive multiomics platform for early cancer detection through a routine blood draw, today announced the close of its $160 million Series B financing, bringing its total financing to $238 million to date. Freenome will use the proceeds to further the development of its early cancer detection blood test powered by its platform. The Company plans to conduct a pivotal validation study and submit to the U.S. Food and Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS) under the Parallel Review Program the first application of its platform in colorectal cancer screening and expand its laboratory infrastructure and software to support its continued growth.

“The only way to achieve meaningful progress against cancer is to interweave normally disparate fields towards a single mission. And the leadership team at Freenome has built a world-class, multi-disciplinary team of molecular biologists, computational biologists, machine learning scientists, and engineers”

The Series B financing was led by RA Capital Management and Polaris Partners. They were joined by other new investors including Perceptive Advisors, funds and accounts advised by T. Rowe Price Associates, Inc., Roche Venture Fund, Kaiser Permanente Ventures, and the American Cancer Society’s BrightEdge Ventures. Freenome’s existing investors also participated in the financing including Andreessen Horowitz, GV (formerly Google Ventures), Data Collective Venture Capital, Section 32, and Verily Life Sciences (a subsidiary of Alphabet focused on life sciences and healthcare).

“We are fortunate to have an experienced and proven group of biotech and healthcare investors who share our mission of making early detection of cancer a routine part of patient care,” said Gabe Otte, Chief Executive Officer of Freenome, “In addition, we are excited to welcome several strategic investors who are committed to our mission. Each brings insight, expertise, and partnership opportunities to accelerate our path to positively impacting patient care.”

“Freenome’s work holds much promise and potential,” said Bob Crutchfield, Managing Director of the American Cancer Society’s philanthropic impact fund, BrightEdge. “We hope our investment will help lead to accelerated patient access to this technology and better outcomes for cancer patients.”

Mr. Otte added, “Since our founding in 2014, we have been focused on building a multi-disciplinary team to achieve our vision of a future where cancer mortality is significantly reduced through early detection matched with the right treatment informed by our blood test. We have already demonstrated promising clinical results at Digestive Disease Week this year, where our cell-free DNA (cfDNA) assay and machine learning approach enabled high sensitivity and specificity in a cohort of mostly early stage colorectal cancer patients. This funding will allow us to execute the necessary validation study for approval and reimbursement coverage of our colorectal cancer screening test, as well as expand our platform to other forms of cancer or immune-driven disease areas in the future.”

Freenome’s multiomics platform detects key biological signals from a routine blood draw. The platform integrates assays for cell-free DNA, methylation, and proteins with advanced computational biology and machine learning techniques to identify additive signatures that improve the accuracy for early cancer detection given the molecular subtypes of cancer are heterogeneous in nature. This strategy incorporates a multidimensional view of both tumor- and immune-derived signatures that enables the early detection of cancer, instead of relying only on tumor-derived markers, which may miss the early signs of cancer. Freenome’s first cancer test is for the screening of colorectal cancer, the second deadliest form of cancer in the U.S. When identified early, colorectal cancer has a 90 percent five-year relative survival rate compared to 14 percent when detected at a more advanced stage according to data from the National Cancer Institute’s Surveillance, Epidemiology, and End Results Program.

"The most affordable and effective treatment for metastatic cancer is to detect it early, when the tumor is still small and local, and we can cure it with surgery. It’s with that vision that we have invested in Freenome,” said Peter Kolchinsky, Managing Partner of RA Capital. “Freenome’s multiomics platform is unlike anything we’ve seen, and we believe it can unlock the promise of using blood tests to detect and treat cancer early."

“The only way to achieve meaningful progress against cancer is to interweave normally disparate fields towards a single mission. And the leadership team at Freenome has built a world-class, multi-disciplinary team of molecular biologists, computational biologists, machine learning scientists, and engineers,” said Amir Nashat, Managing Partner of Polaris Partners. “Having seen the tremendous progress Freenome has made in early cancer detection, we are excited to continue charting that path together.”

About Freenome

Freenome is a biotechnology company that has pioneered the most comprehensive multiomics platform for early cancer detection. By combining a deep expertise in molecular biology with advanced computational biology and machine learning techniques to recognize disease-associated patterns among billions of circulating, cell-free biomarkers, Freenome is developing simple and accurate blood tests for early cancer detection and integrating the actionable insights into health systems to operationalize a machine learning feedback loop between care and science. Examples of Freenome’s novel research include advancing the fields understanding of using machine learning for early stage colorectal cancer detection featured at Digestive Disease Week and using cfDNA fragment coverage to predict gene expression featured at American Association for Cancer Research’s Annual Meeting. Freenome is headquartered in South San Francisco, California. For more information about Freenome, visit www.freenome.com and view open positions at freenome.com/careers.

About Freenome’s AI-PATTERNS Oncology Studies

By using artificial intelligence (AI) to recognize disease-associated patterns among billions of circulating, cell-free biomarkers, Freenome is developing simple and accurate blood tests for early-cancer detection. Freenome’s AI-PATTERNS studies are a series of rigorous clinical development and validation studies across a diverse range of cancer types. The first in the series, AI-EMERGE, is focused on colorectal cancer.

Contacts

Sylvia Aranda
saranda@purecommunications.com
424-201-9464

07/24/2019

CenExel Clinical Research Establishes Clinical Trial Centers Of Excellence Company

Thu, 01 Aug 2019 02:24:46 GMT

Unites Four of the Top US Clinical Research Facilities to Reduce Time and Cost for New Drug Development

SALT LAKE CITY, July 18, 2019 /PRNewswire/ -- CenExel Clinical Research, Inc., ("CenExel" or the "Company") announces the creation of their Centers of Excellence company, which unites four of the most experienced clinical research units in the country to design and execute Phase I-IV trials, including Phase I studies in patient populations, to help pharmaceutical companies improve the time and cost of new therapy development for better patient care. CenExel operates state-of-the-art facilities in Utah, California, Georgia and Maryland, with some of the most accomplished Clinical Opinion Leaders and experienced staff in the world for conducting clinical trials.

The CenExel Centers of Excellence include JBR Clinical Research, Atlanta Center for Medical Research (ACMR), Anaheim Clinical Trials (ACT), and CBH Health, each recognized as one of the most experienced and trusted research facilities in their respective fields: post-operative pain, central nervous system (CNS) disorders, chronic disease management, Asian pharmacokinetic bridging studies, psychiatric illnesses, and others. "CenExel Centers of Excellence offer pharmaceutical companies and clinical research organizations access to some of the finest investigators and facilities in the world for conducting research," said Tom Wardle, CEO.

"We are focused on delivering the highest possible quality through our combined expertise, the engagement of our investigators and staff, and most importantly, our results." Their renowned principal investigators include Todd Bertoch, MD, Robert A. Reisenberg, MD, Peter Winkle, MD, and Robert E. Litman, MD. Dr. Bertoch also chairs the CenExel Scientific Advisory Board with noted analgesia research experts Stephen Cooper, DMD, PhD, and Paul Desjardins, DMD, PhD. Kevin Quinn, VP of Business Development and Integration, said, "The level of engagement among staff and patients is a key differentiator with our Centers of Excellence.

This commitment has enabled our Centers to routinely meet or exceed patient recruitment goals in hundreds of clinical trials, so we are able to complete studies on-time and within budget." CenExel Clinical Research, Inc., was formed in 2018 with the merger of JBR Clinical Research, a Salt Lake City facility specializing in analgesia research and vaccine testing, with ACMR, an Atlanta-based psychiatric research facility.

Since its formation, CenExel has aggressively pursued organic growth as well as the acquisition of other state-of-the-art research centers around the country, assisted by Edgemont Partners. The mission of CenExel is to work with trial sponsors and contract research organizations to reduce costs and development times for innovative therapies which may advance patient care.

07/18/2019

Sharecare names Quest Diagnostics its preferred laboratory partner to advance digital health management

Tue, 16 Jul 2019 14:34:27 GMT

ATLANTA (July 12, 2019) – Sharecare, the digital health company that helps people manage all their health in one place, and Quest Diagnostics (NYSE: DGX) have formed a collaboration designed to improve digital health and disease management for a range of health care consumers.

Sharecare has named Quest its preferred laboratory partner for its comprehensive digital health platform. Sharecare and Quest Diagnostics also intend to jointly explore the development of disease management programs and other services to empower better health. In addition, Quest has made a strategic investment in Sharecare for an undisclosed sum with Goldman Sachs serving as Sharecare’s financial advisor. Additional terms were not disclosed.

“With its expertise, quality and reach, Quest Diagnostics is the trusted leader in diagnostic information services. Together, we will elevate the Sharecare experience and empower individuals to access better insights into their health risks,” said Jeff Arnold, co-founder, chairman and CEO for Sharecare.

The Sharecare platform engages people in all aspects of their health, from developing better eating habits, improving sleep and reducing stress to managing a chronic condition such as diabetes or heart disease. Starting with the RealAge test, the Sharecare platform enables people to go from assessment to action, and connect to personalized information, evidence-based programs, benefits, community resources and health services they need, while helping employers, health plans and health systems improve outcomes and close gaps in care for their populations.

About Sharecare
Sharecare is the digital health company that helps people manage all their health in one place. The Sharecare platform provides each person – no matter where they are in their health journey – with a comprehensive and personalized health profile where they can dynamically and easily connect to the information, evidence-based programs and health professionals they need to live their healthiest, happiest and most productive lives. In addition to providing individual consumers with direct access to award-winning and innovative frictionless technologies, scientifically validated clinical protocols and best-in-class coaching tools, Sharecare also helps providers, employers and health plans effectively scale outcomes-based health and wellness solutions across their entire populations.

Strategic investors in Sharecare include hospitals, health care investment firms and health plans, in particular, HCA (NYSE:HCA), Trinity Health, the Heritage Healthcare Innovation Fund and CareFirst; media companies Discovery Communications, Harpo Productions, Remark Holdings and Sony Pictures Television; high growth technology investment firms such as Claritas Capital; noted crossover fund Wellington Management; Wells Fargo; and Swiss Re, one of the world’s largest reinsurance providers. Since its founding, Sharecare has raised in excess of $400 million in total capital.

To learn more, visit www.sharecare.com.

07/12/2019

Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection

Thu, 11 Jul 2019 20:59:59 GMT

Washington, D.C. (July 11, 2019) – BIO’s President and CEO Jim Greenwood issued the following statement after it was reported that the Trump administration is withdrawing its proposed rebate rule that would have required savings from drugmakers’ rebates be passed along to seniors enrolled in the Medicare drug benefit program:

“The administration has abandoned one of the only policy solutions that would have truly lowered what patients are forced to pay out of pocket for the medicines they need. This decision discards a proposal that would have also delivered meaningful transparency to an opaque system that puts the financial interests of middlemen ahead of the well-being of patients.

“It is deeply disappointing the administration succumbed to the same old scare tactics we see from the insurance industry whenever policymakers aim to address the discriminatory tactics insurers use against patients. The president has promised to rein in the role of middlemen and ensure patients directly benefit from the significant rebates biopharmaceutical companies provide, but today that promise was broken.

“This decision has dealt a blow to some of the most vulnerable patients, and it only heightens the urgency for Congress to adopt a reasonable cap on out-of-pocket costs for America’s seniors.”

Remarks by President Donald Trump, May 11, 2018:

“We’re also increasing competition and reducing regulatory burdens so drugs can be gotten to the market quicker and cheaper. We’re very much eliminating the middlemen. The middlemen became very, very rich. Right? Whoever those middlemen were — and a lot of people never even figured it out — they’re rich. They won’t be so rich anymore.”

“Our plan will end the dishonest double-dealing that allows the middleman to pocket rebates and discounts that should be passed on to consumers and patients.”

###

About BIO

BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world. BIOtechNOW is BIO's blog chronicling “innovations transforming our world” and the BIO Newsletter is the organization’s bi-weekly email newsletter. Subscribe to the BIO Newsletter.

07/11/2019

New pharma boss: Next EU Commission should be clear on how to protect innovation

Tue, 09 Jul 2019 13:40:12 GMT

The next EU Commission should take a stronger position on innovation in the pharma sector, the new leader of the European Federation of Pharmaceutical Industries and Associations (EFPIA) told EURACTIV.com in an interview.

“It will be important for the next European Commission to make an official statement on how they feel about innovation and how they want to protect and develop innovation,” Jean-Christophe Tellier, the newly elected President of EFPIA and CEO of biopharmaceutical company UCB, told EURACTIV.

He added that it is equally important to put in place frameworks to facilitate access to innovation. “We’ve noticed that EU countries are delaying the ability to put innovations on the market due a very long process of pricing, but the deadline of the patent is always the same,” he said.

“Protecting Intellectual Property rights (IPs) is very important for us considering that they are the best way to protect innovation and ensure best outcomes for the patients,” he said.

The addition of a manufacturing waiver to supplementary protection certificates (SPC) also limits innovation, he said.

“The pressure on the IP, the expiry date of the patent is the same and with the SPC waiver, the hit is even harder, we are facing additional hurdles that delay the moment where we can get the benefit for the innovation,” he said.

“If we can prevent more diseases, even stop the progression of chronic diseases, it is thanks to innovation,” he added.

“IPs and innovations are very well connected together. The question is, what is the fair balance between this protection and the ability to stimulate innovation.”

The top priority for EFPIA in the next two years will be to break through the silos and bring healthcare stakeholders together to achieve better outcomes for patients, the new EFPIA boss said.

“The focus of the next two years will be on connecting healthcare by aligning the different stakeholders into creating the best possible outcome for patients,” Tellier said.

“Today, the system is too much fragmented and it’s not so easy for the different stakeholders, from physicians to health systems and payers, to engage. But we cannot win without each other because the reality is that we are interdependent on each other,” the pharma boss added.

He cited as an example, the Innovative Medicines Initiative (IMI), a European initiative focused on pharmaceutical research.

“Different stakeholders put their efforts together into what is today the most important public-private partnership in the world, with more than €5.3 billion in investment.”

He said the IMI, which connects databases across different countries in Europe has accelerated research. “I do feel that the current fragmentation and the vertical expertise, the way it’s structured today, will be challenged by affordability, and then we will be able to better work together.”

He said the pharmaceutical industry represents 20% of the total cost investments and one should look at the wider picture: “We need to find out the best way to allocate the resources to avoid waste of investment, and progress into a better usage of investments.”

Read more here.

06/28/2019

BIO Applauds Enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act

Tue, 02 Jul 2019 14:43:24 GMT

Legislation will strengthen pipeline of medical countermeasures against serious public health threats

Washington, DC (June 25, 2019) – The Biotechnology Innovation Organization (BIO) today applauds the enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act, signed into law by President Trump late yesterday. The law re-authorizes critical federal biodefense programs and agencies, including the BioShield Special Reserve Fund (SRF), the Biomedical Advanced Research and Development Authority (BARDA), and the Strategic National Stockpile (SNS). It authorizes funding for pandemic influenza product development and procurement for the first time.

BIO President and CEO Jim Greenwood issued the following statement:

“I applaud President Trump for signing this historic bi-partisan legislation. The PAHPAI Act provides critical flexibility and predictability for government agencies and their private sector partners by authorizing increased, multi-year funding for the BioShield Special Reserve Fund and by empowering BARDA to better address CBRN threat agents, pandemic influenza, emerging infectious diseases, and antimicrobial resistance. These investments in preparedness and medical countermeasure development will greatly enhance our ability to respond to potentially catastrophic attacks on the American public.”

“I would like to thank Representatives Susan Brooks and Anna Eshoo, Senators Richard Burr and Robert Casey, as well as the leaders of the House Energy & Commerce and Senate HELP Committees, for their tireless bi-partisan championship of this vital legislation.”

About BIO

BIO World Congress

July 8-11, 2019

Des Moines, Iowa

BIO Investor Forum
October 22-23, 2019
San Francisco, CA

06/25/2019

FDA’s Atlanta lab relocating from Midtown to Fort Mac

Tue, 02 Jul 2019 14:50:29 GMT

The U.S. Food and Drug Administration (FDA) is relocating its Atlanta operations to Fort McPherson, a former Army base in southwest Atlanta.

The FDA, which is currently located on Peachtree Street in Midtown, will open a new lab and offices at Fort Mac, bringing 350 scientist and staff jobs to the project.

That opens up a potentially big redevelopment opportunity in Midtown.

It also boosts a massive plan to redevelop the remaining 145 acres of Fort Mac. Tyler Perry Studios already occupies a majority of the former Army base, and now the hope is to remake the remaining property into a mixed-use project for the surrounding community.

"The time is now for the redevelopment of Fort Mac," said Brian Hooker, executive director of the Fort Mac LRA, the state agency overseeing the rebirth of Fort Mac. "We really had to put together a strong bid to compel [the FDA] to be an early adopter in southwest Atlanta."

The FDA lab will come to the former U.S. Army Forces Command building (FORSCOM) at Fort Mac, a compound once run by Gen. Colin Powell.

Easterly Government Properties Inc. (NYSE: DEA) will buy the Forces Command building from the Fort Mac LRA. Easterly will renovate it and lease it to the FDA. It will house the FDA’s Atlanta lab and office, as well as the Southeast Food and Feed Laboratory and Southeast Tobacco Laboratory, including four labs for nutritional analysis, chemistry, microbiology and tobacco

“The approximately 350 FDA employees and contractors are expected to benefit from the laboratory’s proximity to MARTA,” William C. Trimble III, Easterly’s CEO, said in an announcement.

There’s more planned for Fort Mac, as Atlanta Business Chronicle reported in April. Atlanta real estate company Macauley Investments LLC is eyeing a roughly 4 million-square-foot project that could bring new housing, retail, office, a hotel and community space. The Fort Mac LRA board still needs to finalize Macauley's master plan. Hooker said the board can't take action until it has two more members, which should happen soon.

Read more here.

06/20/2019

Georgia Bio to Deliver Life Science Teacher Training Program to Rural Georgia

Tue, 02 Jul 2019 14:53:14 GMT

Public-private investment will prepare 8th-12th grade students in rural communities for careers in biomanufacturing of agriculture, medicine, food and beverage products.

ATLANTA--(BUSINESS WIRE)--Included in Georgia’s 2020 budget signed into law by Governor Brian Kemp on May 10 are funds to support life sciences education in rural school systems through the Georgia Department of Education and the Georgia Youth Science & Technology Centers.

“The life sciences industry is a leading driver of employment nationally, but leaders express concern about the availability of a strong workforce,” said Georgia Bio President & CEO Maria Thacker-Goethe. “We need educators to be aware of the vast, high paying jobs available in the life sciences industry here in Georgia. By expanding our proven teacher trainings statewide, we will equip educators with the academic, technical, and leadership skills to meet the students’ interests and industry’s needs.”

These trainings are the first of their kind nationally and set Georgia to be a premier training location for this skilled workforce. Curriculum developed in collaboration with the Georgia Institute of Technology and University of Georgia, specifically the Center for Cell Manufacturing Technologies (CMaT), will prepare students to work in biomanufacturing and the emerging biotech industry. These hands-on applications of STEM learning will solidify what students learn in other classes, as well as provide skills required for tomorrow’s workforce. More on the programs at www.gabio.org.

Georgia Bio’s membership has been supporting these initiatives for years. Adding State support improves alignment to fuel a high growth, high income industry through educators and students in rural Georgia. Georgia Bio recently reported that employment in the life sciences industry grew by 14.9 percent between 2007 and 2017, a rate nearly twice the national average.

“The best thing we can do here in Georgia is create an ecosystem that continues to allow for a growing economy, a talented workforce and significant potential in front of it,” Lt. Governor Geoff Duncan told us recently.

Georgia Bio expresses our gratitude to the following state legislative leadership for helping to make this valuable initiative real to the benefit of all Georgians: Governor Brian Kemp, Lt. Governor Geoff Duncan, House Appropriations Chairman Terry England, Senate Appropriations Chairman Jack Hill, House Appropriations Education Subcommittee Chairman Robert Dickey, Senate Appropriations Education Subcommittee Chairman Ellis Black, Senate Agriculture Chairman John Wilkinson, and House Ethics Chairman Randy Nix.

Georgia Bio is the state’s trade association committed to driving growth in Georgia’s biosciences industry and its many sectors, including agri-biotech, food and nutrition, bio-based technologies and renewable chemicals, industrial and environmental biotech, medical devices and technologies, pharmaceuticals and consumer healthcare, diagnostics and research products, testing and research services, and clinical research. Georgia Bio members include bioscience companies, academic and research institutions, bioscience service providers, digital health companies, and related organizations. For more information, visit www.gabio.org or follow us on Twitter @Georgia_Bio.

06/18/2019

Pfizer acquisition suggests more deals on the horizon

Tue, 02 Jul 2019 14:54:35 GMT

Shares of cancer-therapy companies shot up on Monday after Pfizer Inc. announced it would acquire cancer drug maker Array BioPharma Inc. in a deal worth up to $11.4 billion.

Shares of Incyte Corp. INCY, +2.94% rose 5.3% on Monday afternoon, while shares of Iovance Biotherapeutics Inc. IOVA, +3.83% shot up 13% and shares of Turning Point Therapeutics Inc. TPTX, +3.40% jumped 12.6%. Shares of Blueprint Medicines Corp. BPMC, +2.77% rose around 6% and Mirati Therapeutics Inc. MRTX, +1.73% shares gained 5.4%, while the SPDR S&P Biotech ETF XBI, +1.70%advanced 4.2%.

Pfizer’s acquisition “signals more deals will happen,” Jefferies health-care trading desk strategist Jared Holz told MarketWatch in an email, adding that the amount Pfizer paid — $48 a share, an almost 13% premium over Monday’s share price — bodes well for potential acquisition targets. Anticipation around M&A should continue to drive momentum in the share price of some cancer-therapy companies, he said.

More on Pfizer and Array: S&P places Pfizer ratings on CreditWatch negative after $11.4 billion Array deal and Array BioPharma’s stock rockets after $11.4 billion buyout deal with Pfizer

Pfizer PFE, +0.79% is looking to expand its pipeline of cancer drugs with this acquisition. Array’s ARRY, +0.75% portfolio includes Braftovi and Mektovi, which have been approved for combined use in the treatment of certain advanced metastatic melanomas. The combined therapy has significant potential for long-term growth, Pfizer said, and is being tested in more than 30 clinical trials for treatment of several other cancers, including metastatic colon cancer.

Moody’s said in a report last week that several biopharma giants — specifically Amgen Inc. AMGN, +1.84% Biogen Inc. BIIB, +1.53% Gilead Inc. GILD, +1.93%and Novo Nordisk A/S NVO, +2.18% — had “very high” capacity for M&A, thanks to generous cash stores and what the agency called moderate debt-to-earnings ratios. The ratings agency said it predicts a rise in M&A, especially in the oncology and gene therapy spaces, mirroring recent moves like Monday’s Pfizer announcement, Eli Lilly & Co’s LLY, +0.83% acquisition of Loxo Oncology and Biogen’s acquisition of Nightstar Therapeutics. Merck & Co. MRK, +1.39% announced just last week that it would be buying cancer-treatment biotech Tilos Therapeutics.

Read more here.

06/18/2019

New BIO Chair Vows Crackdown on Biopharma’s “Bad Actors”

Tue, 02 Jul 2019 14:55:50 GMT

The new chairman of the Biotechnology Innovation Organization (BIO) is promising to crack down on “bad actors” that increase drug prices “dramatically”—in part by expelling member companies that carry out the sky-high hikes.

Jeremy M. Levin, D.Phil., MB BChir., who is also chairman and CEO of Ovid Therapeutics, told GEN such expulsions would be considered individually, and didn’t define how high a dramatic price increase would be to incur the wrath of BIO.

“We need to look case-by-case. There are some that are blatantly obvious,” Levin said in an interview during BIO’s 2019 International Convention, held in Philadelphia at the Pennsylvania Convention Center. “We’ve seen gentlemen dressed in hoodies who’ve taken action to do this in a way which is nothing short of daylight robbery.”

“Hoodies” is an allusion to “Pharma Bro” Martin Shkreli, who is now serving a seven-year federal prison sentence following his conviction on security fraud and conspiracy charges.

“We are obliged to confront this transparently, openly, acknowledge past efforts that were incorrect, acknowledge past mistakes, and now engage incredibly constructively with everybody to ensure that we get the right policies put in place,” Levin acknowledged. “We are now garnering the results of a really poorly thought through strategy in the past of how you should represent the industry, how the industry needs to behave.”

“We’re harvesting what I think can only be described as the consequences of a number of years of failing to address public concerns,” Levin added. “We’re harvesting that in the form of tremendous anger by the public, very negative views by the press, and as a consequence of that, there’s some very serious and rapid-fire policymaking. And that’s exacerbated by the political environment of the 2020 election.”

As chairman, Levin said, he will lead BIO in trying to persuade biopharma companies to scale back price increases by tying compensation of top executives to innovation rather than simply the bottom line.

“If you have an organization that consistently relies on its price rises to increase its top line, they have no incentive whatsoever to develop new drugs to replace that old drug. And at the end of the life of the drug, the patent life, they’ll fight vigorously to protect it. We’ve seen that,” Levin said. “The question is, how do you change that? We’re going to have to tackle that. We can’t let that go by.”

Levin said the industry faces a risk that if it doesn’t act to contain drug prices, Congress will—and not necessarily in the interest of biopharma companies or the broader industry.

“At the end of the day, you’re going to face that, or you’re going to face the question of whether outside legislators are going to say, you can’t do price rises. Real simple. So why would we wait for someone else to control our lives when we can ourselves control our lives by saying, ‘Look, we may change our compensation structure. We’re going to focus on innovation. Let’s reward our teams for that: New launches, new drugs.’”

A persuasion campaign from BIO could succeed, Levin asserted, because a younger generation of biopharma executives have a stake in helping the industry chart its own course on prices rather than be forced to do so by lawmakers.

Additional pressure to contain drug prices has come from President Donald Trump, who has vowed to address the issue.

Blaming PBMs

Like the other major U.S. biopharma industry trade group, Pharmaceutical Research and Manufacturers of America (PhRMA), BIO also blames escalating drug prices on pharmacy benefit managers (PBMs) due to consolidation that has three PBMs—CVS, Express Scripts, and UnitedHealth’s Optum—accounting for about 75% of all prescription claims.

Together with Humana Pharmacy Solutions, MedImpact Healthcare Systems, and Prime Therapeutics, the top six PBMs process more than 95% of total U.S. equivalent prescription claims, according to an article posted May 29 on the Drug Channels Institute website by its CEO Adam J. Fein, PhD, who tracks pharmaceutical economics and the drug distribution system as president of the Institute’s parent company Pembroke Consulting.

PBMs counter that they lower drug prices through discounts and rebates negotiated with pharmacies, wholesalers, and pharmaceutical manufacturers. “In classes where several products may be considered therapeutically equivalent, PBMs can negotiate with drug manufacturers for higher rebates, which in turn benefit patients and payers,” the PBM industry group Pharmaceutical Care Management Association (PCMA) states.

The issue of containing drug prices resurfaced last month, when the U.S. Senate Committee on Health, Education, Labor, and Pensions Chairman Lamar Alexander (R-TN) and Ranking Member Patty Murray (D-WA) released the Lower Health Care Costs Act of 2019—a bipartisan discussion draft legislation designed to reduce health care costs.

In January, Sen. Bernie Sanders (D-VT), one of some two dozen Democrats seeking the party’s 2020 presidential nomination, introduced the Prescription Drug Price Relief Act of 2019 (S. 102). It would require the Department of Health and Human Services (HHS) to review all brand-name drugs for excessive pricing at least annually or upon a petition. If any such drugs are found to be excessively priced, HHS would be required to void any government-granted exclusivity; issue open, nonexclusive licenses for the drugs; and accelerate the review of corresponding applications for generic drugs and biosimilar biological products. HHS must also create a public database with its determinations for each drug.

Sanders’ bill defines a drug price hike as “excessive” if the domestic average manufacturing price exceeds the median price for the drug in Canada, the United Kingdom, Germany, France, and Japan. If a price does not meet this criteria, or if pricing information is unavailable in at least three of those countries, the price is still considered excessive if it is higher than reasonable in light of specified factors, including cost, revenue, and the size of the affected patient population, according to a summary of the bill posted on Congress.gov.

Levin will lead BIO’s board for 2019–2020. He succeeds John Maraganore, PhD, the CEO of Alnylam Pharmaceuticals.

Rare neurological focus

Ovid develops treatments for rare neurological disorders. Levin joined Ovid after serving as CEO of Teva Pharmaceutical Industries for 17 months until resigning in October 2013, about three weeks after unveiling a global restructuring program that included the elimination of 5,000 jobs worldwide, touching off outrage in Israel.

Before Teva, Levin held roles of increasing responsibility at Bristol-Myers Squibb, the Novartis Institutes of Biomedical Research, and other companies. Levin was also chairman and CEO of Cadus Pharmaceuticals, which he took public, from 1992 to 1997.

Two years later, Cadus lost a patent infringement lawsuit filed by Sibia Neurosciences over U.S. Patent No. 5,401,629, directed to a cell-based screening method useful for the identification of compounds that exhibit agonist and antagonist activity with respect to particular cell surface proteins.

Cadus was assessed $18 million in damages—a judgment reversed by the U.S. Court of Appeals for the Federal Circuit in 2000, after Cadus sold its drug discovery assets to OSI Pharmaceuticals and ceased internal drug discovery operations and research efforts. OSI was acquired in 2010 by Astellas Pharma.

Levin has served as Ovid’s chairman since April 2014, and as CEO since March 2015. Ovid’s pipeline includes OV935/TAK-935, being developed in collaboration with Takeda Pharmaceutical for the treatment of rare developmental and epileptic encephalopathies (DEE).

Ovid’s lead candidate is OV101, a treatment for Angelman syndrome and Fragile X syndrome. Ovid is set to dose its first patient in the Phase III NEPTUNE trial for OV101 in Angelman syndrome in the second half of this year, which is also when the Phase II ROCKET trial in Fragile X is expected to show results.

“We face the common challenge of having to educate the analyst and the investor community in a disease that they’ve never heard of, in an endpoint that they’ve never heard of,” Levin said of Angelman syndrome. “This is a very hard thing to do, but it’s a challenge that’s absolutely worthwhile doing because we are right on track to start Phase III. And if we are successful, in a very short period of time, we’ll have the first-ever therapy in an area that nobody had even heard of largely four or five years ago.”

Read more here.

06/07/2019

High School Student from Pennsylvania Receives Top Honor at International BioGENEius Challenge: Students from California and Georgia named runners-up

Tue, 02 Jul 2019 14:58:05 GMT

June 4, 2019 – Philadelphia, Pennsylvania – Neil Deshmukh (11^thGrade, Monrovian Academy, Bethlehem, PA) was named the grand prize winner of the International BioGENEius Challenge, the premier competition for high school students that recognizes outstanding research and innovation in biotechnology. Judged by industry and academic experts, Neil’s research on a low cost, scalable device and associated algorithms with diagnostic potential for multiple states stood out among the impressive research from his 15 fellow finalists. Along with the top honor, Neil will return home with a cash prize of $7,500.

"Every year, we are incredibly impressed with all of the talented young people who compete in the BioGENEius Challenge. This year's winner, Neil Deshmukh, especially wowed us with his innovative thinking and spirit of tenacity, curiosity, and passion for humanity that leads to major breakthroughs in human health," said Seema Kumar, Vice President, Innovation, Global Public Health and Science Policy Communication, Johnson & Johnson. "We are pleased to provide support to the Biotechnology Institute and the BioGENEius Challenge, and we hope to fuel young scientists like Neil and all of the BioGENEius participants by expanding our commitment to champion science through the Dr. Paul Janssen Project."

Ananya, Ganesh (11^thGrade, Westminster Schools, Atlanta, GA) and Melanie Quan (10^thGrade, Los Lomas HS, Walnut Creek, CA) were awarded highest honors for their research on the novel assessment of pulmonary function in early onset scoliosis and utilizing algal-based biofuel byproducts to create novel bioplastics respectively.

The winner and runners-up were named during the keynote at the 2019 BIO International Convention, which featured Siddhartha Mukherjee, author of The Emperor of All Maladies: A Biography of Cancer and winner of the 2011 Pulitzer Prize in general nonfiction. The International BioGENEius Challenge allows students the unique opportunity of attending the BIO International Convention, a leading biotechnology industry conference, which helps them gain valuable insights from leading biotech companies, scientists, leaders and innovators.

“We could not be more inspired by this year’s International BioGENEius Challenge winner and those receiving highest honors. They represent the next generation of innovative scientists working today on solving some of the most pressing global health, sustainability and environmental crises in the years to come,” said Dr. Lawrence Mahan, President of the Biotechnology Institute. “We are especially proud that young women of broad cultural and ethnic diversity represent more than 50% of our finalists historically – significant to our effort to advance women in STEM.”

Students were assessed on the quality of their research, presentation skills and the ability to handle challenging questions regarding their research, scientific knowledge and on the potential commercial and practical applications of their project.

The BioGENEius Challenge is organized by the Biotechnology Institute, a U.S. based organization dedicated to biotechnology education. Generous support of the Institute and its programs come from Johnson & Johnson Innovation and the Biotechnology Innovation Organization.

# # #

About the Biotechnology Institute

The Biotechnology Institute is an independent, national nonprofit organization dedicated to education about the present and future impact of biotechnology. Its mission is to engage, excite and educate the public, particularly students and teachers, about biotechnology and its immense potential for solving human health, food and environmental problems. For more information, visit www.biotechinstitute.org.

06/04/2019

UGA startup gateway generates $531M in economic value

Tue, 02 Jul 2019 14:59:21 GMT

The University of Georgia’s startup program generates economic value of more than half a billion dollars annually, according to a new analysis. Startup companies created through Innovation Gateway, the university’s arm for research commercialization, have an economic impact of $531 million across the United States, including $322 million in the state of Georgia.

“We’re thrilled to be able to attach an economic impact number to the university’s work in startups,” said Derek Eberhart, associate vice president for research and executive director of Innovation Gateway. “We know there’s a lot of value created by startup companies emerging from UGA research, and we now have data that quantify that impact.”

The study, conducted by UGA economist Jeffrey Dorfman, is the most comprehensive survey to date on the impact of UGA-assisted startups. Dorfman used data from Innovation Gateway’s 2018 survey of startup companies—including jobs created, payroll and operating expenses—to calculate an estimate of overall economic impact.

Despite the impressive results, Dorfman’s study probably isn’t capturing all the relevant impact data, according to Eberhart.

“This is just the tip of the iceberg,” he said. “The startup survey is voluntary, and not all of the more than 175 companies based on UGA research provide a response. In addition, this study only captures a portion of the overall economic impact of UGA’s commercialization program, which includes a robust licensing program in addition to supporting startups.”

Such data demonstrates why UGA is known nationally for its strong innovation ecosystem, which has seen a 40 percent increase in new discoveries by university researchers over the past three years. UGA is among the best in the nation at licensing these new discoveries to industry partners for product development, ranking among the top 10 universities for deal flow for 11 consecutive years.

This licensing activity leads to new products that benefit the citizens of Georgia and beyond. In 2017, the university ranked No. 1 in the country for the number of new products brought to market. Such products include things like poultry vaccines—for which College of Veterinary Medicine professor Holly Sellers was recently honored as UGA Inventor of the Year—as well as an eco-friendly charcoal lighter; soil remediation products; research and educational tools; and new peanut, pecan, soybean, wheat, citrus and ornamental plant varieties.

Sales of these products generate licensing revenues for UGA. Since 2015, there has been a 60 percent increase in licensing revenue to more than $10 million in 2018, placing UGA in the top 15 among public universities.

Growth in Innovation Gateway’s startup pipeline, from 42 projects to more than 100, was facilitated by a $500,000 Innovation Corps (I-Corps) grant from the National Science Foundation and a $500,000 i6 Challenge award from the Department of Commerce. The I-Corps grant enhances UGA’s ability to provide early evaluation of projects through a customer discovery process. The i6 Challenge award created a New Materials Innovation Center, a large-scale testing facility for new materials being developed by entrepreneurs, startups and researchers.

Innovation Gateway represents just one option available to UGA entrepreneurs, who can also receive assistance through the Small Business Development Center or the student-focused Entrepreneurship Program. UGA’s innovation ecosystem is poised to accelerate through development of a new Innovation District, a hub designed to encourage innovation, entrepreneurship, creativity and industry collaboration. Plans include an interconnected set of facilities offering a broad range of spaces and amenities that will foster collaboration, nurture a culture of entrepreneurship and help develop the pathways necessary to accelerate commercialization of discoveries and ideas generated at the university.

Read more here.

05/30/2019

Celgene's Revlimid combo OK'd for certain lymphomas

Tue, 02 Jul 2019 15:01:03 GMT

Officials with the FDA today approved lenalidomide (Revlimid, Celgene) in combination with a rituximab product (R²) for the treatment of adult patients with previously-treated follicular lymphoma (FL) or marginal zone lymphoma (MZL), according to a press release.

R² previously received Priority Review designation from the FDA. With this approval, this is the first combination regimen for patients with these indolent forms of non-Hodgkin lymphoma (NHL) that does not include chemotherapy. Indolent lymphomas, which account for approximately 40% of all NHL cases, are slow-growing forms of the disease, which can often be asymptomatic or have fewer symptoms upon diagnosis. Most patients with indolent forms of NHL will relapse or become refractory to their current treatment, according to Celgene.

“Nearly 15 years following the initial FDA approval, Revlimid continues to demonstrate benefits for new patient populations,” Jay Backstrom, MD, MPH, chief medical officer for Celgene, said in a statement. “Revlimid in combination with rituximab (R²) leads to immune-mediated treatment effects and represents a chemotherapy-free treatment option that can help patients with previously-treated follicular lymphoma and marginal zone lymphoma delay disease progression.”

The approval of R² is based on data from the phase 3 AUGMENT study evaluating the safety and efficacy of the combination regimen compared with rituximab plus placebo in patients with previously-treated FL and MZL. The study included 358 patients who have received at least 1 prior chemotherapy, immunotherapy, or chemoimmunotherapy regimen. Participants could not be rituximab refractory.

According to the study, patients treated with R² showed statistically significant improvement in the primary endpoint of progression-free survival (PFS), as evaluated by an independent review committee, compared with rituximab plus placebo. Patients were randomized to rituximab at 375 mg/m² on days 1, 8, 15, and 22 of cycle 1, and day 1 of cycles 2 through 5, plus either 20 mg of lenalidomide daily on days 1 through 21 every 28 days for up to 12 cycles or placebo.

The data showed that the median PFS was 39.4 months for patients treated with R² versus 14.1 months for those treated with rituximab plus placebo (HR: 0.46; 95% CI, 0.34-0.62; P<0.0001). In the intent-to-treat population, median follow-up time was 28.3 months. The study also demonstrated a numeric trend for improvement in overall survival with R² versus rituximab plus placebo at early analysis.

Overall, treatment with R²showed superior efficacy over rituximab monotherapy as measured by PFS, as well as secondary endpoints of overall response rate, complete response, duration of response, and time-to-next antilymphoma treatment.

“Despite additional hematological toxicity, greater efficacy of the R² regimen (and fewer early progressions) allowed more patients to complete the planned therapy and delayed the need for subsequent treatment,” the study authors concluded.

The most common adverse effects associated with R² were neutropenia, diarrhea, constipation, cough, fatigue, rash, pyrexia, leukopenia, pruritus, upper respiratory tract infections, abdominal pain, anemia, headache, and thrombocytopenia.

Lenalidomide is also approved for indications in multiple myeloma, mantle cell lymphoma, myelodysplastic syndromes, and autologous hematopoietic stem cell transplantation. It is only available through a restricted distribution program called Revlimid REMS program.

Read more here.

05/28/2019

ArunA Bio to Provide Corporate Update and Participate on a Panel at the 2019 BIO International Convention

Tue, 02 Jul 2019 15:02:36 GMT

-- Panel Discussion Will Highlight Impact of Exosomes as Therapeutics and Drug Delivery Vehicles --

Athens, GA—May 22, 2019—ArunA Bio, Inc., a leader in the development of neural exosomes for the treatment of neurodegenerative diseases, today announced that Dr. Mark A. Sirgo, Chief Executive Officer, will lead a corporate presentation at the 2019 BIO International Convention occurring June 3-6, 2019 in Philadelphia, PA. Dr. Sirgo will provide an update on the company’s emerging pipeline and proprietary neural exosome drug delivery capabilities.

In addition, Dr. Steven Stice, Co-Founder and Chief Scientific Officer, will participate on a panel entitled “Harnessing the Potential of Exosomes”. The panel will explore the full potential of exosomes, and Dr. Stice will discuss the use of exosomes as both a therapeutic and a drug delivery vehicle.

Details of the Corporate Presentation:
Date: Tuesday, June 4, 2019
Time: 11:15-11:30 am ET
Location: Company Presentation Theater 2, Level 200, Philadelphia Convention Center

Details of the Panel:
Title: Harnessing the Potential of Exosomes
Date: Tuesday, June 4, 2019
Time: 3:15-4:15 pm ET
Location: 105AB, Level 100, Philadelphia Convention Center

About ArunA Bio

Contact

Lauren Arnold, 781-235-3060 larnold@macbiocom.com

05/22/2019

FDA OKs extended use of Takeda's Gattex

Tue, 02 Jul 2019 15:03:37 GMT

Officials with the FDA have approved extending the indication of Takeda Pharmaceuticals’ teduglutide (Gattex) for injection to pediatric patients age 1 year and older with Short Bowel Syndrome (SBS) who need additional nutrition or fluids from intravenous (IV) feeding, according to the drug manufacturer.

Children with SBS are unable to absorb enough nutrients and fluids from what they eat and drink alone. A goal of SBS treatment is to restore the patient’s ability to absorb nutrients and reduce long-term dependence on parenteral support (PS).

“As a pediatric gastroenterologist, one of my main treatment goals for children with SBS is to reduce their dependency on parenteral support,” said Beth Carter, MD, Medical Director of Intestinal Rehabilitation and Nutrition Support, Children’s Hospital Los Angeles, in a prepared statement. “I’m pleased that patients have access to a medication that may help them reach that goal.”

According to Takeda, teduglutide is the first and only medicine that mimics naturally occurring glucagon-like peptide-2 (GLP-2). The recommended dosage of GATTEX for both adults and pediatric patients is 0.05 mg/kg once daily by subcutaneous injection. Use of the GATTEX 5 mg kit is not recommended in pediatric patients weighing less than 10 kg.

In a pharmacodynamic study in adults, teduglutide was shown to improve the amount of fluids absorbed by the intestines.

In a 24-week pediatric study, teduglutide helped reduce the volume of daily PS required and time spent administering PS. Some children achieved complete freedom from PS. Fifty- nine pediatric patients ages 1-17 years with SBS chose whether to receive teduglutide or standard of care (SOC). Patients who chose to receive teduglutide treatment were subsequently randomized in a double-blind manner to 0.025 mg/kg/day (n=24) or 0.05 mg/kg/day (n=26), while 9 patients enrolled in the SOC arm.

At the end of the 24-week study, 69% of patients who took teduglutide 0.05 mg/kg each day reduced PS volume by 20% or more. Based on patient-diary data, patients who received teduglutide 0.05 mg/kg/day experienced a 42% mean reduction in PS volume (mL/kg/day) from baseline (-23 mL/kg/day from baseline).

At week 24, 38% of patients (10/26) were able to reduce PS infusion by at least 1 day per week. Patients reduced their PS infusion time by 3 hours per day on average compared to baseline. In addition, during this study 12% children who received teduglutide 0.05 mg/kg/day completely weaned off PS.

Teduglutide has a demonstrated safety profile that is similar overall in pediatric and adult patients. The most common adverse reactions (≥10%) seen in adult patients treated with teduglutide in clinical trials were abdominal pain, nausea, upper respiratory tract infection, abdominal distension, injection site reaction, vomiting, fluid overload, and hypersensitivity.

Malabsorption of fluids and nutrients can place children with SBS at risk for diarrhea, dehydration, electrolyte disturbances, and malnutrition. Parents and caregivers of children with SBS who are dependent on PS have reported in studies that they experience deterioration in overall quality of life. PS reductions may benefit children with SBS, and potentially give them more freedom for daily-life activities.

“Addressing high unmet needs of patients with complex and debilitating gastrointestinal (GI) conditions is a focus of Takeda’s work,” said Andrew Grimm, Global Clinical Development Lead, Takeda, in a prepared statement. “As the first US-approved therapy in pediatric SBS patients dependent on PS that improves absorption, Gattex offers these patients new hope to reduce PS requirements and the potential for PS independence.”

Reference

U.S. FDA Approves GATTEX® (teduglutide) for Children 1 Year of Age and Older With Short Bowel Syndrome (SBS) [news release]. Lexington, MA; May 17, 2019: Takeda Pharmaceuticals. https://www.prnewswire.com/news-releases/us-fda-approves-gattex-teduglutide-for-children-1-year-of-age-and-older-with-short-bowel-syndrome-sbs-300852294.html?tc=eml_cleartime. Accessed May 17, 2019.

Read more here.

05/17/2019

Celgene's lenalidomide recommended by NICE for multiple myeloma

Tue, 02 Jul 2019 15:05:07 GMT

An immunomodulator drug to fight multiple myeloma should be available for more patients on the NHS in England and Wales, the National Institute for Health and Care Excellence (NICE) announced today.

Lenalidomide (Revlimid, Celgene) could soon be offered to patients with this form of plasma cell cancer as a first- and second-line drug, it said.

Multiple Myeloma

In final draft guidance, NICE recommended lenalidomide in combination with dexamethasone as an option for previously untreated multiple myeloma in adults who are not eligible for a stem cell transplant and cannot take thalidomide.

The committee explained that people with multiple myeloma are first treated with thalidomide-based therapy but, if a patient cannot have thalidomide, bortezomib-based therapy is an option.

For people who have had bortezomib (Velcade, Janssen-Cilag) as a first treatment, the second treatment would be with cytotoxic chemotherapy. However, clinical evidence shows that lenalidomide plus dexamethasone is more effective than cytotoxic chemotherapy.

NICE decided that as it already recommended lenalidomide as both a first and third treatment for multiple myeloma, it was appropriate to recommend lenalidomide for this small patient group as a second treatment.

In further final draft guidance, NICE also recommended lenalidomide as an option for treating multiple myeloma in adults if they have had only one previous therapy, which included bortezomib.

It said patients were currently offered chemotherapy as a second treatment after bortezomib. However, clinical evidence showed that lenalidomide with dexamethasone substantially improved the length of time people lived compared to bortezomib-based therapy. In one clinical study, patients taking lenalidomide lived on average seven months longer, it said.

Since NICE already recommended lenalidomide as a third-line treatment, it considered it appropriate to also recommend it as second-line option.

NICE estimated that the changes would benefit an estimated 320 people.

Meindert Boysen, director of the Centre for Health Technology Evaluation at NICE, said: "We are pleased to recommend lenalidomide for these patients.

"Not only will this drug improve the length of time people live, but it will also have fewer side effects compared with current treatments.

"Multiple myeloma is normally treated with a thalidomide-based therapy at first line; however, there is considerable need for new therapies for those who cannot take thalidomide. The new decision by NICE now means that those patients have an effective alternative."

The manufacturer has agreed to provide lenalidomide at a commercially confidential discount.

Shelagh McKinlay, head of patient advocacy at the charity Myeloma UK, commented: "This double approval from NICE is a significant step forward in building the best possible treatment pathway for patients in England and Wales.

Read more here.

05/17/2019

New Georgia Research Alliance report shows $6B economic impact

Tue, 02 Jul 2019 15:06:12 GMT

The Georgia Research Alliance (GRA) has used $649 million in state tax dollars to generate $6 billion in federal money and private investment, the Atlanta-based nonprofit reported Thursday.

The numbers come from an 11-page report put together after freshman Gov. Brian Kemp asked GRA officials to document its impact on the state economy.

Launched in 1990 during the administration of the late Gov. Zell Miller to grow Georgia's technology industry, the GRA budget has shrunk under recent governors. However, the fiscal 2020 spending plan the General Assembly adopted this year holds its funding steady at about $5.1 million.

The GRA's strong suit has never been publicizing its mission to state decision-makers, GRA board Chairman David Ratcliffe told his board colleagues Thursday. But the alliance is working on a new strategic plan the board hopes to adopt at its next meeting in September.

"One of our strategies is to communicate what GRA is and how it operates," Ratcliffe said. "This is an effort to do that."

The report also outlines Georgia's enhanced standing in research and development funding since the GRA was formed. The Peach State is now up to No. 1 in the nation in the growth rate of university research funding and ranks 11th for total university R&D funding.

The GRA Venture Fund, established in 2009 to invest in the most promising start-up companies and seeded with $7.5 million in state funds, has generated $38 million in private investment and 920 jobs, according to the report.

Mark Sanders, a lobbyist who represents the GRA at the state Capitol, said the future for the alliance looks promising under Kemp.

Sanders noted that Kemp chaired the Georgia Senate Appropriations Committee's subcommittee on higher education while he was in the General Assembly. As a state senator whose district included The University of Georgia, Kemp also helped the GRA recruit an eminent scholar to UGA, Sanders said.

"Governor Kemp's the first person to show up in our office who really gets it," Sanders said. "We're in a better place."

Read more here.

05/16/2019

GeoVax Reports 2019 First Quarter Financial Results and Highlights Corporate Development Progress

Tue, 02 Jul 2019 15:07:54 GMT

GeoVax Labs, Inc. (OTCQB: GOVXD), a biotechnology company developing human vaccines, today announced its financial results for the three months ended March 31, 2019 and provided an update on its corporate development progress.

David A. Dodd, GeoVax’s President and CEO, commented, “To date during 2019, we continue to make progress in several of our key focus areas despite the limited capital resources which have constrained our activities. Nonetheless, through the efforts of our dedicated staff here are a few recent examples of our collaboration and funding achievements:

- Cancer Immunotherapy – We continued our work with Leidos, Inc. under our collaboration to evaluate delivery of Leidos’ novel PD-1 checkpoint inhibitors with our MVA-VLP platform for multiple immunotherapeutic vaccine candidates;

- Malaria Vaccine – We expanded our relationship with Leidos to include development of malaria vaccine candidates supported under a contract to Leidos from the United States Agency for International Development (USAID) Malaria Vaccine Development Program (MVDP);

- Lassa Fever Vaccine – We continued our progress in this program with support from a U.S. Department of Defense grant to advance the vaccine through nonhuman primate testing and manufacturing process development in preparation for human clinical trials;

- Zika, Lassa, Ebola and Marburg Vaccines, Unique Delivery – We began a collaboration with Enesi Pharma related to their novel, needle-free ImplaVax® device. We expect this program to result in development of thermostable solid-dose needle-free vaccines for a variety of infectious diseases;

- HIV Preventive Vaccine – We are progressing to the next stage of human clinical testing with support from the HIV Vaccine Trials Network (HVTN) and funding from the National Institute of Allergy and Infectious Diseases (NIAID). We expect HVTN to begin the next study (HVTN 132) within the next several months;

- HIV “Cure” Program - Our collaboration with American Gene Technologies International, Inc. (AGT), for use of our vaccine in combination with AGT’s gene therapy for development of a functional cure for HIV, is on track to enter human clinical trials sponsored by AGT during the second half of 2019. We also are continuing discussions with other consortiums for the use of our vaccine in similar efforts toward developing a cure for HIV infection;

- Joint Development Collaborations – We continue to engage in promising discussions related to various joint development collaborations that may result in full product development agreements, as well as strategic investments by potential partners.

Mr. Dodd continued, “We are intent upon entering clinical development status for one or more of our development programs within the next 12-18 months, expanding beyond and building upon, our HIV clinical trials. To that end, our goals include restructuring our equity capital, including new capital investment, with our shares trading on a more acceptable stock exchange (e.g. Nasdaq) that will support and sustain the level of operational investment necessary to proceed into human clinical trials. On May 2, 2019, we took one step toward realizing this goal by effecting a one-for-five hundred (1:500) reverse split of our common stock, following shareholder approval of the reverse split on April 15. While this may be an unpopular action among some of our shareholders, it is necessary to ensure our access to the capital critical to continue with and, more importantly, to accelerate our promising product development. There is still additional work needed to be done before we can realistically achieve a Nasdaq listing and a larger capital raise, but that remains our goal and we are confident we will be successful – the promise of our science is too good for us to fail.”

Financial Review

GeoVax reported a net loss for the three months ended March 31, 2019 of $701,454, or $1.43 per share, based on 491,707 weighted-average shares outstanding. For the three months ended March 31, 2018, the Company reported a loss of $621,813, or $2.50 per share, based on 248,340 weighted-average shares outstanding. The Company reported revenues of $364,232 for the three months ended March 31, 2019, primarily related to grants from the NIH. This compares to $221,299 of grant revenues reported for the same period in 2018. Research and development (R&D) expenses were $555,718 for the three months ended March 31, 2019, compared with $486,994 for the comparable period in 2018. General and administrative (G&A) expenses were $510,064 and $357,228 for the three months ended March 31, 2019 and 2018, respectively. Cash balances were $175,985 at March 31, 2019, as compared to $259,701 at December 31, 2018.

Summarized financial information is attached. Further information concerning the Company’s financial position and results of operations are included in its Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing human vaccines against infectious diseases and cancer using a novel patented Modified Vaccinia Ankara-Virus Like Particle (MVA-VLP) based vaccine platform. On this platform, MVA, a large virus capable of carrying several vaccine antigens, expresses proteins that assemble into VLP immunogens within (in vivo) the person receiving the vaccine. The production of VLPs in the person being vaccinated mimics virus production in a natural infection, stimulating both the humoral and cellular arms of the immune system to recognize, prevent, and control the target infection. The MVA-VLP derived vaccines elicit durable immune responses in the host similar to a live-attenuated virus, while providing the safety characteristics of a replication-defective vector.

GeoVax’s current development programs are focused on preventive vaccines against HIV, Zika Virus, hemorrhagic fever viruses (Ebola, Sudan, Marburg, and Lassa), and malaria, as well as therapeutic vaccines against chronic Hepatitis B infections and cancers. The Company has designed the leading preventative HIV vaccine candidate to fight against the subtype of HIV prevalent in the larger commercial markets of the Americas, Western Europe, Japan, and Australia; this program is currently undergoing human clinical trials managed by the HIV Vaccine Trials Network (HVTN) with the support of the National Institutes of Health (NIH). GeoVax’s HIV vaccine is also part of collaborative efforts to develop an immunotherapy as a functional cure for HIV. For more information, visit www.geovax.com.

Forward-Looking Statements

Certain statements in this document are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act. These statements are based on management's current expectations and are subject to uncertainty and changes in circumstances. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax can develop and manufacture its vaccines with the desired characteristics in a timely manner, GeoVax's vaccines will be safe for human use, GeoVax's vaccines will effectively prevent targeted infections in humans, GeoVax’s vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete vaccine development, there is development of competitive products that may be more effective or easier to use than GeoVax's products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements and does not intend to do so. More information about these factors is contained in GeoVax's filings with the SEC including those set forth at "Risk Factors" in GeoVax's Form 10-K.

Contact:

GeoVax Labs, Inc.

investor@geovax.com

678-384-7220

FINANCIAL TABLES

Read more here.

05/14/2019

Takeda promises more cost savings from Shire acquisition

Tue, 02 Jul 2019 15:09:24 GMT

Takeda Pharmaceutical CEO Christophe Weber promised greater cost savings from the company's purchase of Irish drugmaker Shire, lifting the savings target by 43% versus its earlier forecast.

"It will be a critical year for Takeda, in which our integration with Shire will begin," Weber said in an earnings briefing on Tuesday in Tokyo.

Takeda raised the cost-savings target for its combination with Shire, stating that by the end of 2021 the annual pretax target will be as high as $2 billion. Previously, the Japanese drugmaker had predicted savings of about $1.4 billion. Optimizing its supply chain, enhancing sales and marketing efficiency and eliminating administrative overlap will bring about the greater savings, Takeda said.

"The integration of the two companies is happening at a fast pace, and we predict more cost synergy in the future," Weber said. "It will also contribute to our underlying core earnings margin hopes as well. We aim to reach the mid 20 [percent range] this year, and our long-term goal is to reach the mid 30s," he added. In 2018, Takeda had a margin of around 22%.

The comments come amid lingering concerns over the company's debt load. In January, Takeda bought Shire for nearly $60 billion in the largest-ever foreign acquisition by a Japanese company.

The purchase vaulted Takeda into the world's top 10 drugmakers, giving it total annual sales of more than 3 trillion yen ($27 billion). But the move has also strained its finances. The company's interest-bearing debt reached about 5.4 trillion yen following the acquisition.

In December, Weber said he aimed to stabilize the company's balance sheet within five years. Since then, Takeda has slowly sold off assets. Last week it announced it will sell its dry-eye drug business to Swiss rival Novartis, with the proceeds going to pay down debt. Takeda has previously said that it plans to sell as much as $10 billion in assets.

Along with the divestments, the company hopes to expand five key businesses in the future, including development of treatments for cancer, in neuroscience and for rare diseases.

Weber pointed to the difficult market environment for the pharmaceutical industry, saying headwinds such as price pressures were becoming stronger. But he added: "We have 14 global brands, which makes our business portfolio unique. We will leverage this uniqueness, and I am confident it will allow us to grow in the future."

On Tuesday, Takeda gave its first annual earnings forecast since the takeover of Shire. For the year ending March 2020, the company expects sales to rise 57% on the year to 3.3 trillion yen.

Although the company predicts a big increase in sales, its profit is forecast to fall as a result of costs associated with the purchase of Shire.

Takeda forecasts a pretax loss of 369 billion yen for this fiscal year, while it expects its net income to log a record loss of 383 billion yen. Core earnings, which Takeda defines as profit excluding the effect of exchange rate fluctuations and divestments, is expected to jump 92% on the year to 883 billion yen. Excluding the effects of the Shire acquisition, its net income is forecast to rise 18%.

Read more here.

05/14/2019

New BIO Report: More Progress Needed in Innovation of Alzheimer’s Disease Therapeutics

Tue, 02 Jul 2019 15:10:46 GMT

Washington, DC (May 14, 2019) – Today, the Biotechnology Innovation Organization (BIO) released a new report, The State of Innovation in Highly Prevalent Chronic Diseases Volume IV: Alzheimer’s Disease Therapeutics, the fourth in a series on the innovation landscape of highly prevalent, chronic diseases. This volume takes an in-depth look at the state of innovation for therapeutics in Alzheimer’s disease, which is expected to affect more than 13.8 million people in the United States by 2050 and cost well over $1 trillion annually.

”The growing health and financial impact of Alzheimer’s disease on American patients, caregivers, and our healthcare system makes the need for new treatments more pressing each day,” said BIO President and CEO Jim Greenwood. “The good news is that America’s biopharmaceutical companies currently are conducting 74 clinical-stage programs intended to stop, prevent, or slow the progression of this looming crisis. The bad news is that, while these programs hold real promise, the R&D challenges with this disease are enormous and the level of investment and innovation is not where our nation needs it to be to address this exploding public health crisis. To win this fight, it is essential that our public policies stimulate more investment in research and innovation.”

The analysis, which aims to assess the depth and breadth of innovation to meet the needs of patients suffering from Alzheimer’s disease, also features historical clinical success rates, failed mechanistic strategies, as well as trends in venture financing and investment into new clinical trials.

Key Takeaways

Lack of Approved Drugs: There are currently no FDA-approved disease-modifying drugs for Alzheimer’s disease.
Insufficient Venture Investment: Venture capital funding of U.S. companies with lead programs in Alzheimer’s disease is 16 times below oncology funding ($1.0 billion vs. $16.5 billion over the last decade).
Poor R&D Success Rates: Clinical development success for disease-modifying drug programs for Alzheimer’s has been difficult in late-stage trials, with no disease-modifying drugs moving beyond Phase III to FDA filing. Since 2008, a total of 87 clinical-stage disease-modifying programs have been suspended.
Inconsistent Clinical Trial Initiations: Clinical trial starts for disease-modifying Alzheimer’s drugs have ranged from 11-21 trial starts per year since 2008, with no detectable trend. Phase III trial starts have been the least consistent, ranging from 0-5 per year.
Growing & Diverse R&D Pipeline: There are 74 clinical-stage programs with disease-modifying potential in Alzheimer’s disease. The drug candidates in these programs are attempting to stop, prevent, or slow the progression of Alzheimer’s disease using 10 different strategies involving 30 distinct molecular targets. Small biotech companies account for more than three-fourths of these clinical programs.

“With a 100% failure rate for disease-modifying Alzheimer’s Phase III studies, this has been the most challenging R&D hurdle in our industry. The combination of a looming crisis in Alzheimer’s-associated healthcare costs and no disease-modifying drug on the market indicates a desperate need for higher levels of investment and innovative approaches,” said report author David Thomas, Vice President, Industry Research for BIO. “This report shows the venture investment trend is positive, but still significantly lower than other therapeutic areas such as cancer. The biopharmaceutical industry is working hard to make progress, with the majority of targeted therapeutics entering the clinic being conducted by small companies. A more supportive policy environment will be critical to developing new treatments that could improve the lives of the millions of patients and families suffering from this disease.”

The report and other BIO Industry Analysis reports are available for download here:www.bio.org/iareports.

05/14/2019

J&J’s Ethicon to acquire Takeda’s TachoSil surgical patch for $400m

Tue, 02 Jul 2019 15:12:25 GMT

Ethicon, a subsidiary of Johnson & Johnson (J&J), has agreed to acquire TachoSil Fibrin Sealant Patch from Takeda for $400m upfront in cash.

Novartis has also agreed to acquire dry eye drug Xiidra from Takeda for $3.4bn upfront in cash. Takeda plans to use the proceeds from these divestitures to decrease its debt and enhance deleveraging toward its target of 2.0x net debt/adjusted EBITDA in the medium term.

TachoSil is a ready-to-use surgical patch developed to help surgeons to achieve fast and reliable bleeding control and tissue sealing.

The product can be used as a supportive treatment in surgery to improve hemostasis and tissue sealing where standard techniques are insufficient. TachoSil is marketed in over 50 countries across the globe.

Around 80 employees associated with TachoSil surgical patch unit will join Ethicon, upon completion of the deal.

Takeda said it recorded full year adjusted net sales of around $155m in the 2018 fiscal year for TachoSil.

As per terms of the deal, Ethicon will purchase the assets and licenses, which facilitate the manufacturing, licensing and commercialization of TachoSil. Takeda will continue to manage its ownership of manufacturing facility in Linz, Austria.

Takeda has signed a long-term manufacturing services agreement to continue the production of TachoSil products and supply them to Ethicon.

Subject to the satisfaction of customary closing conditions, the deal is expected to be completed in the second half of this year.

Takeda president and CEO Christophe Weber said: “These initial divestitures represent important steps in advancing the growth strategy Takeda outlined following our transformational acquisition of Shire earlier this year.

“We are working to strategically simplify and optimize our portfolio, while also rapidly deleveraging and continuing to invest in our growth drivers as a global, values-based, R&D-driven biopharmaceutical leader.”

In 2017, Ethicon acquired medical devices maker Torax Medical, which manufactures and markets Linx reflux management system and Fenix continence restoration system.

Linx system is a minimally invasive device designed for use in the surgical treatment of gastroesophageal reflux disease (GERD).

Read more here.

05/09/2019

Novartis buys dry eye drug from Takeda for up to $5.3 billion

Tue, 02 Jul 2019 15:13:38 GMT

TOKYO/ZURICH (Reuters) - Novartis is buying dry-eye drug Xiidra from Takeda Pharmaceutical Co for up to $5.3 billion as the Swiss drugmaker refreshes its ophthalmic medicines portfolio with a potential blockbuster.

The deal, announced early on Thursday, calls for $3.4 billion up front and milestone payments up to $1.9 billion, Novartis said.

The acquisition from Takeda, which is jettisoning the medicine to reduce debt, adds to several big Novartis transactions over the last year as the Basel-based company both beefs up its portfolio and sheds non-core assets to focus on prescription drugs.

It is also the latest Japanese-European deal in the pharmaceutical sector following British drugmaker Astrazeneca’s $6.9 billion agreement in January to work with Daiichi Sankyo on an experimental breast cancer drug.

Expected to close after July, the transaction includes 400 Takeda employees, which analysts from Bank Vontobel in Zurich said gives Novartis a marketing team to sell not only Xiidra but another prospective eye drug entrant, RTH258 for macular degeneration, now awaiting regulatory approval.

“Despite generic competition...we think that Xiidra is sufficiently differentiated,” Vontobel analyst Stefan Schneider said. “The market (is) big enough for it to reach blockbuster status, justifying the price.”

Xiidra, with $400 million in 2018 sales and approval in markets including the United States, Canada and Australia, competes with Allergan’s older Restasis.

Generics maker Teva has a generic version of Restasis in Canada and is planning a launch in the United States, as is Mylan, pending resolution of legal disputes.

Xiidra has yet to get European regulatory approval.

“Following closing, we will explore the opportunity for the other territories acquired,” a Novartis spokesman told Reuters.

BLOCKBUSTER BOUND?

For Takeda, this is its first divestment since its leveraged takeover of Shire in January, part of a flurry of multibillion-dollar pharmaceutical deals as drugmakers seek to buy other companies to combat expiring patents on their blockbuster medicines and renew their drug pipelines.

Japan’s biggest drugmaker aims to dispose of $10 billion worth of assets to cut debt, and also said it is selling TachoSil, a surgical patch for bleeding control, to Johnson & Johnson’s Ethicon for $400 million.

“We are working to strategically simplify and optimize our portfolio, while also rapidly deleveraging,” Takeda CEO Christophe Weber said in a statement.

For roughly 34 million U.S. dry eye sufferers, tears fail to adequately lubricate their eyes, and the condition can become painful, potentially leading to eye damage, Novartis said.

Xiidra, which treats signs and symptoms of dry eye by controlling inflammation, won U.S. regulatory approval in 2016 under Shire’s watch and was considered then its most important new medicine.

“We look forward to leveraging our well-established commercial infrastructure to bring this medicine to more patients,” said Paul Hudson, who heads Novartis’s drugs business, adding the company sees Xiidra “well positioned for blockbuster potential” topping $1 billion annual sales.

Novartis just shed its eyecare division Alcon into a separate publicly listed company in a $30 billion shareholder spin-off, but only after moving Alcon’s prescription eye drugs into Novartis’s main pharmaceuticals business.

Novartis shares were down 0.7 percent at 0812 GMT. Takeda shares closed up 0.2 percent in Tokyo.

Read more here.

05/08/2019

National Institutes of Health Awards Moonlight Therapeutics with a $2.5 Million Grant to Advance Development of Peanut Allergy Treatment

Tue, 02 Jul 2019 15:14:35 GMT

Funding to support company’s preclinical development of a breakthrough allergy treatment

Moonlight Therapeutics, Inc., a biotechnology company developing treatments for food allergies, announced today the receipt of $2.5 million in funding for preclinical studies and product development that will enable preparations for a clinical trial for its lead program in peanut allergy. This funding was awarded through a highly competitive Small Business Technology Transfer (STTR) Fast Track grant from the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health (NIH).

Moonlight’s proprietary platform, TASIS — Targeted Allergen-Specific Immunotherapy within the Skin — involves the application of a small, minimally invasive dermal stamp that uses microneedles to target the delivery of allergens to the skin’s immune cells. The stamp is removed within a few minutes and the administration is complete.

“We are delighted to receive this grant from the NIAID to advance the development of our novel therapy to help the millions of people who are suffering from peanut allergies,” said Samir Patel, president and CEO of Moonlight Therapeutics. “We will be working with Harvinder Gill, inventor of this technology and the Whitacre Endowed Chair of Science and Engineering at Texas Tech University.”

Moonlight is currently focused on developing a peanut allergy treatment using TASIS, but the technology has broad capabilities that can be used to deliver a combination of allergens in a single stamp. Preclinical animal studies have demonstrated the efficacy of TASIS for peanut and other respiratory allergies.

“There is a significant need for therapies for food allergies since there are currently no Food and Drug Administration approved options for patients, said Dr. Carla Davis, director of the Texas Children's Hospital Food Allergy Program and Chief of the Section of Immunology, Allergy and Retrovirology in the Department of Pediatrics at Baylor College of Medicine.

A nationally known food allergy expert and leader in the field, Dr. Davis serves as a medical advisor to Moonlight.

“Moonlight’s approach has the potential to offer a meaningful treatment option for both children and adults,” she added.

About Moonlight Therapeutics

Moonlight Therapeutics is an early-stage biotechnology company developing targeted, allergen-specific immunotherapy treatments for food allergies. Food allergies are estimated to affect more than 30 million people in the United States. Moonlight uses its proprietary platform, TASIS, to target the delivery of allergens to immune cells in the skin. This technology was invented at Texas Tech University. TASIS can be used to deliver individual or combinations of allergens to treat multiple allergies. Founded in 2017, the company is a member of the Advanced Technology Development Center (ATDC) at the Georgia Institute of Technology, is supported by the Georgia Research Alliance, and is headquartered in Atlanta, Ga. To learn more, visit moonlighttx.com.

05/07/2019

Emory plans $475M cancer tower at Emory University Hospital Midtown

Tue, 02 Jul 2019 15:15:53 GMT

Emory University is planning a $475 million cancer tower at Emory University Hospital Midtown.

The new cancer tower at 550 Peachtree Street would be 17 stories and be located on the north side of the EUHM campus and connected to the existing hospital, according to plans filed with the Georgia Department of Community Health.

The tower will consist of approximately 455,000 square feet of new construction and will include about 64 inpatient beds and 26 observation beds. "The tower will also include research space, perioperative services, imaging services, radiation oncology, a clinical laboratory, pharmacy, infusion therapy and outpatient clinic space. In addition, an array of support services will located in the new tower," Emory says.

In a statement to Atlanta Business Chronicle, Emory said, "Emory University has submitted a Letter of Intent to the Georgia Department of Community Health for the construction of a new cancer tower on the Emory University Hospital Midtown campus. The new building would be part of Emory's Winship Cancer Institute. The proposed building would consist of 17 floors above ground and approximately 455,000 square feet of new construction, located on the north side of the Midtown campus."

News of the new cancer tower come just days after Emory filed plans for a $1 billion "health innovation district" at Executive Park on North Druid Hills road at Interstate 85.

Emory has recently expanded its real estate holdings around Emory University Hospital Midtown. In December it bought the former Peachtree Pine Homeless Shelter at 477 Peachtree Street. Atlanta Business Chronicle reported in March that Emory envisions a new cancer institute that would rise next to Bank of America Plaza.

Read more here.

05/06/2019

Skyhawk signs neuro deal with Takeda as it prepares to expand its partnered indications

Tue, 02 Jul 2019 15:16:55 GMT

Skyhawk signed its third major deal in a year, this time with Takeda. Like its first two partnerships, the focus will be in neurology, but Skyhawk is in discussions with companies that could help extend its platform to other areas.

On Tuesday, Skyhawk Therapeutics Inc. (Waltham, Mass.) granted Takeda Pharmaceutical Co. Ltd. (Tokyo:4502; NYSE:TAK) exclusive worldwide rights to therapies against multiple targets for undisclosed neurodegenerative diseases. Skyhawk will be responsible for discovery and preclinical development using its SkySTAR platform, after which Takeda will take over the programs. Financial details are undisclosed.

Skyhawk uses SkySTAR to discover and develop small molecules capable of modulating RNA splicing within the spliceosome, dictating which exons are included in the final mRNA transcript and offering drug developers a mechanism to control protein expression at the level of mRNA. The therapeutic approach can be applied broadly to indications where attempts at drugging a target at the protein level have been unsuccessful (see "Splice Time").

Skyhawk's lead program is in preclinical development for an undisclosed oncology indication, but so far it has kept its deals centered on neurology.

Since launching in January 2018, Skyhawk has entered option deals with Celgene Corp. (NASDAQ:CELG) and Biogen Inc. (NASDAQ:BIIB) covering undisclosed neurology targets. Skyhawk received $134 million up front combined from the two deals (see "Skyhawk Raises $40 Million, Partners with Celgene"; "Biogen Looks to Expand Neuro Pipeline via C4, Skyhawk Deals").

Skyhawk co-founder, Chairman and CEO William Haney told BioCentury its first deals were in neurology in part because the roots of the technology are there.

He said Skyhawk limited the scope of its partnerships following the Celgene deal, turning down companies seeking partnerships outside of neurology, so it could reach a point where it felt confident it could execute well. Getting to that point included building out its team internally and with its CRO partners and expanding its chemical libraries.

Now that its management team and platform has evolved, Haney said Skyhawk this year opened up partnering discussions in other fields. "We have term sheets in oncology, and in active discussion in immunology, autoimmune disease and infectious disease," he said, but declined to disclose the potential partners.

Read more here.

05/06/2019

Emory files plans for $1 billion Executive Park campus

Tue, 02 Jul 2019 15:18:09 GMT

Emory University plans a $1 billion, 15-year-plus development of a new "health innovation district" on North Druid Hills Road at Interstate 85.

In 2016, Emory bought about 60 acres in Executive Park, directly across North Druid Hills Road from where Children's Healthcare of Atlanta is now developing a $1.5 billion hospital campus.

On May 1, Emory filed a rezoning application with the city of Brookhaven in which it envisions a mixed-use development on the property with office, medical services, a hospital, commercial space, a hotel and multifamily. Emory says it seeks to replace the retail and office developments now on the property with a development "that builds on the successful programs in orthopedics, sports medicine, brain health, medical science education and health information technology already located on the site."

The current zoning on the site allows for 2.8 million square feet of residential, retail/commercial, office, flex office/retail, and hotel development. "The proposed rezoning accommodates a total of 3,174,260 square feet on the property owned by Emory, of which some is already existing, or under construction," the rezoning application says.

Enlarge

Site plan of Emory's planned "health innovation district" at Interstate 85 and North Druid Hills Road in Brookhaven.

The plan includes a new 140-bed, non-emergency inpatient hospital. Emory said the plans for Executive Park are still under development and specifics about a hospital have yet to be determined.

"The estimated value of the proposed plan at full build-out is up to $1 billion dollars which includes direct and indirect investments," Emory says, adding that "new business activity on the site is proposed to generate an ongoing economic impact of more than $650 million within Brookhaven each year. The plan also creates robust job growth in stable fields with good compensation and career development opportunities."

The interchange at I-85 and North Druid Hills is already often clogged with traffic, but Emory says it "will provide ways to improve traffic flow in the North Druid Hills corridor and surrounding area" and that it's coordinating with Children's Healthcare to align entrances. Emory says it's working with the Atlanta Regional Commission and Georgia Regional Transportation Authority on recommendations for road projects and traffic improvements.

Read more here.

05/03/2019

Takeda Inks Licensing Option Agreement with Gene Editing Platform Developer Emendo

Tue, 02 Jul 2019 15:20:11 GMT

Takeda Pharmaceutical has advanced further into gene editing, inking a licensing option agreement with and, through its venture capital arm, investing in Emendo Biotherapeutics, the gene editing discovery platform developer said today.

The value of the agreement and the investment were not disclosed.

Through the licensing option agreement, Emendo has granted Takeda the option to use its proprietary nuclease program OMNI to edit two genes as part of the pharma’s R&D efforts to treat unspecified genetic disorders.

Headquartered in New York City, with an R&D center in Ness-Ziona, Israel, Emendo focuses on engineering site-specific nucleases for an accurate, sequence-specific and efficient correction mechanism that is homology-directed repair (HDR) mediated, and effective in post-mitotic cells. Emendo uses proprietary protein engineering and selection platforms that are designed to generate ultra-specific and highly active CRISPR OMNI nucleases.

“We are working towards a well-established platform that will enable us to address a large pool of genetic diseases, many of which have been untreatable until now,” Emendo states on its website.

In the agreement with Takeda, Emendo agreed to apply its novel gene editing engineering platform to optimize the OMNI nuclease, with the aim of achieving the highest specificity and activity on Takeda’s chosen genes, which were not disclosed in Emendo’s announcement.

“This agreement further positions Emendo as a leading, next-generation, high-precision, gene editing company and promotes its allele-specific editing programs that can potentially cure severe genetic disorders,” Emendo CEO David Baram, PhD, said in a statement.

In addition, Takeda agreed to issue Emendo convertible notes through its venture arm Takeda Ventures, with funds from the investment intended to further advance Emendo’s novel nuclease gene editing discovery platform and proprietary product development programs.

Financing toward clinical trials

The notes will be converted to a future Series B financing round being planned by Emendo, which the company said is intended to allow it to advance its high precision gene editing biotherapies into initial clinical trials.

Emendo said it is moving several preclinical programs through optimization, in preparation for moving towards the clinic in a number of “promising” clinical indications.

The transactions expand an unspecified Takeda investment in Emendo that stretches back to the founding of Emendo in 2015, when Takeda Ventures invested in the company along with OrbiMed, a healthcare investment firm that manages approximately $14 billion across public and private company investments worldwide.

“Extending our investment in Emendo and licensing its nuclease discovery platform and gene editing technology is another example of Takeda’s commitment to investing in transformative advances in science via mutually advantageous partnerships,” stated Takeda Ventures senior partner Rob Woodman, PhD.

Takeda has disclosed its partnership with Emendo in the lists of partnerships with other companies that are included in its data supplements to the quarterly results it furnishes to investors.

Over the past year, those lists have also included two other partnerships that incorporate gene or genome editing. Takeda has teamed up with the Japan Agency for Medical Research and Development (AMED) through its Cyclic Innovation for Clinical Empowerment (CiCLE) program toward the development of a hypertrophic cardiomyopathy drug that uses induced pluripotent stem cell-derived cardiomyocytes with disease-causing mutations that were induced by gene-editing technology.

Takeda also disclosed retaining a financial interest in spinout company GenAhead Bio, a Fujisawa City, Japan, company to which Takeda provides “efficient genome editing, fee for service and/or collaboration in cell/gene therapies,” as well as nucleic acid delivery on specific cell types.

Augusta University Medical Center moving forward on $150M hospital, medical campus

Tue, 02 Jul 2019 15:21:27 GMT

Augusta University Medical Center is moving forward with plans to construct a new hospital and medical campus on Interstate 20 in Columbia County, Ga., 13 miles west of downtown Augusta.

AU Medical Center on April 19 filed plans with the state of Georgia for the project as a development of regional impact. Plans call for a medical mixed-use campus consisting of an approximately 600,000-square-foot hospital with associated uses, approximately 125,000 square feet of medical office buildings, and approximately 60,000 square feet of professional, health, and retail uses.

Earlier in April, AU Medical Center filed to rezone the 52-acre site of the proposed medical campus. Check out a site plan here. The project is being designed by Catalyst Design Group of Nashville, Tenn.

Enlarge

Site plan of Augusta University Medical Center's proposed medical campus in Columbia County, Ga.

COLUMBIA COUNTY, GEORGIA

It would be the first hospital in Columbia County, which AU Medical Center says is Georgia’s fastest-growing county without its own hospital. The surrounding area has been a center of population growth.

"The primary goal of this development is to create a diverse and integrated medical mixed-use campus with activated retail, office, hospitality, and primary medical services," Catalyst Design says in a visioning guidebook for the project. "The vision is to create a destination environment where patrons can have their medical needs addressed while concurrently enjoying a spa treatment, fitness class, specialty shopping or a bite to eat. Offering multiple services in a pedestrian friendly, neighborhood-scale development creates a welcoming destination that patrons, patients and employees enjoy spending time in."

The project has been in the works for five years. In 2014, the Georgia Department of Community Health issued AU Medical Center a Certificate of Need (CON) to build a 100-bed hospital in Columbia County. The hospital, with a Level II trauma center, would represent a $150 million investment. Plans for the two-story, 260,000-square-foot design included an 18-bed emergency department; six operating rooms, with pre- and post-anesthesia care units; and 24 dedicated intensive care and 76 medical-surgical rooms with universal beds for the bulk of the inpatient care.

AU Medical Center bought an 82-acre parcel in Columbia County for the project in 2017.

But the project has been held up by an appeal filed by Doctors Hospital of Augusta, a competing hospital owned by Nashville, Tenn.-based HCA Healthcare Inc. (NYSE: HCA).

AU Medical Center is still waiting on the final appeal by Doctors Hospital on the CON for the Columbia County Hospital to be decided. Final legal approval could come this summer, Augusta University spokesperson Denise H. Parrish told Atlanta Business Chronicle.

Recro, Teva Extend License and Supply Agreement

Tue, 02 Jul 2019 15:22:29 GMT

CDMO Recro Gainesville will continue to supply Verapamil SR capsules through 2024

Recro Gainesville, the contract development and manufacturing organization (CDMO) division of Recro Pharma, has amended its existing license and supply agreement with Teva Pharmaceutical to extend the agreement for six years, effective January 1, 2019.

Under the terms of the amended agreement, Recro Gainesville will continue to supply Teva with Verapamil SR capsules through 2024 and Teva will continue to be Recro Gainesville’s exclusive U.S. distributor of the product, for which Recro Gainesville is the New Drug Application (NDA) holder. The 2019 Teva agreement provides to Recro Gainesville the same revenue economics as the original agreement, including both manufacturing and profit sharing components. Prior to this amendment, the license and supply agreement with Teva for Verapamil SR was renewable on a year-to-year basis.

“Teva is the largest generic pharmaceutical company in the world and continues to do a tremendous job as our exclusive marketing partner for Verapamil SR,” said Scott Rizzo, senior vice president, general manager, Recro Gainesville. “The 2019 Teva Agreement both extends our baseline manufacturing business for a substantial period of time and serves as a solid foundation upon which to add new CDMO customers.”

Gerri Henwood, president and chief executive officer, Teva, said, “We have maintained a close working partnership with Teva and they have delivered strong product volume through their unparalleled distribution channels. This amendment underscores the commitment and dedication of our employees in Gainesville to maintain high quality standards and consistently deliver product on time to meet increasing demand. We are delighted Teva will continue to be our exclusive distributor in the U.S. for the next six years.”

For more information, click here.

04/17/2019

Georgia Bio CEO: Investment in life sciences has produced 14.9% growth in jobs

Tue, 02 Jul 2019 15:23:47 GMT

Georgia’s life science industry has experienced a 14.9 percent growth in employment during the past decade, according to the results of the 2019 Georgia Life Sciences State of the Industry Report released Wednesday morning.

That was nearly double the growth of life sciences employment nationally – 7.7 percent – over the same decade (2007 to 2017).

“We can attribute this growth to increased investment in research and our academic institutions,” said Maria Thacker-Goethe, president and CEO of Georgia Bio.

The report was conducted by RTI International for Georgia Bio. The last time the organization commissioned a similar study was in 2012.

The report identified 1,960 unique life science establishments that contributed 68,300 jobs and $10 billion to Georgia’s gross domestic product. When including the multiplier effects, the industry supports a total of about 194,000 jobs, and it contributes $21.8 billion to Georgia’s GDP.

That represents 3.7 percent of Georgia’s total non-farm employment and 3.7 percent of Georgia’s 2016 GDP.

Thacker-Goethe said the life sciences industries in Georgia has the potential to enhance the economic and physical well-being of all Georgians.

Georgia Bio and the Georgia BioEd Institute are dedicated to ensuring the state’s educators and career development professionals can access the resources they need to meet the needs of the fast-growing industry.

“It’s one of the highest paying industries in the state,” Thacker-Goethe said. “Increased state investment in the bio sector and med tech could really propel Georgia to be a leader in the Southeast for the life sciences.”

According to the report, the life sciences industry offers Georgians high-value jobs commensurate to education and experience. Of the 20 most common occupation types, 42 percent of jobs require a high school education or equivalent, while 32 percent require a bachelor’s degree.

Georgia’s research universities and the presence of the Centers of Disease Control and Prevention have translated into the state receiving $549 million in funding from the National Institutes of Health (NIH) for research in 2018.

Annual funding from the NIH to Georgia institutions has grown by 20 percent since 2010. That is more than double the national average of less than 8 percent, according to the report.

“Since 2010, the number of federal small business research innovation grants for life science startups has doubled in Georgia,” said Russell Allen, president and CEO of the Georgia Research Alliance and former CEO of Georgia Bio, in a statement.

“With the ingenuity of our universities and the strong support from our government and industry, we are seeing more life science inventions making their way from the lab to the marketplace, and most importantly, into the lives of Georgians,” Allen continued.

Thacker-Goethe also emphasized the need for the state to continue investing in the life sciences industry.

“Georgia Bio is going to continue to advocate for increased investment in the life sciences sector in Georgia,” she said. “Georgia has a unique opportunity to collaborate across sectors to become a global center for health.”

The state of the industry report was made possible through funding from the Biotechnology Innovation Organization (BIO), the Georgia Department of Economic Development, the Georgia Global Health Alliance, the Georgia Research Alliance, Johnson & Johnson, PhRMA, UCB, Inc. and VWR, part of Avantor.

Read more here.

04/17/2019

Boehringer Ingelheim, PureTech to Partner on Cancer Immunotherapies

Tue, 02 Jul 2019 15:24:59 GMT

Boehringer Ingelheim plans to develop new immuno-oncology treatments for an undisclosed number of targets using PureTech Health’s lymphatic targeting technology for immune modulation, through a collaboration that PureTech said today could generate for it more than $226 million.

The companies will initially focus on applying PureTech’s internally-developed lymphatic targeting platform to an unspecified Boehringer Ingelheim immuno-oncology candidate for gastrointestinal (GI) cancers that is administered directly to the gut lymphatics, PureTech said.

PureTech specializes in developing novel medicines for dysfunctions of the Brain-Immune-Gut (BIG) axis. The company’s platform is designed to harness the gut’s lipid transport mechanisms to enable oral administration and transport of drug candidates directly through the gut-draining lymphatic vasculature, also bypassing first pass metabolism in the liver.

Specifically, the company’s therapeutic candidates are directed to the mesenteric lymph nodes, which program as many as 70% of circulating adaptive immune cells. By targeting the lymphatic system directly, PureTech reasons, its proprietary technology could achieve more effective and precise immunomodulation of local tissues, while sparing patients from the risks of extensive systemic exposure to the drug.

PureTech’s lymphatic targeting approach is based on the research of Chris Porter, PhD, director of the Monash Institute of Pharmaceutical Sciences (MIPS) at Monash University.

According to its website, Porter’s lab aims to use drug delivery technologies:

To overcome limitations to drug absorption resulting from low drug solubility
To target drugs to the lymphatics (a site rich in immune cells and tissues and therefore a site of action for many immunotherapeutics)
To better understand the mechanisms by which drugs are trafficked specifically to critical organelles within the cell
To design nanomaterials to better target drug delivery to a range of diseases, including cancer

Promise beyond cancer

The targeting approach developed by Porter’s lab can potentially be applied to therapeutic molecules across a range of physiochemical properties and holds promise for the development of novel therapeutics for gastrointestinal, central nervous system, and autoimmune diseases as well as cancer, according to the company.

In cancer, PureTech presented two posters at the recent 2019 American Association for Cancer Research (AACR) Annual Meeting in Atlanta detailing the company’s development of two immuno-oncology candidates targeting solid tumors—first-in-class, fully-human monoclonal antibodies targeting Galectin-9 (LYT-200) and immunosuppressive γδ1 (gamma delta) T cells (LYT-210).

LYT-200 and LYT-210 are designed to target foundational, novel mechanisms of tumoral immune escape and immunosuppression in cancer. The two candidates have been tested as monotherapy, as well as in combination with PD-1 inhibitors in preclinical murine and human-derived ex vivo models, PureTech said.

During AACR, Boehringer Ingelheim highlighted several of its cancer candidates, including: BI 905677, a novel highly potent and selective LRP5/6 antagonist now in a Phase I trial (NCT03604445) in patients with advanced cancers; BI 907828, a novel MDM2-p53 antagonist also in a Phase I trial involving patients with advanced or metastatic solid tumors (NCT03449381); and BI 905711, a novel CDH17-targeting TRAILR2 agonist for which preclinical results were presented at the meeting.

Access to tumor targets

On March 29, Boehringer Ingelheim also signaled growing interest in cancer drug development by acquiring Berlin-based ICD Therapeutics for an undisclosed price. The deal gave Boehringer Ingelheim rights to ICD’s MacroDelbiologics-delivery platform, believed to facilitate access to targets inside tumor cells, for use in novel therapeutics in collaboration with a former ICD shareholder, nanoPET Pharma.

Boehringer Ingelheim has agreed to pay PureTech up to $26 million in upfront payments, research support, and preclinical milestone payments—as well as more than $200 million in payments tied to achieving development and sales milestones, plus royalties on product sales.

Once product candidates enter the development stage, Boehringer Ingelheim has agreed to assume full responsibility for development, PureTech added.

Headquartered in Boston with labs in Cambridge, MA, PureTech has launched partnerships with more than 70 research investigators based at numerous institutions and eight biopharma giants, including Amgen, Eli Lilly, Johnson & Johnson, Merck KGaA, Novartis, Pfizer, Roche, and Shire (now Takeda Pharmaceutical). PureTech plans to release full-year 2018 results on April 24.

“This collaboration signals the exciting potential of another proprietary platform from our internal R&D to enable novel immunotherapy approaches by harnessing the lymphatic system’s capacity for immune cell trafficking and immunomodulation,” PureTech co-founder and CEO Daphne Zohar said in a statement. “We look forward to working with the excellent scientific teams at Boehringer Ingelheim to advance this important program, which has the potential to greatly expand therapeutic options for patients with cancer.”

Gwinnett Chamber Announces New President & CEO

Tue, 02 Jul 2019 15:26:56 GMT

The Gwinnett Chamber, one of the largest suburban Chambers of Commerce in the nation, recently announced its selection for its new President & CEO, effective July 1.

Following a four-month search process, members of the Gwinnett Chamber board of directors voted in support of appointing Nick Masino, currently Gwinnett Chamber & Partnership Gwinnett’s Chief Economic Development Officer, to take the reins from Dr. Dan Kaufman, who has served in the role since 2013.

“The Gwinnett Chamber of Commerce is pleased and excited to announce the selection of Nick Masino as the new President & CEO of the Chamber to succeed retiring Dr. Dan Kaufman. The Chamber conducted a rigorous search for Dr. Kaufman’s successor, resulting in the interviews of six very capable finalists, with Nick emerging as the unanimous choice of the search committee and the Board of Directors,” said 2019 Gwinnett Chamber Board Chairman Tom Andersen. “Nick brings incredible energy and dynamism to the job, with great experience in having directed economic development for the Chamber through the Partnership Gwinnett initiative for over a decade. He’s well respected, not only in Gwinnett County, but in the entire metropolitan Atlanta region, and, with his experience and skill set, he will clearly be able to hit the ground running in leading the Gwinnett Chamber to new heights. He will continue in the line of extremely talented and effective CEOs for the Gwinnett Chamber.”

Masino joined the Gwinnett Chamber in 2007 and has served in the key economic development leadership role for the past 12 years. He oversees the business recruitment and retention efforts for Gwinnett, as well as the implementation of the Partnership Gwinnett Strategy. To create this community-focused economic development (ED) organization, Masino worked with public and private leadership to commission ED studies in 2011 and 2016; and spearheaded the implementation efforts of the initial plan in 2007—which has since brought approximately 250 company expansions or relocations, more than 23,000 new jobs and more than $1.7 billion in investment to Gwinnett. Over the past 12 years, Masino has led his team in significant accomplishments, including major project wins such as Asbury Automotive (2007); Hisense (2010); Primerica (2011); Mitsubishi Electric Trane HVAC US (2012); Comcast (2015); Kaiser Permanente (2017) and Hapag-Lloyd (2018), as well as International Economic Development Council (IEDC) Excellence in Economic Development Awards (2010, 2012, 2014, 2016). In addition, Masino has been awarded Georgia Trend’s Most Notable Georgians (2015-2019); 40 under 40 – Georgia Trend magazine; 40 under 40 – Atlanta Business Chronicle; and International Person of the Year – Governor’s Award Finalist – Atlanta Business Chronicle.

Masino’s economic development career began in February 2007, when he accepted his current role, but he was no stranger to the field. In December 2007, he ended his second term as mayor of the City of Suwanee having been one of the youngest mayors in Georgia’s history. During his tenure as mayor, the city of Suwanee embarked on a comprehensive economic and community development project highlighted by the construction of a 24,000 square foot City Hall and the popular 65-acre Suwanee Town Center, which led Suwanee to be named a CNN-Money magazine’s Top 10 Town in America. Prior to his position with the Gwinnett Chamber, Masino spent 12 years in the recruiting and staffing industry.

A graduate of The Ohio State University, Masino holds a bachelor’s degree in Interpersonal and Organizational Communication. He and his wife—his high school and college sweetheart, Suzanne—are the parents of three children, Anna, Vincent and Julia.

04/12/2019

House Bill Targets Looming $20 Billion Tax On MedTech Industry

Tue, 02 Jul 2019 15:27:57 GMT

April 10, 2019. WASHINGTON, D.C. – Scott Whitaker, president and CEO of the Advanced Medical Technology Association (AdvaMed), issued the following statement on introduction of bipartisan legislation (H.R. 2207) in the U.S. House of Representatives to permanently repeal the medical device excise tax:

“America’s medical technology industry is facing a $20 billion tax increase at year-end, when the current medical device tax suspension expires. Urgent action is essential to protect future medtech innovations that benefit patients and to avoid putting good-paying U.S. jobs at risk.

“House introduction today of the Protect Medical Innovation Act in the 116^thCongress brings us one step closer to ensuring this innovation-stifling burden on the medtech industry never returns, supporting continued American leadership of this vital industry.

“We thank the bill’s lead sponsors, Reps. Ron Kind (D-Wis.), Jackie Walorski (R-Ind.), Scott Peters (D-Calif.), and Richard Hudson (R-N.C.) for their leadership on this issue. This bill – and the strong bipartisan support they have gathered – reflect the high priority this Congress places on patients, jobs, and future investment.

“While past suspensions of the medical device tax have enabled manufacturers to invest in R&D, infrastructure and new hiring – which in turn benefits patients and the U.S. economy – these benefits are at risk. Now that bipartisan legislation to permanently repeal the device tax has been introduced in both the House and Senate, AdvaMed will urge Congress and the administration to act as expeditiously as possible to get rid of the tax once and for all this year.”

AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit www.advamed.org.

POLICY CONTACT:

Joseph Santoro

404-334-7538

jsantoro@gabio.org

04/10/2019

Georgia Bio Names Westminster School Junior as Georgia BioGENEius Winner

Tue, 02 Jul 2019 15:29:00 GMT

Ananya Ganesh Advances to Philadelphia in International Competition Against Top Students

Atlanta, GA (April 10, 2019)– Georgia Bio and the Georgia BioEd Institute today named Ananya Ganesh, a junior at The Westminster Schools in Atlanta, GA, as the winner of the 2019 Georgia BioGENEius Challenge, the premier competition for high school students that recognizes outstanding research and innovation in the biotechnology field. As Georgia’s BioGENEius finalist, Ananya will attend the 2019 BIO International Convention, the industry’s trade conference from June 3-6 in Philadelphia, PA where she will engage with leading companies, scientists and innovators currently transforming the scientific landscape in order to gain valuable insights into an industry making significant contributions to the world.

While in Philadelphia, Ananya will compete against high school students from the U.S., Canada and Germany in the International BioGENEius Challenge. The student projects will represent a range of biotechnology topics such as healthcare, agriculture, and the environment.

Ananya’s award-winning research uses algorithms to assess and classify lung function in young children with Early Onset Scoliosis (EOS). The purpose of this project was to develop a prediction model for lung function using the shape of the rib cage, and to create a functional classification method for EOS patients. This classification method can replace the traditional testing method of spirometry, which typically provides unreliable results in children.

“The BioGENEius Challenge highlights the breakthroughs made when we invest in and encourage young people to pursue their ideas,” said Georgia Bio President and CEO Maria Thacker. “Georgia Bio is thrilled that Ananya will represent our state at the upcoming BIO Convention. We are proud to support this Georgia scholar as she develops tomorrow’s healthcare innovations.”

Georgia Bio also congratulates the Georgia BioGENEius runner-up, Nicole Frey of Paulding County High School in Dallas, GA. Frey’s project focused on isolation of the chiAgene from a soil bacterium, Serratia marcescens. The chiAgene codes for an enzyme that breaks down chitin, the primary component of the cell walls in fungi. This gene could be inserted into plants to help them defend against disease-causing species of fungi.

Judging the 2019 Georgia BioGENEius were Jamie L. Graham, Kilpatrick Townsend & Stockton; Ralph L. Cordell, CDC; Teshome Mebatsion, Boehringer Ingelheim; and Ian Biggs, UGA.

National and International winners will be announced during June 3-6, 2019 BIO International Convention. Winners will receive cash scholarships.

Follow the BioGENEius Challenge:Throughout the challenge, @BiotechInstitutwill be tweeting interviews, photos, and engaging with the biotechnology community by using the hashtag #BioGENEius.

About the Biotechnology Institute

About the GeorgiaBioEd Institute
The Georgia BioEd Institute is a division of Georgia Bio, a 501(c)(3) nonprofit organization serving the state’s life science industry. The Institute’s mission is to strengthen Georgia’s life sciences workforce pipeline through classroom-to-career initiatives that align with industry needs. Learn more at www.georgiabioed.org| www.gabio.org.

MEDIA CONTACT:

Maria Thacker

404-920-2042

mthacker@gabio.org

04/10/2019

FDA Approves EVENITY™ (romosozumab-aqqg) For The Treatment Of Osteoporosis In Postmenopausal Women At High Risk For Fracture

Tue, 02 Jul 2019 15:30:09 GMT

One in Two Women in the United States Will Suffer a Fracture in Her Lifetime Due to Osteoporosis(1) EVENITY is the First and Only Bone Builder With a Dual Effect That Both Increases Bone Formation and Decreases Bone Loss(2) EVENITY Rapidly Reduces Fracture Risk and Builds New Bone With 12 Months of Therapy(2)

THOUSAND OAKS, Calif. and BRUSSELS, April 9, 2019 /PRNewswire/ -- Amgen (NASDAQ: AMGN) and UCB (Euronext Brussels: UCB) today announced that the U.S. Food and Drug Administration (FDA) has approved EVENITY™ (romosozumab-aqqg) for the treatment of osteoporosis in postmenopausal women at high risk for fracture. EVENITY is the first and only bone builder with a unique dual effect that both increases bone formation and to a lesser extent reduces bone resorption (or bone loss) to rapidly reduce the risk of fracture. A full course of EVENITY therapy is 12 monthly doses administered by a healthcare provider.2 Since osteoporosis is a chronic disease, continued therapy with an anti-resorptive agent should be considered once EVENITY therapy is completed.

Experience the interactive Multichannel News Release here: https://www.multivu.com/players/English/8490251-amgen-evenity-postmenopausal-osteoporosis/

"One in two women will experience a fracture due to osteoporosis in her lifetime.1 These fractures can be devastating, with many leading to hospital stays and life-altering consequences.3 The FDA approval of EVENITY represents an important therapeutic development for patients who need a medicine that can rapidly increase bone mineral density and help reduce the risk of future fractures within 12 months," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "Postmenopausal osteoporosis is a significant women's health issue that far too often gets overlooked. As a leader in bone health with more than 20 years of osteoporosis research experience, Amgen is as committed as ever to combatting this disease to help women at high risk for fracture reduce their risk of a first and subsequent fracture."

Osteoporosis is a serious, chronic condition with no cure.4,5 According to the World Health Organization (WHO), osteoporosis is a major public health crisis, affecting millions of people worldwide. In the U.S. alone, 10 million Americans suffer from osteoporosis.6 Osteoporosis-related fractures, known as bone breaks, are common, and the disease is responsible for an estimated two million fractures per year.6 After her first fracture, a woman is five times more likely to suffer another fracture within a year.7 In fact, her fracture risk remains elevated over time if left untreated. Fractures for postmenopausal women can be life-altering events which can lead to loss of mobility.4 Each year, osteoporosis-related fractures account for 432,000 hospital admissions and 180,000 nursing home admissions.3 Given the aging population in the U.S., annual direct costs from osteoporosis are expected to reach approximately $25.3 billion by 2025.1

"After spending 30 years caring for women with osteoporosis and in clinical research, I know that women at high risk of fracture need another therapy that reduces fractures quickly," said Felicia Cosman, M.D., professor of medicine at Columbia University College of Physicians and Surgeons in New York, co-editor in chief of the journal Osteoporosis International and principal investigator of the FRAME trial. "EVENITY acts by a novel mechanism of action to reduce the risk of new vertebral fracture within 12 months, and it produces rapid and dramatic improvements in bone mass. These benefits are sustained upon transition to an anti-resorptive medication and address a critical need for patients at high risk of fracture."

The FDA based its approval of EVENITY on the results of two Phase 3 studies. In the placebo-controlled FRAME study, treatment with EVENITY resulted in a significant reduction of new vertebral (spine) fracture at 12 months compared to placebo. This significant reduction in fracture risk persisted through the second year in women who received EVENITY during the first year and transitioned to denosumab compared to those who transitioned from placebo to denosumab. In addition, EVENITY significantly increased bone mineral density (BMD) at the lumbar spine, total hip and femoral neck compared to placebo at 12 months. Following the transition from EVENITY to denosumab at month 12, BMD continued to increase through month 24.

In the active-controlled ARCH study, treatment with EVENITY for 12 months followed by 12 months of alendronate significantly reduced the incidence of new vertebral fracture at 24 months. EVENITY followed by alendronate significantly reduced the risk of clinical fracture (defined as a composite of symptomatic vertebral fracture and nonvertebral fracture) after a median follow-up of 33 months. EVENITY significantly increased BMD at the lumbar spine, total hip and femoral neck at 12 months compared to alendronate. Twelve months of treatment with EVENITY followed by 12 months of treatment with alendronate significantly increased BMD compared with alendronate alone.

EVENITY has a Boxed Warning in its product label which advises that EVENITY may increase the risk of myocardial infarction (heart attack), stroke and cardiovascular death. EVENITY should not be initiated in patients who have had a heart attack or stroke within the preceding year. Consider whether the benefits outweigh the risks in patients with other cardiovascular risk factors. If a patient experiences a heart attack or stroke during therapy, EVENITY should be discontinued.2

The most common adverse reactions (≥5 percent) reported with EVENITY were arthralgia (joint pain) and headache.

This approval comes with a post-marketing requirement from the FDA to assess the cardiovascular safety of EVENITY in postmenopausal osteoporosis women. The requirement includes a five-year observational feasibility study, potentially followed by a comparative safety study or trial. Amgen is committed to the safety of patients and will continue to monitor all safety data as it emerges.

"Women who experience a fracture due to osteoporosis are at significant risk for another fracture within one to two years;7 however, many of these patients are not diagnosed with osteoporosis as the underlying cause of fracture so they do not receive the proper care, and as a result, may experience new fractures," said Dr. Pascale Richetta, head of bone and executive vice president, UCB. "We are excited EVENITY is now approved in the U.S. and that physicians will have a new treatment option for postmenopausal women with osteoporosis who are at high risk for fracture."

"Osteoporosis is a serious disease that is underdiagnosed and often goes untreated. In fact, approximately 80 percent of patients who have had one or more osteoporotic-related fractures are not being identified or treated,"8,9 said Elizabeth Thompson, chief executive officer, National Osteoporosis Foundation. "This approval is great news for patients and physicians because it gives them another much needed treatment option to help reduce the risk of life changing fractures."

Amgen is committed to supporting the osteoporosis community and to helping appropriate patients with affordable access to EVENITY. The Amgen Assist® support program can help patients and physician offices navigate insurance coverage and identify access resources for patients. Amgen also provides patient assistance for its medicines marketed in the U.S. in a variety of ways, including free medicines through The Amgen Safety Net Foundation for qualifying individuals with no or limited drug coverage.

EVENITY is expected to be available in approximately one week from select wholesalers in the U.S., at which time the price of EVENITY will be publicly available.

Find out more here.

04/09/2019

Alpharetta biopharma company names board member as interim CEO

Tue, 02 Jul 2019 15:31:48 GMT

An Alpharetta company that is working on treatments for eye disease patients has named a member of its board of directors as interim CEO.

George Lasezkay succeeds Daniel H. White as chief executive of Clearside Biomedical Inc. (NASDAQ: CLSD). White resigned as president, CEO and as a member of the Clearside board to pursue other opportunities, according to a company announcement.

Lasezkay has served as an independent director on the boards of a number of domestic and foreign emerging biopharmaceutical companies for the past 15 years. He has been a director of Clearside since August 2017. Previously, he served as executive vice president and general counsel at Acucela Inc., a development stage company that identifies and develops ophthalmic therapeutics. For the 10 years prior to Acucela, he was president of Horizon Pharma Group, a private life sciences consultancy practice. Prior to Horizon, Lasezkay was corporate vice president for corporate development at Allergan Inc.

Clearside's board is initiating a search to identify a permanent CEO, according to the announcement.

“We believe there is tremendous potential in our proprietary suprachoroidal space (SCS) injection platform, as evidenced by the acceptance of our New Drug Application (NDA) for XIPERE (triamcinolone acetonide ophthalmic suspension) for Suprachoroidal Injection. We want to thank Daniel for his visionary contributions, including licensing the original scientific technology, building our versatile therapeutic platform, leading our IPO and other financings, and hiring an experienced team to bring these important innovative products to market," William Humphries, chairman of the Clearside Board of Directors, said in the announcement.

“We are at an important stage in the evolution of our Company, so we are pleased to have Dr. George Lasezkay serve as CEO on an interim basis as we conduct a search for our next CEO. George has broad expertise in ophthalmology established during his tenure at Allergan, Inc., where he served on the company’s Executive Committee," Humphries continued. "With proven management experience and substantial industry knowledge, we believe George will help lead our team as we prepare for commercialization of our first product and look to leverage our unique platform through pipeline expansion and partnerships. We expect to benefit from his combination of clinical, legal, business development and executive expertise, and his diverse experience working with a number of emerging biopharmaceutical companies."

Lasezkay said, “We are excited about our suprachoroidal drug delivery platform and potential approval of our first agent for the treatment of macular edema associated with uveitis, which would be a significant milestone for Clearside. We also believe the platform has broad applicability in other eye diseases and continue to explore utilizing suprachoroidal administration with other small molecules and gene therapy. I am confident in the capabilities of the Clearside team and look forward to working with them to ensure the long-term success of XIPERE, prudently build our ophthalmic pipeline, and work with potential partners to leverage our platform and provide international reach.”

In September 2018, Clearside Biomedical named Leslie Zacks its general counsel and chief compliance officer.

The company went public in 2016.

See full article here.

04/08/2019

Congressman Collins Honored as Innovator in Biotechnology

Tue, 02 Jul 2019 15:35:05 GMT

Washington, D.C. (April 4, 2019) – Congressman Doug Collins was recognized today by the Biotechnology Innovation Organization (BIO) for his leadership as an Innovator in Biotechnology. Congressman Collins received the award in conjunction with today’s BIO Legislative Day Fly-In.

BIO’s Innovator in Biotechnology award recognizes Members of Congress who have been collaborative partners, advocates, and champions of the biotechnology and life sciences industries.

“The life sciences industry in Georgia provides jobs for over 32,000 people. Congressman Collins has been an invaluable advocate for the biotechnology community – both in Georgia’s 9th District and the nation at large,” said Maria Thacker Goethe, President & CEO, Georgia Bio. “On behalf of the Georgia life science industry, we thank him for outstanding leadership and dedication to supporting the innovative capacity and job-creating potential of American life science companies.”

“Congressman Collins has been a stalwart advocate for sound public policies that advance the jobs creating potential of America’s biotechnology industry as we address the most pressing medical, agricultural, industrial and environmental challenges facing our nation and the world,” said BIO President and CEO Jim Greenwood. “His commitment to support the needs of America’s innovative life science companies allows them to focus on what matters – delivering life-saving and life-enhancing products.”

More than 200 biotechnology industry representatives from over 40 states, representing hundreds of thousands of American workers, will participate in hundreds of meetings with Members of the House and Senate during the BIO Legislative Day Fly-In. Participants will discuss issues critical to the biotechnology industry, including drug development, discovery and delivery reforms, targeting abuses of the U.S. patent system while protecting innovation, providing adequate reimbursement for vital therapies under Medicare, FDA funding, trade, tax policy, Farm Bill Implementation, protecting the Renewable Fuel Standard and capital formation issues relevant to biotechnology companies.

Congressman Collins pictured (center) with Jed Perry, Head, U.S. Public Affairs, UCB (left) and Joseph Santoro, VP of External Affairs, Georgia Bio (right).

Photos of the award presentation are available upon request.

04/04/2019

Senator Isakson Honored as Innovator in Biotechnology

Tue, 02 Jul 2019 15:36:18 GMT

Washington, D.C. (April 4, 2019) – Senator Johnny Isakson was recognized today by the Biotechnology Innovation Organization (BIO) for his leadership as an Innovator in Biotechnology. Senator Isakson received the award in conjunction with today’s BIO Legislative Day Fly-In.

BIO’s Innovator in Biotechnology award recognizes Members of Congress who have been collaborative partners, advocates, and champions of the biotechnology and life sciences industries.

“The life sciences industry in Georgia provides jobs for over 32,000 people. Senator Isakson has been an invaluable advocate for the biotechnology community – both in Georgia and the nation at large,” said Maria Thacker, President and CEO of Georgia Bio. “On behalf of Georgia’s life science industry, we thank him for outstanding leadership and dedication to supporting the innovative capacity and job-creating potential of American life science companies.”

“Senator Isakson has been a stalwart advocate for sound public policies that advance the jobs creating potential of America’s biotechnology industry as we address the most pressing medical, agricultural, industrial and environmental challenges facing our nation and the world,” said BIO President and CEO Jim Greenwood. “His commitment to support the needs of America’s innovative life science companies allows them to focus on what matters – delivering life-saving and life-enhancing products.”

Photos of the award presentation are available upon request.

04/04/2019

EMA accepts Takeda application for subcutaneous Entyvio

Tue, 02 Jul 2019 15:37:27 GMT

The European Medicines Agency (EMA) has accepted Takeda’s marketing authorisation application for its subcutaneous formulation of Entyvio (vedolizumab) for maintenance therapy in moderately to severely active ulcerative colitis and Crohn’s disease.

If approved, the drug would be the only maintenance therapy to offer the options of both intravenous or subcutaneous formulations across ulcerative colitis or Crohn’s disease.

The company proposes to make it available in both pre-filled syringe and pen options, helping provide greater choice in how patients receive therapy.

The application is based on the pivotal VISIBLE 1 Phase III study, which assessed the safety and efficacy of a subcutaneous formulation of Entyvio as maintenance therapy in 216 adult patients with moderately to severely active UC.

The results of the study found that 46.2% of patients receiving the maintenance therapy administered every two weeks achieved clinical remission, compared to 14.3% on placebo.

“This regulatory application marks an important milestone in our continued commitment to delivering innovative medicines and treatment modalities that meet the diverse needs of patients living with ulcerative colitis and Crohn’s disease across Europe,” said Adam Zaeske, head, GI Franchise, Europe and Canada Business Unit, Takeda.

“If approved, a subcutaneous formulation of vedolizumab, together with the currently available intravenous option, will provide greater choice, enhancing the patient experience in line with their treatment preferences and lifestyle.”

Entyvio is a humanised monoclonal antibody designed to specifically antagonise the alpha4beta7 integrin, potentially limiting the ability of certain white blood cells to infiltrate gut tissues.

04/03/2019

UCB's inflammatory arthritis drug gains FDA approval

Tue, 02 Jul 2019 15:38:48 GMT

The US Food and Drug Administration (FDA) has approved certolizumab pegol injection (Cimzia) for the treatment of adults with non-radiographic axial spondyloarthritis (nr-axSpA), with objective signs of inflammation. This is the first FDA-approved treatment for the inflammatory arthritis condition.

"Today's approval of Cimzia fulfills an unmet need for patients suffering from non-radiographic axial spondyloarthritis as there [have] been no FDA-approved treatments until now," said Nikolay Nikolov, MD, associate director for rheumatology of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA's Center for Drug Evaluation and Research.

The FDA’s decision to approved was supported by efficacy results from a clinical trial of adult patients with non-radiographic axial spondyloarthritis with objective signs of inflammation— elevated C-reactive protein (CRP) levels and/or sacroiliitis on MRI. The trial included 317 adult patients who were randomized to certolizumab or placebo.

Efficacy was gauged using the Ankylosing Spondylitis Disease Activity Score, a composite scoring system that assesses disease activity including patient-reported outcomes and CRP levels. Patients receiving certolizumab had better responses compared to those receiving placebo. The safety profile in the active treatment group was similar to the known safety profile of the drug.

Certolizumab, a tumor necrosis factor (TNF) blocker, was originally approved by the FDA in 2008 and has indications for moderate-to-severe plaque psoriasis, Crohn’s disease, moderate-to-severe rheumatoid arthritis, and active ankylosing spondylitis (AS).

The prescribing information for Cimzia includes a Boxed Warning about the risk of serious infections leading to hospitalization or death, including tuberculosis, bacterial sepsis, invasive fungal infections, and infections due to other opportunistic pathogens.

To learn more click here.

03/28/2019

MiRus receives FDA Approval for First Medical Implant with New Superalloy- MoRe®

Tue, 02 Jul 2019 15:40:13 GMT

ATLANTA, March 27, 2019 /PRNewswire/ -- MiRus has received FDA 510(k) approval for the MoRe® based Europa™ Pedicle Screw System making it the first FDA approved medical device with this new class of implant material. The Europa™ System received the 2018 Spine Technology Award at the NASS meeting for excellence and innovation in spine surgery.

MiRus has developed MoRe®, a proprietary molybdenum rhenium superalloy for medical implants, to provide an unprecedented combination of strength, ductility, durability, and biological safety that is unmatched by current materials. MoRe® was designed to meet these criteria and is patent protected for use in all medical devices.

The clinical needs of many patients remain unmet due to the limitations of current titanium, cobalt and iron based alloys originally developed more than 40 years ago. The MoRe® superalloy allows for the design of a new generation of smaller, stronger, more durable, and bio-friendly implants that will result in less soft tissue disruption, quicker recovery and better outcomes for patients.

"Spine deformity surgery in adults remains plagued by the poor performance of current implants with rod failure occurring in 18%-20% of patients," noted Munish Gupta MD, Mildred B. Simon Distinguished Professor of Orthopaedic Surgery, Director of Adult/Pediatric Spinal Deformity service and Professor of Neurological Surgery at Washington University, "The MoRe alloy shows great promise in improving the durability of adult spine deformity constructs. This advance will help prevent early revision surgery and improve outcomes in adult deformity surgery in particular."

Peter Newton, MD, Chief of Orthopaedic Surgery at Rady Children's Medical Practice Foundation and Clinical Professor, UCSD observed "I am excited by the excellent material properties of this new alloy and the potential to improve orthopaedic implants."

James Nunley, MD, Goldner Jones Professor of Orthopaedic Surgery at Duke, remarked "This new material with its greater strength, fatigue resistance and superior biological properties will allow us to make lower profile foot and ankle implants leading to smaller surgical exposures and reduced revision rates. "

Jay S. Yadav MD, Founder and CEO of MiRus, stated:

"FDA approval of the Europa™ Pedicle Screw System with our patented MoRe® superalloy is the culmination of over ten years of research and development. Our scientists and engineers working with world class metallurgists have created the greatest advance in medical implant material technology in at least four decades. The MoRe® superalloy will revolutionize many aspects of the medical device industry as the first alloy approved by the FDA for use in an implant which is not based on titanium, cobalt or iron with their inherent limitations.

The FDA requires a rigorous level of scientific investigation to establish the safety and effectiveness of a spine implant that utilizes a new medical alloy. In response to FDA guidance, our scientific team led by Jordan Bauman, VP of Regulatory, developed a comprehensive body of evidence which served as the basis for approval of this major advance in patient care.

We are fortunate to be collaborating with an outstanding worldwide group of orthopaedic and neurosurgeons in developing transformative spine solutions. Additionally, MiRus is rapidly expanding into other orthopaedic applications such as foot and ankle and has made significant progress in cardiovascular applications of the MoRe® superalloy."

Contact:
Mahesh Krishnan
VP, Sales and Marketing, MiRus
mkrishnan@mirusmed.com
770-317-5564

About MiRus, LLC.
MiRus is a medical device company that has developed and is commercializing proprietary novel biomaterials, implants and software solutions for spine, orthopaedics and cardiovascular disease. We are addressing the demands of today's healthcare environment with an integrated platform of pre-operative planning and risk assessment tools, a breakthrough navigation and robotics system and post-operative monitoring and risk mitigation. Find more information about MiRus at www.mirusmed.com.

Statements made in this press release that look forward in time or that express beliefs, expectations or hopes regarding future occurrences or anticipated outcomes are forward-looking statements. A number of risks and uncertainties such as risks associated with product development and commercialization efforts, expected timing or results of any clinical trials, ultimate clinical outcome and perceived or actual advantages of the Company's products, market and physician acceptance of the products, intellectual property protection, and competitive offerings could cause actual events to adversely differ from the expectations indicated in these forward looking statements.

* MoRe® is a registered trademark of MiRus, LLC. Europa™ and MiRus™ are trademarks of MiRus, LLC.

SOURCE MiRus

Alcon announces $285M acquisition of PowerVision

Tue, 02 Jul 2019 15:46:27 GMT

Novartis (NYSE:NVS) subsidiary Alcon said today that it acquired intraocular lens developer PowerVision for $285 million.

PowerVision is developing fluid-based intraocular lens implants that use the eye’s natural accommodating response to transport fluid in the implanted lens, Fort Worth, Texas-based Alcon said.

The fluid-based lens creates a continuously variable monofocal lens using the natural contractions of the eye’s muscles, Alcon said, allowing a patient to actively focus on objects in a style similar to a young eye’s crystalline lens.

“We’re thrilled to officially join Alcon and its pioneering history of launching new innovation in the field of ophthalmology. We look forward to bringing this innovative IOL technology to eye care providers and customers in the years ahead,” PowerVision prez & CEO Barry Cheskin said in a prepared statement.

Alcon said that the commercial availability of the newly acquired IOL devices will be “determined following significant additional development and clinical trials of the intraocular lens.

The deal includes additional payments tied to regulatory and commercial milestones slated to begin 2023, Alcon said.

“As the industry leader in cataract surgery, we’re eager to accelerate development of this potentially breakthrough accommodating lens technology. By treating cataracts and restoring natural, continuous range of vision, this intraocular lens may be the preferred IOL for cataract surgery patients who desire spectacle independence,” Alcon global business and innovation prez Michael Onuscheck said in a press release.

Last December, Alcon said that it acquired Tear Film Innovations for an undisclosed amount.

To find out more information, click here.

03/18/2019

ArunA Bio Appoints Al Medwar as Executive Vice President, Corporate and Commercial Development

Tue, 02 Jul 2019 15:47:39 GMT

ATHENS, Ga – March 18, 2019 - ArunA Bio, a leader in the development of exosomes and exosome therapeutics for the treatment of neurodegenerative disorders, today announced the appointment of Al Medwar as Executive Vice President, Corporate and Commercial Development. Mr. Medwar joins the company and its leadership team contributing over 30 years of pharmaceutical industry experience.

Mr. Medwar joins recently appointed Chief Executive Officer, Dr. Mark A. Sirgo, and team as they focus on progressing ArunA’s neural exosome platform toward commercialization, including partnerships with companies in the CNS therapeutic area.

“I am pleased to have Al join the leadership team at ArunA Bio as we move aggressively to utilize our neural exosome platform to develop novel therapeutics to treat serious neurodegenerative disorders through both our internal pipeline and industry collaborations,” said Dr. Sirgo. “Al played a significant role in building BioDelivery Sciences into a fully integrated pharmaceutical company based on a platform technology. I look forward to successfully collaborating with Al again in this new and exciting venture.”

Prior to joining the company, Mr. Medwar was Senior Vice President, Corporate and Business Development for BioDelivery Sciences (Nasdaq: BDSI), where he spent eleven years and played a key role in building the company from a development to a commercial stage enterprise and in securing a number of licensing and partnership deals. In his capacity at BioDelivery Sciences, Mr. Medwar also led investor and public relations working closely with the investor and analyst communities. While at EMD Pharmaceuticals, the U.S. subsidiary of Merck KGaA, Mr. Medwar served as Head of Oncology Marketing, where he was responsible for developing the global market for a pipeline of immuno-oncology products. Earlier in his career, he was also the Marketing Director for Triangle Pharmaceuticals, a start-up company focusing on the development and commercialization of compounds for HIV and hepatitis. Mr. Medwar's pharmaceutical career began in sales at Glaxo Wellcome. He received a BS degree from Cornell University and an MBA from Bentley University.

About ArunA Bio

ArunA Bio is harnessing the natural abilities of neural exosomes to cross the blood brain barrier and enhance the body’s anti-inflammatory, self-repair and protective mechanisms to treat a range of neurodegenerative disorders. We are leveraging our proprietary exosomes and manufacturing platform to create synergistic therapies by enhancing our exosomes with small molecules, RNA, oligonucleotides and antibodies.

For more information, please visit www.arunabio.com.

Contact

MacDougall

Lauren Arnold

larnold@macbiocom.com

781-235-3060

03/18/2019

Takeda receives U.S. FDA Approval to Manufacture FLEXBUMIN® at New Plasma Manufacturing Facility near Covington, Georgia

Tue, 02 Jul 2019 15:48:50 GMT

March 18, 2019

− FLEXBUMIN 25% [Albumin (Human)], USP, 25% Solution is indicated for hypovolemia, hypoalbuminemia, (burns, Adult Respiratory Distress Syndrome (ARDS), and nephrosis), cardiopulmonary bypass surgery, and hemolytic disease of the newborn (HDN). Albumin is not indicated as an intravenous nutrient

− Takeda received its first FDA approval for the Georgia facility, to manufacture GAMMAGARD LIQUID® [Immune Globulin Infusion (Human)] 10% Solution, in June 2018

− This state-of the art facility supports continued growth of Takeda’s plasma-derived therapies portfolio and further strengthens our ability to deliver these complex therapies for patients

Cambridge, Massachusetts, March 18, 2019 --- Takeda Pharmaceutical Company Limited [TSE: 4502 / NYSE: TAK], (“Takeda”) today announced that the United States Food and Drug Administration (FDA) has approved the company’s second submission for its new plasma manufacturing facility near Covington, Georgia for the production of FLEXBUMIN 25% [Albumin (Human)], USP, 25% Solution, indicated for hypovolemia, hypoalbuminemia, (burns, Adult Respiratory Distress Syndrome (ARDS), and nephrosis), cardiopulmonary bypass surgery, and hemolytic disease of the newborn (HDN). Albumin is not indicated as an intravenous nutrient. The Georgia facility received its first FDA approval, to manufacture GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10% Solution, in June 2018.

“This latest approval is a significant milestone for the Georgia facility, Takeda and our patients,” said Thomas Wozniewski, Global Manufacturing & Supply Officer. “This new state-of-the-art facility is providing much needed additional capacity for meeting increasing global demand for plasma-derived therapies, and our team there will continue to scale up production over the coming years.”

“Following the acquisition of Shire, Takeda created a Business Unit dedicated to meeting the large and growing demand for plasma-derived products, essential for treating patients with a variety of rare, life-threatening, chronic and genetic diseases. Our strategic focus and increased investment in plasma innovation and our world-class plasma collection and production capabilities will enable us to expand our broad, differentiated portfolio of medicines and serve more patients. Our Georgia facility is a key part of these plans,” added Julie Kim, President of Plasma-Derived Therapies at Takeda.

The Georgia facility currently employs more than 1,000 full-time and contract employees, and continues to hire to fill additional roles in manufacturing, quality, engineering, maintenance, utilities, warehouse, and various support and facility roles.

03/18/2019

CSI Laboratories Begins Offering VENTANA PD-L1 (SP142) Assay as Companion Diagnostic Test for Triple Negative Breast Cancer as a Result of FDA Approval for TENCENTRIQ® (atezolizumab)

Tue, 02 Jul 2019 15:49:48 GMT

ALPHARETTA, Ga.--(BUSINESS WIRE)--CSI Laboratories, a nationally renowned laboratory specializing in comprehensive cancer diagnostics, today announced that it has added the newly approved VENTANA PD-L1 (SP142) Assay as a companion diagnostic test for use in selecting triple-negative breast cancer (TNBC) patients for TENCENTRIQ® (atezolizumab).

TENCENTRIQ® was granted accelerated approval for use in combination with paclitaxel protein-bound for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 on March 8, 2019. The indication is approved under accelerated approval based on progression-free survival and continued approval may be contingent on verification and description of clinical benefit in confirmatory trials, according to the FDA.

CSI is one of the first reference laboratories to offer the new companion test. The new Assay is used to determine PD-L1 stained tumor-infiltrating immune cells of any intensity covering ≥ 1% of the tumor area.

“We are pleased to add this companion test to our diagnostic testing services, which will enable health care teams to treat TNBC patients with newer therapeutic options,” said Ron Ghafary, founder and CEO of CSI Laboratories. “We continue to focus on providing a superior client experience, exceptional and accurate lab results, and quick turnaround to help our clients provide personalized cancer care to their patients.”

For more information, please visit csilaboratories.com or contact Eric Diersen 678-248-8000.

ABOUT CSI LABORATORIES

CSI Laboratories is a specialized cancer diagnostics laboratory focused specifically on meeting the unique needs and challenges of pathologists and community hospitals. CSI Laboratories offers flow cytometry, cytogenetic analysis, fluorescence in-situ hybridization (FISH), immunohistochemistry, molecular genetics, and consultations in the areas of hematopathology and surgical pathology. CSI Laboratories is a CLIA-certified and CAP-accredited laboratory located in Alpharetta, GA. CSI Laboratories is independently owned and operated by medical professionals and has provided expert diagnostic testing to pathologists across the United States since 1997. For more information, please visit www.csilaboratories.com.

03/18/2019

Advantage Capital Invests $6.5 Million in Danimer Scientific, Supporting Company’s Growth in Rural Georgia

Tue, 02 Jul 2019 15:50:57 GMT

NEW ORLEANS--(BUSINESS WIRE)--Advantage Capital today announced a $6.5 million investment in Danimer Scientific, a leading biotechnology company producing biodegradable and compostable polymers used in consumer and industrial products. The investment was made through the GARJA program and supports the company’s anticipated growth as it seeks to boost capacity and significantly increase its workforce at its Bainbridge, GA location over the next few years.

“The Georgia Agribusiness and Rural Jobs Act was created to bring investment capital and jobs to the more rural parts of the state,” said State Representative Jay Powell (R-Camilla). “Danimer’s growth is not only helping to solve key environmental issues facing the world today but is also bringing additional high-quality jobs to the local community of Bainbridge.”

Bainbridge, with a population just north of 12,000, faces many of the same challenges confronting towns, businesses and residents across Georgia’s rural areas. The loss of both residents and jobs looms large. And as many rural communities are still struggling to recover from the 2008-2009 recession, barriers to investment capital make it difficult for rural businesses to compete, expand, and create good quality jobs.

The investment in Danimer, currently one of the largest employers in the region, will enable the company to increase production capacity which will require many new employees, most hired from the surrounding area. Three-fourths of the company’s anticipated new jobs will be accessible to those with a high school degree or equivalent, helping to grow the local work force. The company also provides specialized training programs, helping to close any local skills gaps and ready employees for upward growth and mobility.

“I grew up in Bainbridge and am proud of the work we are doing at this company,” said John “Jad” Dowdy, CFO of Danimer. “Our employees work hard every day to create products that lead to a cleaner, more sustainable environment by replacing traditional petroleum-based plastics that are neither compostable nor biodegradable. This investment will allow us to more than double our capacity, hire new employees, and continue Danimer’s rapid growth.”

The Danimer investment is Advantage Capital’s first investment through the GARJA program, which was designed to bring private capital to rural Georgia, helping businesses like Danimer secure the financing they need to grow. The GARJA capital served to anchor a larger $11 million cumulative financing, with the balance provided by an affiliate of People Incorporated of Virginia, a community action agency serving the southeast United States.

“This is our first investment through the Georgia Agribusiness and Rural Jobs Act. Our participation in GARJA allowed us to identify Danimer’s growth opportunity, and then build a comprehensive financing package to meet the company’s need,” said Abhi Chandrasekhara of Advantage Capital. “We are excited to continue investing across the state to create considerable impact, strengthen the local economy, and continue job growth in rural parts of the state.”

About Advantage Capital

Advantage Capital provides financing to established and emerging companies located in communities underserved by conventional sources of capital. Since 1992, the firm has invested more than $2.6 billion in companies from a diverse array of industry sectors and has helped support more than 48,000 jobs. Learn more at www.advantagecap.com, or via Twitter or LinkedIn.

About Danimer Scientific

Danimer Scientific is a pioneer in creating more sustainable, more natural ways to make plastic products. Danimer Scientific’s Nodax™ PHA possesses seven TUV AUSTRIA certifications and statements of industrial and home compostability, is biodegradable in anaerobic, soil, fresh water and marine environments and is 100% bio-based. All of Danimer Scientific’s biopolymers, including its Nodax™ PHA, are FDA approved for food contact.

Advantage Capital is an investment adviser registered under the Investment Advisers Act of 1940. Registration does not imply a certain level of skill or training. The information in this release is not intended to be an advertisement concerning investment advisory services or an offer to buy or sell securities of any type.

The investments and portfolio companies referenced in this release represent only a sample of companies that have received investment capital from Advantage Capital-related entities. For a complete list of such companies, please see our website at advantagecap.com. It should not be assumed that recommendations made in the future will be profitable or will equal the performance of the securities highlighted herein or contained in any other information provided by Advantage Capital. Past performance is no guarantee of future results.

03/18/2019

BIO Statement on President’s Proposed 2020 Budget

Tue, 02 Jul 2019 15:52:22 GMT

Washington, DC (March 11, 2019) – Biotechnology Innovation Organization (BIO) President and CEO Jim Greenwood issued the following statement today regarding President Trump’s FY 2020 budget proposal:

“While we are still reviewing the details of the President’s proposed budget, we applaud the President’s efforts to lower patients’ out of pocket costs for prescription drugs, and to rein in abuses and increase accountability within the 340B drug discount program."

“That said, we have serious concerns that elements of this proposal threaten to harm some of the nation’s most vulnerable patients, including seniors and low-income families. The budget would fundamentally upset the successful Medicare drug benefit that has provided American seniors with affordable prescription drug coverage while costing taxpayers less than originally expected."

"This includes a proposal to increase out of pocket costs for patients in the coverage gap who rely upon brand name drugs. We are also concerned that proposed changes to Medicaid could limit beneficiary access to needed cures and treatments. We will continue to review these proposals and stand ready to work with the administration and members of both parties in Congress to advance policies related to health, agriculture, and energy that will preserve America’s role as the world leader in biotechnology innovation.”

03/14/2019

Emory Technology Transfer presents 13th Celebration of Technology & Innovation

Tue, 02 Jul 2019 15:53:37 GMT

Emory University’s Office of Technology Transfer will celebrate its faculty entrepreneurs and their innovative discoveries at the 13th Annual Celebration of Technology and Innovation.

The celebration will be held Thursday, March 21, 2019 at the Emory Conference Center, Silver Bell Pavilion, 1615 Clifton Rd., Atlanta, GA 30322.

Registration begins at 4:30 p.m., and the program begins at 5 p.m., followed by a reception.

RSVP here!

For questions, contact Quentin Thomas: qjthoma@emory.edu, 404-727-1899

Learn more here.

03/12/2019

Senate Moves to Stop $20 Billion Tax Increase on MedTech Industry

Tue, 02 Jul 2019 15:54:51 GMT

WASHINGTON, D.C. – Scott Whitaker, president and CEO of the Advanced Medical Technology Association (AdvaMed), issued the following statement on introduction of bipartisan legislation –the Protect Medical Innovation Act – in the U.S. Senate to permanently repeal the medical device excise tax:

“Unless Congress acts quickly, America’s medical technology companies face a $20 billion tax hike at the end of 2019 when the device excise tax returns. If not stopped, this tax will put future patient innovations and good-paying U.S. jobs at risk.

“Today’s Senate action is the first step in ensuring continued American leadership of this vital industry. We thank the bill’s lead sponsors, Sens. Pat Toomey (R-Pa.) and Amy Klobuchar (D-Minn.), for their long-standing support of improving patient lives and medtech innovation. The broad bipartisan backing of this bill reflects members’ understanding of the negative impact on job creation, investment and patient care should this tax return, and the urgent need for repeal.

“The time to act is now. We look forward to the House introducing companion legislation in the near future and pledge to work with Congress, the administration and other stakeholders to ensure this burdensome tax is eliminated once and for all.”

03/07/2019

GeoVax and Leidos Expand Collaboration to Malaria Vaccines

Tue, 02 Jul 2019 15:56:11 GMT

ATLANTA, GA, March 4, 2019 – GeoVax Labs, Inc. (OTCQB: GOVX), a biotechnology company developing human vaccines, announced today that it has expanded its collaboration activities with Leidos, Inc. to develop malaria vaccine candidates. The work will be supported under a contract to Leidos from the United States Agency for International Development (USAID) Malaria Vaccine Development Program (MVDP). Leidos has been tasked by USAID to advance promising vaccine candidates against P. falciparum malaria and selected the GeoVax MVA-VLP platform as part of this development effort.

GeoVax’s vaccine technology is based on its live Modified Vaccinia Ankara (MVA) platform, which generates vaccine antigens, in the form of multimeric proteins or noninfectious VLPs, in the individual being vaccinated. Gene sequences of target antigens are inserted into the MVA genome which drives their expression and budding from the infected cells. In this way, vaccination strategy mimics a natural viral infection which induces two pools of proteins – virus-infected cells and released multimeric or VLP proteins.

Farshad Guirakhoo, PhD, GeoVax’s Chief Scientific Officer, commented, “Currently there is a shortage of malaria vaccine candidates that can offer the high efficacy rates (e.g. >75%) set by the World Health Organization (WHO) as a requirement for the second-generation malaria vaccines. Although protein-derived vaccines can deliver multiple antigens in immunogenic VLP conformation, they hardly produce a balanced functional cellular immune response needed to confer a high protection. In contrast, vectored-derived live vaccines are capable of producing the appropriate balanced immune responses, but they suffer from limitations in delivering the required number of transgenes needed to protect against all stages of malaria parasite. GeoVax’s MVA-VLP platform can overcome both limitations of antigen conformation and transgene capacity by delivering multiple transgenes (e.g. from parasite’s liver stage, blood stage and mosquito stage) in the form of VLPs delivered in vivo. This new collaboration with Leidos complements our ongoing malaria vaccine development project with Burnet Institute in Australia and offers multiple opportunities for success.”

David Dodd, GeoVax’s President and CEO, said, “We are delighted to broaden our relationship with Leidos to include malaria vaccines. This remains a significant unmet healthcare need and we believe that this collaboration has the potential to result in a significant improvement in this critical area. Our hope is to successfully proceed through product development and identify promising vaccine candidates that can be taken into clinical development as quickly as possible, demonstrating an effective, safe vaccine for malaria prevention. We are confident that our technology, combined with Leidos’ has an excellent chance for success.”

About GeoVax

GeoVax Labs, Inc., is a clinical-stage biotechnology company developing human vaccines against infectious diseases using its MVA-VLP vaccine platform. GeoVax was the winner of the 2018 “Best Biotech” Vaccine Industry Excellence Awards, a finalist for the 2018 “Best Prophylactic Vaccine” Award for its Zika vaccine at the World Vaccine Congress, as well as a finalist for Pipelines of Promise at Buzz of Bio 2018. The Company’s development programs are focused on vaccines against HIV, Zika, hemorrhagic fever viruses (Ebola, Sudan, Marburg, Lassa) and malaria. GeoVax also is evaluating the use of its MVA-VLP platform in cancer immunotherapy, and for therapeutic use in chronic Hepatitis B infections. GeoVax’s vaccine platform supports in vivo production of non-infectious VLPs from the cells of the very person receiving the vaccine. The production of VLPs in the person being vaccinated mimics virus production in a natural infection, stimulating both the humoral and cellular arms of the immune system to recognize, prevent, and control the target infection. For more information, visit www.geovax.com.

About Leidos

Leidos is a Fortune 500® information technology, engineering, and science solutions and services leader working to solve the world’s toughest challenges in the defense, intelligence, homeland security, civil, and health markets. The company’s 32,000 employees support vital missions for government and commercial customers. Headquartered in Reston, Virginia, Leidos reported annual revenues of approximately $10.19 billion for the fiscal year ended December 28, 2018. For more information, visit www.Leidos.com.

About the United States Agency for International Development (USAID) Malaria Vaccine Development Program (MVDP)

USAID’s mission is to partner to end extreme poverty and promote resilient, democratic societies while advancing our security and prosperity. The MVDP is housed in the Malaria Division of the Office of Infectious Diseases of USAID’s Bureau for Global Health. Initiated in 1965 in response to the end of the first malaria eradication era, the MVDP has worked with a variety of partners to contribute early research on the circumsporozoite protein, as well as blood-stage and liver-stage vaccine approaches. Its mission is to develop and introduce malaria vaccines to protect vulnerable populations in the developing world. For further information, please visit www.usaid.gov.

Forward-Looking Statements

Certain statements in this document are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act. These statements are based on management's current expectations and are subject to uncertainty and changes in circumstances. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax can develop and manufacture its vaccines with the desired characteristics in a timely manner, GeoVax's vaccines will be safe for human use, GeoVax's vaccines will effectively prevent targeted infections in humans, GeoVax’s vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete vaccine development, there is development of competitive products that may be more effective or easier to use than GeoVax's products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements and does not intend to do so. More information about these factors is contained in GeoVax's filings with the Securities and Exchange Commission including those set forth at "Risk Factors" in GeoVax's Form 10-K.

03/04/2019

Georgia Research Alliance 'at a pivot point,' refocusing for the future

Tue, 02 Jul 2019 15:57:29 GMT

By Maria Saporta – Contributing Writer, Atlanta Business Chronicle

Leaders behind the Georgia Research Alliance are seeking to gain traction under the administration of newly-elected Gov. Brian Kemp.

The Alliance, launched during the administration of the late Gov. Zell Miller, is a well-respected organization of top business, university and government leaders dedicated to increasing the state’s technology portfolio.

At its quarterly board meeting Feb. 7, a combination of old and new faces were present. David Ratcliffe, retired CEO of Southern Co., was named board chairman – a role he had held in 2005. It also was Russell Allen’s first board meeting as president and CEO of the organization.

“We are on the verge of taking this to the next level,” Ratcliffe said. “I think we are at a pivot point with a new administration and a new focus."

Already Ratcliffe, Allen and Mark Sanders, who is GRA’s lobbyist and a longtime friend of the new governor, have met with Kemp, who has promised to attend future meetings. Ratcliffe said Kemp understands the success the Alliance has had over the years and appears open to exploring new opportunities to work with the organization.

That is a significant change from the past two administrations. Former Gov. Sonny Perdue had never been a strong advocate for the Alliance, and he even proposed to incoming governor Nathan Deal to drastically reduce state funding to the organization. Over the years, state funding for the Alliance has gone from about $40 million a year to about half that amount.

Allen called GRA’s funding levels “inconsistent” with a trend line that has been “going in the wrong direction.”

But now the Alliance is working on a new strategic plan, and it is seeking input from the Kemp administration to make sure there’s a close partnership.

“This is historic,” said Larry Gellerstedt, executive chairman of Cousins Properties Inc. and GRA’s outgoing board chair. “We’ve been defensive for many years. We now can refocus GRA for great things in the future.”

Allen said the Alliance has been instrumental in helping grow the state’s research funding to more than $1 billion a year. About half of those dollars come from the National Institutes of Health, which has had a 20 percent growth rate in grants to Georgia universities since 2010 (compared to a national growth rate of 7.5 percent).

“I’m not viewing this as a blank slate,” Allen said. “GRA has a really strong foundation."

But Allen said there are areas that need attention, such as a need to increase endowment levels given to eminent scholars the Alliance is trying to lure to the state. There also is increased competition from other states for scholars and commercialization support.

Allen listed several opportunities for increased support – investing more in brain health research and “translational” agriculture, that encompasses food security and research.

A draft strategic plan will be presented at the May board meeting, which the governor is expected to attend. The plan will be delivered to Kemp during the summer for his input, and an implementation plan will be presented at the September board meeting.

02/15/2019

An inside look at the policy issues Georgia Bio is tackling in 2019

Tue, 02 Jul 2019 15:58:50 GMT

As Georgia welcomes its new Governor and a wave of newly elected legislators, we asked Kallarin Mackey, Emory University Director of State Affairs, Government and Community Affairs and Joseph (Joe) Zorzoli, Head of U.S. Government Relations for UCB to weigh in on the state of play in life sciences policy in Georgia.

How does Georgia Bio plan to work with the incoming Governor and newly elected legislators to ensure they are aware of the important issues of the life sciences industry?

KALLARIN: It will be important to begin by educating the newly elected officials on who Georgia Bio is as an organization, the issues that are important to the membership and the impact that the life sciences industry has on our state. Georgia’s bioscience firms have grown their employment base by 10.6 percent since 2014 and employed just over 32,000 in 2016. To the point above, one of the best ways to illustrate this is by bringing legislators on site to see the work that Georgia Bio members are doing across the state. It’s important to make it personal. Seeing in person the research and innovation that Georgia Bio members engage in every day is a great way to help a lawmaker understand the impact that these companies have in their own district and across the state.

Regarding workforce development, Georgia’s life science industry is consistently seeing a shortage of employees with necessary skills to fill jobs. One example is biomanufacturing. Our research universities, through federal, private and state funding, have advanced their bio manufacturing centers and programs helping to position Georgia as a leader in the future of biotechnology in medicine, agriculture and industrial applications. However, many of our high school students don’t have the opportunity to learn and advance into these degree programs.

How could Georgia Bio help support a student and workforce pipeline for the industry?

KALLARIN: Georgia has a unique opportunity to grow its life science workforce and improve opportunities for young people in rural communities by investing in cutting-edge teacher training workshops that will provide them skills to successfully compete for jobs in the one of the highest paying career sectors. Georgia Bio is leading an effort to seek state support for rural teacher training in biomanufacturing for agribusiness, medicine, and industrial applications. The initiative will reach eight rural and under-served school districts with hands-on, life science curriculum and training for 7-12^thgrade teachers. The program will train 64 teachers and impact over 5,000 students. As a result, these schools districts will provide a more experienced cohort of students skilled in applicable capabilities.

On patient access, there is discussion that we could see a state waiver for Medicaid expansion this year. Do you think we are likely to see that happen this year? How does that issue impact Georgia Bio’s membership and getting patients access to cutting edge drugs on the market?

KALLARIN: The Governor has announced that he is dedicating $1 million in the FY2020 budget to develop a Medicaid waiver plan that would allow Georgia to have more flexibility in how it administers the program. We are hopeful that a waiver will expand access to care for Georgians and provide them with the drugs that they need. Another critical piece to providing patients greater access to these medications is the passage of legislation to establish clinical review criteria for step therapy protocols. This is an issue that Georgia Bio has been working on for the past few years and we are grateful to the lawmakers who have championed the issue. We hope to continue the conversation this session to seek final passage of the legislation.

Economic Development - Georgia Bio promotes tax incentives to support emerging technology companies. 28 other states have created matching grant program for recipients of National Institutes of Health SBIR (Small Business Innovative Research) and STTR (Small Business Technology Transfer) grants. Do you think Georgia should enact similar measures?

JOE: I do. It makes a lot of sense to me as we know these incentives work and helps to create and grow the health sciences ecosystem in Georgia.28 other states have passed measures for the state to match SBIR & STTR grants.

Federal Issues.What federal issues could impact Georgia’s state policy agenda?

JOE: University Research, patient access and net operating loss. Let’s take these one at a time.

University Research - The immigration debate has already led to one government shutdown and could perhaps lead to another mid-month. Fortunately, NIH and CDC funding have already been approved for the remainder of the fiscal year, but the National Science Foundation (NSF) has not. Another shutdown when the latest funding bill expires could once again put a hold on NSF research grants.

Patient Access - Gov. Brian Kemp announced plans to apply to CMS for a waiver to expand patient access through the State’s Medicaid program. CMS has already approved more than 30 such waivers and this Administration remains receptive to such waivers. Georgia’s application details have yet to be decided, but if approved it could lead to access for many of the 500,000 uninsured who might otherwise qualify for Medicaid through a straight Medicaid expansion. Applying for a waiver is consistent with GA Bio’s support for expanding access to innovative therapies through the State’s Medicaid program.

Net Operating Loss - The Tax Cuts and Jobs Act of 2017 limited the deductibility of net operating losses (NOLs) in a way that adversely impacts Georgia’s biotech startups, especially when it comes to potential valuations. The next time Congress makes changes to the tax code, it needs to address the needs of capital-intensive biotechnology start-ups by allowing them to fundraise without sacrificing accumulated NOLs.

Why is it valuable that Georgia Bio is enhancing its policy work?

KALLARIN: The life science industry routinely reports shortages of skilled employees and without intervention, the deficit will continue to grow. It is critical for lawmakers to understand the impact that this industry has on Georgia’s economic development and the significant loss we could face if we do not continue to invest in the education and resources necessary to continue its growth trajectory. There’s tough competition for the attention of lawmakers, between healthcare, public safety, transportation and education, that Georgia Bio must put the spotlight on the life sciences industry to demonstrate that it cuts across many of these policy areas.

Georgia Bio works on behalf of 200 member organizations to drive public policy, build a network of industry leaders, create access to capital, introduce cutting-edge STEM education programs, and create robust value-driven purchasing programs. We partner with BIO to offer members discounted prices and/or enhanced services on products and services essential to their business operations. Learn more here.

Follow Georgia Bio on LinkedIn,Twitterand Facebook.

02/13/2019

Statement re ECO Animal Health and University of Georgia sign second poultry vaccine development licencing deal

Tue, 02 Jul 2019 16:00:07 GMT

ECO Animal Health Group plc

(AIM: EAH)

ECO Animal Health and University of Georgia sign second poultry vaccine development licencing deal

ECO Animal Health Ltd (ECO), a wholly owned subsidiary of ECO Animal Health Group plc, is pleased to announce that it has entered a second worldwide exclusive licensing deal with the Poultry Diagnostic & Research Center, College of Veterinary Medicine at the University of Georgia (UGA).

This deal, which follows on from the one leading to the development of potential vaccines in the field of Mycoplasma gallisepticum, allows ECO to further develop, register and commercialize a live attenuated Mycoplasma synoviae vaccine for poultry developed by UGA. University researchers have concluded preliminary proof of concept efficacy and safety studies with this vaccine.

Peter Lawrence, Non-Executive Chairman of ECO Animal Health Group plc said, “Mycoplasma synoviae is a bacterium thataffects predominately commercial layers and breeding birds worldwide resulting in a 5 to 10 per cent loss in egg production and lower egg quality in affected flocks “.

UGA Professor Naola Ferguson-Noel, a researcher in the Poultry Diagnostic & Research Center said, “We look forward to working with ECO Animal Health to help further develop this Mycoplasma synoviae vaccine into an approved product”.

The information contained within this announcement is deemed by the Group to constitute inside information as stipulated under the Market Abuse Regulations (EU) No. 596/2014 ("MAR"). Upon the publication of this announcement via a Regulatory Information Service ("RIS"), this inside information is now considered to be in the public domain.

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About ECO Animal Health Ltd

ECO Animal Health based in London U.K. is a leader in the development, registration and marketing of pharmaceutical products for global animal health markets. Its products for these growth markets promote well-being in animals and include the novel antimicrobial, Aivlosin®, as well as a range of generic therapeutic products.

About University of Georgia

UGA is an American public, flagship, and comprehensive research university based in Athens, Georgia. It has been ranked in the Top 10 of all USA universities for licensing deals for the past decade and, to date, more than 700 UGA products and technologies have been introduced to the marketplace.

02/11/2019

Animal Health company pledges $120M Georgia investment, 225 new jobs

Tue, 02 Jul 2019 16:01:16 GMT

Duluth-based Boehringer Ingelheim Animal Health USA Inc. is bolstering its investment in Georgia with a commitment to invest $120 million in Gwinnett, Clarke, and Hall counties, according Gov. Brian Kemp's office.

Boehringer Ingelheim said Friday the animal health company will create 225 jobs in the counties, including 75 at its North American headquarters in Duluth. More than 100 new jobs will go to its manufacturing and R&D facility in Athens, and 50-plus more at the company’s Gainesville manufacturing facility, according to a news release from the governor's office.

Boehringer Ingelheim announced in November of 2016 it would move its North American animal health headquarters from Kansas City to Duluth.

“We’re excited to welcome Boehringer Ingelheim Animal Health USA Inc. to the Peach State,” said Gov. Kemp, according to Friday's news release. His office later amended the quote to read, “We’re excited to announce further investment from Boehringer Ingelheim Animal Health USA Inc. in our state.”

“As a family-owned business, they will join a first-class corporate family here in Georgia," Kemp added. "I look forward to working with them to strengthen our university system and existing industries in agribusiness, health technology, and science.”

Boehringer Ingelheim's animal-health business focuses on preventive healthcare by developing vaccines, parasiticides and pharmaceuticals. The company's products for dogs and cats as well as cattle, swine, poultry and horses include the brands Frontline, Heartgard, Nexgard, Gastrogard and Ingelvac.

The company employs more than 3,000 people in the United States. Earlier this week, Everett Hoekstra was named the new president of Boehringer Ingelheim Animal Health USA Inc., succeeding Paul Fonteyne, who retired after 15 years with the company.

“For nearly 40 years, the company and its predecessors have helped make the state of Georgia a key player in animal health — from its beginning producing rabies vaccines in Athens, to multiple facilities today, that are playing an instrumental role in advancing animal health and well-being,” Hoekstra said in the news release. “Our investments will expand our capabilities and presence in Georgia, and drive future growth and innovation to help prevent disease in livestock and pets.”

Boehringer Ingelheim, headquartered in Ingelheim, Germany, is the second largest animal health business in the world with net sales in 2017 of $4.4 billion and around 10,000 employees worldwide.

Parent company Boehringer Ingelheim is one of the world's top 20 pharmaceutical companies, headquartered in Ingelheim, Germany, with approximately 50,000 employees.

“It’s a great day in Georgia when we can announce that a project will spur job creation in three counties,” said Georgia Department of Economic Development Commissioner Pat Wilson. “Boehringer Ingelheim’s new US animal health headquarters and dual expansions are a testament to our colleges and universities as well the resources surrounding agribusiness and veterinary sciences in Georgia."

02/11/2019

Georgia Bio Names Maria Thacker-Goethe President and CEO

Tue, 02 Jul 2019 16:02:36 GMT

Atlanta, Georgia (February 8, 2019) – Georgia Bio has named Maria Thacker-Goethe President and CEO of the state’s public policy and business solutions organization representing Georgia’s life sciences industry.

“For more than a decade, Maria has established a strong reputation for her industry knowledge and expertise with Georgia businesses, leaders and legislators,” said Georgia Bio Chair Patricia Fritz, Vice President, U.S. Corporate Affairs at UCB Inc. “Maria’s experience, determination and decisiveness give the board confidence that she is the right person at the right time to lead Georgia Bio.

Ms. Thacker-Goethe has served in a variety of roles for Georgia Bio over the years including Marketing, Membership and Project Manager. From 2013 to 2018 she served as Vice President of Operations. An innovative thinker with broad-based expertise in operations, community relationship building, and marketing Ms. Thacker-Goethe has been a driving force behind Georgia Bio’s programs and the development of the Georgia BioEd Institute.

“Among our top priorities for 2019 are ensuring our members know the value we bring to them through legislative affairs, ecosystem encouragement and purchasing opportunities that drive down the cost of doing business in life sciences in Georgia,” Ms. Thacker-Goethe said. “We will also seek to highlight our members’ industry contributions as we celebrate our 30th anniversary, expand the organization’s membership to encompass digital health, agricultural, plant and industrial biotechnology.”

The Georgia Bio 30th Anniversary Gala and Golden Helix Awards are February 8, 2019 at the Hyatt Regency Atlanta Perimeter at Villa Christina.

Mrs. Thacker-Goethe has been working alongside Georgia BioEd Institute and industry government affairs leaders to develop a proposal to grow Georgia’s biomanufacturing workforce and improve opportunities for young people in rural communities. The proposal involves investing in cutting-edge teacher training workshops which provide students with access and opportunity to high-paying and innovative jobs in the life science industry. Thacker is the first woman to hold this leadership position and had been serving under an “Interim” title following the departure of Russell Allen in September 2018.

Ms. Thacker-Goethe earned her master’s in public health in health education/communication, and maternal and child health at the Tulane School of Public Health and Tropical Medicine, and her Bachelor of Arts in environmental studies from Sweet Briar College. She is a 2009 recipient of the Power 30 Under 30 Award for professional and community excellence. Ms. Thacker currently sits on the CJD Foundation Board of Directors and an executive committee member for the Coalition of State Bioscience Institutes. Additionally, Ms. Thacker Goethe volunteers with the Junior League of Atlanta co-chairing the La Amistad Estrellitas program which works to empower Latina teens; she has volunteered with this program for 9 years now.

About Georgia Bio

Georgia Bio (www.gabio.org) is the state’s private, non-profit life sciences association. Members include pharmaceutical, biotechnology and medical device companies, medical centers, universities and research institutes, government groups and other business organizations involved in the development of life sciences related products and services.

02/08/2019

Boehringer Ingelheim Animal Health USA promotes CFO to president

Tue, 02 Jul 2019 16:03:55 GMT

Everett Hoekstra is the new president of Duluth-based Boehringer Ingelheim Animal Health USA Inc.

Hoekstra, who most recently was chief financial officer of the U.S. animal health business, succeeds Paul Fonteyne, who retired after 15 years with Boehringer Ingelheim.

Hoekstra takes the helm two years after Boehringer Ingelheim's animal-health business acquired Merial from Sanofi.

Together with Timothy Bettington, who leads the company's U.S. commercial operations, he will oversee the company's largest animal health market.

Hoekstra has held a variety of leadership roles since joining Boehringer Ingelheim in 1997, mainly in finance at the company's human pharmaceutical business. He also co-led the launch of Boehringer Ingelheim's global diabetes alliance with Eli Lilly and Co., as well as serving as CFO of its animal health company.

A native of Iowa, Hoekstra early in his career spent 12 years as co-owner and business manager for a veterinary group in the Midwest. As part of that group, he helped build several successful veterinary agriculture businesses, including a swine biologics business that today is part of Boehringer Ingelheim, a veterinary distribution company, and a bovine reproductive technology services company.

"Those experiences gave me a deep appreciation of the invaluable contributions veterinarians make every day," Hoekstra said in a Jan. 29 announcement. "Preventing disease in pets and livestock — and keeping animals healthy — contributes to human health and wellbeing. I look forward to helping advance Boehringer Ingelheim's legacy as a leader, good steward and key innovator in the animal health industry."

The company employs more than 3,000 people in the United States, including at its U.S. headquarters in Duluth, Ga., an R&D and manufacturing site in Athens, Ga., manufacturing sites in Gainesville, Ga, and Barceloneta, Puerto Rico, and a manufacturing and R&D site in St. Joseph, Mo. It also has a presence in U.S. communities including North Brunswick, N.J.; Worthington, Minn.; and Ames, Iowa.

Boehringer Ingelheim is the second largest animal health business in the world with net sales in 2017 of $4.4 billion and around 10,000 employees worldwide.

Parent company Boehringer Ingelheim is one of the world's top 20 pharmaceutical companies, headquartered in Ingelheim, Germany, with approximately 50,000 employees.

02/06/2019

BIO Statement on New Proposal for Lowering Out-of-Pocket Costs for Medicines

Tue, 02 Jul 2019 16:04:48 GMT

Washington, DC (January 31, 2019) – BIO’s President and CEO Jim Greenwood issued the following statement today after the Trump administration released a proposed rule that would alter safe harbor policies under the federal anti-kickback statute:

“BIO strongly supports the goal of this proposed rule to lower out-of-pocket costs for consumers. Every year innovative drugmakers provide tens of billions of dollars in rebates to help expand affordable access to prescription medicines. But far too often these rebates are not passed along to patients and are instead used to pad the profits of middlemen. The current system creates perverse incentives that are driving the affordability crisis many patients face today.

“We firmly believe that the rebates drugmakers provide insurers and other middlemen should be used to lower what patients pay out of pocket for prescription medicines. While we intend to carefully review the details of this proposed rule, we are encouraged the administration is moving forward with market-based reforms that are aimed at lowering out-of-pocket costs for prescription drugs. We urge the administration to adopt a final rule that leads to a fairer system and helps provide more patients affordable access to the medicines they need.”

02/04/2019

GeoVax Zika Vaccine Study Published in the Atlas of Science

Tue, 02 Jul 2019 16:07:02 GMT

GeoVax Zika Vaccine Provides Potential for 100% Protection & Reduced Side-Effect Risks

ATLANTA, GA, January 24, 2019 – GeoVax Labs, Inc. (OTCQB: GOVX), a biotechnology company developing human vaccines, today announced the publication of a manuscript entitled “A Vaccine Candidate for Zika with Potential for Reduced Risk of Antibody-Dependent Enhancement (ADE).” The article is published in the open-access journal Atlas of Scienceand can be viewed at http://atlasofscience.org/a-vaccine-candidate-for-zika-with-potential-for-reduced-risk-of-antibody-dependent-enhancement-ade/#more-27090.

The article reports a major step forward in the development of a vaccine for protection against Zika virus (ZIKV). Testing in a highly rigorous challenge model showed the GeoVax vaccine, GEO-ZM02, provided 100% protection to mice infected with a lethal dose of ZIKV delivered directly into the brain. The study was funded by a grant from the U.S. Centers for Disease Control and Prevention (CDC), which also provided technical assistance.

GEO-ZM02 not only has the potential of a single-dose vaccine, which is practical to combat epidemics in resource-strained countries, but also does not bear the risk of enhancing other flavivirus infections, such as Dengue serotypes 1-4. This phenomenon, called Antibody Dependent Enhancement (ADE) of infection, has been shown to increase severity of Dengue infection in vivo, and is a safety concern for other Zika vaccines under development that utilize the structural Envelope (E) protein of ZIKV for their vaccine construct. GEO-ZM02 is based on the non-structural 1 (NS1) protein of ZIKV, which is not packaged into the virions and is not involved in ADE. Moreover, the NS1 protein is abundantly secreted into the blood of a ZIKV-infected individual and has been shown to play a critical role in flavivirus acquisition by mosquitoes by overcoming the immune barrier of the mosquito midgut. Therefore, a vaccine that targets the NS1 protein has the potential to protect both humans and mosquitoes from ZIKV infection; a novel vaccination strategy that could stem epidemics at a low vaccine coverage.

Results of the study were originally published in the peer-reviewed open access journal Scientific Reports by Nature Research and can be viewed at www.nature.com/articles/s41598-017-15039-8.

About Atlas of Science

Atlas of Science was started by scientists to promote the dissemination of scientific research and provides the opportunity for scientists to write and publish a short and accessible layman summary of their latest research, based on peer-reviewed articles.

About GeoVax

GeoVax Labs, Inc., is a clinical-stage biotechnology company developing human vaccines against infectious diseases using its patented MVA-VLP vaccine platform. GeoVax was the winner of the 2018 “Best Biotech” Vaccine Industry Excellence Awards, a finalist for the 2018 “Best Prophylactic Vaccine” Award for its Zika vaccine at the World Vaccine Congress, as well as a finalist for Pipelines of Promise at Buzz of Bio 2018. The Company’s development programs are focused on vaccines against Zika, hemorrhagic fever viruses (Ebola, Sudan, Marburg and Lassa), HIV and malaria. GeoVax also is evaluating the use of its MVA-VLP platform in cancer immunotherapy, and for therapeutic use in chronic Hepatitis B infections and in treating Human Papillomavirus (HPV) infections. GeoVax’s vaccine platform supportsin vivo production of non-infectious VLPs from the cells of the very person receiving the vaccine. The production of VLPs in the person being vaccinated mimics virus production in a natural infection, stimulating both the humoral and cellular arms of the immune system to recognize, prevent, and control the target infection. For more information, visithttps://www.geovax.com

Contact:

GeoVax Labs, Inc.

investor@geovax.com

678-384-7220

01/24/2019

Georgia Bio to Celebrate 30 Years at Annual Awards Dinner

Tue, 02 Jul 2019 16:08:13 GMT

GRA’s Russell Allen and Inventor Richard Hillstead to Receive Top Honors

ATLANTA, GA (January 22, 2019) – Georgia Bio, the state’s life science trade association, will celebrate its 30^thAnniversary Gala & Annual Golden Helix Awards on Friday, February 8 at the Hyatt at Villa Christina in Atlanta. Georgia Bio is pleased to announce the winners of the 2019 Golden Helix Awards.

The 2019 Golden Helix Awards celebrate the contributions and achievements of Georgia individual and company leaders working to advance the growth of the life sciences industry and foster strategic partnerships that can create a healthier world. The event is expected to draw 300 of the state’s life sciences industry leaders.

Russell Allen, President & CEO of Georgia Research Alliance and former President & CEO of Georgia Bio; and Dr. Richard Hillstead, a long-time entrepreneur, inventor and investor who champions industry workforce development, are the recipients of the 2019 Georgia Bio Industry Growth Awards. The Industry Growth Awards are the highest honors bestowed each year by Georgia Bio.

Learn more and register at www.gabio.org/awards.

“Our life sciences community employs more than 32,000 Georgians,” said Bob McNally, Chair of the Georgia Bio Awards Committee. “It is important to recognize the individuals and organizations supporting healthcare innovations and leadership here in Georgia. As the association representing and advocating for medical devices, pharmaceuticals and biotechnology in Georgia, we look forward to bringing the sector together on February 8th for an evening of networking and celebration.”

Georgia Bio presents awards to individuals and companies in seven categories: Industry Growth; Deals of the Year; Community; Innovation; Emerging Leader; Biotech Teacher of the Year; and the Metro Atlanta Chamber sponsored Phoenix Award. Winners are some of Georgia’s hardest working innovators and entrepreneurs producing advanced medicines, diagnostics and technologies to improve medical care.

Companies being honored with the distinguished Deal of the Year award include: Antios Therapeutics for their $25 Million raise in an oversubscribed series A financing to pursue a Hepatitis B cure; Arbor Pharmaceuticals for its licensing agreement with Tasly Pharmaceuticals to develop and market an investigational modern innovative Chinese medicine compound; BD (Becton, Dickinson and Company) for the acquisition of C. R. Bard, Inc.; Boehringer Ingelheim Animal Health USA Inc. for investments in Georgia facilities; Rimidi, Inc. for a $6.575 Million Series A raise with strategic investment from Eli Lilly to grow and accelerate the digital health company’s market penetration; and Wright Medical Group for the acquisition of Cartiva Inc.

“This year’s winners showcase the best in innovation and leadership in our community working to improve patients’ lives,” said Maria Thacker Goethe, Acting President and CEO, Georgia Bio. “The awards program is one night for our members to pause and recognize the individuals and companies who are making lasting contributions to the sector in Georgia.”

AWARD WINNERS

Georgia Bio Industry Growth Awards: Presented to two people who have made an extraordinary contribution to the growth of the life sciences industry in Georgia.

C. Russell Allen, President & CEO, Georgia Research Alliance
Richard A. Hillstead Ph.D., FAHA

Phoenix Award: Presented to two Georgia honorees who have forged academic and industry relationships that will drive translation and lead to new treatments and cures. This award is sponsored by the Metro Atlanta Chamber.

Global Center for Medical Innovation / Rambam Healthcare Campus

Deals of the Year Awards: Presented to one or more companies or institutions for the most significant financial or commercial transactions closed from November 1, 2017-October 31, 2018, based on the importance of the transaction to Georgia’s life sciences industry.

Acquisitions

Becton, Dickinson & Co. & C. R. Bard, Inc.
Wright Medical Group & Cartiva

Economic Development

Boehringer Ingelheim Animal Health USA Inc.

Licensing Agreement

Arbor Pharmaceuticals & Tasly Pharmaceuticals

Private Financing

Antios Therapeutics
Rimidi Diabetes Inc.

Community Awards: Presented to a small number of individuals, companies or institutions whose contributions to Georgia’s life sciences community are worthy of special recognition.

Atlanta Science Festival
Chaarles G. Fogelgren, MBA, med fusion – a Quest Diagnostics Company
Pediatric Technology Center, Children's Healthcare of Atlanta
Joseph Hobbs, MD, Augusta University
Kornelius Bankston, Color Genomics, Inc.
International Biomedical Regulatory Sciences Program, University of Georgia, College of Pharmacy

Innovation Awards: Presented to the department, institution, company or individuals who are forging new ground by thinking outside traditional paradigms to create some unique technology.

GloShieldTM, Jackson Medical
3D-Printed Tracheal Splint in Pediatric Patient, Children’s Healthcare of Atlanta / Georgia Institute of Technology

Emerging Leader of the Year Awards: Presented to young individuals who have made a significant impact on the life sciences industry through their studies or employment.

Benjamin Boward, University of Georgia
James R. Lewis, Co-Founder/CEO, Innovation Hub Enterprises

Teacher of the Year Award: Presented to a Georgia biotechnology high school teacher who exhibits excellence in STEM teaching and support for the biotechnology pathway.

Tricia Pedersen, Paulding County High School
Elizabeth Proctor, Jasper County High School

For a list of past Georgia Bio Industry Growth Award recipients, click here.

ABOUT GEORGIA BIO (GaBio)

Georgia Bio (GaBio) is the state’s life science advocacy and business leadership industry association whose members include pharmaceutical, biotechnology and medical device companies, medical centers, universities and research institutes, government groups and other business organizations involved in the development of life sciences related products and services. GaBio works closely with industry, government, academia and others to shape public policy, improve access to innovative technologies and grow Georgia’s life sciences economy. Visit GaBio at www.gabio.org, and follow us on Twitter @Georgia_Bio,Facebook, and LinkedIn.

Media Contact:Maria Thacker Goethe, 404-920-2042, mthacker@gabio.org

Credentialed members of the news media are invited to attend as guests. Please register with Georgia Bio.

01/23/2019

Georgia Bio Bolsters Policy Resources Naming Joseph Santoro New VP of Business Development and External Affairs

Tue, 02 Jul 2019 16:09:22 GMT

Atlanta, Georgia (January 17, 2019) – Georgia Bio, the state’s public policy and business solutions organization representing Georgia’s life sciences sector, today announced an expansion to its team hiring Joseph Santoro as the full-time Vice President of Business Development and External Affairs. This newly created role will provide expanded leadership in developing and implementing sound public policy strategies for Georgia Bio members and strengthen the voice of life sciences in the state.

“My number one priority is ensuring Georgia’s elected leaders and policy makers are aware of, and understand, the value and potential the life sciences ecosystem and industry bring to the state,” Mr. Santoro said.

According to the national Biotechnology Innovation Organization (BIO), the bioscience industry employs more than 32,000 Georgians and received $537 million in National Institutes of Health (NIH) Awards in 2017.

As Georgia’s biotechnology, medical device, agbio, and the digital health community continues to grow, the addition of Mr. Santoro bolsters the organization’s government relations activities. Those activities seek to drive solution-oriented public policies and advocacy that support life sciences research, investment and innovation in the state. In addition to his policy duties, Mr. Santoro is responsible for recruiting new members from life science organizations and research institutions in Georgia, as well as the service providers that support the industry.

Mr. Santoro previously served as director of external affairs for the Technology Association of Georgia (TAG). He comes to Georgia Bio with previous experience working with economic development organizations including the Metro Atlanta Chamber of Commerce and Invest Atlanta. He is a graduate of the Georgia Institute of Technology with a degree in Public Policy.

“This new role, with ongoing support from our lobbyist Cornerstone Government Affairs, will deepen our relationship with policymakers,” said Maria Thacker Goethe, Georgia Bio’s acting president and CEO. “Joseph will enhance awareness at the state level for the contributions our life sciences sector and member companies make to Georgia’s economy and improvements in patient care. I am delighted to welcome him to Georgia Bio.”

About Georgia Bio

01/22/2019

Georgia bio company names new CEO

Tue, 02 Jul 2019 16:11:06 GMT

An Athens, Ga., bio company has named a new CEO.

ArunA Bio, founded by a University of Georgia professor more than 12 years ago, is developing a type of cell-free biologics called exosomes for the treatment of central nervous system and neurodegenerative disorders.

Mark Sirgo takes over as chief executive from Steve Stice, co-founder and chief scientific officer of ArunA Bio. Sirgo has more than 35 years of pharmaceutical experience, including serving as president and CEO of BioDelivery Sciences International (Nasdaq: BDSI), a specialty pharmaceutical company focused on the central nervous system and pain. At BDSI, Sirgo raised nearly $600 million to support the development, FDA approval and commercial launch of three products utilizing the company’s proprietary drug delivery technology.

Stice directs the company’s clinical and research operations. He is also UGA DW Brooks Distinguished Professor and Director of the Regenerative Bioscience Center, and he holds a Georgia Research Alliance Eminent Scholar endowed chair.

“Mark is joining ArunA Bio at a pivotal time in the company’s evolution as we move toward clinical trials and industry collaborations,” Stice said in an announcement. “Mark brings a wealth of pharmaceutical industry experience and a proven track record of successfully building a portfolio of products, raising capital, securing industry partnerships and progressing products through FDA approval and commercialization. With the addition of Mark to the leadership team, I am able to focus completely on my true passion — directing research and scientific development.”

Prior to joining BioDelivery Services, Sirgo spent 16 years in a variety of clinical and commercial leadership positions at Glaxo, Glaxo Wellcome, and GlaxoSmithKline, including vice president of International OTC Development and vice president of New Product Marketing. Sirgo received his BS in pharmacy from Ohio State University and his doctorate in pharmacy from Philadelphia College of Pharmacy and Science.

“I look forward to working closely with Steve, the ArunA team and the Board in raising the visibility of the company by advancing their exciting and novel neural exosome technology into a portfolio of therapeutics both internally and through industry partnerships,” Sirgo said in the announcement. “ArunA Bio has the opportunity to dramatically improve the outcomes for patients suffering from serious and debilitating CNS diseases and cancers by overcoming the challenges of delivering products across the blood brain barrier. I look forward to contributing to the growth and expansion of the company.”

01/16/2019

Deal: BioIQ to locate headquarters in Cobb County

Tue, 02 Jul 2019 16:12:49 GMT

Health IT company to create 500 jobs, invest more than $5 million

Gov. Nathan Deal today announced that BioIQ, a health IT company, will create 500 jobs and invest more than $5 million in Cobb County through the location of its new headquarters. New jobs will include positions in technology, sales and operations.

“BioIQ has significant reach across the nation and has proven itself to be a leader in health care innovation,” said Deal. “By locating its headquarters in Cobb County, BioIQ will join Georgia’s thriving technology innovation sector and enjoy the benefits of our deep talent pool. I am confident BioIQ will find quick and lasting success with the help of Georgia’s low-tax, top-ranked business climate. We are proud to welcome BioIQ to the No. 1 state for business and we look forward to the growth of this partnership in the years to come.

BioIQ simplifies health testing and immunization programs for health plans, employers and government organizations, and empowers people to take action to improve their health. BioIQ’s platform provides a single-source solution to drive health plan quality, cost savings and value-based care initiatives. The platform configures and connects national laboratories, diagnostics companies, digital health solutions and other stakeholders through underlying engagement, analytics and interoperability technology.

“We selected Atlanta as BioIQ’s headquarters because of the city’s exceptional talent pool, forward-thinking business community, and convenient access to our growing client base,” said BioIQ CEO Justin Bellante. “Our Cobb County headquarters is a reflection of BioIQ’s investment in its employees and commitment to bringing together talent, technology and innovation to achieve our mission of positively impacting 100 million lives.

BioIQ works with more than 35 leading health plans, including seven of the nation’s ten largest health plans. BioIQ enables individuals to conveniently access care at more than 16,000 locations, including leading retail pharmaciesand lab testing centers across the county.

“Cobb County has proven to be a top site for corporate relocation and expansion,” said Sharon Mason, president and CEO of the Cobb Chamber. “We’re excited for BioIQ to expand their presence and relocate their global corporate headquarters in our community. BioIQ’s investment in our county represents a collaborative effort between our regional and statewide partners to establish a pipeline of skilled workers ready to meet the needs of today’s industry leaders.”

"Congratulations to BioIQ on their decision to locate their headquarters in Cobb County,” said Hala Moddelmog, president and CEO of the Metro Atlanta Chamber. “Their presence in metro Atlanta creates a significant addition to an already robust digital health ecosystem. With our thriving climate of innovation and business-friendly environment, we look forward to watching BioIQ succeed here.”

Georgia Department of Economic Development (GDEcD) Project Manager Sunny Anderson represented the Global Commerce Division in partnership with the Metro Atlanta Chamber, the Development Authority of Cobb County, the Cobb Chamber of Commerce and Georgia EMC.

“BioIQ is laying a foundation to improve the future of healthcare, and I’m glad they chose to do it right here in Georgia,” said GDEcD Commissioner Pat Wilson. “Their new headquarters operation in Cobb County is an example of how our strong healthcare network, thriving health IT sector, and abundant talent pool helps leading companies like BioIQ flourish.”

About BioIQ

BioIQ is a health care engagement and quality care gap closure company that is redefining the way payers, employers and consumers navigate and connect with the nation’s health care system. BioIQ leverages consumer analytics, real-time program intelligence, omnichannel engagement strategies and an extensive ecosystem of health care partners to provide a comprehensive view of individuals throughout their health journey and engage them in making better decisions that lead to healthier outcomes. With more than a decade of health care industry experience and a first-of-its-kind health connectivity platform, BioIQ is uniquely positioned at the convergence of population health and the consumerization and retail preparation of health care to drive the shift to value-based care for payers and employers. Since 2005, BioIQ has launched thousands of successful health testing programs to serve millions of participants. For more information, visit  https://www.bioiq.com/.

01/14/2019

Diversity in Clinical Trials: Preparing Physicians to Make a Difference

Tue, 02 Jul 2019 16:13:35 GMT

The U.S. has become increasingly diverse, yet that diversity is not reflected in the clinical trials that play a key role in which new medicines are approved and, ultimately, prescribed to the general public. Because of this underrepresentation, much of what we know about new medicines—including their effectiveness and potential side effects—might not apply to nearly one-third of Americans.

Black or African Americans represent 13.4 percent of the U.S. population but only 5 percent of clinical trial participants. Hispanics or Latinos represent 18.1 percent of the U.S. population but only 1 percent of clinical trial participants.

How can we increase minority participation? Studies show that a good place to start is with physicians who serve minority patients, especially if those physicians also are minorities.

That’s why Morehouse School of Medicine has partnered with Clinical Research Pathways on its new program, Training Minority Clinical Teams: Getting New Quality Medicines to All Americans. The program recognizes that minority physicians can reduce barriers to participation in clinical trials—provided obstacles are removed from the physicians’ paths as well.

We know that, in general, the people who provide patient care have an incredible impact on whether patients choose to participate in clinical trials. We also know that minority providers do not participate at the same rate as others. Minority providers simply don’t get asked, either because of lack of experience or because they are not known to those responsible for recruiting investigators.

At Morehouse School of Medicine, there are 134 physicians that serve 110,000 patients. In addition, we have a Community Physicians’ Network of 133 physicians who provide care to more than 460,000 patients. At least 30 percent of patients in each practice are minorities. We will use a three-year grant from Clinical Research Pathways to tap this network and open the pipeline for minority physicians by training and mentoring them to become clinical investigators. They, in turn, will open access to clinical trials for minority patients.

The opportunities are considerable.

As trained investigators, our minority physicians will be able to recruit and enroll patients for clinical trials and give patients the opportunity to benefit from potential medical advances. The results of those trials will have a positive effect beyond the patients involved. If the participants are more diverse, we will have a better understanding of who can benefit from which type of treatment and in what doses. We also will know who might be likely to react negatively to a specific medicine.

Equally important, our newly trained clinical investigators will be instrumental in helping to bring the benefits of research findings to all their patients.

One reason new treatments are not being used consistently is that while those involved in the research are aware of the results, many treating physicians are not. That contributes to a lag in the flow of information from discovery to practice. We can help accelerate that by increasing the number of physicians on the front line who are involved in research, know where to find the latest information, and can use it to better treat their patients.

01/09/2019

GeoVax and Enesi Pharma to Collaborate on Development of Multiple Vaccines Administered by ImplaVax(R), a Novel Needle-Free Vaccine Delivery Platform

Tue, 02 Jul 2019 16:14:36 GMT

Atlanta, GA - (NewMediaWire) - January 02, 2019 - GeoVax Labs, Inc. (OTCQB: GOVX), a biotechnology company developing human vaccines, and Enesi Pharma, an innovative pharmaceutical company developing unique injectable solid-dose drug-device vaccine products, announced today a collaboration to develop solid-dose needle-free vaccine formulations utilizing GeoVax’s novel MVA-VLP vaccine platform in combination with Enesi’s ImplaVax® device and formulation technology. The collaboration is expected to include development of thermostable solid-dose needle-free vaccines for a variety of infectious diseases and evaluation of the potential to generate improved vaccine responses with simplified administration and reduced storage and distribution costs.

GeoVax’s vaccine technology is based on its patented Modified Vaccinia Ankara (MVA) Virus-Like Particle (VLP) platform, which generates noninfectious VLPs in the individual being vaccinated. This technology mimics a natural viral infection, triggering the body to produce a robust and durable immune response (the way that vaccines protect against diseases), typically with only a single dose required for desired protection. As a result, the GeoVax vaccines provide the opportunity to deliver a more efficient, lower cost, highly effective vaccine.

Enesi’s proprietary ImplaVax® solid-dose formulation and needle-free device technology comprises three main components: a single precision-engineered solid-dose Universal Vaccine Implant (UVI) containing the vaccine construct, a separate single-use disposable unit dose cassette pre-loaded with a single solid UVI and a reusable handheld spring-powered actuator. The benefits include assured consistency with dosing, better product stability and ease of use as well as the potential to minimize vaccination pain and stress, and to eliminate needle disposal and needle stick injuries.

Farshad Guirakhoo, PhD, GeoVax’s Chief Scientific Officer, said, “We are delighted to begin this collaboration with Enesi Pharma, as we believe their technology has the potential to revolutionize needle-free vaccine delivery for multiple indications in key global markets. The combination of our thermally stable vaccines with Enesi’s ImplaVax® needle-free device is a natural fit and we think there is significant scientific rationale for expecting success especially in resource constrained countries where cold chain storage is an issue.”

David Hipkiss, CEO of Enesi Pharma, commented “Our novel ImplaVax® technology has great potential for developing the next generation of vaccine products for infectious diseases and allergies. We have been impressed with the GeoVax MVA-VLP vaccine platform and feel that when taken together makes an excellent potential combination. We look forward to working with GeoVax on this exciting new project.”

About Enesi Pharma

Enesi Pharma is an innovative pharmaceutical company developing new products with potential to transform performance and delivery of vaccines and make a material impact on global healthcare.

The company’s primary focus is the development of novel solid-dose vaccines against a range of infectious and other select diseases, working in partnership with global companies, government agencies and non-governmental organisations.

Enesi’s ImplaVax® formulation and device technologies offer significant potential benefits for patients, care givers, healthcare professionals and payers through enhanced effectiveness, safety, ease of use, reliability and stability, and are supported by a strong patient preference over a standard needle and syringe.

Enesi’s experienced leadership team has a proven track record in the successful development and commercialisation of innovative products delivering high value outcomes for all stakeholders. For more information visit www.enesipharma.com or follow Enesi on Twitter at www.twitter.com/enesi_pharma.

About GeoVax

GeoVax Labs, Inc., is a clinical-stage biotechnology company developing human vaccines against infectious diseases using its patented MVA-VLP vaccine platform. GeoVax was the winner of the 2018 “Best Biotech” Vaccine Industry Excellence Awards, a finalist for the 2018 “Best Prophylactic Vaccine” Award for its Zika vaccine at the World Vaccine Congress, as well as a finalist for Pipelines of Promise at Buzz of Bio 2018. The Company’s development programs are focused on vaccines against Zika, hemorrhagic fever viruses (Ebola, Sudan, Marburg and Lassa), HIV and malaria. GeoVax also is evaluating the use of its MVA-VLP platform in cancer immunotherapy, and for therapeutic use in chronic Hepatitis B infections and in treating Human Papillomavirus (HPV) infections. GeoVax’s vaccine platform supports in vivo production of non-infectious VLPs from the cells of the very person receiving the vaccine. The production of VLPs in the person being vaccinated mimics virus production in a natural infection, stimulating both the humoral and cellular arms of the immune system to recognize, prevent, and control the target infection. For more information, visit https://www.geovax.com.

Forward-Looking Statements

Certain statements in this document are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act. These statements are based on management's current expectations and are subject to uncertainty and changes in circumstances. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax can develop and manufacture its vaccines with the desired characteristics in a timely manner, GeoVax's vaccines will be safe for human use, GeoVax's vaccines will effectively prevent targeted infections in humans, GeoVax’s vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete vaccine development, there is development of competitive products that may be more effective or easier to use than GeoVax's products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements. More information about these factors is contained in GeoVax's filings with the Securities and Exchange Commission including those under "Risk Factors" in its Form 10-K.

01/02/2019

The right way to address prescription drug costs

Tue, 02 Jul 2019 16:16:31 GMT

With a new Democratic majority in the House pledging to address the rising cost of health care — including prescription drugs — a fundamental question arises: Will lawmakers focus on the real issues that can drain a family’s finances, or simply adopt extreme policies that fail to take on the underlying problems in our health care system?

As policy professionals from different sides of the aisle, we believe there is a right way to address these issues and a wrong way. The right way will reduce out-of-pocket costs for Americans, improve access to new medicines, and allow the United States to remain the global leader in medical innovation. The wrong way leads to price controls, weakened intellectual property protections, and restricted access to medicines, not to mention stifling innovation and doing little to make drugs more affordable.

Judging from the current state of the drug-pricing debate, we are concerned that policymakers will adopt the wrong approach.

Take Medicare, for example. Leading politicians are calling on the government to directly “negotiate” drugs prices under Medicare’s prescription drug program. But the Congressional Budget Office has concluded that this proposal won’t lower prices unless the government also restricts access to new medical breakthroughs.

Denying patients access to the medicines they need has never been popular. One proposal would give Medicare the power to directly negotiate drug prices. When the government doesn’t get the price its demands, federal bureaucrats would have the power to seize the drug developer’s intellectual property rights and give them to their competitors.

It gets worse. Another proposal would void the intellectual property of any drug with a price that exceeds the artificially low price controls set by foreign countries with socialized health care. This pricing scheme would apply to any medicine or treatment sold within the U.S. health care system, not just those provided through Medicare.

These ideas, known as compulsory licensing and international reference pricing, are counterproductive and antithetical to the best interests of patients. They fail the key test that any drug pricing proposal should have to pass: Are people who suffer from disease better off?

The United States develops more new medicines than the rest of the world combined precisely because we reject government price controls and assaults on intellectual property. Instead, our policies provide incentives for biomedical discovery through temporary market protection for innovators followed by generic competition.

This social compact works for all Americans — boosting our innovation economy, accelerating access to innovative treatments, and creating the most robust marketplace for cheaper generic medicines in the developed world.

If we go down the path of government control, we will destroy the delicate balance between innovation and competition. It costs on average $2.6 billion for each drug that successfully makes it to market, and more than 90 percent of clinical programs for new drugs ultimately fail. Further, more than 70 percent of drug development programs are being led by small biotechnology companies, which rely heavily on private-sector investments over a decade or more.

If forced to confront price controls and compulsory licensing, investors will put their money in the latest gadget rather than the next miracle cure. And if America targets its own innovators for such treatment, we can be sure that other countries would eagerly do the same for their innovators. The result? The number of new cures and treatments would be cut dramatically, which is bad news for the tens of millions of people who currently lack effective treatments.

That is a heavy price to pay when there is little evidence that compulsory licensing actually works. Indeed, there is no guarantee that any company receiving such a license would sell its copycat product for less, or that any savings would flow to patients. And what hasn’t been discussed is that when the government seizes property, it must pay reasonable compensation for it, creating a potentially significant liability for taxpayers.

The midterm election would be a missed opportunity if Congress fails to provide real relief to vulnerable patients and seniors. They and their families are too smart to accept a flawed bargain of potentially lower drug list prices in exchange for denial of robust access to the medicines they need today — and fewer new medicines tomorrow.

Rather than pursuing policies that will destroy innovation and harm patients, we need to adopt responsible reforms that make a meaningful difference in the lives of all patients by reducing their out-of-pocket expenses for prescription drugs and improving access to innovative medicines. There are numerous ideas available to help do just that, such as removing regulatory barriers to value-based pricing and capping what seniors must pay for medicines in Medicare.

We know what the right approach is for lowering prescription drug costs. All we need is for our elected policymakers to take it.

Jim Greenwood is president and CEO of the Biotechnology Innovation Organization. He represented Pennsylvania’s 8th Congressional District in the U.S. House of Representatives from 1993 to 2005. David Beier is managing director of Bay City Capital, a venture capital firm investing in life science companies. He previously served as a senior policy adviser for the Clinton administration and counsel to the U.S. House of Representatives Committee on the Judiciary.

Source: STAT

12/21/2018

Avanos Medical, Inc. Appoints David Ball as Senior Vice President, Global Supply Chain & Procurement

Tue, 02 Jul 2019 16:17:46 GMT

ALPHARETTA, Ga., Dec. 17, 2018 /PRNewswire/ -- Avanos Medical, Inc. today announced that David Ball has been appointed senior vice president, global supply chain & procurement. In this role, Ball will spearhead an integrated supply chain strategy to support Avanos' continued growth and transformation. Previously, Ball served as senior vice president of operations at Acelity where he led the company's global manufacturing operations and oversaw its inventory, supply chain, procurement and facilities functions.

"We are very pleased to have Dave join Avanos as senior vice president of global supply chain & procurement," stated Joe Woody, chief executive officer. "His prior experience at Acelity in transforming its global service organization, optimizing cost structures and driving continuous improvement and efficiency programs will be of great value as we focus on optimization and consolidation of our global operations."

While at Acelity, Ball was credited with helping to transform the company's global service organization, increasing efficiency within the company's manufacturing sites. Ball was instrumental in optimizing the company's cost structure and sustaining savings throughout the company's expansion. In addition, for over 30 years, Ball worked for GE's Healthcare, Transportation Systems and Railway Electronics businesses, as well as Harris Corp's Communications and Aerospace Systems divisions. He earned his bachelor's and master's degrees in electrical engineering from Georgia Tech.

Ball currently lives in South Carolina and will be transitioning to the company's Alpharetta headquarters in early 2019.

About Avanos Medical, Inc.
Avanos Medical, Inc. (NYSE: AVNS) is a medical technology company focused on delivering clinically superior breakthrough medical device solutions to improve patients' quality of life. Headquartered in Alpharetta, Georgia, Avanos is committed to addressing some of today's most important healthcare needs, such as reducing the use of opioids while helping patients move from surgery to recovery. Avanos develops, manufactures and markets its recognized brands in more than 90 countries. For more information, visit avanos.com.

SOURCE Avanos Medical, Inc.

12/20/2018

Avanos Among Winners of FDA's Opioid Innovation Challenge

Tue, 02 Jul 2019 16:18:33 GMT

ALPHARETTA, Ga., Dec. 10, 2018 /PRNewswire/ -- Avanos Medical, Inc. (NYSE: AVNS) is pleased to announce it has been selected as one of eight winners of the FDA's Opioid Addiction Innovation Challenge. The product selected is an enhanced nerve visualization system in development by Avanos' Acute Pain division.

The FDA launched the challenge in May 2018 to spur the development of medical devices and solutions to help combat the growing epidemic of opioid misuse and abuse. Avanos was selected as one of eight winners among more than 250 submissions from medical device companies and/or developers.

"The opioid epidemic is one of the most severe health crises we face today, and we are committed to being part of the solution," said Joe Woody, Avanos chief executive officer. "Our selection is an exciting recognition of our focus on innovation and demonstrates that our increased R&D investment and capability is being recognized."

The product selected by the FDA as part of the challenge is currently in pre-approval stages and the award does not confer potential agency approval status. However, being among the selected companies for this challenge will provide Avanos with critically important access to and integration with FDA's Center for Devices and Radiological Health (CDRH) experts, allow for enhanced clinical trial development plans, and expedite the FDA review process of our winning product.

SOURCE Avanos Medical, Inc.

12/20/2018

BIO Applauds Bipartisan 2018 Farm Bill

Tue, 02 Jul 2019 16:23:33 GMT

WASHINGTON--(BUSINESS WIRE)--Biotechnology Innovation Organization (BIO) President & CEO James C. Greenwood today issued the following statement on the 2018 Farm Bill:

"BIO applauds the Farm Bill Conference Committee, led by Senators Pat Roberts (R-KS) and Debbie Stabenow (D-MI) and representatives Michael Conaway (R-TX) and Collin Peterson (D-MN), on coming to a long-term agreement on a 2018 Farm Bill. At a time of uncertainty for our nation’s farmers, the agricultural economy, and rural America, this bipartisan Farm Bill will provide the much-needed confidence and certainty for many Americans who rely on its programs and funding.

“As a result of BIO’s advocacy, the conference committee provided mandatory funding for key programs in the Farm Bill’s energy title. While BIO would have preferred the conference committee adopted the Senate-passed funding levels for the title, we applaud the conferees for understanding the importance of these programs and thank them for providing mandatory funding to allow these programs to continue. As I testified to Congress when work first began on this important legislation, the Farm Bill’s energy title programs are critical to our nation’s farmers and rural communities as they develop new renewable chemicals, bio-based products, advanced biofuels, and other products of industrial biotechnology.

“Due to the adoption of several program improvements BIO promoted, the updated energy title ensures that new, innovative technologies and processes can qualify for these critical programs. This will help create entirely new value chains for sustainable, renewable products. It will also grow and strengthen America’s rural economy by allowing companies to rapidly commercialize renewable chemicals, bio-based products, advanced biofuels, and other products of industrial biotechnology.

“Additionally, BIO applauds the Farm Bill’s negotiators for including the Growing American Food Exports Act, which reauthorizes funds to USDA’s Foreign Agricultural Service (FAS) and reaffirms FAS’s broad authority to advocate on behalf of all agricultural technologies. These resources will also allow FAS to continue advocating for reduced trade barriers on behalf of America’s farmers and rural communities.

“Lastly, BIO thanks the conference committee for including language from the House version of the bill that directs definitional clarity and a regulatory improvement report for biostimulants. Biostimulants have tremendous potential to provide a new class of tools to farmers that will help with conservation, crop improvement, disease prevention and other uses, and this legislation establishes a clearer path for these tools going forward.

“BIO urges Congress to move swiftly to pass this greatly needed legislation. Moreover, BIO looks forward to continuing to work with Congress and the Administration to ensure the 2018 Farm Bill is implemented in a timely manner.”

About BIO

12/17/2018

AdvaMed Statement on Medical Device Tax Moratorium

Tue, 02 Jul 2019 16:26:10 GMT

Washington, D.C. – The Advanced Medical Technology Association (AdvaMed) issued the following statement from President and CEO Scott Whitaker as the House Ways and Means Committee released legislation that includes an extension of the moratorium on the medical device tax for an additional 5 years:

“The medical device excise tax is bad health policy and bad economic policy. No one disagrees on these points. We applaud the Committee for including a 5-year extension of the moratorium on the tax in its new extenders package, and we thank congressional medtech champions Rep. Erik Paulsen, Rep. Jackie Walorski, and Chairman Kevin Brady for spearheading this piece of the bill.

“A 5-year moratorium will give companies greater confidence in planning long-term R&D—a component that is critical to maintaining the longevity of the industry and sustaining the innovation ecosystem. Future breakthroughs in patient care are undermined by the threat of the medical device tax.

“If passed by Congress and signed into law, this action will help unleash new life changing technologies, heightened job creation, and economic growth. Most importantly, action by Congress to further delay the reinstatement of this onerous tax will help usher in the next leap forward in patient care.

“We stand ready to work with our congressional champions on both sides of the aisle and in both the House and the Senate to help ensure that this language becomes law.”

12/11/2018

MiMedx Announces Organizational Realignment Program

Tue, 02 Jul 2019 16:27:09 GMT

Plan Will Improve Cost Structure and is Designed to Position Business for Long-Term Success

MARIETTA, Ga., Dec. 5, 2018 /PRNewswire/ -- MiMedx Group, Inc. (OTC PINK: MDXG), a leading developer and marketer of regenerative and therapeutic biologics, today announced its plans to implement a broad-based organizational realignment, cost reduction and efficiency program to better ensure the Company's cost structure is appropriate given its revenue expectations. MiMedx plans to execute these initiatives while continuing to deliver products and support for healthcare providers and the patients they serve.

"Today's announcement is a continuation of management's efforts to position the business for long-term success by focusing on our wound care business, where our clinical studies best support patient outcomes and for which reimbursement policy has traditionally been more stable," said David Coles, Interim Chief Executive Officer. "Recent business trends and our internal analysis have led us to simplify and streamline our organizational structure, and reduce costs in order to improve profitability and liquidity."

The Company remains dedicated to executing its long-term strategic plan. In the near term, this includes a sharp focus on its traditional wound care business, further developing the Company's product pipeline, and continuing to pursue FDA approval for micronized dehydrated human amnion/chorion membrane (dHACM) to treat certain musculoskeletal pain indications as MiMedx transitions to a biopharmaceutical company.

The wound care market in which the Company operates is undergoing a transition as it adapts to a changing regulatory environment for human cells, tissues, and cellular and tissue-based products (HCT/Ps), as well as to recent third-party payer decisions eliminating health insurance coverage for certain uses of amniotic tissue products. Moreover, the Audit Committee's independent investigation has required changes to business practices to address issues identified in the investigation. MiMedx's realignment program was developed largely in response to these changes that have resulted in a material softening in the Company's recent revenue performance and expected near-term sales forecast.

The realignment will include a reduction of the MiMedx workforce by approximately 240 full-time employees, or 24% of its total workforce, of which about half are salesforce personnel. The cost reductions also include various non-employee expenses. As a result of this realignment program, management expects the Company to realize material, annualized cost savings beginning in the first quarter of 2019.

"Today's announcement is difficult as it affects many of our colleagues. I'd like to thank all of our employees for their contributions to our Company and their support of our mission," Coles continued. "We are confident these organizational changes will both better align our cost structure with our near-term revenue expectations and allow us to operate more efficiently and effectively. By tackling the cost structure now, we believe we are better able to position MiMedx to capitalize on the market opportunities presented by our products and pipeline and, hence, preserve and drive long-term shareholder value."

As previously announced, the Company is restating its financial statements. Due to the depth, breadth and complexity of issues identified, management has expanded the scope of work in connection with the preparation of the Company's financial statements and is unable to estimate the expected completion date at this time.

Due to the changes in business practices discussed above and other factors, including the inability to provide the full context of current or past performance, the Company is not currently in a position to provide any financial performance-related information. Moreover, at this time, the Company cannot estimate its exposure, if any, to potential contingent liabilities related to pending and threatened shareholder lawsuits, pending governmental investigations or other legal proceedings.

As previously disclosed, the Compensation Committee and the Board determined that the separations of the Company's former CEO, COO, CFO and Corporate Controller should be treated as "for cause" and that these former executive officers had engaged in, among other things, conduct detrimental to the business or reputation of the Company. The departures of these former executives have enabled the Company to progress in the preparation of its financial statements.

The Audit Committee's independent investigation is still ongoing, and there may be other actions taken based, at least in part, on information from the investigation. The Company continues to incur significant legal and accounting-related expenses related to, among other things, the Audit Committee's independent investigation and other legal matters, the Company's work to prepare its restated financial statements and the implementation of improved business controls.

Separately, the Board of Directors' search process for a permanent CEO is active and ongoing, and the Board has been meeting with candidates. However, the ongoing investigation, resulting extensive accounting analysis and pending financial restatement process make it challenging to attract qualified candidates. In addition, the financial restatement process has presented a practical issue with respect to candidates having sufficient information to evaluate the Company's financial situation and overall business.

"We regret that the tough decisions being made as a result of the realignment program are affecting team members across the organization," said Charles E. Evans, Chairman of the Board. "We do believe MiMedx is making significant progress on numerous, critical fronts. In particular, the Company has established an independent compliance function, assessed and improved sales and other business practices, is advancing the financial restatement process, continues to remediate the internal control environment, and is developing a long-range strategic plan."

About MiMedx
MiMedx® is a leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. The Company processes the human placental tissue utilizing its proprietary PURION® process methodology, among other processes, to produce allografts by employing aseptic processing techniques in addition to terminal sterilization. MiMedx has supplied over 1.3 million allografts to date. For additional information, please visit www.mimedx.com.

Safe Harbor Statement
This press release includes forward-looking statements including statements regarding the Company's expectation that the realignment program will improve profitability and liquidity, operating efficiency and align the Company's cost structure with expected near-term revenue projections; statements regarding the Company's expected near-term sales forecast; statements regarding the Company's long-term strategic plan including the Company's product pipeline and pursuit of FDA approval of micronized products, and expected cost savings from the realignment program. Forward-looking statements may be identified by words such as "believe," "expect," "may," "plan," "potential," "will," "would" and similar expressions and are based on management's current beliefs and expectations. Forward-looking statements are subject to risks and uncertainties, and the Company cautions investors against placing undue reliance on such statements.

Actual results may differ materially from those set forth in the forward-looking statements as a result of various factors, including the extent, timing and financial aspects of the realignment program, including the reduction in workforce and non-employee-related expenses; the Company's strategy, future operations, future financial position, future revenues or projected costs, including its ability to manage its operating expenses; and future actions that may be taken in connection with the Audit Committee's independent investigation. For more detailed information on the risks and uncertainties that may apply to the Company's business and the ownership of Company common stock, please review the Risk Factors section of the Company's most recent annual report filed with the SEC. Any forward-looking statements speak only as of the date of this press release, and except as required by law, the Company assumes no obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

View original content:http://www.prnewswire.com/news-releases/mimedx-announces-organizational-realignment-program-300760429.html

12/07/2018

AdvaMed Statement on ICIJ Medical Device Stories

Tue, 02 Jul 2019 16:28:29 GMT

Washington, D.C. – The Advanced Medical Technology Association (AdvaMed) issued the following statement on the recent stories from the International Consortium of Investigative Journalists (ICIJ) on the medical technology industry:

“Every one of us will inevitably face a moment where we will hope for a miracle to make a child, sibling, parent, grandparent or loved one well again. Whether it’s a pacemaker that keeps a heart beating, an implant that allows a child to hear for the first time, or an artificial knee that allows a grandmother to play with her grandkids, medical devices are the foundation of modern medicine, providing physicians and nurses the tools they rely on to improve patient care.

“Yet, instead of a comprehensive look at both the challenges and the achievements of an industry that touches almost every human life, these stories counterfeit the life-changing and life-saving solutions delivered to billions of people worldwide.

“We should never discount any patient's experience. But by magnifying the stories of only a few individuals, we overlook the overwhelmingly positive experiences of millions of others. We take seriously all reports of patient impact, and though the medical community can never completely eliminate risk, we always strive to improve our technologies and care delivery.

“As we do that work, we recognize why we developed these technologies in the first place: to address the critical, debilitating, and often life-threatening needs of patients who are desperate for solutions—who need a miracle.”

11/26/2018

GeoVax and Leidos Enter into a Collaboration Agreement on Immunotherapy Research Program

Tue, 02 Jul 2019 16:30:06 GMT

Combined Technologies May Yield Therapies for Multiple Cancer Indications

ATLANTA, GA, - (NewMediaWire) - November 19, 2018 - GeoVax Labs, Inc. (OTCQB: GOVX), a biotechnology company developing human vaccines, announced today that it is collaborating with Leidos, Inc. on a research program evaluating the combination of the companies’ respective technologies. The project will include the design, construction, and characterization of multiple immunotherapeutic vaccine candidates using GeoVax’s MVA-VLP vaccine platform combined with certain novel peptide PD-1 checkpoint inhibitors developed by Leidos. The vaccine design, construction, and characterization will be performed at GeoVax with further analysis conducted by Leidos.
GeoVax’s vaccine technology is based on its live Modified Vaccinia Ankara (MVA) platform, which generates vaccine antigens, in the form of multimeric proteins or noninfectious VLPs, in the individual being vaccinated. Gene sequences of target antigens are inserted into the MVA genome which drives their expression and budding from the infected cells. In this way, vaccination strategy mimics a natural viral infection which induces two pools of proteins – virus-infected cells and released multimeric or VLP proteins.

Farshad Guirakhoo, PhD, GeoVax’s Chief Scientific Officer, commented, “We are very pleased to be collaborating with Leidos on this project, which may lead to expanded efforts in cancer immunotherapy, treatments for chronic Hepatitis B infections, or other diseases where an immunological-based therapeutic approach would be beneficial. The Leidos life sciences team is recognized as having solid expertise in biopharmaceutical concept prototyping, regulatory strategy, and product development, and we look forward to working closely with them.”

Dr. Guirakhoo continued, “Currently, there are major limitations on cancer immunotherapies which include high costs (limiting patient access, straining both the healthcare system and the patient’s own finances), the need for multiple injections, and significant side effects. Moreover, monotherapy with one checkpoint inhibitor drug can induce drug resistance in some patients making it necessary to combine with other drugs and treatments, which in turn may further increase toxicity. We have shown that our MVA platform is safe in humans without any major side effects and hope that delivery of the immune checkpoint inhibitors with or without the tumor-associated antigens may overcome some of the challenges associated with the use of immune checkpoint inhibitors in cancers or other chronic infectious diseases.”

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing human vaccines against infectious diseases using its MVA-VLP vaccine platform. GeoVax was the winner of the 2018 “Best Biotech” Vaccine Industry Excellence Awards, a finalist for the 2018 “Best Prophylactic Vaccine” Award for its Zika vaccine at the World Vaccine Congress, as well as a finalist for Pipelines of Promise at Buzz of Bio 2018. The Company’s development programs are focused on vaccines against HIV, Zika, hemorrhagic fever viruses (Ebola, Sudan, Marburg, Lassa) and malaria. GeoVax also is evaluating the use of its MVA-VLP platform in cancer immunotherapy, and for therapeutic use in chronic Hepatitis B infections. GeoVax’s vaccine platform supports in vivo production of non-infectious VLPs from the cells of the very person receiving the vaccine. The production of VLPs in the person being vaccinated mimics virus production in a natural infection, stimulating both the humoral and cellular arms of the immune system to recognize, prevent, and control the target infection. For more information, visit www.geovax.com.

About Leidos

Leidos is a Fortune 500® information technology, engineering, and science solutions and services leader working to solve the world’s toughest challenges in the defense, intelligence, homeland security, civil, and health markets. The company’s 32,000 employees support vital missions for government and commercial customers. Headquartered in Reston, Virginia, Leidos reported annual revenues of approximately $10.17 billion for the fiscal year ended December 29, 2017. For more information, visit www.Leidos.com.

Forward-Looking Statements

Certain statements in this document are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act. These statements are based on management's current expectations and are subject to uncertainty and changes in circumstances. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax can develop and manufacture its vaccines with the desired characteristics in a timely manner, GeoVax's vaccines will be safe for human use, GeoVax's vaccines will effectively prevent targeted infections in humans, GeoVax’s vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete vaccine development, there is development of competitive products that may be more effective or easier to use than GeoVax's products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements and does not intend to do so. More information about these factors is contained in GeoVax's filings with the Securities and Exchange Commission including those set forth at "Risk Factors" in GeoVax's Form 10-K.

11/19/2018

Georgia Bio Welcomes Kristina Forbes as Senior Director of Member Engagement

Tue, 02 Jul 2019 16:31:09 GMT

The board and staff of Georgia Bio are delighted to announce the newest member of our team: Kristina Forbes, who officially joined Georgia Bio as our full-time Senior Director of Member Engagement. This newly created role will increase the depth of Georgia Bio’s collaboration with our members as we continue to amplify learning and engagement across our community, and strengthen the voice of life sciences in Georgia.

“Kristina’s role will enable Georgia Bio to keep its finger on the pulse of our growing membership, as we continue to inform and strengthen the voice of Georgia’s innovative biotech, medtech and digital health sectors,” said Maria Thacker Goethe, Georgia Bio’s Acting President and CEO. “We trust her passion for and commitment to member engagement, community growth, and partner development will serve her well as a member of the Georgia Bio team.”

Kristina comes to Georgia Bio with a depth of experience in association management and member engagement, in her role as Director of Business Development for the Technology Association of Georgia (TAG). There, her work focused on expanding the TAG network and onboarding new members. Kristina brings with her a rich background across a spectrum of community engagement initiatives and organizations that we are sure will help to provide more value to members and growth of the sector.

She achieved her bachelor’s degree in Psychology from the University of Georgia and was raised in Alpharetta. In addition to her work at TAG, Kristina previously worked with the Boy Scouts of America and Chi Phi Educational Trust, bringing more than sixyears of experience in non-profit membership and fundraising. Kristina lives in Midtown Atlanta and has been a volunteer member of Rotary International, Cobb County Chamber of Commerce, Delta Gamma and Children’s Healthcare of Atlanta. In her spare time, she enjoys spending time with her dog and baking apple pies.

Kristina may be reached at kforbes@gabio.orgor 404-920-2043.

11/15/2018

GeoVax and Virometix to Collaborate on Immunotherapy Program for HPV Infections and Related Cancers

Tue, 02 Jul 2019 16:32:34 GMT

GeoVax Continues Expansion of International Collaborative Efforts for its Unique MVA-VLP Vaccine Technology

Atlanta, GA - (NewMediaWire) - November 13, 2018 - GeoVax Labs, Inc. (OTCQB: GOVX), a biotechnology company developing human vaccines, and Virometix AG, a company developing next-generation Synthetic Virus-Like Particle (SVLPTM) based vaccines, announced today the start of a collaboration to develop a therapeutic vaccine for human papillomavirus (HPV) infection. The collaboration will include preclinical animal testing of GeoVax’s MVA-vectored HPV vaccine candidates in combination with Virometix’ synthetic HPV vaccine candidate.

GeoVax’s vaccine technology is based on its live Modified Vaccinia Ankara (MVA) platform, which generates vaccine antigens, in the form of multimeric proteins or noninfectious VLPs, in the individual being vaccinated. Gene sequences of target antigens are inserted into the MVA genome which drives their expression and budding from the infected cells. In this way, vaccination induces two pools of antigens as targets for the immune response – virus-infected cells and released multimeric or VLP proteins. This strategy mimics a natural viral infection, triggering the body to produce a robust and durable immune response with involvement of both antibodies and T cells.

Farshad Guirakhoo, PhD, GeoVax’s Chief Scientific Officer, commented, “This new collaboration perfectly complements our ongoing collaboration with Emory University for HPV-related head and neck cancers in patients who express oncogene products of HPV16, E6 and E7 proteins. Similar to the strategy we are utilizing in our clinical trials for HIV and preclinical testing of our cancer vaccines (e.g. vector and protein combination), we believe the combination of our MVA-vectored HPV vaccines and Virometix’ SVLP-based HPV vaccine will bring a synergy that significantly increases the therapeutic potential of each platform. This and other collaborations that we’ve established and continue to establish, are focused on providing critically needed solutions to either prevent or cure critical areas of infectious diseases and cancers utilizing our unique expertise and know-how, resulting in highly effective, safe, simple to administer and low-cost manufactured solutions, improving the lives of millions worldwide.”

“We are pleased to enter into this collaboration, which will expand our commitment to the development of cancer immunotherapies,” said Arin Ghasparian, PhD, Virometix’ Chief Executive Officer. “We appreciate the clinical and preclinical development work done by GeoVax on their vaccine candidates for viral diseases and cancer. We believe that a combination of MVA-vectored HPV vaccine candidates with our SVLPTM platform could be potentially beneficial for the immunotherapy of HPV-induced cancers and look forward to working with GeoVax on this combination.”

About HPV

HPV refers to a group of more than 200 related viruses. More than 40 viruses can easily be spared through sexual contact, whereas other types can cause genital warts that are not sexually transmitted. Sexually transmitted HPV are classified into 2 categories; Low risk HPV (e.g. type 6 and 11) that cause benign tumors and high-risk HPV (e.g. type 16 and 18) that cause cancers (e.g. cervical, anal, penile and oropharyngeal). Every year in the United States, there are an estimated 14 million new HPV infections, with around 50% occurring in 15 to 24-year-olds. Currently, there are an estimated 79 million Americans, most in their late teens and early 20s, infected with HPV. In fact, HPV is so common that it infects nearly all men and women at some point in their lives, but fortunately, in most cases, HPV infections are asymptomatic and do not cause any health problems. However, in some instances, HPV can cause health problems like genital warts and cancer. Although there are vaccines that can prevent infections with the types of HPV that most commonly cause cancer, there is currently no cure for an HPV infection after it has established in a person.

About Virometix

Virometix AG is a privately held biotechnology company developing a new generation of fully synthetic vaccines and immunotherapeutic drugs for the prevention and treatment of infectious diseases and cancer. Fast growing demands, health threats from newly arising complex viral and bacterial pathogens and increasingly stringent requirements for stability, safety and tolerability require new approaches to tackling current and future challenges. Rational molecular design, and Virometix' proprietary “Synthetic Virus-Like Particle” (SVLPTM) and “Synthetic Antigen Mimetics” (SAMTM) platforms allow for the rapid production and optimization of vaccine candidates with superior properties in terms of safety, efficacy and stability. Virometix is based in Zurich, Switzerland. For more information about Virometix AG please visit: https://www.virometix.com/.

About GeoVax

GeoVax Labs, Inc., is a clinical-stage biotechnology company developing human vaccines against infectious diseases using its MVA-VLP vaccine platform. GeoVax was the winner of the 2018 “Best Biotech” Vaccine Industry Excellence Awards, a finalist for the 2018 “Best Prophylactic Vaccine” Award for its Zika vaccine at the World Vaccine Congress, as well as a finalist for Pipelines of Promise at Buzz of Bio 2018. The Company’s development programs are focused on vaccines against HIV, Zika, hemorrhagic fever viruses (Ebola, Sudan, Marburg, Lassa) and malaria. GeoVax also is evaluating the use of its MVA-VLP platform in cancer immunotherapy, and for therapeutic use in chronic Hepatitis B infections. GeoVax’s vaccine platform supports in vivo production of non-infectious VLPs from the cells of the very person receiving the vaccine. The production of VLPs in the person being vaccinated mimics virus production in a natural infection, stimulating both the humoral and cellular arms of the immune system to recognize, prevent, and control the target infection. For more information, visit www.geovax.com.

Forward-Looking Statements

Certain statements in this document are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act. These statements are based on management's current expectations and are subject to uncertainty and changes in circumstances. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax can develop and manufacture its vaccines with the desired characteristics in a timely manner, GeoVax's vaccines will be safe for human use, GeoVax's vaccines will effectively prevent targeted infections in humans, GeoVax’s vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete vaccine development, there is development of competitive products that may be more effective or easier to use than GeoVax's products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements and does not intend to do so. More information about these factors is contained in GeoVax's filings with the Securities and Exchange Commission including those set forth at "Risk Factors" in GeoVax's Form 10-K.

11/13/2018

Clearside Biomedical Announces SAPPHIRE Phase 3 Study of Combination Therapy in Retinal Vein Occlusion Did Not Meet Its Primary Endpoint

Tue, 02 Jul 2019 16:35:06 GMT

ALPHARETTA, Ga., Nov. 05, 2018 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing treatments that restore and preserve vision for people with serious eye diseases, today announced that the primary endpoint was not achieved in its Phase 3 clinical trial (“SAPPHIRE”) investigating the superiority of XIPERE (formerly “suprachoroidal CLS-TA”) used together with the intravitreal anti-VEGF agent EYLEA® (aflibercept) (“intravitreal Eylea”), compared to intravitreal Eylea monotherapy, for the treatment of retinal vein occlusion (‘RVO”). The primary endpoint of this trial was the proportion of patients in the combination treatment arm, compared to the intravitreal Eylea-alone control arm, with improvements in best corrected visual acuity (“BCVA”) from baseline of at least 15 letters on the Early Treatment Diabetic Retinopathy Study (“ETDRS”) scale at eight weeks after initial treatment.

“In the SAPPHIRE trial, approximately 50% of patients in both arms showed at least a 15 letter improvement in vision; unfortunately, there was no additional benefit for patients receiving XIPERE together with intravitreal Eylea,” said Daniel White, Chief Executive Officer and President of Clearside. “In light of these 8-week topline data, we plan to discontinue clinical development of combination therapy for RVO, which includes SAPPHIRE and its companion Phase 3 clinical trial, TOPAZ.”

“We believe the opportunity in our primary indication, uveitis, remains very attractive. Awareness and acceptance of the strong clinical profile of XIPERE as a potential monotherapy in treating uveitic macular edema is growing, and we remain on track to submit our NDA for this indication before the end of this year,” added Mr. White.

Topline SAPPHIRE Trial Results

SAPPHIRE, a multicenter, multi-country, randomized, masked, controlled Phase 3 clinical trial, enrolled 460 patients with treatment naïve RVO. A similar proportion of patients in both arms of the SAPPHIRE trial gained at least 15 ETDRS letters in BCVA at eight weeks, showing no additional visual outcome benefit for patients in the XIPERE-plus- intravitreal Eylea combination arm compared to patients in the intravitreal Eylea-alone control arm. The safety profile appeared consistent with previous studies of XIPERE through 8 weeks.

Conference Call & Webcast Details

Clearside invites all interested parties to participate in a conference call today at 8:30 a.m. Eastern Time, during which management will discuss the 8-week topline data from the SAPPHIRE trial. To participate in this conference call, please dial (844) 263-8310 (U.S.) or (213) 358-0959 (international), conference ID 1699836, approximately 10 minutes prior to the start time. A live, listen-only audio webcast of the conference call can be accessed by visiting the “Investor Relations” section at www.clearsidebio.com. An archive of the webcast will be available until February 5, 2019.

About XIPERE

XIPERE, Clearside’s first investigational treatment, is a proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the back of the eye via the suprachoroidal space, or SCS®, which is the space located between the choroid and the outer protective layer of the eye known as the sclera. Clearside’s proprietary suprachoroidal treatment approach is designed to enable rapid dispersion of medicine to the back of the eye so that adequate medicine reaches and stays at the site of disease and has potential to act longer. This approach has potential to provide efficacy advantages and require fewer treatments and office visits while minimizing harm to the surrounding healthy parts of the eye.

XIPERE is being studied as part of Clearside’s pipeline of treatments for unmet or underserved sight-threatening eye diseases that manifest in the retina and the choroid.

About Clearside

Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing treatments that restore and preserve vision for people with serious eye diseases. Clearside’s proprietary suprachoroidal treatment approach offers unprecedented access to the back of the eye where sight-threatening disease often occurs. The company’s unique platform for eye disease treatments is inherently flexible and intended to work with established medicines, new formulations of medicines, as well as future innovations. Clearside’s pipeline includes advanced and pre-clinical product candidates in diseases where macular edema is a common complication, including uveitis and diabetic macular edema (“DME”). Clearside’s most advanced program is in non-infectious uveitis and it expects to submit a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for XIPERE for the treatment of uveitic macular edema by the end of 2018. In addition, Clearside recently announced positive topline results from a Phase 2 clinical trial of XIPERE used with Eylea in patients with DME, and is continuing to analyze additional data from the trial. Clearside is headquartered in Alpharetta, GA. For more information, please visit http://www.clearsidebio.com. Follow @clearsidebio on Twitter and LinkedIn.

11/06/2018

Oncology Analytics Moves Corporate Headquarters to Atlanta

Tue, 02 Jul 2019 16:38:35 GMT

ATLANTA, October 31, 2018 – Oncology Analytics, a leading technology-enabled service company which provides health plans, providers and patients with an evidence-based, analytics focused approach to utilization management that is purpose-built for oncology, announced today it is expanding its operation by moving its corporate headquarters to Atlanta, Georgia.

“Atlanta is a mecca for organizations focused on cutting edge technology and breakthrough research and innovation in cancer treatments,” said Rick Dean, CEO of Oncology Analytics. “Driving the nexus of technology and patient care is fundamental to our company’s mission. We want to be part of a dynamic, forward thinking business community that shares this vision.”

Oncology Analytics provides the critical missing link for health plans in being able to manage the total cost of cancer care – which is access to current, evidence-based, disease-specific analytics on all cancer types and treatment options, backed by board-certified oncology physicians and pharmacists, to provide their members with the ability to achieve the best possible outcomes.

Founded in Plantation, FL by Dr. Marc Fishman, a hematologist, oncologist and patient advocate, Oncology Analytics will continue to retain an active presence there. The company’s new corporate headquarters will be located at 7000 Central Parkway in the vibrant Perimeter District of Atlanta, home to over 5,000 companies.

“Having our corporate headquarters in Atlanta provides us access to some of the finest clinical, technical and analytics talent in the country,” said Shay Hurst, SVP of Human Resources, Oncology Analytics. “As we look to significantly expand our team in roles focused on data science, software engineering, clinical oncology, product management and client services, we are confident Atlanta offers the resources we need for our next stage of growth.”

About Oncology Analytics
Oncology Analytics, Inc. provides health plans, providers and patients with an evidence-based, technology-driven approach to utilization management, which is purpose-built for oncology. Used by physicians to support over 3.5 million health plan members in the US and Puerto Rico, the Oncology Analytics e-Prior Authorization platform is updated daily to accurately reflect more than 6,000 oncology treatment protocols for anti-cancer treatment across all cancer types and stages, including chemotherapy, radiation therapy, precision medicine, targeted therapy, and supportive care. The company’s real-world evidence analytics is based on tens of thousands of annual chemotherapeutic cases. For more information, please visit www.oncologyanalytics.com.

11/06/2018

Georgia Tech names new director for Advanced Technology Development Center

Tue, 02 Jul 2019 16:39:33 GMT

Georgia Tech said Monday it's named John Avery as its next director of its Advanced Technology Development Center (ATDC) business incubator.

The announcement follows a four-month national search for a new leader at ATDC following the departure of Jen Bonnett, who left in June 2018 to become the Savannah Economic Development Authority’s vice president of innovation and entrepreneurship.

Most recently, Avery -- a Georgia Tech graduate -- was engineering group manager of Panasonic Automotive Systems’ Panasonic Innovation Center at the Georgia Tech campus.

As director of the ATDC, Avery will lead a team of 26 full- and part-time staff and advisors who run ATDC’s various initiatives. Read the complete announcement here.

In 2017, ATDC worked with more than 1,838 entrepreneurs across the state of Georgia. Its portfolio companies and program graduates received more than $823 million in capital investments, reported more than $148 million in revenue, and supported 2,260 jobs.

11/06/2018

Shire Files Submission for U.S. FDA Approval to Manufacture FLEXBUMIN® at New Plasma Manufacturing Facility near Covington, Georgia

Tue, 02 Jul 2019 16:40:40 GMT

Dublin, Ireland – October 25, 2018 – Shire plc (Shire) (LSE: SHP, NASDAQ: SHPG), the leading global biotechnology company focused on rare diseases, today announced that it has filed its second submission to the United States Food and Drug Administration (FDA) for its new plasma manufacturing facility near Covington, Georgia.

This second submission is for the manufacturing of FLEXBUMIN 25% [Albumin (Human)], USP, 25% Solution, a treatment primarily used as plasma-volume replacement therapy in immune disorders, trauma and other critical conditions. The Georgia facility received its first FDA approval, to manufacture GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10% Solution.

“We are very pleased to file this second submission for our state-of-the-art manufacturing facility in Georgia, after the facility received FDA approval earlier this year,” said Matt Walker, Head of Technical Operations for Shire. “Expanding our capacity for manufacturing FLEXBUMIN will allow us to better meet the increasing global demand for plasma protein therapies and further supports our growing immunoglobulin and bio-therapeutics portfolio by enabling us to deliver these important treatments to our patients.”

Shire's Immunology franchise has seen strong demand, with product sales increasing +13% in the second quarter of 2018 versus the prior year.

The Georgia site currently employs approximately 900 full-time colleagues and contract employees. Since the beginning of 2018, Shire has ramped up hiring to fill roles in manufacturing, quality, engineering, maintenance, utilities, warehouse, and various support and facility roles.

Shire also plans to continue expanding its plasma collection network in Georgia and throughout the United States through its subsidiary, BioLife Plasma Services. BioLife collects the human plasma used in the manufacturing process for immunology products at the Georgia facility.

GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10% Solution

INDICATION

GAMMAGARD LIQUID is indicated as replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients ≥2 years.

Important US Safety Information

WARNING: THROMBOSIS, RENAL DYSFUNCTION, and ACUTE RENAL FAILURE

Thrombosis may occur with immune globulin (IG) products, including GAMMAGARD LIQUID. Risk factors may include advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors.
Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur in predisposed patients with immune globulin intravenous (IGIV) products. Patients predisposed to renal dysfunction include those with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. GAMMAGARD LIQUID does not contain sucrose.
For patients at risk of thrombosis, administer GAMMAGARD LIQUID at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk of hyperviscosity.

Contraindications

History of anaphylactic or severe systemic hypersensitivity reactions to human IG
IgA-deficient patients with antibodies to IgA and a history of hypersensitivity to human IG. Anaphylaxis has been reported with intravenous (IV) use of GAMMAGARD LIQUID.

Warnings and Precautions

Hypersensitivity: Severe hypersensitivity reactions may occur, even in patients who have tolerated previous treatment with human IG. If a hypersensitivity reaction occurs, discontinue infusion immediately and institute appropriate treatment. IgA-deficient patients with antibodies to IgA are at greater risk of developing potentially severe hypersensitivity reactions, including anaphylaxis.

Renal Dysfunction/Failure: Acute renal dysfunction/failure, acute tubular necrosis, proximal tubular nephropathy, osmotic nephrosis, and death may occur with IV use of IG products, especially those containing sucrose. Ensure patients are not volume depleted prior to infusion. In patients at risk due to pre-existing renal insufficiency or predisposition to acute renal failure, assess renal function before initiation and throughout treatment, and use the minimum infusion rate practicable for IV administration. If renal function deteriorates, consider discontinuation.

Hyperproteinemia, increased serum viscosity, and hyponatremia may occur. It is critical to distinguish true hyponatremia from a pseudohyponatremia because certain treatments may lead to volume depletion, a further increase in serum viscosity, and a predisposition to thromboembolic events.

Thrombosis: May occur following treatment with IG products and in the absence of known risk factors. In patients at risk, administer at the minimum dose and infusion rate practicable. Ensure adequate hydration before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

Aseptic Meningitis Syndrome: Has been reported with use of IG and may occur more frequently in females. Conduct a thorough neurological exam on patients exhibiting signs and symptoms, to rule out other causes of meningitis. Discontinuing IG treatment has resulted in remission within several days without sequelae.

Hemolysis: GAMMAGARD LIQUID contains blood group antibodies, which may cause a positive direct antiglobulin reaction and hemolysis. Monitor patients for signs and symptoms of hemolysis and delayed hemolytic anemia and, if present, perform appropriate confirmatory lab testing.

Transfusion-Related Acute Lung Injury: Non-cardiogenic pulmonary edema may occur with IV administered IG. Monitor patients for pulmonary adverse reactions. If suspected, perform appropriate tests for presence of anti-neutrophil and anti-HLA antibodies in both product and patient serum. May be managed using oxygen therapy with adequate ventilatory support.

Transmittable Infectious Agents: Because GAMMAGARD LIQUID is made from human plasma, it may carry a risk of transmitting infectious agents (e.g., viruses, other pathogens). No confirmed cases of viral transmission or variant Creutzfeldt-Jakob disease (vCJD) have been associated with GAMMAGARD LIQUID.

Interference with Lab Tests: False positive serological test results and certain assay readings, with the potential for misleading interpretation, may occur as the result of passively transferred antibodies.

Adverse Reactions

IV administration for PI: The serious adverse reaction seen during IV clinical studies was aseptic meningitis. The most common adverse reactions observed in ≥5% of subjects were headache, fatigue, pyrexia, nausea, chills, rigors, pain in extremity, diarrhea, migraine, dizziness, vomiting, cough, urticaria, asthma, pharyngolaryngeal pain, rash, arthralgia, myalgia, oedema peripheral, pruritus, and cardiac murmur.

Subcutaneous administration for PI: The most common adverse reactions observed in ≥5% of subjects were infusion site (local) event (rash, erythema, edema, hemorrhage, and irritation), headache, fatigue, heart rate increased, pyrexia, abdominal pain upper, nausea, vomiting, asthma, blood pressure systolic increased, diarrhea, ear pain, aphthous stomatitis, migraine, oropharyngeal pain, and pain in extremity.

Drug Interactions

Passive transfer of antibodies may transiently interfere with immune responses to live attenuated virus vaccines (e.g., measles, mumps, rubella, and varicella).

Please click for Full Prescribing Information, including Boxed Warning regarding Thrombosis, Renal Dysfunction and Acute Renal Failure.

FLEXBUMIN 25% [Albumin (Human)], USP, 25% Solution

1. What is FLEXBUMIN?

FLEXBUMIN 25% is indicated for hypovolemia, hypoalbuminemia, (burns, Adult Respiratory Distress Syndrome (ARDS), and nephrosis), cardiopulmonary bypass surgery, and hemolytic disease of the newborn (HDN). Albumin is not indicated as an intravenous nutrient

Important US Safety Information

Contraindications

History of hypersensitivity reaction to albumin preparations or to any of the excipients (N-acetyltryptophan and sodium caprylate). Reactions have included anaphylactic shock, anaphylactic reaction, or hypersensitivity/allergic reactions
Severe anemia or cardiac failure with normal or increased intravascular volume.

Warnings and Precautions
Hypersensitivity Reactions: have been observed (including anaphylactic reactions). If hypersensitivity reaction is suspected, discontinue administration immediately and implement appropriate standard medical treatment.

Hypervolemia/Hemodilution: Under conditions where hypervolemia and/or hemodilution may occur, adjust the dose and rate of infusion to the patient’s volume status. When administering large volumes, monitor hemodynamic parameters. Ensure adequate substitution of other blood constituents and monitor electrolyte balance. Discontinue administration at the first clinical signs of cardiovascular overload.

Hemodynamics: Closely monitor hemodynamic parameters after administration for evidence of cardiac or respiratory failure, renal failure or increasing intracranial pressure

Blood Pressure: Monitor blood pressure in trauma patients and postoperative surgery patients in order to detect re-bleeding secondary to clot disruption.

Hemolysis: Do not dilute with Sterile Water for Injection, as there is potential risk of fatal hemolysis and acute renal failure in recipients.

Transmission of Infectious Agents: Because FLEXBUMIN 25% is made from human plasma it may carry a risk of transmitting infectious agents (e.g., viruses, other pathogens). No cases of transmission of viral diseases, Creutzfeldt-Jakob disease (CJD) or variant Creutzfeldt-Jakob disease (vCJD) have ever been identified.

Adverse Reactions:
The most serious adverse reactions are hypersensitivity reaction (including anaphylactic reaction) and pulmonary edema.

Administration Caution
Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before the administration of the fluid from the secondary container is complete.

Please click for Full Prescribing Information.

11/01/2018

GeoVax Announces Further Positive Results of its HIV Preventive Vaccine Program at International HIV Research Conference

Tue, 02 Jul 2019 16:41:46 GMT

Booster Vaccination After ~7 Years Resulted in 600-fold Increase in Antibody Response

Atlanta, GA - (NewMediaWire) - October 24, 2018 - GeoVax Labs, Inc. (OTCQB: GOVX), a biotechnology company developing human vaccines, today announced the presentation of positive results from HVTN 114, a phase 1 trial testing a late protein boost of participants from a phase 2a trial of GeoVax’s GOVX-B11 preventive HIV vaccine candidate. The presentation was made by the Protocol Chair, Paul A. Goepfert, M.D., University of Alabama, during the HIV Research for Prevention (HIVR4P) conference in Madrid, Spain. HVTN 114 was conducted by the HIV Vaccine Trials Network (HVTN) through the support of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

GOVX-B11 consists of two experimental vaccine components – a recombinant DNA component and a recombinant live MVA (modified vaccinia Ankara) virus component. Both components produce non-infectious virus-like-particles (VLPs) in the cells of the vaccinated, HIV-negative, person.

The DNA component is intended to prime a protective immune response, and the MVA component to boost the immune response. HVTN 114, which enrolled 27 individuals who previously participated in the HVTN 205 Phase 2a trial of GOVX-B11, tested the ability of late boosts (given on average 6.9 years after the original vaccination) to increase the antibody responses elicited by the original GeoVax vaccine regimen. These “late boosts” consisted of the GeoVax MVA62B vaccine candidate with or without a bivalent HIV-1 gp120 envelope glycoprotein vaccine candidate (AIDSVAX^®B/E). AIDSVAX^®B/E includes the same glycoproteins used to boost immune responses in participants in the 2009 RV144 clinical trial in Thailand led by the U.S. Military HIV Research Program and the Thai Ministry of Health. RV144, the only preventive HIV vaccine to show some limited efficacy, protected 31.2% of participants. In the HVTN 114 trial, participants received either (a) another MVA62B boost, (b) a combined boost of MVA62B and AIDSVAX^®B/E, or (c) AIDSVAX^®B/E alone. By far the most effective boost was the combination of MVA62B live vector and AIDSVAX^®B/E proteins, which increased titers of antibodies to the HIV envelope glycoproteins by more than 600-fold.

Dr. Goepfert stated, “This study demonstrated that combining GOVX-B11 with a protein boost significantly enhanced the antibody responses, which might play a role in protecting the individuals against a genetically diverse pathogen such as HIV.”

Harriet L. Robinson, Ph.D. Director of HIV Vaccines at GeoVax, commented, “The results of HVTN 114 inform the use of protein boosts with the GOVX-B11 vaccine candidate and indicate that an effective way to boost antibody responses is to combine delivery of protein with the MVA. The results also show that late boosts can be highly effective in recalling immunological memory responses to the original vaccine and enhance the levels of antibodies that decrease with time. This trial was designed to develop regimens for a phase 2b efficacy trial and highlights the use of a vector plus protein boost strategy.”

Commenting on these recent, positive results, David A. Dodd, CEO of GeoVax stated, “We continue to be encouraged by the positive results and progress of our HIV preventive vaccine program. As recently reported by the NIH and the Gates Foundation, there continues to be a critical need for such a vaccine, providing a preventive intervention to the continued spread of HIV. Considering the HIV-related disparities among African American individuals, who comprise 43% of the 1.1 million people living with HIV in the US despite being only 12% of the nation’s total population, an effective vaccine should be part of an HIV elimination strategy. We therefore remain focused on progressing the successful development of an effective preventive vaccine, while encouraging all policy makers to continue support for effective, durable HIV preventive vaccines.”

About the HIV Vaccine Trials Network (HVTN)

The HVTN is the world’s largest publicly funded collaboration bringing together global study participants, communities and acclaimed scientific leadership on a journey to find an effective HIV vaccine. The HVTN’s mission is to fully characterize the safety, immunogenicity, and efficacy of HIV vaccine candidates with the goal of developing a safe and effective vaccine as rapidly as possible for prevention of HIV infections globally. The network is founded on a relationship of trust with global communities who work with specialized teams using science to serve global populations in the pursuit to find answers that will impact and change lives. Headquartered at the Fred Hutchinson Cancer Research Center in Seattle, Washington, the HVTN conducts all phases clinical trials and includes over 30 sites located on five continents. Website: www.hvtn.org

About GeoVax

GeoVax Labs, Inc., is a clinical-stage biotechnology company developing human vaccines against infectious diseases using its MVA-VLP vaccine platform. GeoVax was the winner of the 2018 “Best Biotech” Vaccine Industry Excellence Awards, a finalist for the 2018 “Best Prophylactic Vaccine” Award for its Zika vaccine at the World Vaccine Congress, as well as a finalist for Pipelines of Promise at Buzz of Bio 2018. The Company’s development programs are focused on vaccines against HIV, Zika, hemorrhagic fever viruses (Ebola, Sudan, Marburg, Lassa) and malaria. GeoVax also is evaluating the use of its MVA-VLP platform in cancer immunotherapy, and for therapeutic use in chronic Hepatitis B infections. GeoVax’s vaccine platform supports in vivoproduction of non-infectious VLPs from the cells of the very person receiving the vaccine. The production of VLPs in the person being vaccinated mimics virus production in a natural infection, stimulating both the humoral and cellular arms of the immune system to recognize, prevent, and control the target infection. For more information, visit www.geovax.com..

Forward-Looking Statements

Certain statements in this document are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act. These statements are based on management's current expectations and are subject to uncertainty and changes in circumstances. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax can develop and manufacture its vaccines with the desired characteristics in a timely manner, GeoVax's vaccines will be safe for human use, GeoVax's vaccines will effectively prevent targeted infections in humans, GeoVax’s vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete vaccine development, there is development of competitive products that may be more effective or easier to use than GeoVax's products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements, and does not intend to do so. More information about these factors is contained in GeoVax's filings with the Securities and Exchange Commission including those set forth at "Risk Factors" in GeoVax's Form 10-K.

10/24/2018

Georgia nonprofit launches with aim of protecting statewide intellectual property

Tue, 02 Jul 2019 16:42:46 GMT

The Georgia Intellectual Property Alliance officially launched Monday as a nonprofit designed to serve the state by establishing a better model for creating, protecting and enabling intellectual property.

GIPA has created a coalition of education institutions, world-leading research labs, innovation-focused organizations, companies ranging from Fortune 500s to startups and other creators to collaborate on the initiative. The organization will focus on accelerating the market launch of ideas that serve the common good, while specializing in protecting IP, including patents, copyrights, trademarks and trade secrets, according to a news release.

Gov. Nathan Deal officially proclaimed October 2018 as “Intellectual Property Month,” in recognition of GIPA and the critical importance of IP to the growth and success of the state’s economy.

“Intellectual property rights incentivize the advancement of knowledge in high-demand fields and support greater investment in innovation and inventions that produce significant economic returns,” Deal stated in the proclamation.

The GIPA Executive Committee is led by Chairman Scott Frank (President and CEO of AT&T Intellectual Property); Vice Chair Keith Cowan (former President of Strategy & Corporate Development for Sprint); Treasurer Michael Wright (former Vice President of Finance for the Coca-Cola Company); Secretary Michael Hobbs (Partner at Troutman Sanders); and Executive Director Carol Beckham (former Vice President of AT&T Intellectual Property).

The GIPA Board currently has more than 50 members from across the IP ecosystem, including representation from the State of Georgia; Georgia Chamber of Commerce; Technology Association of Georgia; Metro Atlanta Chamber; FinTech Atlanta; Georgia Research Alliance; Emory University; Georgia Institute of Technology; Georgia State University; University of Georgia; Georgia and Atlanta Bars; and Georgia Lawyers for the Arts. Additional members include more than a dozen law firms, corporations, consultants and inventors.

“GIPA is honored to collaborate with business and civic leaders from across the state’s strong IP ecosystem,” Frank said in a statement. “This alliance will further enhance Georgia’s success in the global economy and inspire new creativity for decades to come.”

10/23/2018

Alpharetta company acquires biomedical firm in Tampa

Tue, 02 Jul 2019 16:44:09 GMT

A medical technology company out of Alpharetta has acquired Tampa-based Regenerative Medicine Solutions LLC, a biomedical services company in an all-stock transaction.

Medovex Corp. was formed to acquire and develop a portfolio of medical tech products and services with disruptive characteristics, the statement said. RMS manages Lung Health Institute, which specializes in cellular therapies to treat chronic obstructive pulmonary disease and other chronic lung disorders.

Bill Horne, and founder and former CEO of Laser Spine Institute, is Medovex’s new CEO and chairman of the board of directors as of Oct. 9. Jarrett Gorlin resigned as president and CEO, a filing with the U.S. Securities and Exchange Commission said.

“I’m excited to join Medovex at what I view as an opportunistic time," Horne said in a statement. "I’ve long felt that the company’s DenerveX System represented a highly disruptive longer-term solution to chronic lower back pain associated with the Facet Joint, a sizeable market opportunity that continues to see large growth."

The purchase reunites Horne's former LSI executive management team, the statement said. Information about who else from the LSI team will be working with Horne is unavailable at this time as the deal is pending closing, a spokeswoman said.

The company expects to target the acquisition of practices in the five cities where RMS has medical facilities: Tampa; Scottsdale, Arizona; Dallas; Pittsburgh; and Nashville, Tennessee. It will then pursue new markets.

More than $32 billion was spent on COPD-related patient care in 2010, and those costs are projected to increase to $49 billion by 2020, the statement said.

10/22/2018

New Initiative to Establish Atlanta as the “Center for Global Health” Discussed at Georgia Bio Innovation Summit

Tue, 02 Jul 2019 16:45:03 GMT

There’s an exciting, new initiative underway to make Atlanta a “center for global health” focusing on disease eradication, economic development and disaster response.

That was the topic of discussion at the closing panel, “The Future of Life Sciences,” at the Georgia Bio Innovation Summit Oct. 9 at the Cobb Energy Centre.

Moderated by KC Decker or Deloitte Consulting, the panel included: Russell Allen, President and CEO, Georgia Research Alliance; Clark Dean, Senior Managing Director, Transwestern; David Hartnett, Chief Economic Development Officer, Metro Atlanta Chamber; and Maria Thacker Goethe, Acting President and CEO, Georgia Bio, and Executive Director, Georgia Global Health Alliance.

In May, the Metro Atlanta Chamber, Georgia Global Health Alliance and Deloitte announced the launch of Global Health ATLas a collaborative initiative designed to create a health innovation district in the heart of metro Atlanta. More details are expected in early 2019.

Panelists agreed the state’s assets around global health are strong. When defining global health, Ms. Thacker Goethe clarified that we include life sciences as part of the global health effort to improve health and achieve equity in health for all people worldwide. She noted that innovations from across health sectors whether that be pharma, therapeutics, diagnostics, or medtech are crucial to public health work. Additionally, she noted that partnership with high-tech and telecommunications are also important to the effort of achieve global health equity.

Atlanta is home to the CDC, Task Force for Global Health, Carter Center, CARE and the American Cancer Society, which just announced their new venture fundto commercialize cancer therapies. The state also has research institutions such as Emory University, Georgia Tech, Kennesaw State, Morehouse, and Georgia State, among others. And we’re home to 15 Fortune 500 companies with global reach, including Delta, UPS and Coca-Cola that are using their influence and capacity to drive global health initiatives.

“Global Health ATL is the only initiative of its kind to have the unified support of the world's top corporate brands, health organizations and higher education institutions backing our efforts," according to the Global Health ATL website.

Among its corporate partners are Delta Air Lines, Sharecare, UPS and UCB whose executives are part of the initiative’s Executive Committee, along with academic and research institutions. Georgia Bio is a member of one of three “tiger” teams involved in developing strategies and helping to bring together metro Atlanta’s best resources.

Life sciences industry growing

The future of life sciences is bright.

The life sciences industry didn’t suffer a downturn like other industries during the Great Recession of 2008, and in fact, has experienced 15 percent employment growth since 2013.

Georgia Bio and the Georgia Global Health Alliance are jointly conducting an industry study to look at the whole life sciences and global health landscape in the state. Defining the assets in Georgia is vital to the success of the sector, and development of Global Health ATL. The report is expected to launch at the February 8^thGeorgia Bio Awards Dinner and 30^thAnniversary Celebration.

Panelists agreed Georgia has what it takes to be a global health center, but there needs to be more communication, cooperation and collaboration between academia and industry.

“As we connect more, we’ll see strong growth,” Russell Allen said.”At Georgia Bio, we’ve enjoyed meeting with non-traditional health partners like the CDC Foundation to get their input. Innovation is key, and the idea is to come up with Atlanta’s own “health district” that will be different from other tech hubs like Boston, Silicon Valley and San Diego.”

David Hartnett described the Global Health ATL initiative as “the single biggest thing we’ve ever done.” The effort will allow sectors to align and cooperate for change on a global scale. The fact is, Atlanta has a significant public and global health presence, and this is something the campaign is working to harass to improve opportunities for public and private entities.

Global Health ATL is already at work identifying challenges and pinpointing strategies to promote a unified voice for global health in the region. Georgia Bio looks forward to being a part of this exciting initiative and raising the profile for life sciences in Georgia.

What are your thoughts about establishing Atlanta as a “center for global health”? Are you interested in getting involved? Interested in real-estate in this groundbreaking effort? To learn more about Global Health ATL or to request information, visit www.globalhealthatl.com.

10/18/2018

2018 Anthony Shuker Scientific Poster Award Winners

Tue, 02 Jul 2019 16:46:42 GMT

October 15, 2018 | Atlanta, GA - Georgia Bio would like to congratulate the 2018 Anthony Shuker Scientific Poster Award winners. Selected from nearly 60 competitors, the awardees showcased the best and brightest of Georgia’s talent. This year’s competition was sponsored by UCB, Inc.

The Georgia Bio Innovation Summit Poster Session is open to representatives from Georgia-based academia, research institutes and industry alike. Competitors represented Georgia’s research universities and companies in a variety of categories including Molecular and Biological Research; Healthcare IT; Nanotechnology; Drug Discovery and Development; Cell Therapy & Tissue Engineering; and Industrial Production.

Each year this session impacts students from across Georgia. Brianna Galbreath, Ph.D. of Georgia State University, was about to graduate with a master’s degree in Chemistry, with a concentration in Industrial Biotechnology, when she participated in the 2017 Poster Session. When asked how the poster session impacted her, she stated “Thanks to my experience presenting my research at the poster session, I decided to get my Ph.D. Georgia Bio is a great organization and has been so supportive.

Upon completing her graduate degree, Ms. Galbreath thought she was going to ‘hang up her shoes and be done with school.’ After winning the poster award and meeting different companies at the Summit, she decided to continue her education. Today Ms. Galbreath is working on her Ph.D. in Applied and Environmental Microbiology at Georgia State and deciding on her next career move which is likely commercialization of products using microbiology or zoonotic infectious disease.

Luke Dickson, a 2018 competitor told Georgia Bio, “I attended the Summit last year and had a great time, so I wanted to come back and network and get more exposure for my research.” Mr. Dickson, a master’s student, Integrated Biology at Kennesaw State Universitywho is doing research in cancer treatment, said he’s planning to go to medical school after he completes his master’s degree.

The 2018 winners:

The Anthony Shuker Scientific Poster Award

Poster #2 – Measho Abreha – Emory University
Comprehensive mapping of Alzheimer’s disease brain

Poster #46 – Hope Didier – Kennesaw State University
Elucidating the Requirements for E2 to Induce Senescence

Poster #22 – Nathan Dillard – R6 Industries Inc. and Medical College of Georgia
Using software to improve evacuee medical care in disaster shelters

Poster #4 – Merhawi Mihreteab – Georgia State University
Microbial Bioconversion of Polypropylene-Derived

Poster #29 – Arnab Mondal – University of Georgia
In vitro cellular response towards a hydrogen sulfide

The Down South House & Home Award for Poise and Grace

Poster #1 – Jitendra Pant – University of Georgia
In vitro study of antibacterial and cellular response

10/16/2018

Biotech start-up RWDC closes US$13 million Series A2 led by Vickers Venture and WI Harper to produce plastic alternative

Tue, 02 Jul 2019 16:47:37 GMT

Accelerating development of its PHA biodegradable biopolymers to replace single-use plastics

SINGAPORE, Oct. 10, 2018 /PRNewswire/ -- Singapore-headquartered biotech start-up RWDC Industries Pte Ltd announced today that it has successfully closed a US$13 million Series A2 round co-led by venture capital firms Vickers Venture Partners and WI Harper Group. Finance firm Ridgevale Enterprises Limited and individual investors also participated in the round.

Vickers Chairman and co-founding partner Dr. Finian Tan, along with WI Harper Chairman Mr. Peter Liu, have joined RWDC's board of directors.

RWDC Executive Chairman Mr.Roland Wee said: "I am heartened by the trust that WI Harper, Vickers Venture Partners, Ridgevale Enterprises Limited and all our other investors have shown in us. We are a highly capable, passionate, and experienced team of scientists, engineers, financiers and marketers. This team is determined and confident in realising our vision of helping make this planet a greener place for future generations."

Series A2 funds will primarily be used to expand RWDC's PHA (polyhydroxyalkanoate) production capacity in Athens, Georgia (USA), to 2,000 tonnes per year, making it among the world's largest PHA producers by early 2019.

RWDC develops innovative and cost-effective biopolymer material solutions. In particular, the company produces medium-chain-length polyhydroxyalkanoate (mcl-PHA). PHAs are naturally produced by bacterial fermentation of plant-based oils or sugar, and are widely recognized as the world's only commercially viable biodegradable bioplastic due to its versatility1.

RWDC's PHA is certified to be fully biodegradable in soil, water and marine conditions (i.e. all potential end-of-life scenarios) by certification agency TUV Austria (formerly Vincotte). It fully biodegrades within weeks with no toxic residue. RWDC's customers will be able to label their products as 100% bio-based, non-toxic and truly biodegradable.

"Over the last few months, we have received strong support from our investors, as well as tremendous interest from potential customers, including major packaging manufacturers and F&B brand owners", Mr.Wee said. "We are extremely excited and focused on the expansion of our PHA facility in the US, as this marks our first step towards producing PHA at commercially affordable prices for the global market. We have concrete plans to scale up very quickly from here."

RWDC Chief Executive Officer Dr.Daniel Carraway said: "This facility will be a training ground for our staff, provide material for customer trials, and serve as a demonstration of our capabilities. At the same time, we have ambitious plans for the future. We look forward to providing the world with a truly biodegradable, 100% renewable, and highly versatile material."

"PHA will be a major component in sustainable packaging materials of the future, and RWDC offers a comprehensive technical and material resource for brand owners and converters in the food service, food packaging, and consumer goods packaging industries.

Dr. Finian Tan said: "Every year, the world produces several hundred metric tonnes of plastic, mostly destined for single-use products that persist in the environment after disposal and creates a huge plastic pollution problem that the world is increasingly acutely aware of."

"While it is unrealistic to curb the massive demand for plastic – especially in emerging markets where consumption is on a constant rise – we can still power innovators such as RWDC to develop a commercially attractive solution to a long-standing socio-ecological problem."

Chairman of WI Harper Group, Mr.Peter Liu commented: "From microplastics in the arctic sea ice to once-pristine beaches in Thailand and Philippines being shut down, not only is plastic pollution at a negative tipping point but the world needs solutions and education on this topic. We are extremely excited to partner with RWDC and their dynamic management team. PHA produced at their pilot facility has already shown purity and yield above expectations."

Mr. Liu further added, "Recycling is still the preferred choice among governments worldwide, as current biodegradable solutions may produce waste that has little value. There are many lobbyists for recycling in government, but not for biodegradability. We look forward to bringing positive change and social impact in sustainability for the future generations to come."

In July, RWDC won the inaugural Liveability Challenge, presented by Temasek Foundation Ecosperity, securing S$980,000 in funding for its proposal to make fully biodegradable drinking straws made of PHA. The company is working towards developing drinking straw prototypes by the end of the year and will produce straws in commercial quantities by mid-2019.

1 RWDC's PHA is suitable for a broad range of applications, including single-use food service articles (e.g. cutlery, drinking straws and cup lids), paper coatings (e.g. cups, bowls, plates and takeout containers), food and beverage packaging, consumer goods packaging, diapers, wipes and agricultural mulch films.

About RWDC Industries:

Founded in 2015 by Mr.Roland Wee and Dr.Daniel Carraway, RWDC Industries Pte Ltd, a biotechnology company, develops innovative and cost-effective biopolymer material solutions. In particular, RWDC produces medium-chain-length polyhydroxyalkanoate
(mcl-PHA) biopolymers that are designed for use across a broad range of applications.

PHAs are linear polyesters naturally produced by bacterial fermentation of plant-based oils or sugar and are widely recognised as the only commercially viable biodegradable bioplastic. RWDC's PHA is certified to be fully biodegradable in soil, water and marine conditions (i.e. all potential end-of-life scenarios) by TUV Austria (formerly Vincotte), fully biodegrading within weeks with no toxic residue. RWDC supports sustainable practices and encourages responsible choice in plastic waste management including recycling so as to best protect our environment.

https://rwdc-industries.com

About WI Harper Group:

WI Harper is a pioneer and leading cross-border venture capital firm investing in early and expansion stage companies across Greater China, Asia Pacific and the US. With offices in Beijing, Taipei, and San Francisco, the firm actively oversees more than $1 billion in assets under management. Since inception nearly three decades ago, WI Harper has invested in over 400 startups and has successfully experienced more than 100 IPO and M&A exits.

We look for innovative companies and visionary founders in healthcare and technology fields where there are high synergies and meaningful value added cross selling opportunities. While our healthcare team is presently focused on bioinformatics as well as digital biology, our technology team has a more generalist approach covering big data, analytics, artificial intelligence, AR/VR, IoT, robotics, drones, autonomous driving, as well as digital media and green energy projects.

https://wiharper.com

About Vickers Venture Partners:

Vickers Venture Partners is a venture capital firm focused on early-stage investments in Asia and beyond. The firm's portfolio covers life sciences, technology, media, and telecommunications as well as consumer and financial services. Some of its partners have track records that include hits such as Baidu.com, Inc (NASDAQ: BIDU), Focus Media Holding Ltd (NASDAQ: FMCN), Kongzhong Corp (NASDAQ: KONG), Cambridge Real Estate Investment Trust (SGX: CREIT), Sunfun Info Co. (Gretai: 5278) Asian Food Channel (trade sale), UUCUN (trade sale), TWG Tea (trade sale), RTG Asia (trade sale), JJE (trade sale), Hillstone (trade sale), M-Daq (trade sale), Tenfen (trade sale), Kuyun (trade sale) and Mainspring (trade sale). The total market value of the companies that the partners have helped grow exceeds US$90 billion today. Vickers Venture Partners announced in October 2017 that they have raised US $230 million to invest in startups across the world, with a particular focus on Deep Tech across the globe and impact investments in emerging markets.

Vickers Venture Partners was founded by Finian Tan, Khalil Binebine, Jeffrey Chi, Damian Tan, and Linda Li in 2005. It is based in Singaporewith offices in Kuala Lumpur, Shanghai, Hong Kong, New York, San Diego with an office opening in San Francisco in 2018.

https://vickersventure.com

View original content:https://www.prnewswire.com/news-releases/biotech-start-up-rwdc-closes-us13-million-series-a2-led-by-vickers-venture-and-wi-harper-to-produce-plastic-alternative-300728362.html

SOURCE WI Harper Group

10/15/2018

Fully biodegradable plastic straw developed by Danimer Scientific

Tue, 02 Jul 2019 16:48:36 GMT

Necessity being the mother of invention, it was only a matter of time before a biodegradable plastic straw—not a poor paper substitute—came on the scene. That’s what Danimer Scientific, a developer and manufacturer of biodegradable plastic products, announced today with the creation of what it calls the first fully biodegradable plastic straw using its Nodax polyhydroxyalkanoate (PHA) material.

“The environmental impact of straws and other single-use plastic items has become a critical issue for cities and companies across the country,” said Scott Tuten, Chief Marketing Officer at Danimer Scientific. “The challenge is that there are few durable, yet eco-friendly alternatives available. Thankfully, research has found that PHA effectively biodegrades in environments ranging from waste treatment facilities to landfills and oceans. With that stamp of approval, we are excited to be bringing truly biodegradable straw resins in the near future to businesses that are looking to replace petrochemical plastic straws in restaurants, amusement parks and more.”

The company cites a 2018 University of Georgia study that compared the biodegradation of Danimer Scientific’s Nodax PHA with cellulose powder, food waste, plastic pellets and other materials in aerobic and anaerobic conditions. The study reportedly showed that, in a proper waste management setting, Nodax PHA biodegrades at a similar rate to cellulose powder, or wood pulp. The study also found that Nodax PHA could be effectively processed alongside food waste and other organic waste in a landfill. Additionally, researchers determined that Nodax PHA will begin to biodegrade over the course of six months in ocean water, while traditional plastics remain intact and unchanged in the same environment.

Danimer Scientific’s Nodax PHA possesses seven TUV Austria certifications and statements of industrial and home compostability, is biodegradable in anaerobic, soil, fresh water and marine environments and is 100% bio-based. All of Danimer Scientific’s biopolymers, including its Nodax PHA, are FDA approved for food contact.

UPDATE: This announcement came two weeks later on September 25: Danimer Scientific to open world's first PHA commercial production plant.

10/04/2018

Former Georgia Research Alliance CEO joining Emory University

Tue, 02 Jul 2019 16:51:28 GMT

The Georgia Research Alliance’s Michael Cassidy is joining Emory University, according to Emory President Claire E. Sterk.

Cassidy will take a new position that is designed to provide vision and leadership to promote biomedical innovation and enhance the university’s economic engagement in the Atlanta region and beyond.

As director of the new Emory Biomedical Catalyst, Cassidy will lead efforts to enhance innovation, entrepreneurship and development of intellectual property, as well as identifying and developing areas of frontier research. He began working with Emory this week.

“Emory University’s research initiatives have benefitted society in many ways,” Sterk said in a release. “Mike Cassidy brings great experience in translating research into impact, and his work here will energize an already vibrant and collaborative faculty and student culture.”

Cassidy served as president and CEO of the Georgia Research Alliance for 18 years, helping the public-private entity become of the nation’s premier organizations for technology-based economic development.

During his tenure, Cassidy generated broad-based support for the GRA’s mission, including economic development and building and sustaining the non-profit’s powerful set of relationships with companies, professional organizations, universities, and leaders at the local, state and national level.

He expanded the GRA’s mission of recruiting world-class scientists to Georgia universities, investing in state-of-the-art research technology for university labs, launching new companies around university inventions, and forging and strengthening alliances among universities and industry.

“I have tremendous respect for Mike Cassidy and his accomplishments at the Georgia Research Alliance in raising Georgia’s stature as a leading state for biomedical innovation and partnership,” said Jonathan S. Lewin, MD, Emory executive vice president for health affairs and executive director of the Woodruff Health Sciences Center. “His skills and experience make him the ideal director for Emory Biomedical Catalyst, which will serve as a results-oriented catalyst for biomedical innovation throughout Emory University, inspiring colleagues to achieve new levels of expertise, confidence and productivity.”

Cassidy will report to Lewin and to Vikas Sukhatme, MD, dean of Emory University School of Medicine. He also will work closely with research leaders and with initiatives in innovation and entrepreneurship throughout the university, including the Office of Research, Office of Technology Transfer, the Emory Healthcare Innovation Hub, the Coulter Translational Research Program, the Georgia Clinical and Translational Science Alliance, the office of the provost and the office of the senior vice president for research.

“I am very excited and honored to be joining one of the nation’s top academic research institutions” Cassidy said. “I look forward to contributing to Emory’s continued leadership in driving innovation and economic impact.”

Cassidy serves on the boards of the State Science and Technology Institute, the Health Care Ethics Consortium, Primary Care Innovation Fund, the Global Center for Medical Innovation, Georgia’s Bio/Med Investor Network, Atlanta Emerging Markets Inc. and the Georgia Chamber of Commerce.

He has a master’s degree in Technology and Science Policy from Georgia Tech and a BBA in Marketing from Georgia State University

10/04/2018

Georgia Bio Announces Keynote and Featured Speakers for Annual Innovation Summit

Tue, 02 Jul 2019 16:52:44 GMT

American Cancer Society CEO Gary M. Reedy to discuss organization’s new venture fund to commercialize promising new cancer therapies Centers for Disease Control and Prevention Director Dr. Robert R. Redfield in conversation with Chief Medical Officers from Quest and Abbvie to discuss digital health innovation in the 21^stcentury

Atlanta, Georgia (October 2, 2018) – Georgia Bio announced today keynote and featured speakers for its Annual Innovation Summit, Tues., Oct. 9, 2018 at Cobb Galleria. Gary M. Reedy, CEO, American Cancer Society (ACS), will discuss the organization’s new venture fund and its plans to commercialize cancer-focused therapies, medical devices and technologies.

Following his keynote address on “Capital Continuum from Research to Commercialization,” Reedy will be joined by Robert L. Crutchfied, managing director of the new ACS BrightEdge Ventures, and Rob King, senior vice president, Enterprise Planning and Business Integration, ACS, in a fireside chat led by Tiffany Wilson, CEO, Global Center for Medical Innovation, 2018 Summit Chair to discuss the fund’s plans to support emerging technologies and its impact on future cancer research and treatment. “It has been an honor to Chair this year’s Summit,” Wilson says. “Along with Gary, Bob and Rob, I am eager to highlight our ecosystem’s latest advancements including ACS’s approach to addressing gaps in the capital continuum for medtech and bio-innovators. We hope to demonstrate how this approach will translate into faster time-to-cures and lower cost of development and care.”

In the area of digital health, Centers for Disease Control and Prevention (CDC) Director Dr. Robert R. Redfield will kick-off a luncheon keynote panel on the “Future of Digitalization in Health.” Joining him will be prominent chief medical officers Dr. Rob Scottof Abbvie and Dr. Jay Wolgemuth of Quest Diagnostics. This panel will provide an overview perspective of digital health for decision makers in the biotechnology, pharmaceutical and healthcare industries and the scientific and clinical community.

The Summit is the largest gathering of life science leaders in the state. According to the2018 TECONOMY/Biotechnology Innovation Organization report, the state’s bioscience firms have grown their employment base by 10.6 percent since 2014 and employed just over 32,000 in 2016. The number of companies has grown by 16 percent during this same period and now number 2,431 across the state. Georgia’s research universities conducted nearly $1.1 billion in bioscience-related academic R&D in 2016; funded, in part, by a growing base of National Institutes of Health awards that reached $537 million in FY 2017.

As many as 500 CEOs, senior executives, investors, university scientists, physicians, and public policy experts are expected to attend the day-long Summit. In addition to the keynote speakers, the Summit will feature more than 50 experts in panel discussions highlighting the full range of bioscience innovation in Georgia. The day-long program will cover the span of life science sectors including biotech/pharma, medical devices, diagnostics, academic research, and healthcare IT.

“We’re excited to host two of the U.S.’s leading experts in life sciences at this year’s Summit, Gary Reedy of ACS and Dr. Robert Redfield of the CDC,” said Georgia Bio Chair, Patricia Fritz, Vice President, U.S. Corporate Affairs at UCB Inc. “We believe the future of the life sciences is strong in Georgia, thanks to established and emerging companies that call our state home. The Summit will be a great showcase of the life sciences industry creating hundreds of jobs, the presence of new venture funds to commercialize research, and our world-class research institutions.”

The breakout sessions throughout the day will focus on Digital Health Innovations Impact on Population Health; Increasing Minority Patient Enrollment in Clinical Trials; Advancing Immunotherapy Breakthroughs; Innovations in Advanced Manufacturing; the EB-5 Visa Program; Capital Raising, and more. Attendees will have the opportunity to participate in peer-to-peer, small group interactive best practice Roundtables facilitated by industry leaders across several functional areas such as regulatory compliance and training and purchasing and procurement.

Georgia’s bioscience industry has consistently outpaced the national growth rate and contributes significantly to the state economy. Attendees will get a chance to learn more about emerging technologies from Georgia’s universities and companies by stopping by the Innovation Stage during the exhibition breaks.

The Summit serves as the only life sciences exposition in Georgia with an Exhibit Hall featuring the latest research, technology and services at companies, universities and other organizations. The Summit also features a scientific poster contest where representatives from Georgia-based academia, research institutes and industry alike will showcase their research. The Anthony Shuker Scientific Poster Awards sponsored by UCB will be presented by Stacy Williams Shuker, Ph.D., Down South Innovation.

The conference will close with a panel discussion on “The Future of Life Sciences in Georgia,” presented by Georgia Research Alliance, Metro Atlanta Chamber, Georgia Global Health Alliance and Georgia Bio. Speakers will discuss the latest efforts to improve access to capital, grow our workforce, and develop resource and innovation centers to position Georgia as a leading state for biosciences. Immediately following remarks, the event will close with a networking reception.

For more information about the Summit, please visit www.georgiabiosummit.org.

About Georgia Bio

Media Registration: Registration is complimentary forcredentialed members of the news media. To request media registration, please contact Maria Thacker at mthacker@gabio.org| 404-920-2042.

10/02/2018

Georgia Bio Appoints Maria Thacker Acting President and CEO

Tue, 02 Jul 2019 16:53:41 GMT

Atlanta, Georgia (September 26, 2018) – Georgia Bio today announced that Maria Thacker Goethe has assumed the role of Acting President and CEO for the trade association and the Georgia BioEd Institute. She will also remain in her capacity as Executive Director for the Georgia Global Health Alliance.

Ms. Thacker Goethe has served in a variety of roles for Georgia Bio over the years including Marketing, Membership and Project Manager. Since 2013, she served as Vice President of Operations. An innovative thinker with broad-based expertise in operations, community relationship building, and marketing Ms. Thacker Goethe has been a driving force behind Georgia Bio’s programs and the development of the Georgia BioEd Institute. As the organization has grown, Ms. Thacker Goethe’s role and responsibilities have continued to increase and evolve. Her institutional knowledge of the organization and the community positions Georgia Bio for continued success.

“Maria has been an invaluable resource to Georgia Bio for more than a decade. During this time she has established a strong reputation for her industry knowledge and expertise with Georgia businesses, leaders and legislators,” said Georgia Bio Chair, Patricia Fritz, Vice President, U.S. Corporate Affairs at UCB Inc. “The executive committee and board are pleased to have her leadership during this transitional period for the organization.”

Most recently, Ms. Thacker Goethe has been working alongside Georgia BioEd Institute and industry government affairs leaders to develop a proposal to grow Georgia’s biomanufacturing workforce and improve opportunities for young people in rural communities. The proposal involves investing in cutting-edge teacher training workshops which provide students with access and opportunity to high-paying and innovative jobs in the life science industry.

There is still much to accomplish to make Georgia and the surrounding Southeast a world-leading life sciences and global health center, and every effort at Georgia Bio and the Georgia BioEd Institute is solidly connected to that mission.

Ms. Thacker Goethe received her master’s in public health in health education/communication, and maternal and child health from Tulane School of Public Health and Tropical Medicine, and her Bachelor of Arts in environmental studies from Sweet Briar College. She is a 2009 recipient of the Power 30 Under 30 Award for professional and community excellence. Ms. Thacker currently sits on the CJD Foundation Board of Directors and an executive committee member for the Coalition of State Bioscience Institutes. Additionally, Ms. Thacker Goethe volunteers with the Junior League of Atlanta co-chairing the La Amistad Estrellitas program which works to empower Latina teens; she has volunteered with this program for 9 years now.

About Georgia Bio

09/26/2018

GeoVax Awarded $2.4 Million from U.S. Department of Defense to Advance Lassa Fever Vaccine

Tue, 02 Jul 2019 16:54:34 GMT

Atlanta, GA - (NewMediaWire) - September 26, 2018 - via NEWMEDIAWIRE -- GeoVax Labs, Inc. (OTCQB: GOVX), a biotechnology company developing innovative human vaccines, announced today that the U.S. Department of Defense (DoD) has awarded the Company a $2,442,307 cooperative agreement in supportof its novel Lassa Fever (LF) vaccine development program. The grant was awarded by the U.S. Army Medical Research Acquisition Activity pursuant to the Peer Reviewed Medical Research Program (PRMRP), part of the Congressionally Directed Medical Research Programs (CDMRP). In addition to the grant funds provided directly to GeoVax, DoD will also fund testing of the GeoVax vaccine by U.S. Army scientists under a separate subaward.

The project award, entitled “Advanced Preclinical Development and Production of Master Seed Virus of GEO-LM01, a Novel MVA-VLP Vaccine Against Lassa Fever”, will support generation of immunogenicity and efficacy data for GeoVax’s LF vaccine candidate in both rodent and nonhuman primate models, as well as manufacturing process development and cGMP production of vaccine seed stock in preparation for human clinical trials. The work will be performed in collaboration with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), the Geneva Foundation, and Advanced Bioscience Laboratories (ABL).

GeoVax previously announced that its LF vaccine candidate, GEO-LM01, provided 100% protection after a single intramuscular immunization of mice, which were subsequently exposed to a lethal dose of a model challenge virus delivered directly into the brain. The Company also announced in April 2018 the award of a Fast Track Phase I/II Small Business Innovative Research (SBIR) grant from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to construct and test second-generation LF vaccine candidates in collaboration with Scripps Research and the Institute of Human Virology at the University of Maryland School of Medicine.

Farshad Guirakhoo, PhD, Chief Scientific Officer at GeoVax, commented, “The work funded by this award will significantly advance the development of our vaccine candidate, GEO-LM01, which has already demonstrated impressive preclinical results. These studies will be complementary to those being funded by our separate SBIR grant from NIAID/NIH which is supporting development of a potentially ‘universal’ LF vaccine by eliciting broadly neutralizing antibodies to the Lassa virus (LASV) glycoprotein designed by Scripps Research. Both avenues are building upon previous work that demonstrates the full protective efficacy of GeoVax’s MVA recombinant vaccines against dangerous diseases after a single inoculation. We are pleased now to have non-overlapping support for our LF vaccine program from multiple federal agencies and excited to be working with influential USAMRIID scientists to combat a pathogen of major concern to our armed forces.”

GEO-LM01 uses GeoVax’s proven Modified Vaccinia Ankara (MVA) Virus-Like Particle (VLP) vaccine platform that has been shown to be safe and to induce durable antibody and T cell responses in multiple human clinical trials for GeoVax’s prophylactic HIV vaccine. In contrast to other LF vaccines in development that rely on a single glycoprotein antigen, GEO-LM01 includes an additional matrix protein that forms VLPs with the LASV glycoproteins. Upon infection of human cells, the MVA-driven expression of the two proteins leads to the formation of non-infectious VLPs that bear natively-folded glycoproteins on their surface, triggering an effective and durable immune response.

Using the same MVA-VLP platform, a single dose of GeoVax’s Ebola (EBOV) vaccine has been shown to protect 100% of rhesus monkeys against a lethal dose of EBOV challenge. Similarly, a single dose of GeoVax’s Zika vaccine showed full protection in preclinical animal models. GeoVax is also developing vaccines against Sudan virus (SUDV) and Marburg virus (MARV), two other lethal hemorrhagic fever viruses for which no effective vaccine currently exists. In addition to developing the four individual vaccines (EBOV, LASV, SUDV, MARV), the Company’s ultimate goal is to combine them into a single tetravalent vaccine to provide broad protection for individuals at risk for these viruses.

Commenting on the award, GeoVax CEO, David Dodd stated, “This validation of the value of our proprietary, patented applications of MVA-VLP technology demonstrates our continued progress in vaccine development in areas of critical healthcare significance worldwide. Our commitment is to further contribute to improved healthcare, providing an attractive investment return to our shareholders, while providing an exciting and motivating career development opportunity for our outstanding staff. We look forward to forthcoming, additional reports of the progress of our product development programs, including additional collaboration agreements in other critical areas.”

About Lassa Fever

Lassa Fever is caused by an infection with LASV, a member of the Arenaviridaevirus family. The virus can cause severe hemorrhagic illnesses with up to 50% case fatality rates in an overlapping region with EBOV. The virus is transmitted to humans by natal multimammate rat or Africanrats (e.g. by direct consumption in food, contact with urine and droppings or inhalation of virus particles from the excreta of infected animals) that live in large numbers in agricultural areas near human habitations. The virus can also be transmitted from human to human through nosocomial infections. In contrast to the unpredictable epidemics of filoviruses such as EBOV, LF is endemic in West Africa with an annual incidence of over 300,000 and leading to 5,000 to 10,000 deaths. Recent study data suggests that the number of annual LF cases may in fact be significantly higher, with three million infections and 67,000 deaths (placing upwards of 200 million individuals at risk). Today, no treatment or vaccine is available to stem LF epidemics, even though LF kills more people in one year than the EBOV did in the last 41 years after its first epidemic in 1976 in West Africa.

The urgent need for a LF vaccine is exemplified by the record-high ongoing outbreak of LF in Nigeria with nearly 2,500 suspected cases and 132 deaths in 2018 according to the Nigeria Centre for Disease Control report on September 2, 2018. The infection of 39 healthcare workers highlights the need for infection prevention and control measurements to stop the spread of disease in healthcare workers and prevent cross-border spread into neighboring countries.

About GeoVax

GeoVax Labs, Inc., is a clinical-stage biotechnology company developing human vaccines against infectious diseases using its MVA-VLP vaccine platform. GeoVax was the winner of the 2018 “Best Biotech” Vaccine Industry Excellence Awards, a finalist for the 2018 “Best Prophylactic Vaccine” Award for its Zika vaccine at the World Vaccine Congress, as well as a finalist for Pipelines of Promise at Buzz of Bio 2018. The Company’s development programs are focused on vaccines against HIV, Zika, hemorrhagic fever viruses (Ebola, Sudan, Marburg, Lassa) and malaria. GeoVax also is evaluating the use of its MVA-VLP platform in cancer immunotherapy, and for therapeutic use in chronic Hepatitis B infections. GeoVax’s vaccine platform supports in vivoproduction of non-infectious VLPs from the cells of the very person receiving the vaccine. The production of VLPs in the person being vaccinated mimics virus production in a natural infection, stimulating both the humoral and cellular arms of the immune system to recognize, prevent, and control the target infection. For more information, visit www.geovax.com.

09/26/2018

The Georgia Research Alliance Names Russell Allen as President and CEO

Tue, 02 Jul 2019 16:55:38 GMT

ATLANTA, Sept. 20, 2018 (GLOBE NEWSWIRE) -- The Georgia Research Alliance (GRA) announces today that it has named Russell Allen as the organization’s new President and CEO.

Russell joins GRA after serving as the president and CEO of Georgia Bio for the past five years. Georgia Bio is the state’s life science industry association, charged with promoting and advocating for the interests and growth of medical technology and biopharmaceutical companies.

Before Georgia Bio, Russell served as president and CEO of BioFlorida, Florida’s bioscience association. His earlier career in Georgia includes co-founding and leading a regional partnering and commercialization association, BioSouth, and serving as the first VP of Biosciences at the Metro Atlanta Chamber.

“We are excited to welcome Russell to GRA,” said Larry Gellerstedt, Chair of the Board of Trustees of the Georgia Research Alliance. “He brings a wealth of expertise in the bioscience and technology sectors and has experience working together with corporations, universities, and government on a shared mission for growing Georgia’s economy.”

Early on in his career, Russell was a tech entrepreneur and launched one of the country’s first digital marketing and consulting firms, based in Atlanta. Subsequently, he created and led a marketing agency with a focus on healthcare and biotechnology. Recently, Russell partnered with healthcare leaders and the GRA to found the Bio/Med Investor Network, aimed at connecting early-stage biomedical and health innovation companies with angel investors. Russell currently serves as a director on numerous industry boards and advisory councils and served as chairman of the U.S. Council of State Bioscience Associations.

“Our universities are drivers of innovation and new startups,” said Russell Allen. “GRA has been a tremendous asset to our state for almost three decades; I look forward to carrying on its legacy and helping grow our innovation economy in Georgia.”

###

About The Georgia Research Alliance 

The Georgia Research Alliance (GRA) grows Georgia’s economy by expanding university research capacity and seeding and shaping startup companies around inventions and discoveries. For over twenty-five years, GRA has worked to strengthen the university research enterprise in Georgia by working in partnership with the University System of Georgia and the Georgia Department of Economic Development to create the companies and jobs of Georgia's future. Visit www.gra.orgfor more information.

09/20/2018

Alpharetta biopharmaceutical company names GC & chief compliance officer

Tue, 02 Jul 2019 16:57:40 GMT

An Alpharetta, Ga., biopharmaceutical company developing eye disease treatments has hired a general counsel and chief compliance officer.

Leslie Zacks will step into the newly created role at Clearside Biomedical Inc. (NASDAQ:CLSD).

Zacks most recently served as vice president, general counsel and chief compliance officer at Arbor Pharmaceuticals in Atlanta. Prior to joining Arbor, Zacks was executive vice president, general counsel and chief compliance officer at Shionogi Pharma Inc. from 2004 to 2010. From 2002 to 2004, he worked at Hunton & Williams LLP, where he was a partner in the Intellectual Property Litigation department.

Zacks is a registered patent attorney who has held associate positions at Powell, Goldstein, Frazer & Murphy LLP and at Webb, Carlock, Copeland, Semler and Stair LLP. His bachelor's degree and law degree are from the University of Florida.

“I am very pleased to welcome Leslie as a member of our executive team,” Clearside’s CEO and President Daniel H. White said in a statement. “His appointment comes at a particularly important time, as we prepare to submit our first NDA before the end of this year and continue to advance our late-stage pipeline. Leslie’s expertise in navigating the legal and regulatory requirements for the development and commercialization of new products, combined with his established record for developing effective strategies that mitigate risk and enhance business value, will be a tremendous asset for us going forward as we continue to plan Clearside’s transition from a clinical-stage to a commercial-stage company.”

Clearside Biomedical is developing treatments that restore and preserve vision for people with eye diseases where macular edema is a common complication, including uveitis, retinal vein occlusion and diabetic macular edema. The company's proprietary suprachoroidal treatment approach offers unprecedented access to the back of the eye, where sight-threatening disease often occurs.

09/20/2018

GeoVax Comments on Recent Vaccine Development Study Funded by the Gates Foundation

Tue, 02 Jul 2019 16:59:33 GMT

Atlanta, GA - (NewMediaWire) - September 19, 2018 - GeoVax Labs, Inc. (OTCQB: GOVX), a biotechnology company developing human vaccines, today commented on a research article describing a study funded by the Gates Foundation. In the article, “Developing new health technologies for neglected diseases: a pipeline portfolio review and cost model”, published at Gates Open Research1, the authors discussed their review of product development pipelines for 35 neglected diseases and over 500 product candidates, concluding there to be a worldwide funding gap over the next 5 years of between $1.5 and $2.8 billion, potentially impacting the development timelines of efficacious vaccines against HIV, Malaria and Tuberculosis.

David Dodd, GeoVax President & CEO, commented, “This study highlights the dire need for increased government and global health organization support for vaccine research and development against various pathogens afflicting humanity. Taking HIV as an example, and examining domestic spending in the United States alone, the federal funding budget request for 2018 includes $26.6 billion related to HIV/AIDS, of which less than $900 million (3%) is designated for domestic vaccine and other prevention research; the rest is mostly directed to care and treatment programs (Sources: Henry J. Kaiser Family Foundation, NIH Office of AIDS Research). These numbers illustrate the stark reality of the ongoing economic burden of HIV/AIDS in the United States, and the dramatic impact that an effective preventive vaccine may have over time. A 2016 report from Research!America further quantifies the impact a vaccine could have on a global scale, stating that “Between 2020 and 2030, an AIDS vaccine could prevent between 5.2 and 10.7 million new HIV infections, saving between $46 billion to $95 billion from the averted costs of current HIV/AIDS treatments alone.” And the human impact in terms of quality of life and vitality is simply immeasurable.

“While we certainly advocate for increased public spending in each of the areas addressed in this article,” Mr. Dodd continued, “we also want to thank the National Institutes of Health which has provided substantial funding (through the National Institute of Allergy and Infectious Diseases) for GeoVax’s HIV vaccine program. Our most advanced vaccines under development are designed to protect against the clade B subtype of the HIV virus that is prevalent in the Americas, Australia, Japan and Western Europe. Our preventive clade B HIV vaccine has successfully completed Phase 2a human clinical testing and has entered a follow-on clinical trial. This vaccine has shown outstanding safety and excellent, highly reproducible immunogenicity. We have also extended our preventive HIV vaccine effort to the most common virus subtype affecting the developing world, clade C, and also are investigating our HIV vaccines for their potential to contribute to combination therapies leading to a cure for HIV infections.”

About GeoVax

GeoVax’s vaccine technology is based on its Modified Vaccinia Ankara (MVA) Virus-Like Particle (VLP) platform, which generates noninfectious VLPs in the individual being vaccinated. Gene sequences of target antigens are inserted into the MVA genome which drives their expression in infected cells. In addition, GeoVax introduces into the viral genome matrix sequences that incorporate antigens into VLPs and simultaneously facilitate their budding from the membranes of host cells. In this way, vaccination induces two pools of antigens as targets for the immune response – host cells and VLPs secreted from host cells. This strategy mimics a natural viral infection, triggering the body to produce a robust and durable immune response with involvement of both antibodies and T cells.

For more information, visit www.geovax.com.

09/19/2018

NIH $3M Grant Will Enable Emory, Georgia Tech Researchers to Tackle Sickle Cell Disease with New Technologies

Tue, 02 Jul 2019 17:00:42 GMT

The National Institutes of Health has awarded a four-year, $3 million grant to a research team at Emory and Georgia Tech that will use new technologies to improve the effectiveness of blood transfusions in patients with sickle cell disease.

The research will take place in the labs of Wilbur Lam, MD, PhD, and Melissa Kemp, PhD, both associate professors in the Coulter Department of Biomedical Engineering at Georgia Tech and Emory University, and at the University of Minnesota lab of David Wood, PhD. Lam is also part of the Aflac Cancer and Blood Disorders Center at Children’s Healthcare of Atlanta.

The NIH-funded project is entitled “Redefining clinical viscosity in sickle cell disease by leveraging microfluidic technologies.”

Sickle cell disease is a life-threatening genetic blood disorder in which red blood cells become physically altered and misshapen. Viscosity, or resistance to flow, is a complex biophysical property of blood that changes in various parts of the circulation in the body and is rendered even more complex by sickle cell disease.

“While blood viscosity in sickle cell disease is poorly understood,” explains Lam, “it remains important clinically, because physicians are instructed to use blood transfusions judiciously to avoid ‘hyperviscosity,’ but are also hampered by clinical transfusion guidelines that are not scientifically sound or evidence-based.”

The researchers propose to use new microfluidic and computational modeling techniques to model the different blood vessels and to more precisely define what “viscosity” means in different parts of the circulation within a sickle cell disease patient. They also will study how viscosity changes in the context of blood transfusions, which will lead to more patient-specific transfusion guidelines.

“We are grateful for this funding, and confident that the grant will allow us to make a significant contribution to redefining and improving guidelines for blood transfusions in sickle cell disease,” says Kemp. “This could make a significant difference in the quality of life and long-term health of these patients.”

09/11/2018

Wright to absorb Cartiva and its arthritis cartilage implant in $435M deal

Tue, 02 Jul 2019 17:03:23 GMT

Wright Medical Group announced plans to snatch up its competitor Cartiva, along with its synthetic cartilage implant for treating arthritis in the big toe, for $435 million in upfront cash.

Wright plans to fully fund the purchase through sales of equity securities, before the transaction is expected to close in the fourth quarter of this year. The deal, which does not include a financing contingency, has been approved by the boards of directors of both companies and by a vote of Cartiva’s stockholders.

Cartiva’s lead product is composed of a biocompatible, low-friction organic polymer that mimics natural cartilage and can be implanted at the base of the toe in about 35 minutes, allowing for a higher volume of procedures to be completed, compared to longer joint fusion operations using metal plates and screws that can inhibit motion. The implant received premarket approval in July 2016 as the first synthetic cartilage to be cleared by the FDA.

“We decided it was better for us to have this product than one of our competitors,” said Wright’s president and CEO, Robert Palmisano, in a conference call with investors. “It would erode our business over time if someone else had it. We’ve been fighting it off with plates and screws.”

In addition, the implant has a less restrictive rehabilitation protocol, with patients typically returning to daily life faster than those who underwent a fusion procedure.

In a statement, Palmisano said the addition would be “a perfect fit” for Wright’s lower extremities portfolio, bringing in a differentiated product for a common condition treated by most foot and ankle surgeons with strong patient demand.

The implant has also received regulatory approvals in Canada, the EU, Brazil, Chile and Australia. Wright said it expects full-year 2018 Cartiva revenues to reach about $35 million, representing about 50% growth compared to 2017.

“We don’t need more kinds of plates and screws—what we need is more, less-traditional orthopedic products,” Palmisano told investors. “Bio- or bio-type products are the ones that I’m most interested in doing.”

For future development, Cartiva’s implant has previously received FDA clearance for clinical trials to treat similar arthritis in the thumb—although the decision to submit the product as a new PMA or as a supplement will take a few years to finalize, following studies and discussions with the agency, Palmisano said.

“We believe that Wright, with its 300-plus direct foot and ankle sales organization in the U.S. and its large international organization, as well as its expertise in medical education and product development, is the ideal partner to realize the full potential of our [synthetic cartilage implant] technology,” Timothy Patrick, president and CEO of the Alpharetta, Georgia-based Cartiva, said in a statement.

In addition, Wright raised its net sales guidance for 2018, outside of the Cartiva acquisition, based on its third-quarter performance. Its guidance was narrowed to about $812 million to $822 million, from its previous guidance of about $808 million to $820 million. Its third quarter earnings report is scheduled for Nov. 7.

Assuming the completion of the Cartiva deal, Wright anticipates an increase in 2019 net sales by about $47 million.

09/05/2018

GeoVax and PharmaJet to Collaborate on Development of Needle-Free Vaccine for Zika Virus

Tue, 02 Jul 2019 17:05:29 GMT

GeoVax Zika Virus Vaccine Provided 100% Protection in Animal Challenge Model

Labs, Inc. (OTCQB: GOVX), a biotechnology company developing human vaccines, announced today that it is collaborating with PharmaJet, Inc., on the evaluation of PharmaJet’s needle-free injection system for administration of GeoVax’s Zika vaccine.

The studies to be conducted pursuant to the collaboration will measure the efficacy of the GeoVax vaccine (designated GEO-ZM02) delivered by either syringe and needle or by the PharmaJet needle-free device. The studies will be conducted at the Division of Vector-Borne Diseases, U.S. Centers for Disease Control and Prevention (CDC) in Fort Collins, Colorado with technical assistance from the CDC. Further analysis will be conducted in the laboratories at GeoVax. PharmaJet is supplying its needle-free device and providing technical expertise.

In a previously published study, GeoVax demonstrated that GEO-ZM02 provided 100% protection in normal outbred mice challenged with a lethal dose of Zika virus (ZIKV) delivered directly into the brain. This is the only Zika vaccine in development based solely on the ZIKV NS1 protein, which provided full protection with a single-dose against a lethal ZIKV challenge using an immunocompetent mouse model.

GeoVax selected the ZIKV NS1 antigen as the target immunogen for its vaccine, as recent findings in mice and non-human primates indicate a potential risk of more severe clinical sequelae of subsequent dengue virus infection following traditional vaccination approaches based on the ZIKV envelope proteins. This “Antibody Dependent Enhancement (ADE) of infection” phenomena, previously shown to enhance dengue infections in humans, is now expected to potentially include ZIKV, dengue virus’ closest relative. Results of a new study performed in Rhesus Macaques provides in vivo evidence that prior exposure to ZIKV infection can enhance dengue infections should the individual be subsequently infected by a dengue infected mosquito. An NS1-based vaccine avoids the potential risk of ADE since this protein is not a surface protein on the virus. This approach holds the promise for a highly effective Zika vaccine, that is inherently safer than enveloped-based vaccines for those who live in areas where the ZIKV co-circulates with other flaviviruses such as dengue.

Farshad Guirakhoo, PhD, GeoVax’s Chief Scientific Officer, commented, “We are pleased to be collaborating with PharmaJet, as we believe their needle-free FDA-cleared injection technology could offer benefits over standard needle and syringe vaccine administration, particularly in areas of the world most affected by the ZIKV. We continue to be encouraged by the efficacy of our Zika vaccine, as well as the high safety profile it could present.”

“We are pleased that the PharmaJet devices have been chosen to participate in these important Zika vaccine studies. The needle-free devices are safe, fast and easy to administer and have already been used successfully in boosting vaccine immunogenicity in numerous clinical trials,” said Ron Lowy, Chairman and Chief Executive Officer, PharmaJet Inc.

About PharmaJet
Based in Golden, Colorado, PharmaJet’s mission is worldwide acceptance of PharmaJet needle-free devices as a standard of care in the vaccine delivery market. The innovative Stratis® Injector has U.S. FDA 510(k) marketing clearance, CE Mark and WHO PQS certification to deliver medications and vaccines either intramuscularly or subcutaneously. The Tropis® device for intradermal injections received authorization to apply the CE Mark in May 2016 and WHO PQS certification in June 2018. The PharmaJet Needle-free Injectors are safe, fast and easy-to-use. They eliminate needlestick injuries, needle reuse and cross contamination, and help reduce sharps waste disposal. For more information go to: www.pharmajet.com or contact Nancy Lillie, pr@pharmajet.com, 888-900-4321 option 3.

About GeoVax
GeoVax Labs, Inc., is a clinical-stage biotechnology company developing human vaccines against infectious diseases using its MVA-VLP vaccine platform. GeoVax was the winner of the 2018 “Best Biotech” Vaccine Industry Excellence Awards, a finalist for the 2018 “Best Prophylactic Vaccine” Award for its Zika vaccine at the World Vaccine Congress, as well as a finalist for Pipelines of Promise at Buzz of Bio 2018. The Company’s development programs are focused on vaccines against HIV, Zika, hemorrhagic fever viruses (Ebola, Sudan, Marburg, Lassa) and malaria. GeoVax also is evaluating the use of its MVA-VLP platform in cancer immunotherapy, and for therapeutic use in chronic Hepatitis B infections. GeoVax’s vaccine platform supports in vivo production of non-infectious VLPs from the cells of the very person receiving the vaccine. The production of VLPs in the person being vaccinated mimics virus production in a natural infection, stimulating both the humoral and cellular arms of the immune system to recognize, prevent, and control the target infection. For more information, visit www.geovax.com.

Forward-Looking Statements
Certain statements in this document are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act. These statements are based on management's current expectations and are subject to uncertainty and changes in circumstances. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax can develop and manufacture its vaccines with the desired characteristics in a timely manner, GeoVax's vaccines will be safe for human use, GeoVax's vaccines will effectively prevent targeted infections in humans, GeoVax’s vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete vaccine development, there is development of competitive products that may be more effective or easier to use than GeoVax's products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements. More information about these factors is contained in GeoVax's filings with the Securities and Exchange Commission including those under "Risk Factors" in its Form 10-K.

08/21/2018

GeoVax Announces Appointment of David Dodd as Chairman, President and Chief Executive Officer

Tue, 02 Jul 2019 17:06:53 GMT

Current President & CEO Robert McNally to Retire Effective August 31

ATLANTA, GA, August 14, 2018 – GeoVax Labs, Inc. (OTCQB: GOVX), a biotechnology company developing human vaccines, announced today that David A. Dodd, has been appointed President and Chief Executive Officer, effective September 1, succeeding Robert McNally, PhD, who has announced his retirement. Dr. McNally will remain as a member of the Company’s Board of Directors.

“It has been a privilege to serve GeoVax, its shareholders and employees, but after 40 years in the life science industry with the last 10 years at GeoVax, I now look forward to a fulfilling retirement,” said Dr. McNally. “I remain committed to continuing to help advise and guide the company as a member of its Board of Directors and am very pleased that David Dodd has agreed to assume the role of President and CEO. David brings a wealth of experience from a successful career of leading and developing multiple companies in the life science industry. His familiarity with GeoVax vaccine targets and overall growth strategy are huge assets in moving the company forward. Also, as a long-term colleague and friend, I look forward to continuing to work with David.”

Mr. Dodd commented, “On behalf of the entire Board of Directors, GeoVax staff, and our fellow shareholders, I want to thank Bob for his service to the Company, and we anticipate his continued contributions as a member of the Board. Under Bob’s leadership, GeoVax has built an impressive pipeline of promising vaccines and immunotherapy programs to address unmet medical needs across a range of infectious diseases and cancer. I look forward to working with our excellent scientific team, our world-class collaborators and research partners to build upon the Company’s strong scientific foundation and focus on the successful development and commercialization of our novel pipeline.”

Mr. Dodd joined the GeoVax Board of Directors in March 2010 and was elected Chairman in January 2011. His executive management experience in the pharmaceutical and biotechnology industries spans more than 40 years. From September 2017 to June 2018, Mr. Dodd served as CEO, and as a member of the Board of Directors, of Medizone International, Inc., a medical device manufacturer. From April 2013 to July 2017, Mr. Dodd served as President and CEO, and as a member of the Board of Directors, of Aeterna Zentaris Inc., a drug development company. He was Chairman of the Board of Directors of Aeterna Zentaris, Inc. from May 2014 to May 2016, and continued to serve as a member of its Board of Directors until May 2018. From December 2007 to June 2009, Mr. Dodd was President, CEO and Chairman of BioReliance Corporation, a leading provider of biological safety and related testing services. From October 2006 to April 2009, he served as non-executive Chairman of Stem Cell Sciences Plc., where he oversaw the development and implementation of a strategic growth plan, implementation of an experienced executive team, and the sale of the company to Stem Cells, Inc. in April 2009. He is also the CEO of RiversEdge BioVentures, an investment and advisory firm focused on the life sciences and pharmaceuticals industries, which he founded in 2009.

During Mr. Dodd's six-year tenure as President, CEO and Director of Serologicals Corporation, the market value of that company increased from $85 million in June 2000 to an all-cash sale to Millipore Corporation in July 2006 for $1.5 billion. That successful transformation followed his five-year term as President and CEO of Solvay Pharmaceuticals, Inc. and as Chairman of its subsidiary Unimed Pharmaceuticals, Inc. Prior to that, Mr. Dodd held various senior management positions at Wyeth-Ayerst Laboratories, the Mead Johnson

Laboratories Division at Bristol-Myers Squibb, and Abbott Laboratories.

He is a frequently invited speaker and panelist at business and economic development conferences, as well as various conferences focused on the life sciences and pharmaceutical industry. He is a recipient of the Oglethorpe Award for UK-US Business Relationships, the Georgia BIO Industry Growth Award, and the FastTech 50 Growth Company Award (2000-2006) while leading Serologicals Corporation.

Mr. Dodd holds Bachelor of Science and Master of Science degrees from Georgia State University and completed the Harvard Business School of Advanced Management Program. His numerous public service activities include the American Foundation for Suicide Prevention, and the Board of Directors of the Institute of Bioengineering and Bioscience at Georgia Institute of Technology.

About GeoVax

GeoVax Labs, Inc., is a clinical-stage biotechnology company developing human vaccines against infectious diseases using its MVA-VLP vaccine platform. GeoVax was the winner of the 2018 “Best Biotech” Vaccine Industry Excellence Awards, a finalist for the 2018 “Best Prophylactic Vaccine” Award for its Zika vaccine at the World Vaccine Congress, as well as a finalist for Pipelines of Promise at Buzz of Bio 2018. The Company’s development programs are focused on vaccines against HIV, Zika, hemorrhagic fever viruses (Ebola, Sudan, Marburg, Lassa) and malaria. GeoVax also is evaluating the use of its MVA-VLP platform in cancer immunotherapy, and for therapeutic use in chronic Hepatitis B infections. GeoVax’s vaccine platform supports in vivo production of non-infectious VLPs from the cells of the very person receiving the vaccine. The production of VLPs in the person being vaccinated mimics virus production in a natural infection, stimulating both the humoral and cellular arms of the immune system to recognize, prevent, and control the target infection. For more information, visit www.geovax.com.

Forward-Looking Statements

Certain statements in this document are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act. These statements are based on management's current expectations and are subject to uncertainty and changes in circumstances. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax can develop and manufacture its vaccines with the desired characteristics in a timely manner, GeoVax's vaccines will be safe for human use, GeoVax's vaccines will effectively prevent targeted infections in humans, GeoVax’s vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete vaccine development, there is development of competitive products that may be more effective or easier to use than GeoVax's products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements. More information about these factors is contained in GeoVax's filings with the Securities and Exchange Commission including those under "Risk Factors" in its Form 10-K.

08/14/2018

Clinical Research Pathways Organization Unveils New Patients' Guide to Clinical Trials and Expanded Access

Tue, 02 Jul 2019 17:13:05 GMT

When someone is diagnosed with a serious or life-threatening illness and they have exhausted standard treatments, it's important to know that there are still options. Two important options are clinical trials and expanded access to experimental products. At Clinical Research Pathways, our role is to help individuals learn about clinical trials and help guide them through FDA's Expanded Access program. The path to these options can feel overwhelming, but it does not need to be so difficult. We have put together a document that provides a simple, concise overview of these options. It also answers frequently asked questions and offers guidance for navigating the process. At the end, we have included a glossary with definitions of terms with which patients or their families may be unfamiliar.

Even if this does not apply to you directly, we are asking your help in sharing this document:

Physicians, share this with your patients as supplemental literature.
Professors, share this with your students to help them gain a patient's perspective on the steps after standard treatment options have been exhausted.
Voluntary health organizations , share this with patients seeking advice or more information. Feel free to copy this code to embed it on your website as a resource

The document can be viewed or downloaded, in a format designed for printing, at our website: clinicalresearchpathways.org

About Clinical Research Pathways:Clinical Research Pathways works to improve health and well-being for all by creating pathways to new medicines. The 501(c)(3) organization develops programs that increase diversity in research and expand access to experimental drugs. By opening access and advancing treatments, Clinical Research Pathways helps make new, effective medicines available to the public. For more information, go to www.clinicalresearchpathways.org.

08/13/2018

Celtaxsys Announces Results of Phase 2 Trial Showing Clinically Meaningful Improvement in Pulmonary Exacerbations in Cystic Fibrosis Patients

Tue, 02 Jul 2019 17:17:18 GMT

Celtaxsys, Inc., a clinical stage pharmaceutical development company focused on advancing treatments for patients with rare inflammatory diseases, today announced top line results of its Phase 2 EMPIRE-CF trial evaluating oral, once daily antiinflammatory molecule, acebilustat, for the treatment of cystic fibrosis (CF), irrespective of the causative genotype. In the 200 patient, double-blind, placebo controlled study, acebilustat demonstrated clinically meaningful improvements in pulmonary exacerbations, both reducing the frequency of pulmonary exacerbations (PEx) and increasing time to next exacerbation over 48 weeks of therapy. Full results from the trial will be presented this fall at the North American Cystic Fibrosis Foundation annual meeting.

“The trial data provide credible evidence to advance the development of this novel antiinflammatory molecule,” said Steven M. Rowe, M.D. MSPH, professor of medicine and director of the Gregory Fleming James Cystic Fibrosis Research Center at the University of Alabama at Birmingham. “Patients in key prospectively-identified sub-groups, including those with mild obstruction at baseline or taking CFTR modulator therapy, derived the most benefit in pulmonary exacerbations. That benefit, when used in combination with a CFTR modulator, is an important consideration given the likelihood of an increase in the number of CF patients who are eligible to be treated with new CFTR modulators over the coming years. This supports the unmet need to address lung inflammation adequately for the optimal treatment of patients with cystic fibrosis.”

On a per protocol assessment, acebilustat-treated patients exhibited an 19% reduction in PEx and a 22% reduced risk in progressing to first PEx versus placebo. Additionally, over 40% of patients treated with acebilustat completed the study without experiencing a PEx, an increase of 32% as compared with patients treated with placebo. The benefits of acebilustat on pulmonary exacerbations were apparent as early as four months after start of treatment and persisted throughout the 48 weeks of the study. No difference in lung function, as measured by the 201 17th Street NW | Suite 530 | Atlanta, Georgia 30363 | P 470.206.0153 | F 470.206.0154 primary endpoint of FEV1 percent predicted (FEV1pp), was observed in acebilustat-treated patients compared to placebo-treated patients over 48 weeks of treatment. Additionally, FEV1pp response did not correlate with PEx rates.

Patients with less severe impairment of lung function (FEV1pp >75) achieved the largest benefit from acebilustat treatment, achieving a 34% reduction in PEx rate, a 43% reduction in risk of experiencing their first exacerbation and a 96% increased likelihood of being exacerbation free after 48 weeks of treatment. Furthermore, patients concomitantly treated with CFTR modulator therapy exhibited a clinically meaningful 20% reduction in PEx, a 29% increased time to first exacerbation and a 47% higher likelihood of no exacerbations compared to patients treated with CFTR modulators and placebo.

Acebilustat was well tolerated with no increased risk of infection, a key attribute for any antiinflammatory development candidate to treat CF patients who have an increased risk of infection. The majority of adverse events were mild or moderate in severity with the most common adverse events regardless of treatment group, were infective pulmonary exacerbation, cough, nasopharyngitis, nasal congestion, headache, sputum increased, hemoptysis and fatigue. There was a low discontinuation rate from adverse events among patients treated with acebilustat, in line with patients treated with placebo. Stuart Elborn, M.D., professor of respiratory medicine at Imperial College, director of the Adult CF Centre, Royal Brompton Hospital London and professor of respiratory medicine at Queen's University Belfast, said, “I am encouraged by the data from this trial showing that acebilustattreated patients had reduced frequency of pulmonary exacerbations, particularly as we recruited patients who had exacerbations in the year prior to study entry and therefore at high risk of new exacerbations. It was also interesting to see that a higher proportion of acebilustat-treated patients remained exacerbation free during the study compared to placebo.

These data suggest that anti-inflammatory therapy effectiveness may be better assessed using clinical events such as pulmonary exacerbations. Pulmonary exacerbations, which are a clinical marker of unbridled lung inflammation, are significant events leading to acute decompensation and chronic decline of lung function and are strongly related to reduced survival. Given this, acebilustat has the potential to help protect patients from the progressive and irreversible damage that is associated with CF.”

Sanjeev Ahuja, M.D., chief medical officer of Celtaxsys, said, “Acebilustat is notably the first novel anti-inflammatory molecule to prospectively demonstrate benefits in both reducing the frequency of pulmonary exacerbations and prolonging time to first exacerbation, when added to a CF patient’s existing treatment regimen in a clinical trial. We would like to thank all the patients who participated in this trial and their families who supported them. We are grateful to the study investigators and coordinators and our advisors who helped us design and execute the program. We also appreciate the scientific insights and financial support of the CF Foundation that were essential in enabling us to conduct this important study.”

About acebilustat: Acebilustat is a once-daily oral drug candidate progressing to Phase 3 development. It is a novel small molecule inhibitor of Leukotriene A4 Hydrolase (LTA4H), the key enzyme in the production of the potent inflammatory mediator Leukotriene B4 (LTB4). LTB4 can create an over activation of neutrophil mediated immune response and inflammation and has been strongly implicated in the pathogenesis of many diseases involving excessive inflammation, including cystic fibrosis (CF). More specifically, an overactive immune response driven by neutrophils results in excessive inflammation in the CF lung. This leads to irreversible damage resulting in excessive morbidity and mortality in CF patients. Acebilustat is designed to modulate the neutrophil driven immune response bringing the inflammation to homeostasis, preventing overactive inflammation from occurring, and thus could be potentially helpful in CF patients. By contrast, pro-resolving agents theoretically tone down inflammation once it is overactive and already contributing to lung damage in patients. Furthermore, unlike immunosuppressive treatments, such as corticosteroids, acebilustat has not demonstrated any evidence of immunosuppression in preclinical studies or in clinical trials in humans, including healthy volunteers and CF patients. Acebilustat is the most advanced therapy in development in the CF anti-inflammatory pipeline.

About Cystic Fibrosis: Cystic fibrosis (CF) is a life-threatening disease that affects the lung and digestive system of 70,000 patients worldwide. CF is caused by mutations in the Cystic Fibrosis Transmembrane conductance Regulator (CFTR) gene leading to abnormal CFTR protein functioning, which causes excessively high levels of thick mucus to accumulate in the lungs, pancreas, and GI tract. Thickened mucus clogs the lungs and serves as a perfect environment to catalyze persistent bacterial infection and inflammation of the lungs. Chronic infection of the lungs in turn elicits an excessive neutrophil driven inflammatory immune response, with the overabundance of neutrophils clogging the lungs, thereby further compromising a patient’s breathing capacity. Excessive production of a neutrophil byproduct, neutrophil elastase, has been shown to be the best predictor of lung damage and dysfunction over the life of a CF patient. Excessive production of neutrophil elastase can also lead to reduced bacterial clearance. Over time, the amplification of this synergistic cycle of infection and inflammation leads to lung function decline and an increase in life-threatening pulmonary exacerbations. Lung inflammation is still the leading cause of morbidity and mortality associated with CF, leading the CF Foundation to identify development of safe and effective anti-inflammatory therapies as a key research priority. For more information about CF, visit: www.cff.org. About Celtaxsys: Celtaxsys is a privately-held drug discovery and development company focused on advancing treatments for serious inflammatory diseases. The company is building a sustainable pipeline of first-in-class immuno-modulators, the most advanced of which is acebilustat. For more information, visit www.celtaxsys.com.

08/02/2018

GeoVax and Emory University to Collaborate on HPV Therapeutic Program for Head and Neck Cancers

Tue, 02 Jul 2019 17:18:43 GMT

GeoVax Labs, Inc. (OTCQB: GOVX), a biotechnology company developing human vaccines, announced today that it is collaborating with Emory University on the development of a therapeutic vaccine for human papillomavirus (HPV) infection, with a specific focus on head and neck cancer (HNC).

The GeoVax/Emory collaboration will include testing GeoVax’s MVA-VLP-HPV vaccine candidates in therapeutic animal models of HPV in the laboratory of Dr. Rafi Ahmed, Director of the Emory Vaccine Center. Dr. Ahmed, a member of the National Academy of Sciences, is a world-renowned immunologist whose work during the past decade has been highly influential in shaping understanding of memory T cell differentiation and T and B cell-mediated antiviral immunity.

GeoVax’s vaccine technology is based on its Modified Vaccinia Ankara (MVA) Virus-Like Particle (VLP) platform, which generates noninfectious VLPs in the individual being vaccinated. Gene sequences of target antigens are inserted into the MVA genome which drives their expression in infected cells. In addition, GeoVax introduces into the viral genome matrix sequences that incorporate antigens into VLPs and simultaneously facilitate their budding from the membranes of infected cells. In this way, vaccination induces two pools of antigens as targets for the immune response – virus-infected cells and released VLPs. This strategy mimics a natural viral infection, triggering the body to produce a robust and durable immune response with involvement of both antibodies and T cells.

In related immuno-oncology studies in rodent solid tumor models, combination therapy consisting of the GeoVax vaccine designed to target MUC1-secreting tumors plus an anti-PD1 antibody and a protein supplied by ViaMune, Inc., successfully arrested progressive growth of the targeted tumors.

Farshad Guirakhoo, PhD, GeoVax’s Chief Scientific Officer, commented, “We are pleased to begin this collaboration with Emory University to further expand GeoVax’s promising pipeline of preventive and therapeutic vaccines against a variety of infectious diseases and cancers. Our collaboration with Emory on the HPV project is extremely valuable as it was Dr. Ahmed who first discovered in 2006 that the PD-1 pathway could also be exploited by many pathogens to repress normal T cell function during chronic viral infection. This led to development of numerous blockbuster anti-PD1 antibodies currently being used for treatment of various cancers and which hold promise as adjunctive therapy for several chronic infectious diseases. GeoVax’s MVA-VLP vaccine candidates have demonstrated eliciting strong antigen-specific CD8+ T cell responses in the host that is critical to fight against HPV infections in HNC patients. To increase the therapeutic efficacy of our HPV vaccine, we intend to apply a combination strategy which could include co-administration of anti-PD1 antibodies and/or other newly discovered immunotherapy drugs to improve a patient’s own anti-cancer immune response.”

Dr. Ahmed stated, “This is an important research area as there are currently no medical treatments for chronic HPV infections, which can lead to the formation of cancerous tumors. We look forward to working with GeoVax on these initial proof-of-concept studies.”

About HPV / Head and Neck Cancers

Cancer is the second leading cause of death in the United States (exceeded only by heart disease) and accounts for one of every four deaths. About 14 million new genital HPV infectionsoccur each year, and the CDC estimates that more than 90% and 80%, respectively, of sexually active men and women will be infected by HPV, a common sexually transmitted virus,at some point in their lives. Around one-half of these infections are categorized as “high-risk” which can lead to several types of cancers including cervical, anal, and HNC. In the United States, 44,430 new cases of Oral Cavity and Pharynx cancers (which includes the tonsils, soft palate, and base of the tongue,collectively known as HNC) were reported, and 9,754 people died of HNC in 2015 (the last year of which incident data are available). About 70% of HNC are linked to HPV infections. Source: National Cancer Institute and CDC.

About the Emory Vaccine Center

The Emory Vaccine Center represents the largest and most comprehensive academic vaccine center in the world and is renowned for its expertise in cellular immunity and immune memory. This expertise leads to the creation of new technologies for the prevention of emerging infectious diseases. Established in 1996 with support from Emory University and the Georgia Research Alliance, the Emory Vaccine Center has 17 faculty who study AIDS, malaria, and other global infectious disease threats.

About GeoVax

GeoVax Labs, Inc., is a clinical-stage biotechnology company developing human vaccines against infectious diseases using its MVA-VLP vaccine platform. GeoVax was the winner of the 2018 “Best Biotech” Vaccine Industry Excellence Awards, a finalist for the 2018 “Best Prophylactic Vaccine” Award for its Zika vaccine at the World Vaccine Congress, as well as a finalist for Pipelines of Promise at Buzz of Bio 2018. The Company’s development programs are focused on vaccines against HIV, Zika, hemorrhagic fever viruses (Ebola, Sudan, Marburg, Lassa) and malaria. GeoVax also is evaluating the use of its MVA-VLP platform in cancer immunotherapy, and for therapeutic use in chronic Hepatitis B infections. GeoVax’s vaccine platform supports in vivoproduction of non-infectious VLPs from the cells of the very person receiving the vaccine. The production of VLPs in the person being vaccinated mimics virus production in a natural infection, stimulating both the humoral and cellular arms of the immune system to recognize, prevent, and control the target infection. For more information, visit www.geovax.com.

Forward-Looking Statements

Certain statements in this document are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act. These statements are based on management's current expectations and are subject to uncertainty and changes in circumstances. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax can develop and manufacture its vaccines with the desired characteristics in a timely manner, GeoVax's vaccines will be safe for human use, GeoVax's vaccines will effectively prevent targeted infections in humans, GeoVax’s vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete vaccine development, there is development of competitive products that may be more effective or easier to use than GeoVax's products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements. More information about these factors is contained in GeoVax's filings with the Securities and Exchange Commission including those under "Risk Factors" in its Form 10-K.

07/31/2018

Novartis announces intention to seek shareholder approval for 100% spinoff of Alcon eye care devices business; initiates share buyback of up to USD 5 bn

Tue, 02 Jul 2019 17:20:11 GMT

Alcon strategic review concludes that 100% spinoff in best interest of shareholders and consistent with the Novartis strategy of focusing as a medicines company
Planned spinoff would create world leading eye care devices company
The Alcon ophthalmology pharmaceuticals portfolio will remain with Novartis, further strengthening its leading ophthalmology pharmaceuticals business
Transaction expected to be tax neutral to Novartis and subject to general market conditions, tax rulings and opinions, final Board endorsement and shareholder approval at the AGM in February 2019; completion expected in H1 2019
Alcon CEO Mike Ball to become Chairman-designate; COO, David Endicott promoted to Alcon CEO, both appointments effective July 1, 2018
Alcon would be incorporated in Switzerland; with Fort Worth continuing to be a key location. Listings planned on SIX Swiss Exchange and New York Stock Exchange
Share buyback of up to USD 5 bn planned to be executed by end 2019, in line with capital allocation priorities highlighting confidence in top line growth and margin expansion

Basel, June 29, 2018 - Novartis today announced its intention to spinoff Alcon, its eye care division, into a separately-traded standalone company. The planned spinoff would enable Novartis and Alcon to focus fully on their respective growth strategies. Completion of the transaction is subject to general market conditions, tax rulings and opinions, final Board of Directors endorsement and shareholder approval at the 2019 AGM in line with Swiss corporate law.

Novartis also announced that it will initiate a share buyback of up to USD 5 billion to be executed by the end of 2019[1]. This action is planned to be largely funded through the proceeds of the divestment to GSK of the consumer health joint venture stake, net of the AveXis acquisition payments.

Joerg Reinhardt, Chairman of Novartis, said: "Our strategic review examined all options for Alcon ranging from retention, sale, IPO to spinoff. The review concluded that a spinoff would be in the best interests of Novartis shareholders and the Board of Directors intends to seek shareholder approval for a spinoff at the 2019 AGM. This transaction would allow our shareholders to benefit from potential future successes of a more focused Novartis and a standalone Alcon, which would become a publicly traded global medtech leader based here in Switzerland."

When Novartis acquired Alcon in 2011, the business included surgical, vision care and ophthalmic pharmaceuticals. In January 2016, Novartis began the process of creating two best-in-class businesses with the transfer of Alcon's ophthalmic pharmaceuticals to the Novartis Innovative Medicines Division. The leading ophthalmology pharmaceuticals business will continue to develop as part of Novartis, with 2017 sales of USD 4.6 billion and the potential blockbuster medicine RTH258 (brolucizumab) in development for neovascular AMD and diabetic macular edema. The Alcon Division is now fully focused on surgical and vision care, and continues to be the global leader in eye care devices.

Vas Narasimhan M.D., CEO of Novartis, said: "We continue to execute our strategy to focus Novartis as a leading medicines company. Alcon has returned to a position of strength and it is time to give the business more flexibility to pursue its own growth strategy as the world's leading eye care devices company. We will work to ensure a smooth transition for Alcon and Novartis associates while preparing for the launch of RTH258 and building our leading ophthalmology pharmaceuticals business."

Commenting on the share buyback, Dr. Narasimhan said: "The share buyback is fully aligned with our strategic capital allocation priorities, reflects our strict financial discipline and our confidence in future top line growth and margin expansion."

Alcon leadership
Mike Ball will become Chairman-designate of Alcon, effective July 1, 2018, reporting to Vas Narasimhan, CEO of Novartis. Mr. Ball will focus on preparing Alcon for the intended spin. In addition, he will start the process of recruiting a Board of Directors (BoD) for Alcon and meeting Novartis shareholders, and other potential investors, in preparation for a potential spinoff. If Alcon becomes an independent company, Mr. Ball would become Chairman of the Alcon BoD. In order to focus fully on the Alcon separation, Mr. Ball will step down from the Executive Committee of Novartis (ECN) on July 1, 2018.

David Endicott, Chief Operating Officer (COO) of Alcon since July 2016, will be promoted to CEO of Alcon, also effective July 1, 2018. In light of the potential spinoff, Mr. Endicott will not become a member of the ECN. He will also report to Vas Narasimhan until the potential spinoff. Over the coming weeks, Mr. Ball will hand over operational management responsibilities to Mr. Endicott.

Mr. Endicott is a highly experienced leader in medical devices and pharmaceuticals having also previously held senior leadership positions with Allergan and Hospira. As Alcon COO he played an integral role in the turnaround of the business.

Mike Ball, CEO of Alcon, said: "This promises to be the beginning of an exciting new chapter for everyone associated with Alcon. The planned spinoff will be key to strengthening our leadership in the large, attractive and growing global eye care devices market. As Chairman-designate, I look forward to working closely with David Endicott and the entire team at Alcon to deliver continued innovation for our customers and patients, while creating shareholder value through long-term, sustainable growth."

If the Alcon spinoff is completed, it would create a new Switzerland-based company with global scale and reach comprising more than 20,000 employees, with around USD 7 billion in 2017 sales. Fort Worth will continue to be a key location for Alcon.

Actions started earlier this year to make Alcon an operationally autonomous medical devices business will continue in preparation for a spinoff.

Transaction Details
The successful completion of the planned spinoff is subject to general market conditions, regulatory approvals, final Board of Directors endorsement and shareholder approval. Required information and consultation of affected employees and employee representatives is planned for the second half of 2018. In the event that all approvals are secured, the planned spinoff is expected to be completed in the first half of 2019. The transaction is expected to be tax neutral to Novartis, subject to the receipt of favorable opinions and rulings. While a dividend policy for Alcon has not yet been set, Novartis intends to continue paying a strong and growing dividend in Swiss francs, building on the CHF2.80 per share paid in March 2018. The proposed distribution ratio will be disclosed in due course.

In addition to being incorporated in Switzerland, the intention would be to list shares of Alcon on the SIX Swiss Exchange and the New York Stock Exchange.

Conference calls / Capital Markets days
Novartis will hold an investor and analyst webcast today at 15:00 CET: https://edge.media-server.com/m6/p/3q53orhv

Novartis will continue to provide regular updates on the potential transaction, including at its quarterly financial results presentations. Alcon Capital Markets days are also planned in Q4 2018.

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, that can generally be identified by words such as "intention," "to seek," "initiates," "strategic review," "strategy," "focusing," "planned," "would," "will," "further strengthening," "expected," "subject to," "to become," "effective," "continuing," "priorities," "confidence," "growth strategies," "initiate," "to be executed," "intends," "potential," "proposed," "continue to," "to focus," "to ensure," "building," "strategic," "expectations," "future," "intention," "preparing," "start the process," "recruiting," "promises," "exciting," "look forward to," "continued," "long-term, sustainable growth," or similar expressions, or by express or implied discussions regarding the potential completion of the announced spinoff of Alcon; regarding the potential completion of the announced share buyback, regarding whether these actions are in the best interests of shareholders, regarding the future commercial performance of Novartis or of a separate Alcon business, or regarding any potential strategic benefits, synergies or opportunities as a result of these actions; or regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products; or by discussions of strategy, plans, expectations or intentions. You should not place undue reliance on these statements. Such forward looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward looking statements. There can be no guarantee that the proposed transaction will be completed in the expected form or within the expected time frame or at all. Neither can there be any guarantee that Novartis will complete the announced share buyback in the expected form, to the expected limits or within the expected time frame or at all. Nor can there be any guarantee that Novartis or a separate Alcon business will be able to realize any of the potential strategic benefits, synergies or opportunities as a result of these actions. Neither can there be any guarantee that shareholders will achieve any particular level of shareholder returns. Nor can there be any guarantee that the spinoff of Alcon or the share buyback will be in the best interests of shareholders, or that the Group or any of its divisions, or a separate Alcon business, will be commercially successful in the future, or achieve any particular credit rating or financial results. Neither can there be any guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. In particular, our expectations could be affected by, among other things: an unexpected failure to complete the required closing conditions, or to obtain the shareholder approvals needed to complete these actions, or unexpected delays in meeting these requirements; the potential that the strategic benefits, synergies or opportunities expected from the transaction may not be realized or may take longer to realize than expected; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; regulatory actions or delays or government regulation generally; the inherent uncertainties involved in predicting shareholder returns; the successful separation of Alcon from the Novartis Group subsequent to the closing of the transaction and the timing of such separation; potential adverse reactions to the proposed transaction by customers, suppliers, strategic partners or key Alcon personnel and potential difficulties in maintaining relationships with such persons; the uncertainties inherent in the research and development of new healthcare products, including clinical trial results and additional analysis of existing clinical data; our ability to obtain or maintain proprietary intellectual property protection, including the ultimate extent of the impact on Novartis of the loss of patent protection and exclusivity on key products which commenced in prior years and will continue this year; safety, quality or manufacturing issues; uncertainties regarding actual or potential legal proceedings, including, among others, actual or potential product liability litigation, litigation and investigations regarding sales and marketing practices, intellectual property disputes and government investigations generally; uncertainties involved in the development or adoption of potentially transformational technologies and business models; general political and economic conditions, including uncertainties regarding the effects of ongoing instability in various parts of the world; uncertainties regarding future global exchange rates; uncertainties regarding future demand for our products; and uncertainties regarding potential significant breaches of data security or data privacy, or disruptions of our information technology systems; and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.

About Novartis
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has leading positions globally in each of these areas. In 2017, the Group achieved net sales of USD 49.1 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 124,000 full-time-equivalent associates. Novartis products are sold in approximately 155 countries around the world. For more information, please visit http://www.novartis.com.

About Alcon
Alcon is the global leader in eye care. As a division of Novartis, we offer the broadest portfolio of products to enhance sight and improve people's lives. Our products touch the lives of more than 260 million people each year living with conditions like cataracts, glaucoma, retinal diseases and refractive errors, and there are millions more who are waiting for solutions to meet their eye care needs. Our purpose is reimagining eye care, and we do this through innovative products, partnerships with eye care professionals and programs that enhance access to quality eye care. Learn more at www.alcon.com (link is external).

Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis
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______________________
[1] Current AGM authority (i.e. the 7th share repurchase program) will allow buyback of up to CHF 2.9bn, consequently a new framework program would be proposed to shareholders at the 2019 AGM

07/26/2018

MiMedx Appoints Mark Graves Chief Compliance Officer To Strengthen Corporate Compliance Practices

Tue, 02 Jul 2019 17:21:12 GMT

MiMedx Group, Inc., a leading developer and marketer of regenerative and therapeutic biologics, announced that it has appointed Mark P. Graves to the position of Chief Compliance Officer. Mr. Graves will be responsible for providing direction and oversight of MiMedx's compliance program, including the Company's regulatory and legal compliance matters related to the Company's risk management, sales operations and financial reporting. Mr. Graves will report to Ed Borkowski, the Company's Executive Vice President and Interim Chief Financial Offficer on a day-to-day basis. He will also report directly to the newly formed Ethics and Compliance Committee of the Board of Directors.

"We are implementing plans to improve our corporate compliance practices in order to ensure our Company adheres to policies with the highest integrity, ethics and legal standards," said David Coles, interim Chief Executive Officer, MiMedx. "Mark has a strong background in driving compliance strategy, risk awareness, training, and crafting effective policy. He will help MiMedx apply and execute on best-in-class compliance standards that reflect our commitment to enhancing value for all stakeholders. We are pleased to welcome him to our organization."

Graves brings more than 20 years of pharmaceutical and biotech industry experience to MiMedx, ranging from compliance and sales management to government affairs. He most recently was the U.S. leader for the global Patient Experience & Value function in the neurology division of UCB, Inc., a biopharmaceutical company. From 2011 to 2015, he was UCB's Deputy Compliance Officer involved in all aspects of compliance, including the implementation and management of the company's corporate integrity agreement. Prior to that, Graves was Senior Director in the Office of Ethics and Compliance for the Pharmaceutical Products Division of Abbott Laboratories, as well as Deputy Ethics & Compliance Officer for Takeda Pharmaceuticals North America, Inc. and TAP Pharmaceutical Products, Inc. Prior to his pharmaceutical and biotech career, he practiced labor and employment law.

Graves holds a B.A. in Criminology and Law, and a J.D. from the University of Florida as well as an MBA from the University of Chicago Booth School of Business.

The Audit Committee and the Company are developing and implementing corrective measures to improve MiMedx's accounting and internal control practices. As part of this initiative, and as noted in the Company's June 7, 2018 press release, the MiMedx Board of Directors established an Ethics and Compliance Committee, which includes independent directors Luis A. Aguilar and Neil S. Yeston M.D. The Company also is conducting a formal search to fill the newly established positions of Chief Accounting Officer and Internal Auditor.

07/20/2018

Georgia State Spinoff Receives $225,000 To Develop Safe, Effective RSV Vaccine

Tue, 02 Jul 2019 17:22:06 GMT

Advac, LLC, a vaccine research company founded by Sang-Moo Kang, a professor in the Institute for Biomedical Sciences at Georgia State University, has received $225,000 from the National Institutes of Health to develop a safer, more effective vaccine for human respiratory syncytial virus.

RSV is a common respiratory virus that can cause serious complications in infants and older adults. It is the leading cause of hospitalization among children less than one year old in the United States.

A vaccine was designed to protect infants and toddlers against the virus in the 1960s, but a large portion of those who were immunized went on to develop a heightened infection, known as enhanced respiratory disease. Many of the children were hospitalized, and two immunized toddlers died. Today, there is still no FDA-approved vaccination for RSV.

Kang plans to assess the safety and efficacy of two promising vaccines that would not induce enhanced respiratory disease. One will use an inactivated split virus—a virus that is killed with chemicals, then split apart—rather than an inactivated whole virus. This is the same method used to create the seasonal flu vaccine, but it has not successfully been developed in an RSV vaccine. Kang’s preliminary data show it is effective, safer and less likely to trigger enhanced respiratory disease.

Kang has also found that vaccines containing virus-like particles (VLP), which are engineered to resemble viruses but do not contain the viral genome, offer protection against RSV by controlling the replication of the virus in the lungs without causing detectable enhanced respiratory disease. He plans to test an RSV VLP vaccine formulated in combination with split RSV vaccine in mice. He believes that the combined approach may boost the vaccine’s efficacy without compromising safety.

He will also further study a unique adjuvant, a substance that enhances the body’s immune response to the vaccine and improves its effectiveness. Licensed adjuvants cannot prevent or reverse the RSV vaccine-induced enhanced respiratory disease in animals. But Kang has demonstrated that certain adjuvants—known as toll-like receptor (TLR) agonist combination adjuvants—can make the vaccine not only more effective but also safer by preventing an enhanced respiratory disease response. Kang will test a second vaccine, a split RSV vaccine administered with TLR agonist adjuvants, in cotton rats.

“It is essential that we develop an RSV vaccine that can effectively and safely protect vulnerable populations,” said Kang. “We have established rigorous models for evaluating these two vaccines, and we are hopeful that the results put us closer to that goal.”

07/18/2018

Nutrisystem, Inc. Launches Groundbreaking DNA Body Blueprint™ Nationwide

Tue, 02 Jul 2019 17:22:57 GMT

Nutrisystem, Inc. (Nasdaq: NTRI), a leading provider of health and wellness and weight management products and services including Nutrisystem® and South Beach Diet® brands, today announced the launch of DNA Body Blueprint™, a genetic-based product using a proprietary algorithm that provides an integrated personal action plan focused on eating behaviors, nutrition and metabolism. The national marketing campaign will debut this week.

“By providing a personalized overview that is the ultimate roadmap for an individual’s ongoing nutritional needs, this product delivers on our mission of helping consumers make more informed choices and achieve outcomes that drive overall health,” commented Dawn Zier, President and CEO, Nutrisystem, Inc. “This groundbreaking use of DNA technology is a major step forward in the areas of weight loss, maintenance, and personalized nutrition. Consumer interest is high and we believe this product will attract new consumers to our brand as well as allow us to extend our relationship with them as they transition from weight loss to an ongoing healthy lifestyle.”

Years of Development Leads to National Debut

As a leader with a history in innovative and scientifically-backed weight loss solutions, Nutrisystem greenlighted the creation of DNA Body Blueprint based on a thorough assessment of market dynamics and scientific reviews from its Science Advisory Board. The board consists of a team of renowned professionals, each with distinct backgrounds and expertise, who helped evaluate existing research to enhance current programs, as well as develop new programs utilizing the latest science and technology trends within weight management.

The Company worked closely with and entered into an exclusive agreement with Genetic Direction, a leading provider of DNA-based health management programs, to develop a simple and secure DNA test that uses advanced genetic testing technology and genomic analysis to create an innovative and comprehensive product in the weight loss and weight management space. Proprietary algorithms were designed to accurately analyze genetic variants known as single nucleotide polymorphisms (SNPs) that may affect absorption and uptake of nutrients, processing of nutrients, metabolism, behaviors and optimal fitness approaches. For example, customers will discover whether they are more genetically inclined to lose weight and maintain weight loss, whether they have a slower or faster metabolism, and how their body processes macronutrients such as carbohydrates, fats and proteins, and what to do about it. Customers will be able to discuss their personalized report with a weight loss counselor and tailor their program based on the report findings.

“Nutrisystem, along with our Science Advisory Board, has had an eye on this space over the last few years and is pleased to see the technology safely and constructively evolve,” said David Burton, Executive Vice President of Operations at Nutrisystem, Inc. “Our mission is to match the most cutting-edge scientific developments with proven nutritional data to give our customers the best weight management experience possible, and we’re pleased to bring this to market after having worked extensively on this initiative for the last 24 months. We did an exhaustive search for the right partners and are proud to be rolling out a high-caliber offering at scale with unprecedented personalization.”

Dr. Tim Church, Medical Director, Genetic Direction, a distinguished researcher and specialist in public health and general preventive medicine and one of the country’s leading physicians in exercise and obesity research, echoed this sentiment, saying, “We’ve worked for many years to refine the science behind DNA testing as it relates to health and wellness. We now have a product that can make a difference in peoples’ lives and by working with Nutrisystem, together we can raise broad awareness and prompt mainstream adoption.”

Nutrisystem, through Genetic Direction, will be utilizing AKESOgen, an industry leading global genetic testing lab, to provide data and results using the most secure data encryption technology available, including de-identified samples and barcode matching.

Dr. Mark Bouzyk, Chief Scientific Officer, AKESOgen, who has been a global scientific leader in the precision genetics space over the last two decades commented, “The time is right to leverage the most robust and exciting scientific discoveries over the last several years in the public health and wellness continuum to benefit the community at large. This comes at a time of unprecedented cost benefits in genetic technologies that is coincidentally timely for the consumer market. Coupling this with Nutrisystem’s vision is absolutely a win-win for all.”

National Advertising & Marketing Campaign

DNA Body Blueprint is slated to be prominently featured in national multi-media marketing and advertising campaigns debuting today, July 16.

“We are thrilled to introduce our DNA-informed product nationwide, via television, social, paid digital, and eCRM. Our DNA Body Blueprint leverages what Nutrisystem does better than anyone. We start with cutting edge science, then make it simple and easy to understand. We’re excited to provide each customer with a blueprint to lose weight successfully. It’s the healthy eating approach designed by your body,” explained Keira Krausz, CMO, Nutrisystem, Inc. “We worked closely with potential customers to develop both the product and our campaign, and we know their ongoing insights will play a pivotal role in how we continue to evolve the offering.”

View one of the Body Blueprint DNA national television ads here.

White Paper & Fact Sheet

The Science Behind Nutrisystem® DNA Body Blueprint™ White Paper can be found here.
Authors: LeeAnn Kindness, MS, Mandi Knowles, RDN/LDN, Courtney McCormick, MPH, RDN/LDN, Noah Voreades, MS, Mark Bouzyk, PhD, Dr. Mark Sarzynski
Reviewers: Gary Bennett, PhD., Ted Kyle, RPh, MBA

Additional information on the Nutrisystem DNA Body Blueprint can be found here along with a fact sheet, here.

About Nutrisystem, Inc.

Nutrisystem, Inc. (Nasdaq: NTRI) is a leader in the weight-loss industry, having helped millions of people lose weight over the course of more than 45 years. The Company’s multi-brand approach to weight loss includes multiple plans for 2018. For more information, go to NutrisystemNews.com and Newsroom.SouthBeachDiet.com.

About Genetic Direction

Genetic Direction is a healthcare software company that improves individuals’ lives by evaluating key genetic markers and developing personalized health management programs in the areas of weight management, healthy aging and peak athletic performance. Genetic Direction’s proprietary algorithms and protocols utilize the latest peer-reviewed genetic research and are delivered to consumers, clients and patients through healthcare providers, retail marketing partners and directly via its secure web platform and one-on-one telehealth consultations.

About AKESOgen

AKESOgen is an integrated Clinical Laboratory Improvement Amendments (CLIA) compliant and College of American Pathology (CAP) accredited genomics, genetics and bio-banking company that services the pharmaceutical, biotechnology, clinical, academic, and government sectors for clinical trials, diagnostic clinical testing, and research. Based in Atlanta, GA, USA, the company’s main focus is oncology, neurology and personalized medicine. AKESOgen’s services include providing high-throughput, biomarker profiling, cytogenetic arrays, sequencing, and genomics analysis utilizing different types of markers (e.g. DNA, mRNA, miRNA, and methylation). For more information, visit www.akesogen.com.

07/16/2018

Rimidi Closes $6.575 Million Series A with Strategic Investment from Eli Lilly

Tue, 02 Jul 2019 17:23:52 GMT

Rimidi Inc., a digital health company that provides software and clinical analytics for chronic disease management, raised $6.575 million in Series A-1 financing, which includes a strategic investment by Eli Lilly and Co., an investment from Turner Investments, and participation from existing investors Cox Enterprises, Village Capital, The Jump Fund, and JAMB Global. Both Lilly and Turner will take board seats.

Rimidi, founded by Dr. Lucie Ide, is a health technology company in the Advanced Technology Development Center’s ATDC Signature portfolio.

The Series A-1 financing will fuel Rimidi’s growth and accelerate its market penetration. Formerly known as Rimidi Diabetes Inc., the company is rebranding to Rimidi Inc. to reflect the expansion of its platform and mission to broadly address cardiometabolic disease.

“We are excited to close this successful round, and focus on the road ahead,” said Rimidi CEO Josh Claman. “Helping healthcare providers transition to more proactive and data-driven care delivery models is proving again and again to improve health outcomes and reduce the avoidable complications of these diseases. This round will allow us to push more aggressively into the market and accelerate our expansion into other cardio-metabolic comorbidities.

Marie Schiller, vice president, Connected Care and site head Cambridge Innovation Center, echoed those sentiments.

“We believe Rimidi is particularly well-positioned to address the complex issue of personalizing treatment decisions across large populations of people with diabetes,” Schiller said. “Rimidi has become a key partner in our connected diabetes ecosystem strategy, and we look forward to supporting their journey as they broaden their impact both in the US and internationally.”

Rimidi’s platform helps clinicians personalize care for individuals by leveraging both patient generated data, clinical information, and the latest practice guidelines. The platform enables clinicians to identify individuals who may benefit from specific therapeutic approaches. The platform integrates with leading electronic medical records systems, providing a seamless workflow experience for clinicians at the point of care.

07/11/2018

Shire Receives U.S. FDA Approval for New State-of-the-Art Plasma Manufacturing Facility Near Covington, Georgia

Tue, 02 Jul 2019 17:24:54 GMT

Dublin, Ireland – June 21, 2018 – Shire plc (LSE: SHP, NASDAQ: SHPG), the global biotechnology leader in rare diseases, announced today that the United States Food and Drug Administration (FDA) has approved the company’s first submission for its new plasma manufacturing facility near Covington, Georgia for the production of GAMMAGARD LIQUID® [Immune Globulin Infusion (Human)] 10% Solution, a replacement therapy for primary humoral immunodeficiency (PI).

The Covington facility will add approximately 30% capacity to Shire’s internal plasma manufacturing network once fully operational. Commercial production at the site began in January 2018, and Shire expects to distribute product shortly now that approval has been granted.

“The approval of our Covington, Georgia facility is a significant milestone for Shire and for the patients we serve,” said Matt Walker, Head of Technical Operations for Shire. “The increased manufacturing capacity from the site will support Shire’s growing Immunology franchise and further strengthens our ability to deliver complex therapies for patients around the world living with a range of rare and immune-mediated conditions.”

In 2017, Shire’s immunoglobulin portfolio delivered significant growth, with product sales increasing +18% versus prior year. In the first quarter of 2018, Shire’s immunoglobulin portfolio grew +12% driven by continued strong sales of subcutaneous products.

“The demand for immunoglobulin continues to accelerate, and we understand that the safe production of these plasma-based therapies is a time-consuming, intricate and highly-regulated process,” said John G. Boyle, President and CEO of the Immune Deficiency Foundation. “The fact that even more people with primary immunodeficiency diseases have the potential to be helped, with the approval of a new, cutting-edge manufacturing facility specifically designed to produce complex plasma-based therapies, is welcome news for our patient community.”

The Covington site currently employs approximately 900 full-time colleagues and contract employees. Since the beginning of 2018, Shire has ramped up hiring to fill roles in manufacturing, quality, engineering, maintenance, utilities, warehouse, and various support and facility roles.

Shire expects to make a second submission to the FDA in 2018 for development of its albumin therapy at the Covington facility. Shire’s albumin therapy is primarily used as plasma-volume replacement therapy in immune disorders, trauma and other critical conditions.

GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10% Solution

What is GAMMAGARD LIQUID?

GAMMAGARD LIQUID is indicated for the treatment of primary humoral immunodeficiency diseases (PI) in patients two years of age and older. GAMMAGARD LIQUID is a ready-to-use, liquid medicine that contains immunoglobulin G (IgG) antibodies, which protect the body against infection.
GAMMAGARD LIQUID is made from human plasma that is donated by healthy people and contains antibodies that replace the missing antibodies in patients with PI.
GAMMAGARD LIQUID is given into a vein (intravenously) or under the skin (subcutaneously). You and your healthcare provider will decide which way is best for you. Most of the time infusions under the skin are given at home by patients or caregivers, after training. Although it is possible to give yourself infusions into a vein at home, they are more often given in a hospital or infusion center by a nurse. Only use GAMMAGARD LIQUID by yourself after you have been instructed by your healthcare provider.

Important Safety Information

What is the most important information that I should know about GAMMAGARD LIQUID?
GAMMAGARD LIQUID can cause the following serious reactions:

Severe allergic reactions causing difficulty in breathing or skin rashes
Decreased kidney function or kidney failure
Blood clots in the heart, brain, lungs or elsewhere in the body
Severe headache, drowsiness, fever, painful eye movements, or nausea and vomiting
Dark colored urine, swelling, fatigue, or difficulty breathing

Who should not use GAMMAGARD LIQUID?
Do not use GAMMAGARD LIQUID if you:

Have a known history of a severe allergic reaction to IgG or other blood products.
Have selective (or severe) immunoglobulin A (IgA) deficiency with antibodies to IgA.

GAMMAGARD LIQUID can cause serious side effects. Call your healthcare professional or go to the emergency department right away if you get:

Hives, swelling in the mouth or throat, itching, trouble breathing, wheezing, fainting or dizziness. These could be signs of a serious allergic reaction.
Bad headache with nausea, vomiting, stiff neck, fever, and sensitivity to light. These could be signs of irritation of the lining around your brain.
Reduced urination, sudden weight gain, or swelling in your legs. These could be signs of a kidney problem.
Pain, swelling, warmth, redness, or a lump in your legs or arms. These could be signs of a blood clot.
Brown or red urine, fast heart rate, yellow skin or eyes. These could be signs of a liver or blood problem.
Chest pain or trouble breathing, or blue lips or extremities. These could be signs of a serious heart or lung problem.
Fever over 100ºF. This could be a sign of an infection.

Whenever giving yourself treatments at home, you should have another responsible person present to help treat side effects or get help if you have a serious adverse reaction occur. Ask your healthcare provider whether you should have rescue medications available, such as antihistamines or epinephrine.

What are the possible or reasonably likely side effects of GAMMAGARD LIQUID for PI?

The following one or more possible reactions may occur at the site of infusion. These generally go away within a few hours, and are less likely after the first few infusions: Mild or moderate pain, swelling, itching, redness, bruising, and warmth.
During the infusion of GAMMAGARD LIQUID, look out for the first signs of the following common side effects: Headache, migraine, fever, fatigue, itching, rash/hives, cough, chest pain/tightness, chills/shaking chills, dizziness, nausea/vomiting, faster heart rate, upper abdominal pain, increased blood pressure, muscle cramps, and sore throat.

These are not all the possible side effects. Talk to your healthcare professional about any side effects that bother you or that don't go away.

For additional information, including Warning regarding blood clots, decreased kidney function, and kidney failure, click here for full Prescribing Information including Patient Information and discuss with your doctor.

You are encouraged to report suspected side effects by contacting FDA at 1-800-FDA-1088 or www.fda.gov/medwatch or Shire at 1-800-999-1785.

The risk information provided here is not comprehensive. To learn more, talk about GAMMAGARD LIQUID with your healthcare provider or pharmacist.

For further information please contact:

Investor Relations
Christoph Brackmann	christoph.brackmann@shire.com	+41 795 432 359
Sun Kim	sun.kim@shire.com	+1 617 588 8175
Scott Burrows	scott.burrows@shire.com	+41 41 288 4195
Media
Katie Joyce	kjoyce@shire.com	+1 781 482 2779

NOTES TO EDITORS

About Shire

Shire is the global leader in serving patients with rare diseases. We strive to develop best-in-class therapies across a core of rare disease areas including hematology, immunology, genetic diseases, neuroscience, and internal medicine with growing therapeutic areas in ophthalmics and oncology. Our diversified capabilities enable us to reach patients in more than 100 countries who are struggling to live their lives to the fullest.

We feel a strong sense of urgency to address unmet medical needs and work tirelessly to improve people’s lives with medicines that have a meaningful impact on patients and all who support them on their journey.

www.shire.com

Forward-Looking Statements

Statements included herein that are not historical facts, including without limitation statements concerning future strategy, plans, objectives, expectations and intentions, projected revenues, the anticipated timing of clinical trials and approvals for, and the commercial potential of, inline or pipeline products, are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire’s results could be materially adversely affected. The risks and uncertainties include, but are not limited to, the following:

Shire’s products may not be a commercial success;
increased pricing pressures and limits on patient access as a result of governmental regulations and market developments may affect Shire’s future revenues, financial condition and results of operations;
Shire depends on third parties to supply certain inputs and services critical to its operations including certain inputs, services and ingredients critical to its manufacturing processes. Any disruption to the supply chain for any of Shire’s products may result in Shire being unable to continue marketing or developing a product or may result in Shire being unable to do so on a commercially viable basis for some period of time;
the manufacture of Shire’s products is subject to extensive oversight by various regulatory agencies. Regulatory approvals or interventions associated with changes to manufacturing sites, ingredients or manufacturing processes could lead to, among other things, significant delays, an increase in operating costs, lost product sales, an interruption of research activities or the delay of new product launches;
the nature of producing plasma-based therapies may prevent Shire from timely responding to market forces and effectively managing its production capacity;
Shire has a portfolio of products in various stages of research and development. The successful development of these products is highly uncertain and requires significant expenditures and time, and there is no guarantee that these products will receive regulatory approval;
the actions of certain customers could affect Shire’s ability to sell or market products profitably. Fluctuations in buying or distribution patterns by such customers can adversely affect Shire’s revenues, financial conditions or results of operations;
failure to comply with laws and regulations governing the sales and marketing of its products could materially impact Shire’s revenues and profitability;
Shire’s products and product candidates face substantial competition in the product markets in which it operates, including competition from generics;
Shire’s patented products are subject to significant competition from generics;
adverse outcomes in legal matters, tax audits and other disputes, including Shire’s ability to enforce and defend patents and other intellectual property rights required for its business, could have a material adverse effect on the Shire’s revenues, financial condition or results of operations;
Shire may fail to obtain, maintain, enforce or defend the intellectual property rights required to conduct its business;
Shire faces intense competition for highly qualified personnel from other companies and organizations;
failure to successfully execute or attain strategic objectives from Shire’s acquisitions and growth strategy may adversely affect the Shire’s financial condition and results of operations;
Shire’s growth strategy depends in part upon its ability to expand its product portfolio through external collaborations, which, if unsuccessful, may adversely affect the development and sale of its products;
a slowdown of global economic growth, or economic instability of countries in which Shire does business, could have negative consequences for Shire’s business and increase the risk of non-payment by Shire’s customers;
changes in foreign currency exchange rates and interest rates could have a material adverse effect on Shire’s operating results and liquidity;
Shire is subject to evolving and complex tax laws, which may result in additional liabilities that may adversely affect the Shire’s financial condition or results of operations;
if a marketed product fails to work effectively or causes adverse side effects, this could result in damage to Shire’s reputation, the withdrawal of the product and legal action against Shire;
Shire is dependent on information technology and its systems and infrastructure face certain risks, including from service disruptions, the loss of sensitive or confidential information, cyber-attacks and other security breaches or data leakages that could have a material adverse effect on Shire’s revenues, financial condition or results of operations;
Shire faces risks relating to the expected exit of the United Kingdom from the European Union;
Shire incurred substantial additional indebtedness to finance the Baxalta acquisition, which has increased its borrowing costs and may decrease its business flexibility;
Shire's ongoing strategic review of its Neuroscience franchise may distract management and employees and may not lead to improved operating performance or financial results; there can be no guarantee that, once completed, Shire's strategic review will result in any additional strategic changes beyond those that have already been announced;
the potential uncertainty resulting from the announcement by Takeda Pharmaceutical Company Limited on 8 May 2018 of a recommended offer for Shire under the UK Takeover Code; and

a further list and description of risks, uncertainties and other matters can be found in Shire’s most recent Annual Report on Form 10-K and in Shire’s subsequent Quarterly Reports on Form 10-Q, in each case including those risks outlined in “ITEM1A: Risk Factors”, and in Shire’s subsequent reports on Form 8-K and other Securities and Exchange Commission filings, all of which are available on Shire’s website.

All forward-looking statements attributable to us or any person acting on our behalf are expressly qualified in their entirety by this cautionary statement. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof. Except to the extent otherwise required by applicable law, we do not undertake any obligation to update or revise forward-looking statements, whether as a result of new information, future events or otherwise.

S40641 06/18

SHIRE and the Shire Logo are registered trademarks of Shire Pharmaceutical Holdings Ireland Limited or its affiliates.

GAMMAGARD LIQUID is a registered trademark of Baxalta Incorporated, a wholly owned, indirect subsidiary of Shire plc

06/25/2018

CryoLife adds health system CEO to board of directors

Tue, 02 Jul 2019 17:25:45 GMT

Atlanta biomedical company CryoLife has bolstered its board of directors by adding a health care CEO as its ninth member.

CryoLife Inc. (NYSE: CRY) announced Tuesday that it increased the size of its board with the appointment of Marna Borgstrom. Since 2005, Borgstrom has worked as president, Chief Executive Officer and board member of the Yale New Haven Health System, an integrated health care delivery system that operates in Connecticut, western Rhode Island and Westchester County in New York.

Borgstrom serves on several other boards, including Vizient Inc., a privately held health care performance improvement company, the Coalition to Protect America's Healthcare, and the Healthcare Institute.

Borgstrom will receive a stock award valued at $114,583, which will be vested after one year of service, according to Securities and Exchange Commission filings. Also, starting July 1, she will receive $3,750 for her service on the board, plus $416.66 for serving on the Compliance Committee.

Pat Mackin, CryoLife's chairman, president, and CEO, cited Brogstrom's nearly 40 years of escalating senior leadership experience as one of the reasons for her appointment.

"Marna is well-versed in driving profitability while operating on a budget and has deep experience in developing partnerships and recruiting and retaining executives and physician leaders," Mackin said. "Her extensive experience coupled with her knowledge and recognition within the healthcare industry will complement our Board and provide invaluable guidance as we continue our mission as a market leader."

CryoLife manufactures, processes, and distributes medical devices and implantable tissues used in cardiac and vascular surgical procedures focused on aortic repair.

06/22/2018

Teachers Get a Hefty Dose of Biotech at Week-Long Georgia Bio Workshop

Tue, 02 Jul 2019 17:26:48 GMT

Local Biopharma Company UCB Invests in Future Local Workforce by
Hosting Intensive Teacher Training

Atlanta, GA (June 21, 2018)– The Georgia BioEd Institute’s Summer Biotech Immersion program, sponsored by local biopharma company UCB, provided a laboratory-intensive professional learning experience to eight high school biology/biotechnology teachers on June 4-8, 2018. If funded for summer 2019, the pilot program is intended to become an annual offering for Georgia educators from Georgia Bio, the state’s life sciences industry association.

Georgia’s biotechnology and medical device industry have grown at a rapid pace in recent years according to a recently released reportfrom TEConomy & the Biotechnology Innovation Organization. According to the report, “the state’s bioscience firms have grown their employment base by 10.6 percent since 2014 and employed just over 32,000 in 2016. Companies have also expanded their establishment count by 16 percent during this same period and now operate 2,431 across the state.” Indicators like these show the need for preparing the workforce for this high-paying STEM sector.

“This was one of the best professional development experiences I have been a part of,” said Iesha Harrison, biology teacher at South Cobb High School. “The resources and contacts that I have made will serve me well. I will be a better educator as a result.”

The five-day workshop immersed teachers in basic and advanced laboratory methods, from using a micropipette, preparing buffer solutions and agar plates, and maintaining sterile technique, to transforming bacteria with plasmids, running gel electrophoresis, PCR, ELISA, and hydrophobic interaction chromatography. The sessions were led by 2017 Georgia Bio teacher of the year, Marc Pedersen, and his wife Tricia Pedersen, both biology and biotechnology instructors at the Paulding County High School Academy of Science, Research, and Medicine. The Pedersens shared lab protocols and teaching tips and discussed how to obtain the necessary equipment and supplies.

“We wanted to help teachers overcome the barriers that prevent them from implementing lab activities in the classroom,” said Jordan Rose, the workshop’s facilitator and consultant with Georgia Bio. “Equipping teachers with the confidence, skills, knowledge, and resources to implement labs will help them to prepare their students for the rigors of post-secondary education and the entry-level requirements of biotech careers.”

Teachers’ confidence in their knowledge, skills, and readiness in relation to teaching laboratory activities increased by 45% compared to self-ratings made before the workshop. “My confidence has elevated. I am not afraid to do something wrong in the lab,” said Roberta Axson, biotechnology instructor at Newton College & Career Academy.

Interspersed with the lab activities were guest speakers, including professionals from the Centers for Disease Control and Prevention, NSF Engineering Research Center (ERC) for Cell Manufacturing Technologies (CMaT), Mercer University College of Pharmacy, IHRC, Applied Bioinformatics Laboratory (ABiL), Saol Therapeutics, and workshop sponsor UCB. The teachers were exposed to a variety of bioscience career types; after the workshop, teachers were able to name 23 new careers in the life sciences that they had not thought of previously.

One of the highlights of the workshop was a design-thinking challenge, facilitated by experts from The STE(A)M Truck, a mobile makerspace. This activity centered around the real-life experiences of a Paulding County High School student living with epilepsy. In a deeply personal storytelling session, the student shared the physical and social challenges he experiences daily. Teachers created and prototyped solutions to address these challenges, including wearable technologies and biosensors. The session provided context for the biotechnology laboratory activities that would follow during the workshop, serving as an introduction to a patient-centered approach in the life sciences industry that seeks to develop innovative pharmaceuticals, medical devices, and other technologies to improve our health.

“At UCB we’re committed to supporting science education in the greater Atlanta area and engaging the next generation of scientists and innovators. We’re proud to support this program for teachers to enhance Georgia schools and help prepare the future STEM workforce,” said Stephanie Hunter-Banks, Director, Patient and Stakeholder Experience – Neurology at UCB.

Additionally, a handful of students from the Paulding County High School biotechnology program served as laboratory assistants for the workshop, helping to prepare the labs and guide the teachers to refine their laboratory techniques. Other students shared their independent research projects to give the teachers an idea of what their own students could accomplish by applying these lab skills. In the end, the participating teachers created action plans outlining how they would bring these labs and lessons back to their own classrooms to cultivate the next generation of life science leaders.

# # #

About Georgia BioEd Institute
The Georgia BioEd Institute is a division of Georgia Bio, a 501(c)(3) nonprofit organization serving the state’s life science industry. The Institute’s mission is to strengthen Georgia’s life sciences workforce pipeline through classroom-to-career initiatives that align with industry needs. Georgia BioEd Institute is building the capacity of Georgia classrooms to support the future life science workforce with teacher professional development in biotechnology, an equipment depot, and the BioGENEius award for student biotechnology projects. Learn more at http://georgiabioed.org.

About UCB
At UCB, everything we do starts with a simple question: “How will this make a difference to the lives of people living with severe diseases?” We have a passionate, long-term commitment to discovering and developing innovative medicines that transform the lives of people living with severe diseases. We do that by connecting with patients and their families around the world living with the physical and social burdens of severe disease. Those connections offer new perspectives, drive innovation, and offer the hope of a new generation of therapies that are helping to transform lives.

With a team of approximately 7,500 employees and operations in more than 40 countries, we are a global biopharmaceutical company investing more than a quarter of our revenue in cutting-edge scientific research to meet unmet patient needs. Global headquarters are in Brussels, Belgium, with U.S. headquarters in Atlanta, Georgia. Additional U.S. UCB sites include global clinical development at our Research Triangle Park, North Carolina campus (UCB Biosciences, Inc.), and research supporting UCB’s pipeline in Cambridge, Massachusetts. UCB is listed on Euronext Brussels (symbol: UCB).

GEORGIA BIO MEDIA CONTACT:

Maria Thacker
mthacker@gabio.org
404-920-2042

UCB MEDIA CONTACT:

Allyson Funk
770-970-8338
ally.funk@ucb.com

06/21/2018

Cambium Enrolls First Patient in Phase I/II Study to Evaluate Platelet Lysate Biologic for Graft-vs.-Host Disease Dry Eye

Tue, 02 Jul 2019 17:27:41 GMT

Cambium Medical Technologies (“Cambium”), a clinical stage company, announced today first patient enrollment for its Elate Ocular topical fibrinogen-depleted human platelet lysate biologic in a randomized, multicenter, double-masked placebo-controlled parallel Phase I/II study. The study is designed to determine safety and exploratory efficacy in patients with dry eye secondary to graft-versus-host disease. The core study involves a minimum of 60 patients at up to five U.S. eye centers. Including two sub-studies, a maximum of 108 patients may be enrolled in the overall study.

“To our knowledge, our study is the first to evaluate a standardized, cGMP processed, allogeneic (donor sourced) versus autologous (patient sourced), enriched platelet-rich-plasma lysate serum drop in a U.S. IND sanctioned dry eye clinical trial,” said Terence Walts, President & CEO of Cambium. “The industry already recognizes autologous and PRP serum as generally proven therapies to treat the symptoms of not only dry eye but numerous additional corneal diseases and conditions. To date, however, their use has been largely relegated to end stage, failed meds status for inherent reasons unrelated to efficacy. Cambium believes, following approvals--its Elate Ocular product has potential as a main stage, first line therapy for many corneal diseases and conditions including GvHD dry eye,” said Walts.

About Cambium Medical Technologies LLC:

Founded in 2013 by four distinguished physician/scientists at Emory University, Atlanta, Georgia (USA)—Cambium is focused on the development of regenerative therapies through the use of novel processed human platelets. Cambium’s Mission: To improve patients’ quality of life—from within. The Company’sfirst FDA-approved therapy is targeted to be Elate OcularTM, a topical eye drop for dry eye syndrome (keratoconjunctivis sicca or KCS). Elate OcularTM utilizes AurarixTM, Cambium’s novel processedenriched platelets depleted of fibrinogen, the clotting agent in platelets. Cambium’s Aurarix technology is currently sold worldwide as UltraGROTM-Advanced and UltraGROTM -PURE in the stem cell growth

supplement market by Cambium’s strategic partner AventaCell Biomedical Corp., Ltd, a subsidiary of Zheng Yang Biomedical Technology Co., Ltd—both headquartered in Taipei, Taiwan with manufacturing facilities in Atlanta, GA.

For more information about Cambium, contact David Doolittle at +1 404-337-5990 or e-mail David at david_e_doolittle@yahoo.com, or go to www.cambiumbio.com. To learn more about AventaCell and their line of UltraGROTM stem cell growth supplements, contact William D. Milligan at bill@atcbiomed.com or visit www.atcbiomed.com.

06/15/2018

SLAS DISCOVERY Publishes Ground-Breakig New Article – “Clinical Trials in a Dish: A Perspective on the Coming Revolution in Drug Development”

Tue, 02 Jul 2019 17:28:42 GMT

SLAS Discovery, a leading peer-reviewed scientific journal, today announced the publication of a ground-breaking new article by Coyne Scientific co-authors Bernard Fermini, Ph.D., Kevin P. Coyne, MBA and Shawn T. Coyne, MBA titled, “Clinical Trials in a Dish: A Perspective on the Coming Revolution in Drug Development”. The article – which describes a novel drug safety testing paradigm that bridges the worlds of preclinical testing and clinical trials – can be accessed for free ahead-of-print on the publisher’s website at: http://journals.sagepub.com/doi/full/10.1177/2472555218775028.

According to Bernard Fermini, Chief Scientific Officer: “The cost of developing new drugs has reached unsustainable levels, fueled in large part by high attrition rates in clinical development. Recent studies have shown that individual drug susceptibility in a population of volunteers with unknown genetic background can be recapitulated in human induced pluripotent stem cells (hiPSCs) derived from these same individuals, providing a proof of concept for in vitropreclinical trials, and enabling cell-based screening for safety and toxicity at the level of a population, similar to clinical trials. This new platform, termed “Clinical Trials in a Dish”, or CTiD, allows researchers to define the incidence and distribution of effects of drugs (whether beneficial or adverse) across a population long before actual clinical trials, so that a pharma company can curtail development of ‘future failures’ early on while continuing development of safe compounds that might not have met traditional safety margins.”

Added Kevin Coyne, CEO: “CTiD studies, which first became commercially available earlier this year, can also help pharma companies address such important issues as repurposing shelved compounds, reducing adverse drug-drug interactions, protecting underserved ethnic populations, and protecting children and geriatric patients – economically, and without regulatory complications.”

To discover how this new platform offers the potential to revolutionize safety and toxicity testing of new drugs, and/or for more information, please contact Shawn Coyne, President, at scoyne@coynesci.com.

* * *

ABOUT COYNE SCIENTIFIC, LLC: Coyne Scientific conducts in vitrosafety and toxicity testing on pharmaceutical compounds. We use human stem cell-based models to estimate the distribution of incidence and severity of reactions to candidate drug compounds across a population as a result of that population’s genetic diversity. We can help clients dramatically reduce drug development costs through early identification of compounds that may negatively affect a portion of clinical trial participants despite appearing to be safe to the “average” human. We can also help improve the safety of drugs in cases where clinical trials are infeasible, such as in the development of compassionate use drugs or orphan drugs, or in the entry of drugs into small national markets with genetically-distinct populations.

ABOUT SLAS: The Society for Laboratory Automation and Screening is an international community of nearly 20,000 professionals and students dedicated to life sciences discovery and technology. The SLAS mission is to bring together researchers in academia, industry and government to advance life sciences discovery and technology via education, knowledge exchange and global community building.

ABOUTSLAS DISCOVERY : Editor-in-Chief Robert M. Campbell, Ph.D., Eli Lilly and Company, Indianapolis, IN (USA). SLAS Discovery(Advancing Life Sciences R&D) was previously published (1996-2016) as the Journal of Biomolecular Screening(JBS).

06/06/2018

Halyard Health Announces Agreement to Acquire CoolSystems, Inc., Marketed as Game Ready

Tue, 02 Jul 2019 17:29:39 GMT

Halyard Health, Inc. announced it has entered into a definitive agreement to acquire CoolSystems, Inc., marketed as Game Ready, a market-leading provider of cold therapy and compression therapy systems for a total consideration of $65 million in cash.

Game Ready develops, manufactures and markets the Game Ready® product line, used in the pain management and rehabilitation of patients recovering from orthopedic surgery or sports-related injuries. Its product line includes GRPro 2.1 cold and compression therapy system; Med4 Elite™ multi-modality therapy unit; ATX Wraps; and a variety of product accessories, all of which complement Halyard's existing Pain Management portfolio.

Game Ready's innovative brands have helped build a strong reputation within the medical community. The Company's customer base includes some of the world's leading orthopedic hospitals and athletic organizations, providing Halyard greater access to the orthopedic and sports medicine markets. GRPro, the flagship Game Ready product, includes a portable control unit and portfolio of anatomical wraps and sleeves, which deliver controlled cold and compression therapy to all major body parts. Game Ready's new rehabilitation product, Med4Elite, performs rapid contrast therapy with compression.

"The acquisition of Game Ready represents another step forward in Halyard's transformation as a pure-play medical device company and is consistent with our strategy to continually generate value for our patients, customers, and shareholders," said Joe Woody, Halyard chief executive officer. "The combination of Game Ready's market leading cold therapy products with our ON-Q Pain Relief System portfolio will significantly enhance our postoperative non-opioid product offerings and broaden our orthopedic footprint. Combined, we will be better positioned to play a critical role in providing innovative non-opioid therapies that reduce or eliminate the use of opioids for surgical patients and get them back to the things that matter."

Game Ready's revenues in 2017 were approximately $35 million. The transaction is expected to be immaterial to Halyard's fiscal year 2018 adjusted dilutive net earnings per share, and slightly accretive to earnings in 2019. Halyard is reaffirming its 2018 adjusted dilutive net earnings per share guidance of $1.65 to $1.85, which includes earnings from both continuing and discontinued operations.

Halyard intends to fund the acquisition from current cash and the transaction is expected to close early in the third quarter.

06/06/2018

National Bioscience Industry Report Shows $2T Economic Impact, Accelerated Venture Capital Investment & Job Growth

Tue, 02 Jul 2019 17:30:42 GMT

A study released today at the BIO International Convention shows that the U.S. bioscience industry has reached $2 trillion in annual economic impact while maintaining accelerated venture capital investment and job growth numbers. Among U.S. technology sectors, the bioscience industry has held a leading position as an economic driver and job generator.

The report, Investment, Innovation and Job Creation in a Growing U.S. Bioscience Industry 2018, finds U.S. bioscience firms directly employ 1.74 million people, a figure that includes more than 273,000 high-paying jobs created since 2001. The average annual wage for a U.S. bioscience worker reached $98,961 in 2016. These earnings are more than $45,000 greater, on average, than the overall U.S. private sector wage. The report further shows that since 2014, the bioscience industry has grown by 4.4 percent with four of its five major subsectors contributing to this overall job gain.

For the first time, the biennial report includes a full assessment of the economic impact of the bioscience industry and finds its total economic impact on the U.S. economy, as measured by overall output, totaled $2 trillion in 2016. This impact is generated by the direct output of the bioscience industry combined with the indirect (supply chain) and induced (employee spending) impacts. The industry and its associated economic output support 8 million jobs throughout the entire U.S. economy through both indirect and induced effects. “This report highlights the enormous economic impact delivered by our industry. This strong performance is due to the vital and wide-ranging collaborations between industry partners, universities, and policymakers that provides a business climate that supports the development of innovative bioscience products and high paying jobs,” said Jim Greenwood, President and CEO of the Biotechnology Innovation Organization."

The report also takes the pulse of the broader U.S. innovation ecosystem for bioscience companies and finds it advancing with positive results. The U.S. is experiencing strong gains in bioscience venture capital funding, growth in patents, a recent ramp-up in bioscience-related university R&D expenditures and increasing research funding from the National Institutes of Health (NIH).

“The bioscience industry is vital to the U.S. not only as an innovation engine that is improving lives, but also as a major economic driver that is consistently generating high-quality jobs and significant economic output across the nation,” said Ryan Helwig, Principal and Project Director with TEConomy Partners.

The state-by-state industry assessment is the eighth in a biennial series, developed in partnership by TEConomy and BIO, presenting data on national, state, and metropolitan area bioscience industry employment and recent trends.

Additional highlights from the industry economic analysis include:

The industry is a major economic driver and is well distributed across U.S. states and cities:
- 41 states experienced net job growth in the biosciences between 2014-2016
- 38 states and Puerto Rico have an employment specialization in at least one bioscience subsector
- 213 of 383 U.S. metropolitan areas have at least one bioscience specialization

Highlights from the analysis of the innovation ecosystem for the bioscience industry include:

Strength in recent venture capital and patenting trends:
- Venture capital investments have reached new highs. More than $66 billion in venture capital was invested in bioscience companies during the 2014 through 2017 period, including a new annual high in 2017 at $20 billion invested.
- Innovation continues to drive the biosciences, since 2014 the U.S. has increased patent totals in bioscience-related technology classes by nearly 5 percent, or 1.6 percent per year, on average. 2017 had a total of nearly 27,000 patents awarded to U.S. inventors, another new high.
Growth for academic biosciences R&D in 2016
- After several years of concerns raised about the declining and/or flat NIH research budgets and the subsequent effects on academic and other research, NIH funding is back on the rise. There have been budget increases sustained each of the last three years.
- Across America’s colleges and universities, the pace of R&D spending in bioscience-related research areas has increased. Following a 1.5 percent decline in 2015, academic R&D expenditures in the biosciences increased 5.5 percent to $42 billion in 2016.

The TEConomy/BIO report includes individual profiles for all 50 states, the District of Columbia and Puerto Rico, and can be found on the BIO website at bio.org/jobs2018.

About BIO
BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world. BIOtechNOW is BIO's blog chronicling “innovations transforming our world” and the BIO Newsletter is the organization’s bi-weekly email newsletter. Subscribe to the BIO Newsletter.

About TEConomy
TEConomy Partners, LLC is a global leader in research, analysis, and strategy for innovation-based economic development. Today we’re helping nations, states, regions, universities, and industries blueprint their future and translate knowledge into prosperity. The Principals of TEConomy Partners include the authors of the prior Battelle/BIO State Bioscience Development reports, published since 2004. For more information, please visit http://www.teconomypartners.com.

06/05/2018

The Coalition of State Bioscience Institutes (CSBI) Releases the 2018 Life Sciences Workforce Trends Report at BIO

Tue, 02 Jul 2019 17:31:39 GMT

“Key Findings Support Industry as a Leading US Employer, providing 1.73 Million Jobs”

The Coalition of State Bioscience Institutes (CSBI) released the 2018 Life Sciences Workforce Trends Report today at the BIO International Conventionheld this week in Boston, Massachusetts. The report provides a national snapshot of the current and anticipated talent needs of the nation’s dynamic life science industry.

The industry continues to be a leading driver of employment across the country, providing 1.73 million jobs in 85,000 companies. In 2017, employers listed almost 264,000 postings for life science positions.

Building on the success of its three prior reports, the 2018 CSBI Workforce Trends Report identifies the most pressing talent needs of the life science industry and the key trends that are driving talent acquisition. With the breakneck speed of new discoveries in the industry and shifting global and regulatory environments, there is growing demand for people with new technical and “soft” skills that can navigate this complex wave of change.

“The CSBI report addresses a continuing major concern of our life science executives: finding the right people who will develop cures for patients and address a host of global health and environmental challenges,” said Peter M. Pellerito, Senior Academic Advisor for the Biotechnology Innovation Organization. “It also points to important trends - such as the importance of diversity, evolving technical and soft skills, and innovative collaborations – that are defining the talent needed to drive discovery in our vibrant industry.”

“Because the life sciences are evolving so quickly, it is imperative that we understand what is impacting the industry’s ability to innovate today:” said Liisa Bozinovic, CSBI Chair and Executive Director of the Biocom Institute, “the skills, functions, and people who can keep us at the forefront of discovery in a globally competitive environment.”

In addition to quantitative analysis of over 50,000 life science job postings and interviews with over 350 hiring decision-makers, the report includes data from interviews with over 135 life sciences executives across the country from which five key trends that impact their talent needs are identified:

Rapid technological innovations, such as CRISPR gene editing, (CAR) T-Cell Therapy, and breakthroughs in fields such as computational biology, are creating the need for expertise in a broad range of cutting-edge technologies, including data analytics, 3D printing, AI, next gen sequencing, process integration, analytic chemistry and CAD design, to name a few. At the same time, evolving business models, dynamic competitive forces, and values-based healthcare are shaping the need for new types of operational and business expertise, and the ability to navigate new regulatory and reimbursement complexities.

While technical skills are important, life science employers continue to cite soft skills as a key determinant of success for their employees and their businesses – critical thinking, teamwork, written and verbal communication, problem-solving, adaptability, resilience, influence, etc. The combination of hybrid backgrounds and strong soft skills are highly desired, but difficult to find.

Regional cluster-specific challenges are impacting employers’ ability to find and retain talent. Businesses in emerging regional clusters consistently cite the scarcity of local talent to help them build or expand their companies. In contrast, some of the more advanced clusters are struggling to recruit or maintain their rich talent pools due to infrastructure and affordability challenges, and compete for talent with other booming sectors such as tech.

Many life science companies cite the benefits of their diverse workforce, including the ability to reach better decisions, facilitate relationships with disparate stakeholders and better compete in global markets. Some have formal diversity initiatives; others state that diversity happens organically by hiring the best local or international talent.

Companies are reaping the benefits of academic partnerships, locating their R&D operations near academic institutions for co-development of technologies. They are also engaging with school science programs through internships, co-op rotations, and other creative collaborations to provide exposure and experience to students and future employees.

"I am delighted that we continue to hear about the innovative ways that industry is partnering with academia to address its talent needs,” stated Lori Lindburg, CSBI Workforce Development Co-Chair, and President & CEO of the California Life Sciences Institute. “I think more companies would engage in such partnerships if they recognized the ‘win-wins,’ and if they knew how. One of our goals at CSBI is to be a platform for sharing and disseminating these successful collaborations to develop the talent needed to fuel the next scientific breakthroughs.”

Download key findings and full report at www.csbioinstitutes.org.

06/05/2018

Halyard Health Announces Corporate Rebranding, Changes Name to Avanos Medical, Inc.

Tue, 02 Jul 2019 17:32:25 GMT

ALPHARETTA, Ga., June 1, 2018 /PRNewswire/ -- Halyard Health, Inc. (NYSE: HYH) a market-leading medical devices company, today announced the business' rebrand to Avanos Medical, Inc. ("Avanos"). Avanos' vision is to be the best at getting patients back to the things that matter. Derived from the words "advanced" and "innovation," the new name and brand emphasize the company's focus on innovating with speed to deliver better, more sustainable patient outcomes.

Avanos provides pioneering pain management and chronic care therapies and solutions, with a relentless focus on advancing change in the medical devices industry to address unmet medical needs and improve patients' quality of life.

"Having completed the divestiture of S&IP, Avanos is now a pure-play medical devices company," said Joe Woody, Avanos chief executive officer. "Today, Avanos is positioned with a forward-thinking mindset and the firepower to make strategic investments in breakthrough innovation and acquisitions in attractive markets."

"Our new name and brand align with our streamlined operational approach and our commitment to delivering the very best for patients," Woody continued. "I am excited to work with our talented team to establish Avanos as a market leader in the industry for years to come."

The change in name from Halyard to Avanos will be effective June 30, 2018. In connection with this rebrand, the company's stock ticker symbol will change from "HYH" to "AVNS" on the New York Stock Exchange. The first day of trading under the new ticker symbol will be July 2, 2018.

About Halyard Health
Halyard Health (NYSE: HYH) is a medical technology company focused on delivering clinically superior breakthrough medical device solutions to improve patients' quality of life. Headquartered in Alpharetta, Georgia, Halyard is committed to addressing some of today's most important healthcare needs, such as reducing the use of opioids while helping patients move from surgery to recovery. Halyard develops, manufactures and markets its recognized brands in more than 90 countries. For more information, visit www.halyardhealth.com.

Forward-Looking Statements
This press release contains information that includes or is based on "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are based on the current plans and expectations of management and are subject to various risks and uncertainties that could cause our actual results to differ materially from those expressed or implied in such statements. Forward-looking statements include all statements that do not relate solely to historical or current facts, and can generally be identified by the use of words such as "may", "believe", "will", "expect", "project", " estimate", "anticipate", "plan", or "continue" and similar expressions, among others. Factors that may cause actual results to differ materially from the anticipated results expressed in such forward looking statements include, but are not limited to: weakening of economic conditions that could adversely affect the level of demand for our products; pricing pressures generally, including cost-containment measures that could adversely affect the price of or demand for our products; changes in foreign exchange markets; legislative and regulatory actions; unanticipated issues arising in connection with clinical studies and otherwise that affect U.S. Food and Drug Administration approval of new products; changes in reimbursement levels from third-party payors; a significant increase in product liability claims; the impact of investigative and legal proceedings and compliance risks; the impact of the federal legislation to reform the United States healthcare system; changes in financial markets; and changes in the competitive environment. Additional information concerning these and other factors that may impact future results is contained in our filings with the U.S. Securities and Exchange Commission, including our most recent Form 10-K and Quarterly Reports on Form 10-Q.

06/04/2018

New Cytokine Network Can Repair Tissue Damage In The Intestine, Study Finds

Tue, 02 Jul 2019 17:33:22 GMT

A new group of proteins called cytokines, critical for antimicrobial activity and repairing the damaged intestinal tissue found in inflammatory bowel disease (IBD), has been discovered by researchers in a study led by Georgia State University.

The research team examined acute intestinal disease in the colons of mice and found a specific network of proinflammatory cytokines was activated in response to intestinal barrier damage and instrumental in repairing the damaged tissue. Cytokines are small proteins that are produced in response to microbial threat and aid in the recruitment and activation of immune cells to protect the host. The findings, which have potential implications for the treatment of intestinal inflammatory conditions, are published in the journal Proceedings of the National Academy of Sciences.

In the intestine, cells form a physical barrier that separates the body cavity from the outside environment and protects the host from microorganisms. However, damage to this barrier can activate immune cells, which promote repair and resolve inflammation. If the damage persists or repair processes are ineffective, chronic intestinal inflammation occurs, as found in human IBD, resulting in abdominal pain, persistent diarrhea, rectal bleeding and other symptoms.

“In this manuscript, we identified a novel cytokine network involving IL-36γ, IL-23 and IL-22 as being involved in the repair of intestinal damage and inflammation,” said Dr. Timothy Denning, lead author of the study and professor and associate director of the Institute for Biomedical Sciences at Georgia State. “I think what is very intriguing about this finding is that inflammation is often viewed in the context of being bad, but it is in fact a physiologic response to damage, injury and infection.

“The real key to inflammation is how to control it. In our study, we found this specific cytokine network was critical for tissue repair, but some of these same factors are being targeted in clinical trials for IBD. This entire cytokine axis is likely beneficial for host protection, but if it goes uncontrolled for too long, which is often seen in chronic diseases like IBD, they could then be pathogenic. So the key is understanding when and how to regulate these cytokines networks for the benefit of human health.”

Another key finding was that IL-36γ induces IL-23, linking them in the repair of acute intestinal barrier damage. In the study, mice that did not have the gene for IL-36γ or IL-36 receptor could not recover from acute intestinal damage, but treating mice with IL-23 helped the mice to resolve the damage. The study also revealed that IL-23 serves as a key intermediary between IL-36γ and IL-22. This shows that IL-23 can be beneficial and part of a network that is instrumental in tissue protection and intestinal barrier repair. Importantly, clinical trials that target and block IL-23 to treat Crohn’s disease and ulcerative colitis, two major types of IBD, are getting promising outcomes, highlighting the importance of context-dependent effects of these factors.

Therefore, one has to be cautioned against classifying this cytokine pathway as exclusively beneficial or deleterious. Instead, critical details such as where these cytokines are produced, and the level and duration of expression, are central to understanding their function, Denning said.

“What we are showing is that for early stages and acute stages of disease, these factors can actually be protective, whereas others are finding that in chronic diseases, these factors can be pathogenic,” Denning said. “Having a clear appreciation for that will afford the ability to manipulate these cytokines during specific phases of disease for the optimal therapeutic benefit.”

It is also important to understand how blocking these cytokines, which can be beneficial if they are at high levels for a long period of time, may impair repair processes, he said.

Co-authors of the study include Drs. Andrew T. Gewirtz, Didier Merlin, Oscar Medina-Contreras, Duke Geem, Akihito Harusato, Estera Maxim, Hirohito Abo and Vu L. Ngo of Georgia State and Dr. Asma Nusrat of the University of Michigan.

The study was funded by the National Institutes of Health and the Crohn’s and Colitis Foundation.

To read the study, visit http://www.pnas.org/content/early/2018/05/11/1718902115.

05/21/2018

Researchers Develop New Chemistry To Make Smart Drugs Smarter

Tue, 02 Jul 2019 17:34:10 GMT

A method to activate targeted drugs, or smart drugs, only at the selected site of action, an approach that improves the drug’s therapeutic effect and minimizes side effects, has been developed in a study led by Georgia State University.

Smart drugs, developed to improve the delivery problems of pharmaceutical drugs, are like guided missiles with warheads. They need a targeting molecule to guide pharmaceutical drug molecules to the desired site of action and a trigger to “drop the bomb” or release or activate the drug. In chemistry terms, such smart drugs are conjugates, or links, between a targeting molecule and a drug molecule.

For the most part, the issue of guiding and enriching such smart drugs to the desired site of action has been resolved. An example is the use of antibody-drug conjugates, an emerging class of cancer treatment that targets the delivery of drugs to cancer cells. However, the issue of when and how to trigger drug release, particularly at a sufficiently high concentration, has been a challenging task.

This study introduces new chemistry and a new concept to allow for “enrichment-triggered activation” of the drug molecule after delivering the smart drug to the desired site of action. The study tested doxorubicin, an anti-cancer drug, and carbon monoxide, an anti-inflammatory agent, using this delivery method and found the targeted approach effectively treated diseases such as acute liver injury in mice and cancer in cell culture. The researchers linked the active drug to a targeting molecule and then triggered the release of the drug at the desired site of action. The findings are published in the journal Nature Chemistry.

“The general idea is we have a targeting molecule that is conjugated to a payload (pharmaceutical drug molecule), and in between, there’s a linker,” said Dr. Binghe Wang, Regents’ Professor of Chemistry and director of the Center for Diagnostics & Therapeutics at Georgia State, a Georgia Research Alliance Eminent Scholar in Drug Discovery and a Georgia Cancer Coalition Distinguished Cancer Scholar. “The entire purpose of this is to enrich drug concentration at the site of action. This allows a higher concentration of the drug at the site of action, but minimizes the concentration elsewhere. Essentially, it’s almost like a guided missile.

“What we have developed is an approach called enrichment-triggered prodrug activation. Most other chemical approaches rely on some kind of linker chemistry that is not specific enough or there’s a premature release in the general circulation. What we have essentially is a way to control release once the concentration of the drug reaches a certain level. Let’s say you have someone who has prostate cancer. If the drug concentration at the prostate can be a hundredfold higher than the concentration in the bloodstream, chances are you can probably kill all the cancer cells without causing all these side effects.”

In this study, the researchers used this targeted drug delivery approach to administer carbon monoxide to mice and treat acute liver injury. They saw a very potent effect, maybe 10 to 30 times more effective than traditional drug delivery, Wang said. They also tested the anti-cancer drug doxorubicin in cell culture.

They found it’s necessary to use a very stable linker to connect the targeted molecule and active drug so the linker can remain steady as it circulates in the bloodstream. They also needed to trigger a mechanism to release the drug at a desired site of action.

“The linker chemistry design has been very tricky,” Wang said. “There’s a lot of effort that went into it. What we have is something very unique in the sense that we have designed an approach that is not based on typical chemistry. When the (drug) concentration reaches a certain level, then it will automatically start releasing very quickly.”

While this study’s targeted drug delivery approach resembles that of antibody-drug conjugates, which target an antibody (a protein that recognizes foreign substances) on the surface of cancer cells, the current approach doesn’t require having antibodies.

“There are many other molecules that one can use to target different kinds of tissues, diseased organs or sites,” Wang said.

This approach is also not limited to the cell surface, as used in antibody-drug conjugate delivery, because small molecules are used for targeting and cleaving the drug from the targeting molecule.

Co-authors of the study include Drs. Yueqin Zheng, Xingyue Ji, Bingchen Yu, Kaili Ji, Mengyuan Zhu, Manjusha Roy Choudhury, Ladie Kimberly C. De La Cruz, Vayou Chittavong, Zhixiang Pan and Zhengnan Yuan of Georgia State; and David Gallo, Eva Csizmadia and Leo E. Otterbein of Harvard Medical School.

To read the study, visit https://www.nature.com/articles/s41557-018-0055-2.

05/21/2018

Nutriband Inc. Acquires 4P Therapeutics Inc.

Tue, 02 Jul 2019 17:34:54 GMT

Nutriband Inc. (OTC: NTRB), a Nevada Corporation, is pleased to announce the acquisition of 4P Therapeutics Inc. on April 5, 2018.

Nutriband has acquired 100% interest in 4P Therapeutics for a total of $1,900,000 payable in both company stock and cash. 4P Therapeutics will receive 250,000 shares of common stock and a cash amount of $400,000. Steven Damon, CEO of 4P Therapeutics, has been appointed to the Nutriband Inc. Board of Directors.

4P Therapeutics will now become the Pharmaceutical and Development arm of Nutriband Inc. with a specific focus on Transdermal and Topical Technologies, prescription drugs and clinical development.

Included in the acquisition of 4P's IP Portfolio is Defent™ abuse deterrent patch technology, an opioid abuse deterrent platform for the transdermal delivery of opioid-based medications. Defent™ lowers the risk of abuse and misuse, creating a safer treatment for patients.

Nutriband has also acquired 4P's Exenatide transdermal delivery system, currently in Phase I clinical development. If successfully taken through Phase III and to commercialization, it will compete with injectable Exenatide such as Byetta® and Bydureon® by providing an injection free alternative for patients with type II diabetes.

A Full Pipeline of drugs and technology can be found on 4P's website http://www.4ptherapeutics.com/.

4P Therapeutics is a private company focused on the research and development of novel drug delivery technologies and therapeutics. 4P develops products that meet the needs of patients, physicians and payers. The company has capabilities for developing pharmaceutical products ranging from pre-clinical testing to clinical manufacturing and early stage clinical development (Phase I/II). A key company focus and area of expertise is in the development of transdermal products for currently injected compounds, including proteins, peptides, macromolecules and biologics. Transdermal delivery of commercially available drugs or biologics that are typically delivered via injection has the potential to improve safety, efficacy and therapeutic outcomes associated with these treatments.

Nutriband Inc. appointed Steven Damon to its Board of Directors. Steven Damon has over 30 years of experience with various business roles in the medical and pharmaceutical industries. As well as founding 4P Therapeutics, Steven also maintains an executive leadership role as Vice President for Business and Commercial Development with Femasys an Atlanta based women's health care medtech company. In addition, he serves on the boards of Micron Biomedical, Carmel Bioscience, Temple Therapeutics and Georgia BIO. He actively consults with various companies on strategy, financing and M&A.

Before founding 4P Therapeutics, Steven led the Business Development team at Atlanta based Altea Therapeutics as the company's Senior Vice President of Business Development. He founded and was President of Absorbable Polymers International a Birmingham, Alabama company. He was an Executive Director at DURECT Corporation in Cupertino California where he led Business Development activities and was responsible for the ALZET research drug delivery pump business. Steve started his life science career with Kimberly-Clark Healthcare (now Halyard Healthcare) with lead responsibilities for commercial development of the healthcare business in Europe and the acquisitions of a number of life science companies and products. Additional activities include industry related speaking engagements, publications and committee participation. Steven has been a long time mentor for the Emory and Georgia Tech Ti:GER program and also participates in other GT student mentoring programs.

Nutriband Inc. appointed Alan Smith Ph.D. as Head of Regulatory and Clinical Operations. Alan Smith, Ph.D., co-founded 4P Therapeutics in 2011 and serves as Vice President, Clinical, Regulatory, Quality, and Operations. Previously, he was with Altea Therapeutics, most recently serving as Vice President, Product Development and Head of Clinical R&D, Regulatory Affairs, and Project Management. At Altea, he led major research and development programs with pharmaceutical companies such as Eli Lilly, Amylin, Hospira, Elan, and Novartis. He joined Altea as one of the first employees and spent 12 years growing its multidisciplinary drug delivery research and development organization.

Dr. Smith has 20 years of experience in the research and development of drug and biologic delivery systems, diagnostics and medical devices for treatment and management of diabetes, chronic pain and cardiovascular disease. Prior to joining Altea Therapeutics, he led the development of transdermal glucose monitoring systems at SpectRx, Inc., a publicly traded noninvasive diagnostics company. Dr. Smith received Ph.D. and M.S. degrees in Biomedical Engineering from Rutgers University and the University of Medicine and Dentistry of New Jersey. He currently serves on the Editorial Advisory Board of Expert Opinion on Drug Delivery.

Nutriband Inc.

Nutriband is a unique, result's driven, health and pharmaceutical Company based in Orlando Florida. Unlike traditional health product companies, Nutriband found its start by spotting and targeting a gross and virtually unexplored niche in the market through its method of ingredient delivery. All Nutriband products are based around the science of transdermal / Topical technologies.

http://www.nutriband.com/

05/21/2018

Dune Medical Sets the Stage for Growth, Naming Alan Bond Chief Financial Officer

Tue, 02 Jul 2019 17:35:45 GMT

Dune Medical Devices has appointed Alan Bond as Chief Financial Officer. Bond is a veteran financial executive with an extensive record of developing and implementing strategy, and driving revenue and profitability in the medical device industry. Bond joins the Dune Atlanta office after years with McKesson and Given Imaging.

“Alan has experience in both large and small organizations during times where the companies were undergoing significant strategic changes and acquisitions,” says Lori Chmura, CEO of Dune Medical. “His experience in driving organizational performance will add significantly to Dune Medical’s capability to manage new growth, and we are pleased to add him to our distinguished team.”

Dune Medical Devices’ proprietary tissue characterization technology utilizing Radiofrequency (RF) Spectroscopy, is a ground-breaking solution to identifying microscopic residual cancer at the surface of the tissue to give surgeons another tool to help identify all the cancerous tissue in the operating room. Dune’s first medical device, the MarginProbe System, achieved FDA approval in 2013 for use in breast cancer lumpectomy procedures. Numerous peer reviewed publications have demonstrated a 50 - 79% reduction in re-excision with the use of MarginProbe.

“Breast conservation surgery is a first line surgical modality for most women facing a breast cancer diagnosis and MarginProbe improves the effectiveness and outcome of the surgery,” says Bond. “I look forward to playing an important role in optimizing Dune’s organizational performance and bringing a strategic focus as we expand our revolutionary technology platform to the diagnosis, surgery and therapy of other cancers.”

05/21/2018

BIO Statement on Trump Administration’s Plan to Lower Drug Costs

Tue, 02 Jul 2019 17:36:40 GMT

BIO President and CEO Jim Greenwood issued the following statement after President Trump announced his administration’s plan to lower prescription drug costs:

“The men and women of the biopharmaceutical industry work every day to help cure disease and improve the lives of patients. Our country leads the world in the discovery of new treatments because of gifted researchers, dedicated entrepreneurs and a competitive marketplace that recognizes the inherent risks of biomedical innovation. But developing cures and treatments is not enough. These advances in medicine must also be accessible and affordable for patients.

“Today the president outlined some of the financial challenges patients face at the pharmacy counter. We look forward to working with the administration on solutions that help provide all patients access to prescription drugs with out-of-pocket costs they can afford. However, we have concerns that some of the ideas proposed today could, if adopted, hurt patient access to the medicines they need today and the future cures and treatments they’re desperately waiting for America’s biopharmaceutical innovators to discover.

“BIO represents an industry with the power to save lives and save money in other parts of the health care system. As more information about the administration’s proposals is released in the coming days and weeks, we will carefully review the details. We will work to ensure that these proposals lower costs for patients, support continued innovation, address the practices of foreign governments that undervalue innovative medicines, and do nothing to hurt small companies who are the backbone of biomedical innovation.”

For more information about prescription drug costs, visit DrugCostFacts.org.

About BIO

05/16/2018

UCB announces BRIVIACT® (brivaracetam) now approved by FDA to treat partial-onset (focal) seizures in pediatric epilepsy patients

Tue, 02 Jul 2019 17:37:37 GMT

UCB announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for the company’s newest anti-epileptic drug (AED) BRIVIACT^® (brivaracetam) CV oral formulations indicated as monotherapy and adjunctive therapy in the treatment of partial onset (focal) seizures in patients age four years and older.

This approval provides clinicians with the convenient option to prescribe BRIVIACT to their pediatric patients as a tablet or oral solution, providing flexible administration options which are important considerations when treating children.

As the safety of BRIVIACT injection has not been established in pediatric patients, BRIVIACT injection is indicated for the treatment of partial-onset seizures only in patients 16 years of age and older. Please see additional BRIVIACT Important Safety Information below.

As a result of the FDA’s decision, children age four years and older with partial-onset seizures in the U.S. can now be treated with BRIVIACT. This extends the clinical application for BRIVIACT which already has a similar indication for adults.

BRIVIACT is the newest anti-epileptic drug (AED) in the synaptic vesicle protein 2A (SV2A) family of medicines – a class of medicines discovered and developed by UCB. BRIVIACT demonstrates a high and selective affinity for SV2A in the brain. It is highly permeable and is rapidly and almost completely absorbed which may contribute to its anticonvulsant effects. Gradual dose escalation is not required when initiating treatment with BRIVIACT for monotherapy or adjunctive therapy, allowing clinicians to initiate treatment at a therapeutic dose from day one.

“As a pediatric neurologist, one of the most challenging aspects in treating epilepsy in children is establishing, quickly, which anti-epilepsy drug will support them best in managing their seizures. The impact of poor seizure control can be extremely detrimental – both to overall quality of life for patients and caregivers and for a child’s development. There is a real sense of urgency for parents and healthcare providers to know whether a particular therapeutic approach is likely to be successful, minimizing some of the challenges associated with epilepsy and potentially allowing them to live a normal and active life,” explained Dr. James Wheless, Director, Neuroscience Institute & Le Bonheur Comprehensive Epilepsy Program - Le Bonheur Children’s Hospital. “The availability of an approved treatment option, such as BRIVIACT, has potential to help improve the lives of children and their families by providing an additional choice to support them in their epilepsy journey.”

Epilepsy in childhood is a complex disorder that can have a significant impact on many aspects of a child's development and function. Social and societal stigma still associated with epilepsy can be especially cruel for children. The prevalence of pediatric epilepsy has been steadily increasing in the U.S.³ Today, it is estimated that nearly 470,000 children in the U.S. under the age of 18 have epilepsy, representing around a quarter of the total worldwide population who develop the condition each year.⁴ The U.S. Centers for Disease Control and Prevention (CDC) estimate that 0.6 percent of children in the U.S. ages 0 to 17 have active epilepsy – equivalent to six students in a school of 1000.⁵ Despite its growing prevalence, approximately 10 to 20 percent of pediatric epilepsy patients experience inadequate seizure control with available anti-epileptic drugs.^6,7,8 Alongside close partnerships with educators, family members, and healthcare providers, there is a need for newer AEDs with better seizure control which can support and maximize a child’s potential for academic success.

“We believe there is a real need for newer AEDs to support and maximize the potential for success for children with epilepsy,” explained Jeff Wren, Executive Vice-President, Head of UCB’s Neurology Patient Value Unit. “The approval of BRIVIACT in the U.S for pediatric patients represents an important milestone for patients, families, doctors, UCB, and the wider epilepsy community, and has the potential to provide additional value for patients - both today and for their future. We are very excited to be able to provide a new pediatric treatment choice, and we are proud to support patients as they progress on their epilepsy journey.”

The expanded FDA indication for BRIVIACT is based on the principle of extrapolation of its efficacy data from adults to children, and is supported by safety and pharmacokinetics data collected in children. Adverse reactions in pediatric patients are generally similar to those seen in adult patients⁹. This principle of extrapolating clinical data from well controlled studies in adults has been recognized by the FDA as potentially addressing the challenge of limited pediatric data availability.

The safety and effectiveness of BRIVIACT in the treatment of partial-onset seizures have been established in patients four years of age and older. Use of BRIVIACT in these age groups is supported by evidence from placebo-controlled partial-onset seizure studies of BRIVIACT in adults with additional pharmacokinetic and open-label safety studies in pediatric patients age 4 to younger than 16 years of age. Partial-onset seizures in pediatric patients aged 4 to 16 years of age are similar to those in adults and a similar AED exposure-response relationship has been demonstrated. Weight-based dose adaptations have been established in the pediatric population to achieve similar plasma concentrations as observed in adults. The safety and tolerability profile for BRIVIACT in pediatric patients 4 to 16 years of age is generally similar to that seen with adult patients.⁹

The most common adverse reactions recorded for adults (at least 5 percent for BRIVIACT and at least 2 percent more frequently than placebo) are somnolence and sedation, dizziness, fatigue, and nausea and vomiting symptoms.⁹

For additional medical information about BRIVIACT, patient assistance, or any other information please visit www.BRIVIACT.com or call 1-844-599-2273.

About Epilepsy^10,11,12,5

Epilepsy is a chronic neurological disorder of the brain. It is the fourth most common neurological condition worldwide and affects approximately 65 million people. In the U.S. more than 3.4 million people have epilepsy. Anyone can develop epilepsy; it occurs across all ages, races and genders, and is defined as one or more unprovoked seizures with a risk of further seizures. Around one third of patients with epilepsy currently live with uncontrolled seizures.

About UCB in Epilepsy

UCB has a rich heritage in epilepsy with over 20 years of experience in the research and development of anti-epileptic drugs. As a company with a long-term commitment to epilepsy research, our goal is to address unmet medical needs. Our scientists are proud to contribute to advances in the understanding of epilepsy and its treatment. We partner and create super-networks with world-leading scientists and clinicians in academic institutions, pharmaceutical companies and other organizations who share our goals. At UCB, we are inspired by patients, and driven by science in our commitment to support patients with epilepsy.

About BRIVIACT^9,13

BRIVIACT (brivaracetam) is a new molecular entity that was rationally designed and developed by UCB.

Brivaracetam displays a high and selective affinity for synaptic vesicle protein 2A (SV2A) in the brain, which may contribute to the anticonvulsant effect. However, the precise mechanism of action by which BRIVIACT exerts its anticonvulsant activity is not known.

In the U.S., BRIVIACT^® (brivaracetam) CV is indicated for the treatment of partial-onset seizures in patients 4 years of age and older. As the safety of BRIVIACT injection in pediatric patients has not been established, BRIVIACT injection is indicated for the treatment of partial-onset seizures only in adult patients (16 years of age and older).

In the European Union, BRIVIACT is approved as adjunctive therapy in the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy. The European Medicines Agency has different regulatory requirements from FDA for approval of monotherapy indications.

Important Safety Information about BRIVIACT^® in the U.S. ⁹

Warnings and Precautions

Suicidal Behavior and Ideation: Anti-epileptic drugs, including BRIVIACT, increase the risk of suicidal behavior and ideation. Monitor patients taking BRIVIACT for the emergence or worsening of depression; unusual changes in mood or behavior; or suicidal thoughts, behavior, or self-harm. Advise patients, their caregivers, and/or families to be alert for these behavioral changes and report them immediately to a healthcare provider.
Neurological Adverse Reactions: BRIVIACT causes somnolence, fatigue, dizziness, and disturbance in coordination. Somnolence and fatigue-related adverse reactions were reported in 25% of adult patients taking at least 50 mg per day of BRIVIACT compared to 14% of adult patients taking placebo. Dizziness and disturbance in gait and coordination were reported in 16% of adult patients taking at least 50 mg per day of BRIVIACT compared to 10% of adult patients taking placebo. The risk is greatest early in treatment but can occur at any time. Monitor patients for these signs and symptoms and advise them not to drive or operate machinery until they have gained sufficient experience on BRIVIACT.
Psychiatric Adverse Reactions: BRIVIACT causes psychiatric adverse reactions, including non-psychotic and psychotic symptoms. These events were reported in approximately 13% of adult patients taking at least 50 mg per day of BRIVIACT compared to 8% of adult patients taking placebo. A total of 1.7% of adult patients taking BRIVIACT discontinued treatment due to psychiatric reactions compared to 1.3% of patients taking placebo. Psychiatric adverse reactions were also observed in open-label pediatric trials and were generally similar to those observed in adults. Advise patients to report these symptoms immediately to a healthcare provider.
Hypersensitivity: BRIVIACT can cause hypersensitivity reactions. Bronchospasm and angioedema have been reported. Discontinue BRIVIACT if a patient develops a hypersensitivity reaction after treatment. BRIVIACT is contraindicated in patients with a prior hypersensitivity reaction to brivaracetam or any of the inactive ingredients.
Withdrawal of Anti-epileptic Drugs: As with all anti-epileptic drugs, BRIVIACT should generally be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus.

DOSING CONSIDERATIONS

Dose adjustments are recommended for patients with all stages of hepatic impairment.
When BRIVIACT is co-administered with rifampin, an increase in the BRIVIACT dose is recommended.

ADVERSE REACTIONS

In adult adjunctive therapy placebo-controlled clinical trials, the most common adverse reactions (at least 5% for BRIVIACT and at least 2% more frequently than placebo) were somnolence and sedation, dizziness, fatigue, and nausea and vomiting symptoms. Adverse reactions reported in clinical studies of pediatric patients 4 years to less than 16 years of age were generally similar to those in adult patients.

BRIVIACT is a Schedule V controlled substance.

Please refer to full Prescribing Information at http://www.briviact.com/briviact-PI.pdf.

For more information on BRIVIACT®, contact 844-599-CARE (2273).

BRIVIACT® is a registered trademark of the UCB Group of Companies.

For further information:

Corporate Communications

France Nivelle

Global Communications, UCB

T +32.2.559.9178 france.nivelle@ucb.com

Laurent Schots

Media Relations, UCB

T+32.2.559.92.64 Laurent.schots@ucb.com

Investor Relations

Antje Witte

Investor Relations, UCB

T +32.2.559.94.14 antje.witte@ucb.com

Isabelle Ghellynck,

Investor Relations, UCB

T+32.2.559.9588, isabelle.ghellynck@ucb.com

Brand Communications

Jim Baxter,

Neurology Communications, UCB

T+32.2.473.78.85.01 jim.baxter@ucb.com

About UCB

UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases in immunology and neurology. With approximately 7500 people operating in 40 countries, the company generated revenue of €4.5 billion in 2017. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news

Forward looking statements - UCB

This press release contains forward-looking statements based on current plans, estimates and beliefs of management. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, political, regulatory or clinical results and other such estimates and results. By their nature, such forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions which could cause actual results to differ materially from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, product liability claims, challenges to patent protection for products or product candidates, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in tax laws or the administration of such laws and hiring and retention of its employees. UCB is providing this information as of the date of this press release and expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report a change in its expectations.

There is no guarantee that new product candidates in the pipeline will progress to product approval or that new indications for existing products will be developed and approved. Products or potential products which are the subject of partnerships, joint ventures or licensing collaborations may be subject to differences between the partners. Also, UCB or others could discover safety, side effects or manufacturing problems with its products after they are marketed. Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement.

References:

Shinnar, S., Pellock, J.M. Update on the epidemiology and prognosis of pediatric epilepsy. J Child Neurol. 2002;17(Suppl 1):S4-17.
Zack MM, Kobau R. National and State Estimates of the Numbers of Adults and Children with Active Epilepsy — United States, 2015. MMWR Morb Mortal Wkly Rep 2017;66:821–825. DOI: http://dx.doi.org/10.15585/mmwr.mm6631a1. accessed 02 May 2018.
Datamonitor Healthcare. Epilepsy disease coverage. 2015.
Featherstone, V. Epilepsy in children and young people. Cerebra – Positively Different. 2010. Available at: http://eprints.hud.ac.uk/id/eprint/14522/1/Epilepsy%2520Brief.pdf. accessed 12th March 2018.
Centers for Disease Control and Prevention. Available at https://www.cdc.gov/epilepsy/basics/fast-facts.htm Accessed 02 May 2018.
Berg AT, Vickrey BG, Testa FM, Levy SR, Shinnar S, DiMario F, et al. How long does it take for epilepsy to become intractable? A prospective investigation. Ann Neurol. 2006;60:14-17.
Berg, A., Shinnar, S., Levy, S., Testa, F., Smith-Rapaport, S., Beckerman, B. Early development of intractable epilepsy in children: a prospective study. Neurology. 2001;56(11):1445-1452.
Geerts A, Arts WF, Stroink H, Peeters E, Brouwer O, Peters B, et al. Course and outcome of childhood epilepsy: a 15-y follow-up of the Dutch study of epilepsy in childhood. Epilepsia. 2010;51:1189–97.
Briviact® U.S. Prescribing Information. Brussels, Belgium: UCB, 2018. https://www.briviact.com/briviact-PI.pdf.
The Epilepsy Foundation of America. About epilepsy basics http://www.epilepsy.com/learn/about-epilepsy-basics accessed accessed 02 May 2018.
The Epilepsy Foundation of America. What is epilepsy? http://www.epilepsy.com/learn/epilepsy-101/what-epilepsy accessed 02 May 2018.
The Epilepsy Foundation of America. Who gets epilepsy? http://www.epilepsy.com/learn/epilepsy-101/who-gets-epilepsy. accessed 02 May 2018
Briviact® EU Prescribing Information. Brussels, Belgium: UCB, 2016. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003898/WC500200206.pdf. accessed 02 May 2018.

USP-BRV0518-0012
HQ/0518/BRV/00003

05/16/2018

Takeda Buys Shire

Tue, 02 Jul 2019 17:38:29 GMT

Japan's Takeda clinches $62 billion Shire deal as pharma M&A rolls on
Source: Reuters
Takeda Pharmaceutical agreed to buy London-listed Shire for 45.3 billion pounds ($62 billion) on Tuesday, the biggest yet in a wave of deals sweeping the drugs industry.
https://www.reuters.com/article/us-shire-m-a-takeda/japans-takeda-clinches-62-billion-shire-deal-as-pharma-ma-rolls-on-idUSKBN1I90IC

Japan's biggest ever deal: Takeda buys Shire for $62 billion
Source: CNN
Japanese drugmaker Takeda has reached a $62 billion deal to buy rival Shire in the world's biggest takeover so far this year.

After waging a lengthy campaign to win over the board of Dublin-based Shire, Takeda (TKPHF) announced Tuesday that they had an agreement.
The deal values Shire (SHPG) at £46 billion ($62.1 billion), excluding debt, according to the companies.
http://money.cnn.com/2018/05/08/investing/takeda-shire-japan-record-deal/index.html

Execution of Bridge Loan Agreement for Shire plc Acquisition
Source: Takeda
https://www.takeda.com/newsroom/newsreleases/2018/execution-of-bridge-loan-agreement-for-shire-plc-acquisition/

Proposed Acquisition of Shire plc by Takeda
Source: Takeda
https://www.takeda.com/newsroom/newsreleases/2018/proposed-acquisition-of-shire-plc-by-takeda/

Shire new pages on Takeda Offer
Source: Shire
http://investors.shire.com/disclaimer-takeda.aspx

05/10/2018

Southeastern U.S. lifescience groups form alliance

Tue, 02 Jul 2019 17:39:37 GMT

Seven Southeastern U.S. life science and medtech groups are joining forces to better promote and advocate for the region.

The Southeastern Medical Device Association (SEMDA) on Wednesday announced the formation of an alliance with six individual state medtech and life science advocacy groups: BioAlabama, Bio Florida, Georgia Bio, ncbio, Life Science Tennessee and SCBIO.

“Industry and academic partners simply cannot invest enough in each individual state’s bio advocacy organization — nor travel to each organization’s annual event every single year,” SEMDA executive director Jason Rupp said in a news release.

“But they can come to SEMDA, where the entire region gathers every year bringing their leading investors, academic and industry partners including the best of their young, innovative, investable companies,” Rupp said.

No single state in the Southeastern U.S. can match the medical device and life science industry strength of the nation’s major hubs in California, Minnesota and Massacusetts. But taken together, the region is more competitive, according to industry advocates there.

“We are strongest as a region,” said Russell Allen, president and CEO of Georgia Bio. “If we are to advance medical technologies to improve care, reduce healthcare costs and create new jobs, our state associations must work closely together to connect innovators and share resources.”

The inaugural 2018 SEMDA Medtech Conference is ongoing through May 4 in Greenville, S.C.

05/07/2018

Halyard Health, Inc. Completes Divestiture of its S&IP Business

Tue, 02 Jul 2019 17:40:23 GMT

Halyard Health, Inc. announced the completion of the previously disclosed divestiture of its S&IP business to Owens and Minor, Inc. for $710 million, subject to certain adjustments as provided in the Amended and Restated Purchase Agreement. Halyard intends to use the approximately $600 million in net proceeds from the sale to pay off its existing Term Loan B credit facility and to fund internal investment and M&A.

"The divestiture of S&IP transforms us into a focused, pure-play medical devices business with a clear playbook for solid revenue and earnings growth," said Joe Woody, Halyard chief executive officer. "The additional financial capacity will fund our dual-track growth strategy, focused on product innovation and strategic M&A and underpinned by a commitment to commercial excellence."

05/02/2018

Reach Health acquired by California-based telehealth platform

Tue, 02 Jul 2019 17:40:59 GMT

Alpharetta health-care tech company Reach Health was acquired telemedicine platform InTouch Health for an undisclosed amount, the companies announced April 30.

Reach Health, whose platform fosters collaboration between bedside clinicians and remote specialists, has about 35 employees in Atlanta. Tim Wright, executive vice president of strategy and development at Santa Barbara, Calif.-based InTouch Health, said the Alpharetta office would remain in place.

The telemedicine industry is rapidly consolidating, Saluke said. The acquisition will offer Reach Health's customers better support, security and compliance. InTouch will gain access to Reach's data driven approach to telemedicine, which brings down the cost of equipment.

05/01/2018

Georgia State Partners With Pinnacle Bio For Fast, Cost-effective Flu Test

Tue, 02 Jul 2019 17:41:43 GMT

ATLANTA—Georgia State has signed a licensing deal with Pinnacle Bio, a biotechnology firm that specializes in developing and marketing technologies to diagnose infectious diseases, to market a point-of-care influenza diagnostic developed by Suri Iyer, professor in the Department of Chemistry and the Center for Diagnostics & Therapeutics.

Methods of diagnosing influenza are often expensive, not sensitive enough and require trained personnel to administer. Iyer and his colleagues have designed an accurate test that can detect influenza viruses in 15 minutes.

The test requires only a nasal swab and detects a protein on the surface of the virus to identify influenza A and influenza B—the two main flu strains in humans. The research was funded by the National Institutes of Health.

“Physicians generally will not administer a flu test except in small children or the elderly. We polled doctors and found that many felt it wasn’t worth the cost,” said Aatish Madhiwala, a physician and the managing director of Pinnacle Bio. “Yet in the past several years, we’ve seen more strains of influenza that aren’t targeted by the flu vaccine and we’ve seen an increase in morbidity and mortality. The flu is scaring people more than it once did in developed nations.”

Madhiwala says Pinnacle sees an opportunity for an accurate, inexpensive influenza diagnostic in the American, Canadian and European markets. Engineers at Pinnacle have developed a reader that works with the test, and the company hopes to begin trials in Europe in the next six months.

“After that, our goal is to get FDA (Food and Drug Administration) approval within the next 24 months,” he said. “We think we’ll be able to make the test more affordable than what’s currently available by a fairly big margin.”

A broadly used diagnostic would also allow doctors to be more selective in who receives Tamiflu, an antiviral medication that works against the flu.

“Currently, doctors are prescribing Tamiflu to anybody with flu-like symptoms, without knowing whether the patient actually has influenza,” said Madhiwala. “As a result, we’ve been experiencing shortages of the medication.”

Pinnacle hopes to refine the test to quantify a patient’s viral load.

“This will show whether you’re a carrier of the virus, in the preliminary stages of the flu, or have full-blown flu, and help determine whether it’s the best time to deliver those antivirals,” Madhiwala said.

“The arrangement with Pinnacle Bio exemplifies Georgia State’s commitment to serve as a bridge between our outstanding scientists and the companies that have the expertise to make the fruits of their research available,” said Vincent La Terza, associate vice president for research and director of technology transfer and commercialization. “We hope the partnership can lead to improved diagnosis of an infectious disease that affects millions of people worldwide.”

04/24/2018

Vincent La Terza Named Director Of Technology Transfer And Commercialization

Tue, 02 Jul 2019 17:42:26 GMT

ATLANTA—Vincent La Terza, assistant vice president and senior licensing agent at Georgia State University since 2017, has been named associate vice president of research and director of technology transfer and commercialization at Georgia State.

He leads the university’s Office of Technology Licensing and Commercialization, which helps scientists bring their inventions and discoveries from the lab into the marketplace.

La Terza, an attorney, is an experienced biopharma entrepreneur and has worked in technology transfer for the University of Georgia, Georgia Institute of Technology and Emory University, where he was the university’s first director of technology transfer.

“We are delighted to name Vince La Terza as head of the technology and commercialization office,” said James Weyhenmeyer, vice president of research and economic development at Georgia State. “Vince has deep experience in moving innovation to market through direct licensing and early-stage company development.”

In recent years Georgia State has become known as one of the nation’s fastest growing research institutions, home to world-class investigators working in biomedical science, diagnostic medicine, nanotechnology and other areas. But for a scientist, the path to commercialization can be challenging, La Terza said.

“Georgia State investigators are generating compelling innovations with great promise to address significant unmet needs,” he said. “Some, such as software, certain vaccines and research tools, are ready to move toward the market shortly after our office gets involved. Other innovations, especially those aimed at combatting diseases such as cancer, are unlikely to attract commercial interest until they are closer to the regulatory evaluation process, a process that can take years of expensive research and development. A key function of our office is to help scientists define a path forward and access resources to pursue that path.”

Nathanael McCurley also joins Georgia State as licensing associate. McCurley, who holds a doctorate in immunobiology from Yale University, spent 15 years in academic research before transitioning to a career in biotechnology. Most recently, he worked as a senior scientist at GeoVax Inc., a Georgia-based clinical-stage vaccine development company. He has expertise in academia and commercial development.

“Nathanael will have an immediate impact in his ability to delve into the research in a sophisticated way and work with faculty to develop critical milestones to advance technology toward the market,” La Terza said. “His experience working on new vaccines, immune hyperreactivity and molecular diagnostics are particularly pertinent to several research programs at Georgia State.”

La Terza and McCurley are working with university scientists who have invented breakthrough technologies, helping them obtain patents and form small companies that can qualify for special federal grants meant to pave the way for research commercialization. In 2017 La Terza worked with Jenny Yang, Regents professor and associate director of the Center for Diagnostics and Therapeutics, whose company, Inlighta Biosciences, was awarded $2 million from the National Institutes of Health to optimize a novel, protein-based contrast agent.

Learn more about Georgia State’s office of technology licensing and commercialization here.

04/23/2018

Georgia Bio Announces 4th Annual Georgia BioEd Institute Golf Outing

Tue, 02 Jul 2019 17:43:36 GMT

The Manor Golf and Country Club to host May 8 event with
proceeds benefiting STEM programming

ATLANTA – April 17, 2018: Georgia Bio has announced that its 4th annual golf outing, Swings fore STEM, will be held on Tuesday, May 8, at The Manor Golf and Country Club in Milton, Ga. Georgia Bio is an organization that aims to grow Georgia’s leadership in life science innovation through support of entrepreneurship, science education and life science career development. Additionally, the Georgia BioEd Institute division strives to make a difference in the world of education by providing the tools and equipment teachers and students desperately need to succeed in STEM fields.

This golf outing is part of the campaign to raise funds to promote and support all STEM education programs run by the Institute. The outing’s revenue will help to train teachers and maintain and stock the GaBioEd Equipment Depot which supplies teachers throughout Georgia with the tools needed to teach biology, chemistry, biotechnology, and other health sciences in the classrooms.

Last year, the Georgia BioEd Institute Golf Outing helped to impact 29,000 students, 124 teachers, and 75 Georgia schools in 27 districts. This year they hope to double those numbers and continue to make a significant difference in the ability of students to access the exciting world of biotech and medtech across the state.

The tournament will be a scramble format. Registration will begin at 10 am and tee-off is 11am. The Manor is located at 15952 Manor Club Dr, Milton, Ga 30004. The event will also feature special contests, prizes and a reception. Reception only tickets are available for those who are unable to play the course.

For more information or to register visit – www.georgiabioed.org/golf.

ABOUT GEORGIA BIO: Founded in 1989, it is a non-profit, membership-based organization that promotes the interests and growth of the life sciences industry. The Georgia BioEd Institute is preparing talented individuals for tomorrow’s careers in biotechnology. The life science industry is seeking creative problem-solvers, clear communicators, and team-players with a passion for addressing the world’s biggest challenges in medicine, agriculture, and energy. More information can be found at http://www.gabio.org/ and http://www.georgiabioed.org.

ABOUT THE MANOR GOLF AND COUNTRY CLUB: The Manor is best known for featuring Georgia’s only Tom Watson-designed championship golf course. In this exclusive high-end gated community in Milton, Ga., the Manor boasts a world-class amenity package and an unparalleled country club lifestyle. More information can be found at http://www.clubcorp.com/Clubs/The-Manor-Golf-Country-Club/.

04/18/2018

Students Spur Animal Health Innovation at Hackathon

Tue, 02 Jul 2019 17:44:41 GMT

Hackathon winners develop innovative solutions for feeding pets, disease detection for backyard chickens and for supporting surgery and care of pets

At the first-ever animal health-focused hackathon conducted in Georgia this past weekend, nearly 100 students applied inspiration and expertise spanning multiple disciplines to develop a number of potential solutions for the care and welfare of pets and livestock.

Ideas ranging from a fitness tracker for owners and their pets to a thermo-detection drone for early identification of sick livestock were developed into four-minute pitches, many of which even featured prototypes developed over the course of the weekend. The grand prize-winning team, PetSense, developed an Alexa-compatible intelligent feeding and weight monitoring system for cats and dogs.

Three other teams were recognized for their projects in three categories: Animal Human Bond; Disease Diagnostics, Preventive Measures and Tracking; and Sustainable Agriculture. The AutoMat team was recognized in the category of Animal Human Bond for their non-slip, self-disinfecting, reusable mat that provides a more comfortable examining table surface for pets.

The Third Arm team was recognized in the category of Disease Diagnostics, Preventive Measures and Tracking for their innovation of a surgical tool to enable precise placement of screws during surgery. In the Sustainable Agriculture category, the Chirp Alert team was recognized for its work on a mobile app-based screening test for five major poultry pathogens commonly seen in backyard chicken flocks.

“Judging these entries was difficult, though very rewarding, because all of the proposed ideas and presentations were highly original and well-conceived,” said Harry Dickerson, associate dean for research and graduate affairs at the University of Georgia’s College of Veterinary Medicine, and one of the hackathon judges. “The enthusiasm and creativity of the students was exceptional.”

The University of Georgia and Boehringer Ingelheim Animal Health co-hosted this first-ever Georgia Animal Health Hackathon on the UGA campus in Athens to explore new ideas and technologies for improving the care of pets and livestock.

Students from varied disciplines, degrees, majors and colleges from UGA and other area universities joined scientists and business leaders from Boehringer Ingelheim Animal Health, and members of the Georgia startup community at this weekend-long event, to brainstorm and explore advances that have the potential to improve the human-animal bond, lead to more sustainable agricultural practices and improve both human and animal health.

“The problem-solving skills and the diversity of ideas displayed by all of the teams was remarkable,” said Monica Dias Figueiredo, director of external innovation and lead finding within Boehringer Ingelheim’s Animal Health Research and Development organization and co-lead of the hackathon organizing committee. “These kinds of events provide a wonderful opportunity to break down barriers in the thought process and tap multi-disciplinary expertise in developing potential new solutions.”

The hackathon began on Friday afternoon with presentations from innovators and leaders, to provide a multifaceted view of emerging trends and the future of animal health and health care services as well as exposure to the realities of early-stage entrepreneurship.

The event continued through the weekend with 13 teams comprised of veterinary students, business students, engineers, designers and more coming together to share ideas and create novel solutions in animal health. Nearly 20 mentors from industry, academia and clinical practice provided feedback and guidance to the teams, culminating in a project showcase on Sunday, April 8, and final pitches to an audience of peers, industry representatives and participants.

“This weekend I participated in my first ever hackathon,” said Lydia Anderson, doctoral student at the UGA College of Veterinary Medicine and a member of the ChirpAlert team. “After two days of hard work, my team was able to translate an idea to an invention that addresses a need for global sustainable agriculture. This experience was life-changing, and I would encourage every student to seek out a similar opportunity. I can’t wait to see where it takes us next.”

In addition to the $2,000 prize, the grand-prize winning PetSense team will receive a one-year Seedling membership from Four Athens startup accelerator, allowing access to members-only events, resources for growing companies, and $3,000 in Amazon Web Services credits. The winning team will also receive admission to a Raising Money for Startups in 2018 session, as well as the opportunity to pitch its concept in a one-on-one session with investor Paul Singh.

Boehringer Ingelheim has a significant presence in Georgia, including the headquarters for its U.S. Animal Health business based in Duluth, manufacturing and R&D operations in Athens, and an additional manufacturing site located in Gainesville. As the second largest animal health business in the world, Boehringer Ingelheim is committed to improving animal health. With more than 10,000 employees worldwide, Boehringer Ingelheim Animal Health has products available in more than 150 markets and a global presence in 99 countries. For more information about Boehringer Ingelheim Animal Health, click here.

04/12/2018

NeurOp Initiates Phase 1 Clinical Trial of NMDA Receptor Inhibitor NP10679

Tue, 02 Jul 2019 17:45:29 GMT

ATLANTA, GA / ACCESSWIRE / April 12, 2018 / NeurOp, Inc., a clinical-stage biotechnology company, today announced the initiation of a Phase 1 clinical trial of NP10679, a highly potent and selective GluN2B subunit-specific NMDA (N-methyl-D-aspartate) receptor inhibitor. NeurOp is investigating NP10679 for several neurological disorders that are associated with over-activity of these receptors.

The randomized, placebo-controlled, single ascending dose study will assess the safety, pharmacokinetics and pharmacodynamics of NP10679 in healthy volunteers. The study is being conducted in collaboration with Pharmaron (Baltimore) and is currently enrolling subjects in the United States. Data collected from the study will inform dose and schedule for further development of NP10679 for potential use in severe pain and the prevention of ischemic damage following subarachnoid hemorrhage (SAH).

Certain areas of the brain become acidified by metabolic insufficiency or increased neuronal activity. This condition or "context" exists in severe pain and SAH and may also exist in brain areas that are undergoing seizures or involved in nicotine or opioid addiction.

"NP10679 is a first-in-class therapy as a context-dependent NMDA receptor inhibitor," said NeurOp's Chief Scientific Officer, Robert Zaczek, PhD. "Preclinical data demonstrate that NP10679 is different from other NMDA therapies, because of its selectivity, safety profile and potency at low pH, a condition found in a number of central nervous system disorders."

"We have achieved a significant milestone for NeurOp now that NP10679 has advanced to the clinic," said James McNamara, MD, Executive Chairman at NeurOp. "We look forward to moving this compound through clinical development and are particularly encouraged by its potential as a treatment for severe pain. With the opioid epidemic facing the nation, the need for effective and safe medications for severe pain is greater than ever."

NP10679 is bioavailable either orally or by IV, and it is currently being evaluated in this study by the IV route. An IND for NP10679 was opened in 2016.

About NeurOp

NeurOp, Inc. is a clinical-stage biopharmaceutical company based in Atlanta that is developing small-molecule therapies for central nervous system disorders, including severe pain, subarachnoid hemorrhage (SAH) and catastrophic juvenile epilepsies. Its proprietary compounds selectively inhibit the GluN2B subunit of neuronal NMDA receptors for potential therapeutic benefit with fewer side effects than currently available NMDA receptor antagonists. For more information, please visit www.neuropinc.com.

NeurOp contact:

Robert Zaczek, PhD
rzaczek@neuropinc.com
Phone: 860.853.0427

SOURCE: NeurOp, Inc.

04/12/2018

Vero Biotech Moves Corporate Headquarters to Georgia Tech’s Technology Enterprise Park in Atlanta

Tue, 02 Jul 2019 17:47:53 GMT

ATLANTA, April 6, 2018 – Vero Biotech is pleased to announce the opening of its new corporate headquarters in Georgia Tech’s Technology Enterprise Park on April 6, 2018. Vero Biotech, formerly GeNO LLC, is an emerging biotechnology company focused on the design, development, and commercialization of next generation inhaled Nitric Oxide (NO) delivery systems to address unmet needs of patients with cardiopulmonary conditions.

“We are excited to be moving to Atlanta, where we will have access to a growing biotech community housed at Technology Enterprise Park, part of the Georgia Tech community; a highly skilled workforce; and an innovation support system that is essential for a startup company like Vero Biotech,” says Brent Furse, President and CEO of Vero Biotech. “It is significant for us to be able to work in an advanced new complex. The modern facility will enable us to continue to accommodate the growing needs of our research, development, and commercial opportunities.”

Vero Biotech will be moving their Administrative, Research & Development, and Manufacturing capabilities from Cocoa, Florida, to Atlanta during the next six to 12 months. Currently, Vero Biotech has approximately 65 employees and plans to hire up to 40 more over the next year.

“We expect to double in size during the next 12 to 18 months, and we will be looking to hire top talent, especially in the areas of software development, engineering, sales and marketing, and quality assurance,” said Marc Morin, CFO of Vero Biotech. “We encourage anyone interested in these outstanding opportunities to visit our website: www.vero-biotech.com.”

In their new location, Vero Biotech will partner with Georgia Tech to provide hands-on experience and internship opportunities for the future leaders of the biotech industry.

“We are pleased to welcome innovative biotech companies like Vero Biotech to Atlanta,” said Russell Allen, President and CEO of Georgia Bio. “Adding to our region’s unique mix of people, facilities, and resources helps position Atlanta as one of the leading global bioscience hubs.”

Chad Koenig and Ben Jackson of Cushman & Wakefield represented Vero Biotech in the 15,585-square-foot lease, and Enio Guerra and Dick Bowers of Richard Bowers & Co. represented the landlord.

For more information, contact Vero Biotech on Facebook, LinkedIn, or on their website.

About Vero Biotech

Vero Biotech (formerly known as GeNO LLC), is a biopharmaceutical company focused on the design development and commercialization of next generation products to address unmet medical needs of patients with a variety of pulmonary and cardiac diseases. We are currently developing inhaled nitric oxide (NO) products for use in both the hospital setting and for longer-term applications outside of the hospital setting. These products, which are based on our GeNOsyl drug delivery technology, are comprised of a single-use drug cassette and either a portable console or wearable controller. Our technology is designed to deliver NO safely for a variety of therapeutic indications and to provide clinicians with a solution that is more user-friendly than currently available NO delivery systems.

Media Contact:

Namita Khanna, Executive Director of Strategic Development

321-785-2642

Namita.Khanna@vero-biotech.com

04/09/2018

Georgia Bio Names Mountain View High School Junior as Georgia BioGENEius Winner

Tue, 02 Jul 2019 17:48:51 GMT

Suraj Modi Advances to Boston to International Competition Against Top Students

Atlanta, GA (April 6, 2018) – Georgia Bio and the Georgia BioEd Institute today named Suraj Modi, Mountain View High School junior of Lawrenceville, GA, as the winner of the 2018 Georgia BioGENEius Challenge, the premier competition for high school students that recognizes outstanding research and innovation in the biotechnology field. As Georgia’s BioGENEius finalist, Suraj will attend the 2018 BIO International Convention, the industry’s trade conference from June 3-6 in Boston, MA, where he will engage with leading companies, scientists and innovators currently transforming the scientific landscape in order to gain valuable insights into an industry making significant contributions to the world.

While in Boston, Suraj will compete against high school students from the U.S., Canada and Germany in the International BioGENEius Challenge. The student projects will represent a range of biotechnology topics such as healthcare, agriculture, and the environment.

Suraj’s award-winning research uses algorithms to predict epileptic seizures. Epilepsy affects over 3.4 million people in the United States alone. Approximately 200,000 new cases of epilepsy are diagnosed each year. The purpose of this project was to detect seizures at least 5 minutes prior to their occurrence through preictal, ictal, and interictal brainwave differentiation. It can be used to save the lives of epileptic patients and provide them with a warning of an oncoming seizure.

“The BioGENEius Challenge highlights the breakthroughs made when we invest in and encourage young people to pursue their ideas,” said Georgia Bio President and CEO Russell Allen. “Georgia Bio is thrilled that Suraj will represent our state at the upcoming BIO Convention. We are proud to support this Georgia scholar as he develops tomorrow’s healthcare innovations.”

Georgia Bio also congratulates the Georgia BioGENEius runner-up, Zoe Weiss of Lakeside High School in Atlanta, GA. Weiss’ research enabled her to create a powerful method to detect rare cell types in a large population of cells. Rare cell type detection would advance early disease diagnosis (e.g., cancer) and allow identification of new cell types.

Judging the 2018 Georgia BioGENEius were Jamie L. Graham, Kilpatrick Townsend & Stockton; Kami McMillan, Chubb; Alex Harvey, Viamune; Monica Dias Figueiredo, Boehringer Ingelheim Animal Health; and Ian Biggs, UGA.

National and International winners will be announced during June 4-7, 2018 BIO International Convention. Winners will receive cash scholarships.

Follow the BioGENEius Challenge: Throughout the challenge, @BiotechInstitut will be tweeting interviews, photos, and engaging with the biotechnology community by using the hashtag #BioGENEius.

About the Biotechnology Institute
The Biotechnology Institute is an independent, national nonprofit organization dedicated to education about the present and future impact of biotechnology. Its mission is to engage, excite and educate the public, particularly students and teachers, about biotechnology and its immense potential for solving human health, food and environmental problems. For more information, visit www.biotechinstitute.org.

MEDIA CONTACT:

Maria Thacker

404-920-2042

mthacker@gabio.org

04/09/2018

Intent Solutions™ Hires Chief Technology Officer

Tue, 02 Jul 2019 17:53:33 GMT

ATLANTA (March 15, 2018) – Intent Solutions™, creator of the breakthrough medical device technology TAD™, is excited to announce the addition of its new Chief Technology Officer, John Kidd. An accomplished technology executive with experience including researching, developing, and implementing technology solutions deployed at multiple Fortune 100 companies, Kidd has a proven track record in developing enterprise software applications for startup and high-growth companies that benefit the businesses bottom-line while addressing customer needs.

TAD, for “Take As Directed,” is a smart, mobile, medication dispenser that assists patients in obtaining better health outcomes by helping the right patient take the right dose at the right time.

“Intent Solutions has a big opportunity in the market and the looming opioid crisis is in need of some good solutions,” said Kidd. “I believe that Intent Solutions is developing technology that will create unprecedented visibility and accountability across all responsible parties from drug manufacturer to distributor to payer to patient. Ultimately, we will shine a light on where the issues are happening and enable early detection of abuse and diversion.”

At Intent Solutions, Kidd will help to provide a clear path for solutions that will impact the company’s customer base.

“Intent Solutions has a massive sea of opportunity,” said Kidd. “Providing technology solutions where we can extract and see commonalities, we will be able to find new product opportunities within this large market space not only moving forward with TAD, but possibly other products that fit our customer’s needs.”

03/21/2018

MiMedx Announces Expectation to Exceed the $92 Million

Tue, 02 Jul 2019 17:54:52 GMT

MiMedx Announces Expectation to Exceed the $92 Million Top End of First Quarter Revenue Guidance

MARIETTA, Ga., March 15, 2018 /PRNewswire/ -- MiMedx Group, Inc. (NASDAQ: MDXG), a leading developer and marketer of regenerative and therapeutic biologics, today announced its expectation for first quarter of 2018 revenue to exceed the $92 million high end of its previously released guidance. MiMedx reiterated its full-year 2018 revenue guidance range of $383 million to $387 million.

Parker H. "Pete" Petit, Chairman and CEO, commented, "This year started off strong, and we have continued to see momentum build through the quarter. With our current revenue pace and more than two-thirds of the first quarter completed, we are confident in our expectation that we will exceed $92 million in revenue for the first quarter of 2018."

"We are particularly pleased with the continual expansion of our customer accounts. Our total number of active accounts grew by approximately 27% in 2017, and we expect a similar level of growth this year," added Bill Taylor , President and COO. "The first quarter has traditional headwinds due the resetting of annual insurance deductibles and changes in plan designs, as well as the typical winter weather obstacles that affect treatment days. Our sales planning and execution have again enabled us to overcome normal first quarter obstacles to exceed our initial guidance. This is very encouraging and shows that our momentum is building."

As previously announced, the Audit Committee of the Company's Board of Directors is conducting an independent investigation into current and prior-period matters relating to allegations regarding certain sales and distribution practices, including allegations made by certain former employees and short sellers. As a result, the Company has delayed the filing of its Form 10-K for the year ended December 31, 2017. The Company looks forward to the completion of the Audit Committee's investigation. Also, as previously announced, the Company received a subpoena last year from the Securities and Exchange Commission (SEC). The Company continues to provide documents in response to the subpoena. In addition, the Company was recently informed that, in parallel with the SEC's investigation, the U.S. Department of Justice is also reviewing these matters on a preliminary basis. MiMedx will continue to cooperate with these regulatory agencies.

Over the last several months, the Company has posted numerous responses to allegations that have been made against it and its employees. In view of the Audit Committee's investigation, the Company no longer intends to post responses to these allegations.

MiMedx remains focused on developing regenerative biomaterials that equip physicians to help improve the lives of patients, and is committed to innovation and product quality, efficiently managing its business and driving value creation.

About MiMedx

MiMedx® is the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. "Innovations in Regenerative Medicine" is the framework behind the Company's mission to give physicians products and tissues to help the body heal itself. The Company processes the human placental tissue utilizing its proprietary PURION® Process methodology, among other processes, to produce safe and effective allografts by employing aseptic processing techniques in addition to terminal sterilization. MiMedx has supplied over 1 million allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. For additional information, please visit www.mimedx.com.

Safe Harbor Statement

This press release includes forward-looking statements that may be identified by words such as "believe," "expect," "may," "plan," "potential," "will," "preliminary," and similar expressions, and are based on management's current beliefs and expectations. Forward-looking statements are subject to risks and uncertainties, and the Company cautions investors against placing undue reliance on such statements. Actual results may differ from those set forth in the forward-looking statements. For more detailed information on the risks and uncertainties, please review the Risk Factors section of the Company's most recent annual report or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and the Company assumes no obligation to update any forward-looking statement.

View original content:http://www.prnewswire.com/news-releases/mimedx-announces-expectation-to-exceed-the-92-million-top-end-of-first-quarter-revenue-guidance-300614625.html

SOURCE MiMedx Group, Inc.

Robert P. Borchert, Vice President, Investor Relations, 770-651-9383, investorrelations@mimedx.com

03/20/2018

AmnioFix® Injectable Granted Regenerative Medicine

Tue, 02 Jul 2019 17:55:41 GMT

Advanced Therapy (RMAT) Designation by the FDA for the Treatment of Osteoarthritis of the Knee

MARIETTA, Ga., March 9, 2018 /PRNewswire/ -- MiMedx Group, Inc. (NASDAQ: MDXG), a leading developer and marketer of regenerative and therapeutic biologics, today announced that the U.S. Food and Drug Administration (FDA) has granted MiMedx's micronized amniotic tissue, AmnioFix® Injectable, the Regenerative Medicine Advanced Therapy (RMAT) designation for use in the treatment of Osteoarthritis (OA) of the knee.

In its letter to the Company, the FDA confirmed its determination that MiMedx Allogeneic Micronized Dehydrated Human Amnion/Chorion Membrane (micronized dHACM) for the treatment of OA of the knee meets the criteria for RMAT designation. The FDA further stated that MiMedxhas provided clinical information to demonstrate preliminary clinical evidence to indicate that the drug has the potential to address unmet medical needs for this condition.

In granting the RMAT designation to MiMedx AmnioFix Injectable for use in the treatment of OA of the knee, the FDA committed to a multidisciplinary comprehensive discussion with MiMedx regarding the Company's development program, including planned clinical trials and plans for expediting the manufacturing development strategy.

"The FDA's RMAT designation for AmnioFix Injectable is an important milestone for MiMedx and highlights the importance of introducing promising therapies in areas of considerable unmet medical need. We are especially pleased that the FDA will meet to discuss expediting our development and manufacturing of this product to serve the needs of patients suffering from OA of the knee. We look forward to discussions with the FDA," said Parker H. "Pete" Petit, Chairman and Chief Executive Officer.

"AmnioFix Injectable has been shown to have the potential to reduce pain and improve function in patients with OA of the knee. Given the lack of treatment options for patients with this condition, and the high risks associated with using opioids to manage pain, AmnioFix Injectable has the opportunity to address a significant unmet clinical need by providing physicians and their patients with a new front-line therapy," added Bill Taylor , President and COO. "In addition, we believe AmnioFix Injectable has the potential to become a blockbuster therapeutic biologic, with long-term peak revenue potentially exceeding $4 billion for musculoskeletal pain management within the more than $12 billion addressable U.S. joint pain injection market."

An investigational regenerative medicine therapy is eligible for RMAT designation if it is intended to treat, modify, reverse, or cure a serious condition, and if preliminary clinical evidence indicates that the regenerative medicine therapy has the potential to address unmet medical needs for such condition.

"Our clinical, scientific and regulatory team has done a superb job in the development of this product, and we are very fortunate to have such a talented and dedicated team in our organization," noted Taylor.

The FDA will also provide MiMedx with intensive guidance on efficient drug development, as well as an organizational commitment to involve senior management in facilitating the product's development program. The RMAT designation includes all of the benefits of the Fast Track and Breakthrough Therapy designation programs, including early interaction with sponsors, which may be used to discuss potential surrogate or intermediate endpoints to support accelerated approval.

About Osteoarthritis of the Knee

Osteoarthritis of the knee is an irreversible and persistent condition, prevalent in adult populations and even more so in older populations, associated with pain, restricted mobility, swelling and ultimately joint instability that can significantly limit day-to-day functioning. Osteoarthritis affects an estimated 31 million Americans and is the leading cause of disability in American adults. Prevalence increases with age ranging from about 2% among persons under age 45 and more than 80% among those over 75. Symptomatic OA of the knee presents in 14 million Americans including 2 million under the age of 45, and more than 6 million between the ages of 45 and 64.

The disorder occurs when the joint surface cartilage (also called hyaline cartilage or articular cartilage) becomes worn away leaving the raw bone beneath exposed. The cartilage normally serves as a "pad" or a bearing in the joint. When the bearing wears away, the result is a roughed joint surface that causes the pain and stiffness associated with osteoarthritis.

Knee osteoarthritis is the leading cause of limitations in activities of daily living such as walking and climbing stairs. Knee osteoarthritis symptoms often develop slowly and may become markedly worse over time or with specific activities. Characteristic signs and symptoms of osteoarthritis include stiffness, pain, soreness, inflexibility, swelling, grating/creaking, bone spurs and deformity. While knee osteoarthritis is often a progressive and irreversible degenerative process, functional improvement and pain control are the most common treatments used to treat this condition.

About MiMedx

Safe Harbor Statement

View original content:http://www.prnewswire.com/news-releases/amniofix-injectable-granted-regenerative-medicine-advanced-therapy-rmat-designation-by-the-fda-for-the-treatment-of-osteoarthritis-of-the-knee-300611583.html

SOURCE MiMedx Group, Inc.

03/13/2018

Atlanta startup creates pill-dispensing device to prevent addiction

Tue, 02 Jul 2019 17:58:22 GMT

Georgia has one of the highest numbers of prescription opioid overdose deaths in the U.S., so it’s only natural that local businesses would seek a solution.

Intent Solutions, a startup in Atlanta, has created a pill bottle called Take As Directed (tad). The device dispenses a set dosage of a medication only when a patient is supposed to take it, and it has a biometric fingerprint scanner so no one but the patient can access the medication. Take As Directed also streams all that data to the cloud, so clinicians and researchers can learn more about how people take medicine.

It remains to be seen whether tad will achieve its goal of making it harder for people to abuse prescription opioids. Intent will deploy its first commercial device April 1. The company is distributing 300 tad devices to its customers, which include a large hospice organization and a population health management company. Intent charges for its services, not the actual tad, so depending on how many devices a customer orders and how long each one is used, the cost can range from $1 to $5 a day.

Sam Zamarripa, CEO of Intent and a former Georgia state senator, spoke with Crain’s Atlanta about tad and how Georgia businesses have responded to the opioid crisis.

Why did you decide to create a device to focus on the opioid crisis?

One of our advisory directors who was a friend and acquaintance of the two founders of the company…they had a friend in common who had a direct experience with prescription opioids. He had an accident and he had hip surgery. He was prescribed the medications and he took them and over the course of about seven or eight months, he became addicted. It nearly ruined his life, and he’s been in recovery from that for seven years, so he has a good story to tell. His view was that an open bottle is basically an invitation to take more medicine than you need.

It’s a simple premise that we all operate with, [which] is if one aspirin pill is good, two is better, especially if you’re in pain. That’s fine as long as it doesn’t become three or four or five because prescription opioids, by their very nature, are addictive. That addiction is a chemical addiction that’s very difficult to resist. [This person’s] view is if he had a tool or technology that would have restricted his access to the medications, yet allowed him to have medications as they were prescribed, he felt like it would have possibly eliminated his addiction or would have made it avoidable…

We spent almost a year studying the market. We talked to hundreds of people – doctors and physicians, researchers and pharmaceutical companies – about this issue, and there seemed to be an interest in it, and so we funded the company.

How do you see tad fitting into opioid addiction prevention methods?

If you think about the evolution of the pill bottle – all the way from a little cup, a little glass, an open vial, to plastic – the first major innovations with the pill bottle came with the [Poison Prevention Packaging Act] and then later with the Tylenol scare [in 1982]… The Tylenol scare was a few people that died in Chicago [after taking Tylenol laced with potassium cyanide] and within a matter of months, every cap in America was then not only child-proof. It was sealed. Those innovations were two of the last big innovations in how we manage the vile itself.

Our feeling is that technologies like ours have a big role to play in improving adherence. So in the opioid space, we know – and you can read all the literature – there’s a consensus that pain is a very real thing and if you have it, you know it. The good thing about prescription opioids is that they work. They can relieve pain in people that are suffering with chronic pain.

Our device just gives them a level of safety that didn’t exist before, and it gives their doctors the ability to monitor them more carefully. We think that tad improves the outcome, the intended outcome, of the medication.

How can businesses address the opioid crisis?

Let’s think about it this way: The wonderful thing about technology, both hardware and software, is it allows us to do things more efficiently than we’ve ever been able to do. If you look at the current system there are a lot of moving parts. And in terms of medications that have addictive properties, like oxycodone and others, we think there’s a lot of room for innovation.

So, today for example, most states have what’s called a [prescription drug monitoring program]. That’s a system for reporting the number of medications a person has been prescribed. That system is actually relatively new, but it gives a way of making sure that a single individual is not shopping prescriptions from one pharmacist to another. That’s a good innovation.

If the broader industry were an automobile, just a car moving down the highway, think about all the safety innovations that have been put into cars that have made them safer like the seat belt, but also air bags. All of those innovations are technologies in the same way tad is a technology that improves the safety and the intended use of medications. It is safety belt. It is an air bag. It is a technology that businesses can deploy.

03/06/2018

Clearside Biomedical Announces Positive Topline Results

Tue, 02 Jul 2019 17:59:32 GMT

Clearside Biomedical Announces Positive Topline Results from Pivotal Phase 3 Clinical Trial of CLS-T

Primary Endpoint Achieved – Statistically Significant Improvement in Proportion of Patients Gaining 15 or More Letters in Visual Acuity

All Key Secondary Endpoints Achieved

Clearside to Host Conference Call Today at 8:30 AM Eastern Time

ALPHARETTA, Ga., March 05, 2018 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a late-stage biopharmaceutical company developing first-in-class drug therapies to treat back-of-the-eye diseases, today announced positive topline results from its pivotal Phase 3 clinical trial of suprachoroidal CLS-TA in patients with macular edema associated with non-infectious uveitis.

Suprachoroidal CLS-TA is Clearside’s proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the back of the eye via the suprachoroidal space, or SCS™, which is the space located between the choroid and the outer protective layer of the eye known as the sclera.

Clearside enrolled 160 patients in this randomized, controlled, masked Phase 3 pivotal clinical (“PEACHTREE”) trial. Of the 160 patients enrolled, 96 patients were randomized to the treatment arm to receive two 4.0 mg doses of suprachoroidal CLS-TA 12 weeks apart, and 64 patients were randomized to undergo sham procedures at the same 12-week interval. Patients were evaluated every four weeks for a total of 24 weeks, and a total of 155 patients, or 97% of those enrolled, completed the full evaluation period of the trial.

In the PEACHTREE trial, 47% of patients who received suprachoroidal CLS-TA every 12 weeks gained at least 15 letters in best corrected visual acuity (“BCVA”), as measured using the Early Treatment of Diabetic Retinopathy Study (“ETDRS”) scale, from baseline at week 24, compared to 16% of patients who underwent a sham procedure. This improvement, which was the primary endpoint of the trial, was statistically significant (p < 0.001). Further, in terms of improvements in BCVA, the mean change from baseline was better in the treatment arm than the sham arm at each monthly evaluation. The mean improvement from baseline was maintained throughout the evaluation period, with 9.6 letters gained at week 4 and 13.7 letters at week 24 in the active arm, compared to 1.2 letters at week 4 and 2.9 letters at week 24 in the control arm, respectively.

The following tables summarize the topline BCVA improvement data observed in the PEACHTREE trial:

Subjects Gaining ≥ 15 ETDRS Letters at Week 24 from Baseline

	CLS-TA (N=96)	Control (Sham) (N=64)
Proportion (n) of Subjects Gaining ≥ 15 ETDRS Letters at Week 24 from Baseline	46.9% (45) <0.001	15.6% (10)
p-value

Mean Change from Baseline

Change from Baseline in Each Arm	CLS-TA Arm [ETDRS Letters]	Control Arm (Sham) [ETDRS Letters]
Week 4	9.6	1.2
Week 24	13.7	2.9

For the other key secondary endpoint, administration of suprachoroidal CLS-TA resulted in a mean reduction from baseline of 157 microns in central subfield thickness at week 24 in the active arm compared to a 19 micron mean reduction in the sham arm, a result that was also statistically significant (p < 0.001).

Suprachoroidal CLS-TA was generally well tolerated, with no treatment-related serious adverse events reported in the trial. Through 24 weeks, corticosteroid-related elevated intraocular pressure adverse events were reported for approximately 11.5% of patients in the CLS-TA treatment group, compared to no patients in the sham group.

Detailed results from PEACHTREE will be presented at an upcoming medical conference.

“These positive topline data from PEACHTREE are very encouraging for this population with macular edema as a complication due to their uveitis,” said Rahul N. Khurana , MD, an investigator for PEACHTREE, Partner at Northern California Retina Vitreous Associates, and Clinical Associate Professor in Ophthalmology at UCSF Medical Center. “The PEACHTREE study was the first pivotal phase 3 clinical trial of a drug candidate for patients with uveitic macular edema in which a BCVA measure was the primary efficacy endpoint, potentially raising the bar for future trials in this population. Typically, uveitic macular edema may persist despite adequate control of uveitis itself, and it is challenging to treat and may persist despite multiple interventions. Also, while corticosteroids are the most common treatment for all complications of uveitis, including the associated macular edema, systematic controlled studies of this kind are rare. I believe that based on these positive results, and if marketing authorization is obtained from the FDA, suprachoroidal CLS-TA has the potential to become a new paradigm for the treatment of visual impairment associated with macular edema associated with non-infectious uveitis.”

“Having nearly 50% of the PEACHTREE trial patients treated with suprachoroidal CLS-TA gain 15 or more letters in vision is highly compelling. It represents a huge step forward in advancing suprachoroidal administration of CLS-TA towards becoming a powerful new approach in potentially treating blinding eye diseases,” said Daniel H. White , Clearside’s Chief Executive Officer and President. “We currently expect to submit a new drug application for suprachoroidal CLS-TA in patients with macular edema associated with uveitis to the FDA in the fourth quarter of 2018, and we are also evaluating a number of options for submissions to regulatory agencies in additional territories outside of the United States.”

Suprachoroidal CLS-TA, used either alone or together with an intravitreal anti-VEGF agent, is being studied as part of Clearside’s pipeline of treatments for unmet or underserved blinding eye diseases where the pathologies manifest in the retina and the choroid.

Conference Call & Webcast Details

Clearside is pleased to invite all interested parties to participate in a conference call today at 8:30 a.m. Eastern Time, during which the PEACHTREE topline results will be discussed. To participate in this conference call, please dial (844) 263-8310 (U.S.) or (213) 358-0959 (international), conference ID 5799948, approximately 10 minutes prior to the start time. A live, listen-only audio webcast of the conference call can be accessed by visiting the “Investor Relations” section at www.clearsidebio.com. An archive of the webcast will be available until June 5, 2018.

About PEACHTREE

PEACHTREE, a randomized, masked, sham-controlled Phase 3 trial, enrolled 160 patients with macular edema associated with non-infectious uveitis. Patients were randomized to receive two unilateral suprachoroidal CLS-TA injections or two unilateral suprachoroidal sham procedures approximately 12 weeks apart. The primary efficacy outcome measure in the trial was the proportion of patients with a change from baseline of at least 15 letters in BCVA using the ETDRS scale at 24 weeks. Safety was assessed by analyzing the occurrence of adverse events and changes in key safety parameters over the course of the trial. Additional efficacy and safety endpoints were also evaluated.

About Uveitis

Uveitis, a set of inflammatory conditions affecting the eye, is one the world’s leading causes of blindness. Uveitis occurs in about 350,000 patients in the United States and is typically found in both eyes. Macular edema is the build-up of fluid in the macula, an area in the center of the retina responsible for sharp, straight-ahead vision. Fluid buildup causes the macula to swell and thicken, which distorts vision. Macular edema occurs in approximately one-third of all non-infectious uveitis cases and is a major contributor to vision loss in these patients.

About Clearside

Clearside Biomedical, Inc., headquartered in Alpharetta, GA, is a late-stage clinical ophthalmic biopharmaceutical company that envisions a world without blindness. Clearside relentlessly pursues transformative, elegant, precise solutions to restore and preserve vision. Clearside is developing advanced clinical and preclinical product candidates using a proprietary treatment approach offering unprecedented access to the back of the eye through the SCS. This offers potentially meaningful treatment benefit to patients suffering from sight threatening diseases like uveitis, retinal vein occlusion, diabetic macular edema and wet age-related macular degeneration, where macular edema is a common complication.

Cautionary Note Regarding Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe”, “expect”, “may”, “plan”, “potential”, “will”, and similar expressions, and are based on Clearside’s current beliefs and expectations. These forward-looking statements include expectations regarding the clinical development of Clearside’s product candidates, the potential attributes and benefits of Clearside’s product candidates and the timing of Clearside’s submission of a new drug application to the U.S. Food and Drug Administration for suprachoroidal CLS-TA for the treatment of macular edema associated with non-infectious uveitis. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside’s reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in Clearside’s Annual Report on Form 10-K for the year ended December 31, 2016, filed with the U.S. Securities and Exchange Commission (“SEC”) on March 16, 2017, and Clearside’s other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Clearside as of the date of this release, and Clearside assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts:

Stephen Kilmer
Investor Relations
(678) 270-3631
stephen.kilmer@clearsidebio.com

Charles Deignan
Chief Financial Officer
(678) 270-4005
charlie.deignan@clearsidebio.com

Source: Clearside Biomedical, Inc.

03/05/2018

The Biobased Economy Is Reaching a Tipping Point

Tue, 02 Jul 2019 18:00:36 GMT

By Brent Erickson, executive vice-president; Head, Industrial & Environmental Section, Biotechnology Innovation Organization

Special to The Digest

This week, I’ll be addressing the Advanced Biofuels Leadership Conference. I’d like to thank Jim Lane for giving me that opportunity again this year. I appreciate it, because BIO is the only trade association that advocates for the diverse policies that support the entire biobased economy – the full value chain of technologies and infrastructure to convert renewable, low-carbon, low-cost feedstocks and waste streams into value-added consumer products, including renewable chemicals and biofuels.

The unifying factor among BIO’s members is their use of biotechnology in their drive to commercialize new, advanced and more sustainable technologies. That mission brings together researchers, producers and companies from across the entire biobased economy. And the value chain is constantly growing and changing, driven by the rapid pace of innovation in industrial biotechnology. It seems there are always new, innovative companies emerging to develop first-of-a-kind products, technologies and new feedstocks.

At the same time, after some fits and starts, the biobased economy is approaching a tipping point in its growth and maturation. Already, a number of companies have successfully commercialized technologies for renewable chemicals, built biorefineries and created supply chains – and turned their attention to commercializing their next product. The economic impact is evident. Bioeconomy Capital estimates that renewable chemicals now generate the equivalent of around one half of 1 percent (0.5%) of U.S. GDP, while petrochemicals generate around 3 percent. Put a different way, for every $7 contributed to the U.S. economy by the chemical industry, $1 is coming from renewable chemicals.

Several studies and market analyses have aimed to calculate the economic value of the entire biobased economy. However, no single study captures all of the economic impacts across the full value chain.

Bioeconomy Capital also estimates that the U.S. industrial biotechnology sector – which they define to include renewable chemicals, nutritional ingredients and biotech R&D industries, among others – generated more than $140 billion in business-to-business revenue in 2016. The sector experienced tremendous growth since 2012, when total revenue was $105 billion, according to their report.

A USDA study shows that direct revenue from renewable chemicals and biobased products (those eligible for the BioPreferred® program) grew to $127 billion, providing direct employment to 1.53 million U.S. workers. With a strong multiplier for job creation, the biobased product sector’s indirect economic impact reached $393 billion in 2014. The two studies cover some of the same industries, but not the entire biobased economy.

Looking at several studies that measure various elements of the value chain, BIO calculates that the global economic value of the biobased economy – including industrial biotechnology, renewable chemicals and polymers, biofuels, enzymes and biobased materials – is $355.28 billion. The United States generates 58 percent of the global value of biased manufacturing, or more than $205 billion. And that economic activity supports employment for 1.66 million U.S. workers.

As industry leaders, we need to help policy makers understand that the entire value chain creates economic opportunities – policy should include support at every stage to ensure that the biobased economy reaches critical mass. For instance, the U.S. tax code should recognize renewable chemicals to keep the United States competitive in commercializing this homegrown technology. A top priority for BIO is the Qualified Renewable Chemicals Tax Credit. We have been building congressional support for this critical legislation, which will provide renewable chemicals similar tax credits enjoyed by other alternative energies. Congress must recognize other countries are providing incentives for companies to build commercial production capacity – those countries will capture the jobs and the economic growth from the biobased economy, unless the United States levels the playing field.

BIO is leading the way to secure reauthorization of the Farm Bill energy title programs that will develop and incentivize investment in the biobased economy. Congress should consider changing the name of that title, because it is now broader than just energy. The Farm Bill energy title programs have supported the emergence of the biobased economy here in the United States and compiled a record of success that deserves to be continued. Reauthorization of these programs will provide crucial access to capital and marketspace for companies developing renewable chemicals; those are key ingredients for building manufacturing infrastructure.

Industrial biotechnology will continue to drive growth in the biobased economy. It’s difficult to predict where innovation will take us. But the economic impact is becoming evident; the biobased economy is a measurable percentage of overall U.S. productivity. BIO is working to ensure U.S. federal and state policy keeps up with this growth.

Source: Biofuels Digest

02/28/2018

Georgia Bio Elects First Female Chair

Tue, 02 Jul 2019 18:01:46 GMT

ATLANTA, GA (February 23, 2018) – This month, UCB’s Vice President for U.S. Corporate Affairs, Patricia A. Fritz, was elected chair of Georgia Bio’s Board of Directors for the 2018-2019 term. Dr. Lee Herron, Vice President for Venture Development at the Georgia Research Alliance will serve as Vice Chair. Ms. Fritz succeeds Dr. Jay Yadav, Founder and CEO of MiRus, who will remain on the Georgia Bio Board and Executive Committee as Immediate Past Chair.

“We are thrilled to welcome Patty as our board chair. As a long-time board member she demonstrates the commitment that our state’s top leaders have in supporting the growth and innovation in Georgia’s life science ecosystem,” said Russell Allen, Georgia Bio president and CEO. Allen continued, “As Georgia’s life sciences sector becomes more recognized for its global leadership, it is important that we show that the community also values gender diversity, fosters leadership opportunities for women and promotes women to its highest offices. Electing Patty is one way we as an organization are achieving that.”

Ms. Fritz and Dr. Herron assume leadership of Georgia Bio during the most exciting time in the organization’s 30-year history. Membership is rapidly growing, the organization is embarking on a new industry study, and it is increasing its efforts to improve the workforce for the sector. Allen added, “We are witnessing a maturity of our industry that is transforming Georgia into a leading life sciences state. It is appropriate that our new chair has played a strong role in this growth via UCB, an innovative global pharmaceutical company that has become such a strong community partner in Atlanta.”

”It is a privilege to serve as the first female chair of Georgia Bio and continue encouraging diversity and inclusion in the life sciences industry,” said Fritz. “Georgia has a rich community of life science leaders and together with Georgia Bio we can push the boundaries of the known and deliver new solutions for people in need. Together we can grow the recognition of innovation taking place here in Georgia and continue working to solve our healthcare challenges.”

Patty Fritz is vice president, U.S. Corporate Affairs for UCB, Inc, overseeing policy, government affairs, advocacy, patient engagement, communications, and UCBCares®. Patty leads efforts to create value for patients and their families through strategic engagement and positively influencing the healthcare environment and policy landscape. With more than 20 years of experience in the industry, Patty is focused on finding opportunities to better understand the unique needs of patients and delivering value. She is a champion of innovative projects to spotlight the importance of access and care for people living with severe diseases. Recent efforts Patty has led include collaborations with the VA Epilepsy Centers of Excellence, PatientsLikeMe®, Emory University, Georgia Tech, and IBM. Outside of UCB, Patty also serves as a member of the Board of Councilors for The Carter Center.

Patty’s inspirational leadership has made her an effective and admired leader, not just among her colleagues at UCB but within the industry as a whole, and most importantly with the communities of patients she serves.

For a complete list of the 2018 Board members visit www.gabio.org.

About Georgia Bio

Georgia Bio (www.gabio.org) is the state’s life science industry association whose members include pharmaceutical, biotechnology and medical device companies, medical centers, universities and research institutes, government groups and other business organizations involved in the development of life sciences related products and services. Georgia Bio's mission is to advance the growth of Georgia’s life sciences industry and foster strategic partnerships that can create a healthier world.

02/23/2018

American Cancer Society, Global Center for Medical Innovation to raise $5 million for research

Tue, 02 Jul 2019 18:02:38 GMT

The Atlanta-based American Cancer Society and Global Center (GCMI)for Medical Innovation partnered to raise $5 million to bring research from the lab to the clinic more quickly.

GCMI will unite members of the medical device community like universities, research centers, hospitals, clinicians and investors to speed up technologies that result from ACS-funded research.

The goal is to reduce the time and cost of bringing new ideas to market.

The partners will pick three to five projects to focus on each year.

“This partnership provides further testimony to the health of the med-tech development ecosystem in Atlanta,” said GCMI CEO Tiffany Wilson in a statement. “Our collective resources should enable us to de-risk innovation bringing new products to market capable of improving cancer treatment. Ultimately this should translate into reduced ‘time-to-cures’ and lower cost of development and care.”

Source: Atlanta Business Chronicle

02/21/2018

BIO Unveils Refreshed Advocate Toolkit

Tue, 02 Jul 2019 18:04:00 GMT

This past March, BIO launched DrugCostFacts.org, an interactive web tool designed to help policymakers, members of the media and the broader public access the best facts surrounding drug costs, spending and value. By featuring a series of commonly asked questions, as well as research and reading materials, BIO created a one-stop shop for answers to some of the most hotly debated questions regarding the important roles of biopharmaceutical innovation and prescription medicines in our nation’s health care system.

As part of our broader effort to tell the biotech story, today BIO is pleased to unveil a redesigned and much-improved Toolkit for Advocates. For more than a year, the toolkit has housed a growing library of infographics and opinion pieces that are helping to shape the debate about the drug cost ecosystem, including U.S. leadership in biotech innovation, the latest on drug spending and prices and key concerns with some of the leading proposals for addressing prescription drug costs.

One of the key features of the toolkit is enhanced shareability on Twitter, Facebook, and LinkedIn all with a simple click. Context is automatically provided for all shared items, but you can feel free to add a personalized message or additional insights.
Larger infographics are now broken up into components that can be shared on their own or easily downloaded and incorporated into your reports or presentations on the drug delivery system.
Our new series of Issue Briefs showcase the important and complex issues in an easily digestible, shareable format. Learn about the 340B Drug Discount Program, how America’s biopharmaceutical industry can help solve the opioid crisis or the basics of Medicare Part D – just to name a few.

We’ve made it easier for you to access information and share content. So check it out and turn to the toolkit now and in the future as the debate around the cost and value of prescription medicines unfolds.

VIEW THE TOOLKIT

CLICK HERE

02/20/2018

FDA Approves Osmotica Pharmaceutical’s Once-Daily OSMOLEX ERTM (amantadine) extended-release tablets

Tue, 02 Jul 2019 18:05:23 GMT

Bridgewater, NJ – February 19, 2018 – Osmotica Pharmaceutical US LLC (“Osmotica” or the “Company”), a privately-held specialty pharmaceutical company developing novel central nervous system (CNS) treatments utilizing its proprietary osmotic drug delivery platform, announced today that the U.S. Food and Drug Administration (FDA) has approved OSMOLEX ERTM, an amantadine extended release tablet, for the treatment of Parkinson's disease and for the treatment of drug-induced extrapyramidal reactions in adult patients. Extrapyramidal symptoms are known side effects of many common medications.

“The FDA’s approval of OSMOLEX ER provides a new treatment option for those patients suffering from Parkinson’s disease and adults who have extrapyramidal reactions, or movement disorders, that are caused by certain medicines. We are eager to make OSMOLEX ER available to physicians and patients in the U.S.,” stated Brian Markison, Chief Executive Officer of Osmotica.

“We are currently finalizing our plans to commercialize the product and ensure patients and providers have access as soon as possible. We believe that the approved indications and compelling value proposition will be important factors in physician adoption and marketing of OSMOLEX ER,” added Markison.

OSMOLEX ER tablets, a proprietary drug formulation containing a combination of immediate release and extended release amantadine utilizing Osmotica’s patented Osmodex® technology, represents a new once-a-day approach to the treatment of Parkinson’s disease and drug-induced involuntary movements in adults. The OSMOLEX ER tablet is taken once-daily in the morning, releasing amantadine throughout the day. Physicians have three dosage options with 129 mg, 193 mg and 258 mg tablets, with a maximum daily dose of 322 mg, providing them with dosing flexibility for each patient.

OSMOLEX ER is protected by three formulation patents with protection extending through March 2030, with additional patent applications pending.

About OSMOLEX ER

adults. The OSMOLEX ER tablet is taken once-daily in the morning, releasing amantadine throughout the day. Tablet strength options include 129 mg, 193 mg, and 258 mg with a maximum daily dose of 322 mg.

For more information about OSMOLEX ER, including the full Prescribing Information, please visit www.OSMOLEX.com or call 1-877-482-3788.

Indications

OSMOLEX ER is indicated for the treatment of Parkinson's disease and for the treatment of drug-induced extrapyramidal reactions in adult patients.

Important Safety Information

INDICATIONS AND USAGE

OSMOLEX ER is indicated for the treatment of Parkinson's disease and for the treatment of drug induced extrapyramidal reactions in adult patients.

CONTRAINDICATIONS
OSMOLEX ER (amantadine) extended-release tablets, is contraindicated in patients with creatinine clearance below 15 mL/min/1.73 m2.

WARNINGS AND PRECAUTIONS
Falling Asleep During Activities of Daily Living and Somnolence: Patients treated with amantadine have reported falling asleep while engaged in activities of daily living, including the operation of motor vehicles, which sometimes has resulted in accidents. Patients may not perceive warning signs, such as excessive drowsiness, or they may report feeling alert immediately prior to the event. If a patient develops daytime sleepiness or episodes of falling asleep during activities that require full attention (e.g., driving a motor vehicle, conversations, eating), OSMOLEX ER should ordinarily be discontinued. If a decision is made to continue OSMOLEX ER, advise patients not to drive and to avoid other potentially dangerous activities that might result in harm if they become somnolent.

Suicidality and Depression: Suicide, suicide attempts, and suicidal ideation have been reported in patients with and without prior history of psychiatric illness while treated with amantadine. Monitor patients for depression, including suicidal ideation or behavior. Prescribers should consider whether the benefits outweigh the risks of treatment with OSMOLEX ER in patients with a history of suicidality or depression.

Hallucinations/Psychotic Behavior: Patients with a major psychotic disorder should ordinarily not be treated with OSMOLEX ER because of the risk of exacerbating psychosis. Monitor patients for hallucinations throughout treatment but especially after initiation and after the dose of OSMOLEX ER is increased or decreased.

Dizziness and Orthostatic Hypotension: Patients should be monitored for these adverse reactions, especially after starting OSMOLEX ER or increasing the dose.

Withdrawal-Emergent Hyperpyrexia and Confusion: Abrupt discontinuation of OSMOLEX ER may cause an increase in the symptoms of Parkinson’s disease or cause delirium, agitation, delusions, hallucinations, paranoid reaction, stupor, anxiety, depression, or slurred speech. It is recommended to avoid sudden discontinuation of OSMOLEX ER.

Impulse Control/Compulsive Behaviors: Patients can experience intense urges to gamble, increased sexual urges, intense urges to spend money, binge eating, and/or other intense urges, and the inability to control these urges while taking one or more of the medications that increase central dopaminergic tone, including OSMOLEX ER. It is important for prescribers to specifically ask patients or their caregivers about the development of new or increased urges while being treated with OSMOLEX ER. Consider dose reduction or stopping the medication if a patient develops such urges while taking OSMOLEX ER.

ADVERSE REACTIONS
The most common adverse reactions reported in ≥5% of patients at the recommended dosage of immediate-release amantadine were nausea, dizziness/lightheadedness, and insomnia.

DRUG INTERACTIONS
Other Anticholinergic Drugs: The dose of anticholinergic drugs or of OSMOLEX ER should be reduced if atropine-like effects appear when these drugs are used concurrently

Drugs Affecting Urinary pH: The pH of the urine has been reported to influence the excretion rate of amantadine. Alterations of urine pH towards the alkaline condition may lead to an accumulation of the drug with a possible increase in adverse reactions. Monitor for efficacy or adverse reactions under conditions that alter the urine pH to more acidic or alkaline, respectively.

Live Attenuated Influenza Vaccines: Amantadine may interfere with the efficacy of live attenuated influenza vaccines. Therefore, live vaccines are not recommended during treatment with OSMOLEX ER. Inactivated influenza vaccines may be used, as appropriate.

Alcohol: Concomitant use with alcohol is not recommended, as it may increase the potential for central nervous system effects such as somnolence, dizziness, confusion, lightheadedness, and orthostatic hypotension.

About Osmotica Pharmaceutical

Osmotica Pharmaceutical US LLC is a privately-held fully-integrated specialty pharmaceutical company utilizing its proprietary osmotic technology platform, Osmodex®, to develop high-quality branded and generic pharmaceutical products. The Osmotica portfolio includes multiple products currently on the market, and a pipeline of therapeutic drug candidates in various stages of development, addressing central nervous system and neurological movement disorders.

Osmotica has a track record of developing products with successful commercialization strategies around the world and through its U.S. affiliates Vertical Pharmaceuticals, LLC and Trigen Laboratories, LLC. Osmotica Pharmaceutical has principal operations located in the United States, Argentina, and Hungary. For more information, please visit the Company’s website at www.osmotica.com.

Investor and Media Relations for Osmotica Pharmaceutical:

Lisa M. Wilson
In-Site Communications, Inc. T: 212-452-2793
E: lwilson@insitecony.com

02/20/2018

Opinion Piece: Our Response to the Opioid Epidemic Needs a Dose of Innovation

Tue, 02 Jul 2019 18:06:34 GMT

The opioid epidemic is the worst public health crisis in a generation. Millions of individuals, families and communities have been impacted. We need new ideas to help strengthen the calls for action by policymakers and health experts to address this growing national emergency.

Fortunately, if we are willing to learn from past experiences, we can first blunt and then end this crisis. In the 1980s, the United States faced the devastating health crisis of HIV/AIDS. But by marshaling resources and ingenuity, the nation contained and rolled back the worst effects of this crisis.

Those who lived during that period will remember the pain and fear felt by so many as reports of this deadly virus surfaced in one community after another.

America’s biopharmaceutical community went to work. Joined by patient advocates, as well as researchers in university laboratories supported by partners at the state and federal levels, we embarked on a determined search for a cure.

KEEP READING

Dr. Jeremy Levin is chairman and CEO of Ovid Therapeutics, and chairs a working group formed by the Biotechnology Innovation Organization that has studied and developed policy solutions to address the opioid epidemic.

SOURCE: https://morningconsult.com/opinions/our-response-to-the-opioid-epidemic-needs-a-dose-of-innovation/

02/14/2018

GeoVax and CaroGen to Collaborate On Development of Therapeutic Hepatitis B Vaccine

Tue, 02 Jul 2019 18:07:42 GMT

Targeting Chronic Hepatitis B Infections Affecting More Than 240 Million People Worldwide

GeoVax Labs, Inc. (OTCQB: GOVX), a biotechnology company developing human vaccines, announced today that it is collaborating with CaroGen Corporation on the development of a combination immunotherapy treatment for chronic hepatitis B virus (HBV) infection.

The project will include testing GeoVax’s MVA-VLP-HBV (Modified Vaccinia Ankara-Virus Like Particle-Hepatitis B Virus) vaccine candidate in combination with CaroGen’s HBV virus-like vesicles (VLVs) vaccine candidate in prophylactic and therapeutic animal models of HBV. Therapeutic experiments may be carried out in combination with anti-viral drugs, TLR agonists, or immune checkpoint inhibitors which are currently in use (or anticipated to be used in future) as part of the standard of care for treatment of this particularly difficult to treat disease. GeoVax’s vaccine candidate is based upon its novel MVA-VLP vector platform, which has been proven safe in multiple human clinical trials of the company’s HIV vaccine. CaroGen’s vaccine candidate employs a transformative VLV platform technology developed at Yale University School of Medicine and exclusively licensed by CaroGen for the development and commercialization of immunotherapies worldwide.

Farshad Guirakhoo, Ph.D., GeoVax’s Chief Scientific Officer, stated, “There is a clear medical need to treat chronic HBV infections, which affect hundreds of millions of people around the world, many of whom die due to complications of HBV including cirrhosis and cancer. Multiple preventive vaccines exist to protect against acquiring HBV infection, but they cannot help patients already diagnosed with the disease. Although HBV infection can be treated with drugs, the treatments cure just 5% of patients and only suppress the replication of the virus in others. Therefore, most people who start treatments must continue with them for life. Moreover, diagnosis and treatment options are very limited in resource/low income-constrained populations, which leads to many patients succumbing to the disease within months of diagnosis.”

Dr. Guirakhoo continued, “We are pleased to begin this collaboration with CaroGen, as it complements our existing collaboration with Georgia State University, increasing our chances of success. Our strategy is to use both vaccines as part of a combination strategy with current or future HBV treatments to induce functional antibodies as well as CD4+, CD8+ T cell responses to break tolerance to HBV antigens and clear the infection. Our ultimate goal is to significantly increase the current cure rate of chronic HBV infection while reducing the duration of drug therapy, overall treatment costs, side effects, and potential drug resistance.”

Valerian Nakaar, Ph.D., Vice President, Research & Development at CaroGen commented, “There is a compelling mechanistic rationale for combining both platform technologies for the treatment of HBV. We are excited to initiate this collaboration because the success accruing from these studies will portend well for other hard-to-treat chronic infections.”

About Hepatitis B

Hepatitis B is a contagious liver disease caused by HBV. It is transmitted person-to-person by blood, semen, or other bodily fluids. This can happen through sexual contact, needle sharing, or mother to infant transmission during birth. For some people, HBV infection is an acute (short-term) illness, but for others it becomes a chronic (long-term) infection that can lead to serious health issues like cirrhosis or liver cancer.

The risk of chronic HBV infection is related to age at infection. Approximately 90% of infected infants will develop chronic infections. As a child gets older, the risk decreases. Approximately 25–50% of children infected between the ages of 1 and 5 years will develop a chronic infection. The risk drops to 6–10% when a person is infected at over 5 years of age. Worldwide, most people with chronic HBV are infected at birth, during early childhood or later in life when vaccine-acquired immunity wanes.

The CDC estimates that between 700,000 to 1.4 million people in the United States suffer from chronic HBV infections, with an estimated 20,000 new infections every year. Many people are unaware that they are infected or may not show any symptoms. Therefore, they never seek the attention of medical or public health officials. Globally, chronic HBV affects more than 240 million people and contributes to nearly 686,000 deaths worldwide each year. Currently, there is no FDA approved therapeutic vaccine available and despite more than $4 billion spent annually on anti-viral drugs, less than 5% of chronic HBV infections are cured.

About GeoVax

GeoVax Labs, Inc., is a clinical-stage biotechnology company developing human vaccines against infectious diseases using its MVA-VLP vaccine platforms. The Company’s HIV-1 vaccine for the clade B, the dominant subtype in the Americas, Western Europe and Australia, is advancing in human trials conducted by the HIV Vaccine Trials Network (HVTN). Preclinical programs are focused on preventive vaccines for the clade C HIV (the subtype that is highly prevalent in countries of Southern Africa, as well as in the horn of Africa and India representing nearly 50% of all people living with HIV), Zika virus, hemorrhagic fever viruses (EBOV, SUDV, MARV, and LASV), and malaria, as well as therapeutic vaccines for HIV (aiming for a functional cure), HBV and cancers. GeoVax’s vaccine platform supports in vivo production of non-infectious VLPs from the cells of the very person receiving the vaccine, mimicking a natural infection and stimulating both the humoral and cellular arms of the immune system to recognize, prevent, and control the target infection. For more information, visit www.geovax.com.

About CaroGen

CaroGen Corporation is a private biopharmaceutical company focused on developing immunotherapies for chronic viral infections and cancers. CaroGen’s proprietary virus-like vesicle (VLV) platform technology developed at Yale University has been licensed by the company exclusively for the development and commercialization of immunotherapies worldwide for both human and animal use. CaroGen has developed a broad technology platform that is safer and with the potential to deliver multiple targets including antigens, cytokines and shRNAs. For further information, visit www.carogencorp.com.

Forward-Looking Statements

Certain statements in this document are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act. These statements are based on management's current expectations and are subject to uncertainty and changes in circumstances. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax can develop and manufacture its vaccines with the desired characteristics in a timely manner, GeoVax's vaccines will be safe for human use, GeoVax's vaccines will effectively prevent targeted infections in humans, GeoVax’s vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete vaccine development, there is development of competitive products that may be more effective or easier to use than GeoVax's products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements, and does not intend to do so. More information about these factors is contained in GeoVax's filings with the Securities and Exchange Commission including those set forth at "Risk Factors" in GeoVax's Form 10-K.

02/07/2018

Researchers Develop Universal Vaccine To Protect Against Influenza A Viruses

Tue, 02 Jul 2019 18:08:45 GMT

ATLANTA—Researchers have developed a universal vaccine to combat influenza A viruses that produces long-lasting immunity in mice and protects them against the limitations of seasonal flu vaccines, according to a study led by Georgia State University.

Influenza, a contagious respiratory illness that infects the nose, throat and lungs, is among the leading causes of death in the United States, according to the Centers for Disease Control and Prevention (CDC). The CDC estimates influenza has resulted in between 12,000 and 56,000 deaths annually in the U.S. since 2010.

Seasonal flu vaccines must be updated each year to match the influenza viruses that are predicted to be most common during the upcoming flu season, but protection doesn’t always meet expectations or new viruses emerge and manufacturers incorrectly guess which viruses will end up spreading. In 2009, the H1N1 pandemic caused 200,000 deaths during the first 12 months, and low vaccine effectiveness was also observed during the 2014-15 and 2016-17 flu seasons. A universal flu vaccine that offers broad protection against various viruses is urgently needed and would eliminate the limitations of seasonal flu vaccines.

Seasonal flu vaccines provide protective immunity against influenza viruses by targeting the exterior head of the virus’s surface protein, which is hemagglutinin (HA). The influenza virus trains the body to produce antibodies against inactivated virus particles containing the head of this protein, ideally preventing the head from attaching to receptors and stopping infection. However, the head is highly variable and is different for each virus, creating a need for better vaccines. This study uses a new approach and instead targets the inside portion of the HA protein known as the stalk, which is more conservative and offers the opportunity for universal protection.

In this study, the researchers found vaccinating mice with double-layered protein nanoparticles that target the stalk of this protein produces long-lasting immunity and fully protects them against various influenza A viruses. The findings are published in the journal Nature Communications.

“Vaccination is the most effective way to prevent deaths from influenza virus, but the virus changes very fast and you have to receive a new vaccination each year,” said Dr. Bao-Zhong Wang, associate professor in the Institute for Biomedical Sciences at Georgia State. “We’re trying to develop a new vaccine approach that eliminates the need for vaccination every year. We’re developing a universal influenza vaccine. You wouldn’t need to change the vaccine type every year because it’s universal and can protect against any influenza virus.

“What we wanted to do is to induce responses to this stalk part of the influenza surface glycoprotein, not the head part. This way you’re protected against different viruses because all influenza viruses share this stalk domain. However, this stalk domain itself isn’t stable, so we used a very special way to make this vaccine construct with the stalk domain and had success. We assembled this stalk domain into a protein nanoparticle as a vaccine. Once inside, the nanoparticle can protect this antigenic protein so it won’t be degraded. Our immune cells have a good ability to take in this nanoparticle, so this nanoparticle is much, much better than a soluble protein to induce immune responses.”

The nanoparticles are unique because they were generated to contain almost entirely the protein capable of inducing immune responses. The double layer also better retains the protein function.

To determine the effectiveness of the nanoparticle vaccine, the researchers immunized mice twice with an intramuscular shot. Then, the mice were exposed to several influenza viruses: H1N1, H3N2, H5N1 and H7N9. Immunization provided universal, complete protection against lethal virus exposure and dramatically reduced the amount of virus in the lungs.

Next, the researchers would like to test the nanoparticle vaccine in ferrets, which are similar to humans in the orchestration of their respiratory system.

“This vaccine is composed of very conserved domains. That’s the reason why the induced immunity can offer universal protection,” said Dr. Lei Deng, first author of the study and a postdoctoral researcher in the Institute for Biomedical Sciences at Georgia State. “The seasonal influenza vaccines induce the dominant immune response against the head domain of the HA molecules, which is hypervariant. That is why we have to adopt new influenza strains for the new vaccine every year. Our vaccine overcomes this problem. For long-term protection, longevity of induced immunity in human still needs to be tested in further clinical tests.”

Co-authors of the study include Drs. Teena Mohan, Gilbert X. Gonzalez, Ye Wang, Young-Man Kwon and Sang-Moo Kang of Georgia State; Dr. Timothy Z. Chang and Julie A. Champion of the Georgia Institute of Technology; and Dr. Richard W. Compans of Emory University School of Medicine.

The study is funded by the National Institutes of Health under grant number R01AI101047 to Wang.

01/26/2018

Avi Pelossof Appointed President and CEO of Immucor

Tue, 02 Jul 2019 18:09:55 GMT

Norcross, Georgia – January 16, 2018 – Immucor, Inc., a global leader in transfusion and transplantation diagnostics and a portfolio company of global alternative asset firm TPG, today announced the appointment of Avi Pelossof as President and Chief Executive Officer, effective immediately. Pelossof succeeds CEO Jeffrey R. Binder (“Jeff”), who retains his role as Chairman of the Immucor Board of Directors.

“Immucor has a capable, dynamic team that strives every day to meet the needs of our customers and their patients. It is exciting to welcome Avi as our new CEO, a seasoned healthcare executive with a proven track record,” said Binder. “I look forward to working with him in my role as Chairman of the Board to capitalize on the many opportunities ahead of us.”

Pelossof joins Immucor from Alere Inc., where he was most recently Global President for the Infectious Disease business, a $750 million unit focused on point-of-care infectious disease diagnostic tests.

“Immucor is an established diagnostics leader with a strong track record of innovative products that meet the needs of transfusion and transplant customers worldwide,” said Pelossof. “I am honored to join the company at this time of great potential and look forward working with the talented team at Immucor to deliver results.”

“Over the last number of years, Immucor has pursued significant growth, bringing new products to market and implementing a number of initiatives to further its global presence,” said Todd Sisitsky, Managing Partner of TPG Capital. “As we continue on this path, we are pleased to welcome Avi to the team. With more than 20 years of experience in the diagnostic space, he is the right leader to take Immucor forward.”

Sisitsky added, “As Chairman, Jeff will continue to lend his experience and expertise to Avi and the Immucor management team.

Pelossof held a variety of positions while at Alere, including Vice President, Infectious Disease Strategic Business Unit and Vice President, Blood Borne Pathogens. Prior to Alere, Pelossof served as Senior Vice President, Sales, Marketing and Business Development for Chembio Diagnostics Systems, Inc., a developer, manufacturer and distributor of point-of-care diagnostic tests. He also held various positions focused on Latin America at Citibank, N.A./Citigroup and founded the consulting firm The IMS Group, Inc., focused on strategic market development for companies seeking to expand into Latin America. Pelossof has a BA in Economics from the University of Michigan and an MBA in Finance and International Business from New York University.

01/26/2018

Georgia Research Alliance CEO Mike Cassidy to retire

Tue, 02 Jul 2019 18:11:05 GMT

Mike Cassidy, president and CEO of the Georgia Research Alliance since 2000, will be stepping down by the end of the year.

The Georgia Research Alliance with its high-powered public-private board has led the state’s technology and innovation efforts since its founding in 1990. Cassidy joined the organization in 1993 as its fourth staff member.

“I will have been there 25 years this May. I will be 65 in November. And we will have a new governor next January,” Cassidy said in an interview. “All those forces converged, and I thought it would be a good time for a change in leadership.”

GRA’s board includes the presidents of Georgia’s public and private research universities as well as some of the top business leaders from around the state. It has helped Georgia’s universities expand their research capacity and create high-value jobs. It probably is best known for recruiting top research scientists to Georgia.

During the 2017 fiscal year, Georgia’s universities attracted a record $2.2 billion in research funding, and the state is now ranked second in the nation for university research growth supported by industry, according to the Information Technology and Innovation Foundation.

The state now has 67 GRA eminent scholars in place – leading researchers in their field – and it has funding for eight more scholars. Cassidy said he expects several of those positions to be filled in the first half of the year.

Keeping Reading (Acct. Required to View): https://www.bizjournals.com/atlanta/news/2018/01/26/georgia-research-alliance-ceo-mike-cassidy-to.html

Source: Atlanta Business Chronicle
By Maria Saporta – Contributing Writer, Atlanta Business Chronicle

01/26/2018

Georgia State Introduces New Research Center Focused On Neuroinflammation

Tue, 02 Jul 2019 18:11:56 GMT

ATLANTA—The Center for Neuroinflammation and Cardiometabolic Diseases, a research center focused on inflammation in the brain and how it may contribute to a number of serious health conditions, has been introduced at Georgia State University.

Neuroinflammation is a complex process now recognized as a common factor in the development of many diseases, including obesity, stroke, hypertension, Alzheimer’s disease and depression. Researchers will seek to uncover the mechanisms underlying the neuroinflammatory response and determine how neuroinflammation may contribute to various conditions.

Javier Stern, a leading expert in in neuroinflammation who joined Georgia State in 2017, will be the founding director of the center. He was recruited from Augusta University as part of the Next Generation Program, which aims to build strength around core and emerging research that has strategic importance to the university.

“Under Stern’s leadership, the Center will unite faculty in areas of existing research strengths, including neuroscience, immunology, cardiovascular health and obesity,” said James Weyhenmeyer, vice president for research and economic development at Georgia State. “In doing so, we have the potential to improve scientific understanding of critical disorders and how they develop.”

The center will also focus on converting laboratory breakthroughs into new clinical tools.

“The translational approach is important because we’re tackling some very important questions related to diseases that are strongly prevalent not only in the state of Georgia but across the country,” Stern said.

The center’s mission will incorporate that of the Center for Obesity Reversal, which was formed in 2014 to promote collaborative research focused on obesity and related diseases. It was discontinued after the death of founding director Timothy Bartness in 2015.

The Center for Neuroinflammation and Cardiometabolic Diseases will mentor and train new graduate students in this research area and provide training for postdoctoral fellows. The center also intends to provide research experience for undergraduate students and increase the numbers of minorities and women at all training levels.

For more information, visit http://neuroinflammation.gsu.edu.

01/11/2018

Performance Validation Becomes a 100% Employee Owned Company

Tue, 02 Jul 2019 18:12:58 GMT

INDIANAPOLIS, Jan. 3, 2018 /PRNewswire/ -- Performance Validation (PV), a nationwide leader in providing commissioning, qualification, validation, and quality services to the pharmaceutical, biotechnology, and medical device industries, is pleased to announce the company has established an Employee Stock Ownership Plan (ESOP), becoming a 100% employee owned company.

Research has shown that ESOPs, coupled with a strong employee ownership culture (characterized as a strong organizational identity, and involvement oriented management philosophy), outperform comparable companies that are non-employee owned. The President of Performance Validation, and Kelso Fellow from Rutgers University, Richard Van Doel, Ph.D., stated "The ESOP is a great way for all of Performance Validation's employees to share in the wealth that they have helped to create. Our culture is characterized by similar traits of empowerment, team building, and employee involvement. While our culture has facilitated past success, the addition of broad based employee ownership will provide a direct connection between employee actions and company outcomes."

Employee education is a key element to the success of the ESOP, and Performance Validation has been preparing to establish the ESOP for quite some time. These steps have included joining The ESOP Association and the National Center for Employee Ownership, as well as participation at state and national level conferences. Additionally, PV has conducted training on employee ownership with all employees prior to the transition to an employee owned company.

Performance Validation was founded in 1988 by W. Thomas Stevens, a longtime advocate of employee ownership. Our teams have experience providing turnkey solutions to your project needs, or can provide resources to supplement your existing team. We have supported projects ranging from 1-2 week system qualifications to multi-million dollar greenfield manufacturing facilities – and everything in between. Learn more at www.perfval.com

01/09/2018

Celtaxsys Secures Private Financing to Advance Acebilustat Phase 3 Cystic Fibrosis (CF) Program Prep

Tue, 02 Jul 2019 18:13:54 GMT

ATLANTA, GA – Celtaxsys, Inc., a clinical stage drug development company focused on developing novel therapies for rare inflammatory diseases, today announced the successful completion of a Series E financing led by Invus. Additional investors in the financing include Domain Associates, Lumira Capital, Masters Capital Management, RMI Partners and the Georgia Research Alliance Venture Fund. In conjunction with the financing, Khalil Barrage, Managing Director at Invus, will join Celtaxsys’ board of directors.

Celtaxsys’ lead candidate, once-daily oral acebilustat, is currently in Phase 2 clinical testing to assess the drug’s safety and efficacy in preserving lung function in cystic fibrosis (CF) patients over the course of 48 weeks of treatment. This fully enrolled Phase 2b trial has been designed and implemented with the scientific and financial support of the Cystic Fibrosis Foundation. Top line results from this trial are expected in mid-2018. Acebilustat has been granted Orphan Drug Designation for the treatment of CF in both the United States and the European Union. The Series E proceeds will support acceleration of Phase 3 clinical and manufacturing preparatory activities.

“This financing, led by top-tier biotech investors, speaks to the investment community’s support for developing innovative anti-inflammatory medicines for CF patients. Two-week treatment with acebilustat has demonstrated reduction in sputum neutrophils, neutrophil elastase and DNA, and serum CRP in CF patients in a Phase 1b study. We believe the anti-inflammatory activity of acebilustat has the potential to preserve lung function and reduce pulmonary exacerbations in CF patients when given concomitantly with standard of care, irrespective of patient-specific CF gene mutation,” said Greg Duncan, President and CEO of Celtaxsys.

“Although new therapies that correct CFTR have markedly improved the outlook for patients with CF over the past few years, the effects of chronic inflammation in the lungs are still an important factor in the morbidity and mortality in CF patients. An effective anti-inflammatory therapy for CF patients is a significant unmet medical need,” said Professor Stuart Elborn CBE, Director of the Adult CF Center at Royal Brompton Hospital and Imperial College, London. “Acebilustat is an advanced stage development candidate in the CF anti-inflammatory pipeline and if proved to be safe and efficacious in current and future development, has the potential to be a component of foundational therapy for CF patients,” added Dr Elborn.

About Cystic Fibrosis: Cystic fibrosis (CF) is a life-threatening disease that affects the lung and digestive system of 70,000 patients worldwide. CF is caused by mutations in the Cystic Fibrosis Transmembrane conductance Regulator (CFTR) gene leading to abnormal CFTR protein functioning, which causes excessively high levels of thick mucus to accumulate in the lungs, pancreas, and GI tract. Thickened mucus clogs the lungs and serves as a perfect environment to catalyze persistent bacterial infection of the lungs. Chronic infection of the lungs in turn elicits an excessive neutrophil driven inflammatory immune response, with the overabundance of neutrophils clogging the lungs, thereby further compromising a patient’s breathing capacity. Excessive production of a neutrophil by product, neutrophil elastase, has been shown to be the best predictor of lung damage and dysfunction over the life of a CF patient. Paradoxically, excessive production of a neutrophil elastase can also lead to reduced bacterial clearance. Over time, the amplification of this synergistic cycle of infection and inflammation leads to lung function decline and an increase in life-threatening pulmonary exacerbations. Lung inflammation is still the leading cause of morbidity and mortality associated with CF leading the CF Foundation to identify development of safe and effective anti-inflammatory therapies as a key research priority. For more information about CF, visit: www.cff.org.

About acebilustat: Acebilustat is a once-daily oral drug candidate currently in Phase 2 development. It is a novel small molecule inhibitor of Leukotriene A4 Hydrolase (LTA4H), the key enzyme in the production of the potent inflammatory mediator Leukotriene B4 (LTB4). LTB4 can create an over activation of neutrophil mediated immune response and inflammation and has been strongly implicated in the pathogenesis of many diseases involving excessive inflammation, including Cystic Fibrosis, Non-CF Bronchiectasis, Pulmonary Hypertension, Multiple Sclerosis, Inflammatory Bowel Disease, Non-alcoholic steatohepatitis (NASH) and a variety of dermatologic diseases including Bullous Dermatoses.

About Celtaxsys: Celtaxsys is a privately-held drug discovery and development company focused on advancing treatments for serious inflammatory diseases. The company is building a sustainable pipeline of first-in-class immuno-modulators, the most advanced of which is acebilustat. For more information, visit www.celtaxsys.com.

01/09/2018

Pure Health and Immucor Sign 5 Year Distribution Agreement for UAE

Tue, 02 Jul 2019 18:15:09 GMT

Dubai, January 04, 2018: Pure Health Medical Supplies and Immucor Inc. have signed a five-year exclusive distribution agreement for theUAE.

In a unified vision for advanced patient safety, this partnership is designed to drive innovation through reagents, scalable automation and data management solutions. The goal is to improve the overall patient experience and optimize efficiency, quality and performance across UAE in the field of transfusion and transplantation diagnostics.

The agreement ensures the UAE gets the latest in diagnostics technology leading to improved treatment outcomes.

Today’s immunohematology labs are facing many challenges: increased workloads and high demand for faster turnaround times while improving efficiency and reducing costs. The challenge has been presented to do more with less while providing the best patient service and meeting all requirements. The solution to address these challenges is a LEAN workflow using Immucor’s walk away, fully automated instruments combined with its data management system.

Immucor shares Pure Health’s vision for empowering healthcare across the region by utilizing state of the art technology and connectivity. Patrick Waddy, Vice President for Emerging Markets and Japan for Immucor, states, “We are excited to partner with Pure Health to demonstrate the value of our solution for patients, the laboratory staff and clinicians. Through standardization, centralized data management, best-in-class automation, and LEAN implementation, we are confident that our solution will deliver now and for the years to come.”

Pure Health and Immucor strive to strengthen their partnership and bring forth innovations that advance patient safety with high quality products and the highest level of service. Dr. Abdul Shakoor Malik, Chief Scientific Officer of Pure Health states, “We are pleased to be a part of a solution that will present technical and professional expertise. We will be bringing equal access to the latest technology for the benefits of patients and laboratories across the region.”

Immucor and Pure Health will also collaborate to set up a Regional Training Center in Dubai for Transfusion products. The center will provide customized, competency-based learning opportunities and solutions for customers. Working with Pure Health, Immucor’s team of LEAN-certified individuals will incorporate LEAN Workflow Analysis to ensure that the full benefits of its solution are realized.

01/04/2018

BIO Anniversary Reflections: We’re Saving Lives at 25

Tue, 02 Jul 2019 18:16:05 GMT

This year the Biotechnology Innovation Organization (BIO) celebrates our 25th anniversary. It’s impossible to review BIO’s interactive historical timeline without reflecting with pride on the role we’ve played in shaping policy to save lives and promote the health of our planet.

So much of our work comes down to educating folks – policy makers, the public and each other – about the work we’re doing and its value to humanity. For 25 years, BIO has convened the biotechnology community in impressive fashion. And we’ve communicated the needs and aspirations of our scientists to Capitol Hill, state capitols and policymakers worldwide to make sure government leaders embrace thoughtful policy that helps science march forward.

I know this, because I was one of those lawmakers inspired by my BIO education. Through this organization, I came to see the miracles our industry makes possible.

I was an eighth-year U.S. Congressman representing suburban Philadelphia in March 2001, doing woodwork painting at home and watching 60 Minutes on my television. Correspondent Steve Kroft was interviewing an American fertility doctor named Dr. Panayiotis Zavos, who claimed he could clone a human being – and planned to do so within the next 24 months.

I recoiled at the thought. As a former child welfare caseworker, I felt that no child should be brought into the world as a “copy” of someone else and that every human deserved to be the unique offspring of two parents. I chaired the U.S. House Committee on Energy and Commerce Subcommittee on Oversight and Investigation and was confident that my colleagues on both sides of the aisle would share my deep ethical and existential objections to human cloning. So I convened a hearing with the goal of outlawing the practice.

As I prepared for that hearing, I was visited at my office by then-BIO CEO Carl Feldbaum. He told me that BIO shared my concerns about reproductive cloning. But he also explained to me the enormous promise of therapeutic cloning. This is a process that entails the removal of a nucleus of a somatic cell – and its transfer by injection into a denucleated, unfertilized human ovum. This process enables researchers to understand how pluripotent stem cells become blood, eye, heart, skin, and brain cells, as well as every other specialized cell in the human body. This work is the basis for regenerative medicine that holds the potential to cure everything from Parkinson’s to Alzheimer’s disease.

Not only did BIO’s advocacy convince me, it made me a champion for the science. When the issue of therapeutic cloning came before the House for a vote, I gave one of the most passionate floor speeches of my political career in defense of “the most promising opportunity to cure the diseases that have plagued humanity for centuries.”

Three years later, I received a call from a headhunter asking if I was interested in interviewing for the job of BIO President and CEO. My first reaction was “thanks but no thanks.” My approval ratings were high, and who gives up a perfectly good seat in Congress anyway? But as I reflected on the opportunity, I thought about the fact that I had served as a legislator at the state and federal levels for nearly a quarter-century. Rather than be a politician for life, perhaps I could use my knowledge of Washington to help this remarkable, young industry realize its vast potential.

I decided to go for it. In my BIO job interview, I was asked if I had a passion for biotechnology. This is what I said:

“Four and a half billion years ago, when the first cell divided, life began on our planet. Since then, Darwinian evolution has led to the birth of human beings – the crown of creation – with these huge brains and opposable thumbs and amazing perceptions and abilities that allow us to literally reach into our bodies, extract our DNA, look at it under a microscope, and create something that will one day prevent a parent from burying a child. Or one day, prevent a man from looking at his wife in their twilight years and say, ‘Who are you?’

Darwinism teaches us about the survival of the fittest, but the truth is, we don’t want just the fittest to survive. So if you’ll give me this opportunity, I’d like to help you outrun Darwin.”

I got the job.

BIO is an industry organization, but I’ve always tried to put my values and the needs of patients first in our work here. Shortly after taking the helm at BIO, Congress debated the issue of biosimilars. These are medicines with no clinically meaningful differences from existing FDA-approved products – essentially a generics industry for biologic medicine. When the biosimilars debate began, it became clear to me that the heads of many Washington pharma offices didn’t want a biosimilars industry. The companies they represented had monopolies on existing biologics and raised questions as to whether biologics could be safely replicated.

I told the BIO Board that opposition to biosimilars would be a mistake. I shared my belief that the pharmaceutical industry’s initial opposition to the creation of a generics industry had cost the drug industry credibility on Capitol Hill, and I argued that we should not repeat the error.

I convinced the BIO Board that we should become the primary advocates for the creation of a safe, well-regulated biosimilars industry. In so doing, we would educate lawmakers about the science and the law. Rather than eventually having biosimilars legislation forced on us, I argued, we could instead lead the way by embracing competition – and this would put us in a strong position to advocate for the necessity of a 12-year period of data exclusivity on innovative biologics.

Biosimilars would give patients access to more affordable treatments when biologic patents expire. Adequate data exclusivity would offer biotech investors confidence that the intellectual property underlying their investment would be protected.

In the end, the Affordable Care Act created a biosimilars pathway and granted 12 years of data exclusivity for innovative biologic drugs. We even won over Democrats on the House Energy and Commerce Committee over the objections of Chairman Henry Waxman. The committee approved BIO’s position by a 47-11 vote.

As our timeline shows, we’ve won many important battles over the last 25 years. As we look forward to the next 25, there will be plenty of thorny ethical issues to debate and critical policy choices to make. The human genome has been mapped and hundreds of new treatments are in the pipeline as a result. The first gene therapies are starting to be approved by the FDA. The CRISPR gene-editing breakthrough holds transformative potential to treat and cure disease. Advanced biofuels, industrial biotech processes and genetically enhanced crops are helping reduce pollution and feed our rapidly growing global population.

Genetics today stands where chemistry did just a few decades ago: People sometimes fear that which they don’t understand. As Americans have learned more about the unintended consequences of putting chemicals in the air, we have discovered ways to utilize science without polluting our environment. When people hear about genetically modified plants, some still worry about unintended consequences. But as President Obama said of GMOs, “We must follow the science.”

Today, I spend a great deal of my time on Capitol Hill helping lawmakers understand the policy choices before them and helping them understand how manipulating genetics – ethically and responsibly – offers us our greatest hope to live longer and sustain our planet. But like all other areas of science, genetics must be appropriately regulated.

And every day BIO’s public affairs team and I work to persuade policy makers and the public that short-sighted attempts at government-imposed price controls would undermine our work to innovate life-changing and life-saving medicines for which patients and their loved ones pray.

It has been an honor to lead this organization for 13 years and counting. I’ve interviewed former U.S. Presidents on the BIO Convention stage and overseen the growth of this organization to a staff of 173 committed advocates who serve a global membership of more than 1,000 companies strong. I’ve racked up uncountable frequent flier miles visiting every corner of this country – and the world – to promote an industry that truly fuels, feeds and heals the world. But my most memorable moments have been the everyday interactions I’ve had with brilliant researchers and whip-smart entrepreneurs, knowing their hard work adds up to beating disease and bringing hope.

Congratulations to everyone who has been part of this indispensable industry for the last quarter-century. There’s no telling what the next 25 years of biotech innovation hold in store for us.

01/04/2018

ArunA Biomedical Launches New Class of Exosome Biologics to Treat Central Nervous System and Neurode

Tue, 02 Jul 2019 18:17:13 GMT

ArunA Biomedical Launches New Class of Exosome Biologics to Treat Central Nervous System and Neurodegenerative Disorders

Company rapidly moving toward clinical development of cell-free biologic therapy as study published in Translational Stroke Research demonstrates human neural exosomes improve tissue and functional recovery in pre-clinical model

January 03, 2018 08:00 AM Eastern Standard Time

ATHENS, Ga.--(BUSINESS WIRE)--ArunA Biomedical announces the official launch of a new class of cell-free exosome biologics to treat central nervous system and neurodegenerative disorders. With an initial focus on an exosome therapeutic for stroke, the company published results of a study today in Translational Stroke Research that found extracellular vesicles (EVs) derived from human neural stem cells improved tissue and functional recovery in murine thromboembolic stroke models.

The study was led by Dr. Steven Stice, a Georgia Research Alliance Eminent Scholar endowed chair, Professor and Director of the Regenerative Bioscience Center at The University of Georgia and who serves as Co-Founder, Chief Executive and Chief Scientific Officer for ArunA Biomedical. The study was conducted in collaboration with Dr. Nasrul Hoda at Augusta University.

Neural stem cell (NSC) and mesenchymal stem cells (MSC) were evaluated for changes in infarct volume as well as sensorimotor function. Results showed that the NSC EVs improved cellular, tissue and functional outcomes in middle-aged rodents whereas MSC EVs were less effective. Acute differences in lesion volume followed NSC EV treatment were corroborated by MRI in aged rodents. NSC EV mechanistically increased circulating regulatory T cell numbers, which are known to enhance remyelination in the injured brain. Specifically, neural stem cell EV treatment has a positive effect on motor function as indicated by beam walk, instances of foot faults and strength evaluated by a hanging wire test. Increased time with a novel object supports improved episodic memory formation in the rodent.

Notably, investigators have been able to duplicate many of these results in a unique large animal model of stroke developed at the University of Georgia, and results will be published in a peer reviewed journal in the next few months.

“With more than twelve years of expertise in developing and providing neural stem cells to the world’s leading research organizations, it was a natural progression to focus efforts on developing a new cell-free class of biologics—exosome therapeutics—for central nervous system and neurodegenerative disorders that have few treatment options today,” said Dr. Stice. “Buoyed by the results of this study and our additional pre-clinical models and internal in vitro studies, we will rapidly move toward the clinic with a plan to initiate first-in-human studies in 2019.”

Dr. Stice is an expert in stem cell technologies and regenerative medicine and is world-renowned for developing the first human pluripotent stem cell (hPSC) derived neural cell product for research and enabled its use throughout the biotechnology and pharmaceutical industries. This expertise has led to the development of an unmodified, stable and proprietary neural cell line that enables scale-up technologies for use in exosome product manufacturing. This proprietary offering coupled with the company’s exosome separation methods enables ArunA to produce billions of cells and up to trillions of exosomes per manufacturing lot.

In addition to the stroke study, ArunA Biomedical plans to initiate a drug delivery platform as well as preclinical studies in epilepsy, traumatic brain and spinal cord injuries in 2018.

Exosomes as a Therapeutic
Since their discovery more than 30 years ago, extracellular vesicles—nanometer-sized cell-signaling particles— have been increasingly found to play a role in intercellular communication, capable of delivering functional proteins, mRNA transcripts and miRNA to cells throughout the body. Exosomes have the potential to target any cell in the body and as proved in ArunA’s study published today, are capable of crossing the blood brain barrier non-invasively to reach the site of injury. Exosomes have shown great promise as potential therapeutics and as vehicles to carry drug payloads to the site of injury or disease.

About ArunA Biomedical
At ArunA Biomedical, we are the experts in the design, loading and scaling of neural-derived exosomes, developing a new class of cell-free biologics and cell-mediated drug delivery systems to treat CNS and neurodegenerative disorders.

Through our lead program in stroke, we have demonstrated the unique ability of exosomes to enhance the nervous system’s self-repair mechanisms, leading to both structural and functional benefits in multiple preclinical models. www.arunabio.com

01/03/2018

Shire files for FDA approval of a new plasma manufacturing facility in Covington, Georgia to support

Tue, 02 Jul 2019 18:18:10 GMT

Shire files for FDA approval of a new plasma manufacturing facility in Covington, Georgia to support growing Immunology franchise

Dublin, Ireland – December 27, 2017 – Shire plc (LSE: SHP, NASDAQ: SHPG), the global biotechnology leader in rare diseases, today announced that it has filed its first submission to the United States Food and Drug Administration for the company’s new plasma manufacturing facility in Covington, Georgia. The facility is expected to add approximately 30% capacity to the company’s internal network once fully operational. Commercial production is expected to begin in 2018.

The first submission is for the transfer of GAMMAGARD LIQUID® [Immune Globulin Infusion (Human)] 10% Solution, a replacement therapy for primary humoral immunodeficiency (PI). The company expects to make a second submission to the FDA in 2018 for its albumin therapy, which is primarily used as plasma-volume replacement therapy in immune disorders, trauma and other critical conditions.

“We are pleased to have filed the Georgia site and look forward to working with the FDA to seek approval for manufacturing in 2018. The additional capacity from this site is a key element to support the growth in our Immunology franchise,” said Matt Walker, Head of Technical Operations for Shire.

Shire has experienced significant growth in Immunology, including a +21% increase in September year-to-date product sales in 2017 (on a pro-forma basis).

The Covington, Georgia site currently employs approximately 900 full-time colleagues and contract employees. The site plans to ramp up hiring in 2018 to fill roles in manufacturing, quality, engineering, maintenance, utilities, warehouse and a variety of support and facility roles.

Shire also expects to continue expansion of its plasma collection network in Georgia and throughout the United States through its subsidiary, BioLife Plasma Services. BioLife collects the human plasma that will be processed into the drugs manufactured at Shire’s new Covington, Georgia facility.

Indication and Important Safety Information

GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10% Solution

What is GAMMAGARD LIQUID?

GAMMAGARD LIQUID is indicated for the treatment of primary humoral immunodeficiency diseases (PI) in patients two years of age and older. GAMMAGARD LIQUID is a ready-to-use, liquid medicine that contains immunoglobulin G (IgG) antibodies, which protect the body against infection.
GAMMAGARD LIQUID is made from human plasma that is donated by healthy people and contains antibodies that replace the missing antibodies in patients with PI.
GAMMAGARD LIQUID is given into a vein (intravenously) or under the skin (subcutaneously). You and your healthcare provider will decide which way is best for you. Most of the time infusions under the skin are given at home by patients or caregivers. Although it is possible to give yourself infusions into a vein at home, they are more often given in a hospital or infusion center by a nurse. Only use GAMMAGARD LIQUID by yourself after you have been instructed by your healthcare provider.

Important Safety Information

What is the most important information that I should know about GAMMAGARD LIQUID?
GAMMAGARD LIQUID can cause the following serious reactions:

Severe allergic reactions causing difficulty in breathing or skin rashes
Decreased kidney function or kidney failure
Blood clots in the heart, brain, lungs or elsewhere in the body
Severe headache, drowsiness, fever, painful eye movements, or nausea and vomiting
Dark colored urine, swelling, fatigue, or difficulty breathing

Who should not use GAMMAGARD LIQUID?
Do not use GAMMAGARD LIQUID if you:

Have a known history of a severe allergic reaction to IgG or other blood products.
Have selective (or severe) immunoglobulin A (IgA) deficiency with antibodies to IgA.

GAMMAGARD LIQUID can cause serious side effects. Call your healthcare professional or go to the emergency department right away if you get:

Hives, swelling in the mouth or throat, itching, trouble breathing, wheezing, fainting or dizziness. These could be signs of a serious allergic reaction.
Bad headache with nausea, vomiting, stiff neck, fever, and sensitivity to light. These could be signs of irritation of the lining around your brain.
Reduced urination, sudden weight gain, or swelling in your legs. These could be signs of a kidney problem.
Pain, swelling, warmth, redness, or a lump in your legs or arms. These could be signs of a blood clot.
Brown or red urine, fast heart rate, yellow skin or eyes. These could be signs of a liver or blood problem.
Chest pain or trouble breathing, or blue lips or extremities. These could be signs of a serious heart or lung problem.
Fever over 100ºF. This could be a sign of an infection.

What are the possible or reasonably likely side effects of GAMMAGARD LIQUID for PI?

The following one or more possible reactions may occur at the site of infusion. These generally go away within a few hours, and are less likely after the first few infusions: Mild or moderate pain, swelling, itching, redness, bruising, and warmth.
During the infusion of GAMMAGARD LIQUID, look out for the first signs of the following common side effects: Headache, migraine, fever, fatigue, itching, rash/hives, cough, chest pain/tightness, chills/shaking chills, dizziness, nausea/vomiting, faster heart rate, upper abdominal pain, increased blood pressure, muscle cramps, and sore throat.

12/29/2017

BD Completes Bard Acquisition, Creating New Global Health Care Leader

Tue, 02 Jul 2019 18:19:00 GMT

FRANKLIN LAKES, N.J., Dec. 29, 2017 – BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced it has completed the acquisition of C. R. Bard, Inc. (NYSE: BCR), creating a new health care industry leader with approximately $16 billion in annualized revenue.

The combined company is uniquely positioned to improve both the treatment of disease for patients and the process of care for health care providers. The transaction builds on BD's leadership in medication management and infection prevention with an expanded offering of solutions across the care continuum. Additionally, Bard's strong product portfolio and innovation pipeline will increase BD's opportunities in fast-growing clinical areas, and the combination will enhance growth opportunities for the combined company in non-U.S. markets.

“Today is a historic day for BD as we welcome Bard and its 16,000 associates to BD,” said Vincent A. Forlenza, chairman and CEO. “These companies each have a legacy of more than 100 years of advancing the world of health and supporting those on the frontlines of health care. We look forward to continuing to lead the industry through innovation and partnerships that bring more valuable solutions to our customers and their patients.”

Under the terms of the transaction, upon completion of the acquisition, Bard became a wholly owned subsidiary of BD, and each outstanding share of Bard common stock was converted to the right to receive (1) $222.93 in cash without interest and (2) 0.5077 of a share of BD common stock. As a result of the completion of the acquisition, Bard shares will cease trading and will be delisted from the New York Stock Exchange.

Excluding transaction-related expenses, BD does not expect the acquisition to have a material impact on the company's financial results in the first quarter of fiscal 2018, which ends on Dec. 31, 2017.

The company continues to expect the transaction to generate low-single digit accretion to adjusted earnings per share in fiscal year 2018, and high-single digit accretion in fiscal year 2019. The company will provide an update to its full fiscal year 2018 outlook on its first fiscal quarter earnings conference call to reflect the anticipated contribution from Bard’s operations through BD’s fiscal year, which ends Sept. 30, 2018.

Beginning with the second quarter of fiscal 2018, BD will report a new Interventional segment structure, which will include a majority of Bard offerings, with the remainder being reported under the Medical segment. For more detailed information on BD's reporting changes, please refer to the BD Reporting Changes slide presentation available on BD's website at www.bd.com/investors.

Information for Bard Shareholders

BD has appointed Computershare Trust Company N.A. as paying agent for payment of the merger consideration described above. For Bard registered shareholders who hold Bard stock certificates or a mix of Bard stock certificates and book-entry shares, information concerning the exchange of Bard shares for the per share merger consideration is being mailed to the holder of record of the certificated Bard shares. This information will outline the steps to be taken to obtain the merger consideration. These registered shareholders do not need to take any action regarding their shares until contacted by the paying agent. For Bard registered shareholders who hold Bard stock solely in book-entry format, Computershare Trust Company N.A. will debit all book-entry Bard shares in the accounts of holders of record, credit the appropriate number of book-entry BD shares to each holder, and make payment of the cash consideration (less any applicable tax withholding) by mailing a check representing such amount to each such holder. For additional information, please contact Computershare Trust Company, N.A. at (877) 498-8861 (within the United States, its territories and Canada) or +1 (781) 575-2879 (outside the United States, its territories and Canada). Bard shareholders who own shares through a bank, brokerage firm or other nominee (in “street name”), should contact their bank, broker or nominee for further information about receiving the merger consideration.

About BD

BD is a global medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. BD leads in patient and health care worker safety and the technologies that enable medical research and clinical laboratories. The company provides innovative solutions that help advance medical research and genomics, enhance the diagnosis of infectious disease and cancer, improve medication management, promote infection prevention, equip surgical and interventional procedures, optimize respiratory care and support the management of diabetes. The company partners with organizations around the world to address some of the most challenging global health issues. BD has more than 45,000 associates across 50 countries who work in close collaboration with customers and partners to help enhance outcomes, lower health care delivery costs, increase efficiencies, improve health care safety and expand access to health.

For more information on BD, please visit bd.com.

12/29/2017

BIO Applauds House Passage of the Corporate Governance Reform and Transparency Act

Tue, 02 Jul 2019 18:20:06 GMT

Washington, DC (December 21, 2017) – Today, the Biotechnology Innovation Organization (BIO) applauds the House of Representatives for passing H.R. 4015, the Corporate Governance Reform and Transparency Act. This bipartisan bill, sponsored by Reps. Sean Duffy (R-WI) and Gregory Meeks (D-NY), was approved by a 238-182 vote.

H.R. 4015 would provide for oversight by the Securities and Exchange Commission (SEC) of proxy advisory firms, ensuring that they operate within appropriate boundaries and are accountable to regulators and the public.

The following statement may be attributed to BIO President and CEO Jim Greenwood:

“By enhancing transparency at proxy advisory firms, this legislation would improve the quality of information available to shareholders as they consider their views on public companies’ corporate governance policies. Proxy votes are the primary means of shareholder engagement with company management, and this bill would ensure that the proxy process is working well for both investors and issuers.

“By requiring proxy advisory firms to minimize conflicts of interest and enhance issuer dialogue, H.R. 4015 would improve the quality of the recommendations disseminated to shareholders and ensure that breakthrough innovation remains at the forefront of company decision-making.

“BIO thanks Representatives Duffy and Meeks for their leadership on this important issue.”

Source: https://www.bio.org/press-release/bio-applauds-house-passage-corporate-governance-reform-and-transparency-act

12/21/2017

AdvaMed Praises House Problem Solvers Bill to Repeal Medical Device Tax

Tue, 02 Jul 2019 18:21:04 GMT

WASHINGTON, D.C. – The Advanced Medical Technology Association (AdvaMed) issued the following statement from President and CEO Scott Whitaker following introduction of legislation (HR. 4695) by the House Problem Solvers Caucus, which includes repeal of the medical device excise tax:

“We commend Reps. Tom Reed (R-N.Y.), Josh Gottheimer (D-N.J.) and Kurt Schrader (D-Ore.) – along with the rest of the Problem Solvers Caucus – for highlighting the need to repeal the medical device tax as part of their solution to the challenges facing the U.S. health care system.

“This is a tax on innovation, a tax on jobs, and a tax on the health and well-being of millions of American patients. It makes no sense from either a health care or a tax policy perspective, which is why bipartisan majorities for years in both the House and Senate have called for this tax to be repealed.

“We only have a few days before this tax goes back into effect, so we urge the Congress and the Administration to follow the Caucus’ lead and repeal this onerous tax once and for all.”

Source: https://www.advamed.org/newsroom/press-releases/advamed-praises-house-problem-solvers-bill-repeal-medical-device-tax

12/21/2017

Steven Stice named National Academy of Inventors Fellow

Tue, 02 Jul 2019 18:21:55 GMT

The National Academy of Inventors has named a University of Georgia faculty member who is a leading researcher in regenerative medicine to the 2017 class of NAI Fellows.

Steven Stice, Georgia Research Alliance Eminent Scholar and director of the UGA Regenerative Bioscience Center, joins an elite group of 912 innovators representing more than 250 prestigious research universities and governmental and nonprofit research institutions.

Election to NAI Fellow status is a professional distinction accorded to academic inventors who have demonstrated a prolific spirit of innovation in creating or facilitating outstanding inventions that have made a tangible impact on quality of life, economic development and the welfare of society. Six UGA faculty members have been named NAI Fellows since the honor was established in 2013, and an additional Fellow joined the faculty last year.

“The election of Steven Stice as an NAI Fellow highlights the innovative research conducted at UGA,” said Vice President for Research David Lee. “We join NAI in celebrating his contributions to science and society.”

Stice, the D.W. Brooks Distinguished Professor in the College of Agricultural and Environmental Sciences, has led industry and academic research teams in the area of pluripotent stem cells for over 25 years. At UGA he has conducted pioneering work in developmental biology and genetics to advance animal and human medicine. His group derived some of the original human pluripotent stem cell lines placed on the first National Institutes of Health human embryonic stem cell registry. Stice was a key member of the team that produced the first cloned rabbit in 1989 and the first cloned transgenic calves in 1998 (George and Charlie), for which he was granted the first U.S. patent in cloning animals. He has produced the first genetically modified pluripotent stem cells derived from pigs and cattle and, more recently, in avian species.

His research has led to 16 U.S. patents in stem cells, cloning and regenerative medicine, including the first U.S. patent on animal cloning and therapeutic cloning from adult animal cells. Multiple startup companies have been based on his technologies. ArunA Biomedical, the first company to commercialize a product derived from human pluripotent stem cells, is now using this original stem cell technology as a basis for preclinical human therapeutics and drug delivery.

Currently, the Stice lab is collaborating with ArunA Biomedical to develop proprietary exosomes for the treatment of central nervous system injury and neurodegenerative disorders, with an initial focus in stroke. Exosomes—tiny structures shed from cells—are cargo carriers that independently or, when packaged with therapeutics, change the behavior, improve the survival and repair of injured cells, reduce inflammation and attack tumor cells while remaining invisible to the body’s own defenses. Their proprietary manufacturing process will have the ability to noninvasively reach the site of injury without adverse responses while reducing inflammation of the brain and improving neural function.

“Steve’s innovative research and entrepreneurial spirit exemplify UGA’s emphasis on translating research discoveries into products that benefit the public,” said Derek Eberhart, director of UGA’s Innovation Gateway. “He has been an integral contributor to the university’s innovation ecosystem, which has generated more than 675 products and 160 companies based on UGA research.”

Stice’s longstanding commitment to growing the life science industry, as well as the advancement of regenerative medicine research and commercialization, was recognized in 2017 when he received the Industry Growth Award from Georgia Bio. He has founded five biotech companies, including four startups in Georgia that have generated more than 100 jobs.

He has published more than 125 peer-reviewed manuscripts and has been an invited speaker at over 200 research conferences, symposia and industry events. In 2016, Stice was invited to serve as a member of the Science Advisory Board to the National Center for Toxicological Research of the Food and Drug Administration. Recently he led UGA’s participation in a successful bid for $20 million in funding from the National Science Foundation to establish an Engineering Research Center for Cell Manufacturing Technologies in collaboration with the Georgia Institute of Technology and other partner institutions.

UGA’s other NAI Fellows are Michael Doyle, retired Regents’ Professor of Food Microbiology and former director of UGA’s Center for Food Safety; Michael A. Dirr, emeritus professor of horticulture; Robert Ivarie, emeritus professor of genetics; David Chu, Distinguished Research Professor emeritus of pharmacy; and Wayne Hanna, professor of crop and soil sciences. Karen Burg, who joined UGA in 2016 as the Harbor Lights Chair in Small Animal Studies, was named a Fellow in 2014.

The university’s innovation programs rank highly, placing top five among all U.S. universities for new products reaching the marketplace for the fourth consecutive year. During the past two years, UGA’s efforts to facilitate industry engagement and catalyze economic development resulted in a 30 percent increase in the number of new inventions and licensing revenue, a 40 percent increase in the pipeline of startup projects, and more than 140 new products reaching the market. Innovation Gateway, formed in 2015 to streamline the path from laboratory or field to marketplace, also brought in $1 million in new grants. The UGA I-Corps Site, a STEM-focused accelerator program funded by a $500,000 grant from the National Science Foundation, launched this fall and helps teams from across the university transition their research discoveries to market-ready products and services.

12/14/2017

AdvaMed Statement on Device Tax Suspension

Tue, 02 Jul 2019 18:22:58 GMT

WASHINGTON, D.C. – The Advanced Medical Technology Association (AdvaMed) issued the following statement from AdvaMed President and CEO Scott Whitaker regarding the proposal in the U.S. House to extend the suspension of the medical device excise tax:

“AdvaMed commends the leadership of House Ways & Means Committee Chairman Kevin Brady and Reps. Erik Paulsen and Jackie Walorski for their proposal to prevent this onerous tax from returning. A five-year suspension is an important first step to provide medical technology innovators with confidence that this tax will not go back into effect. With time running short, we urge Congress to adopt this suspension immediately.

“During the current suspension, medtech companies have been able to reinvest millions that otherwise would have been lost to the tax into new jobs, capital improvements and R&D to fuel the next generation of life-changing technologies for patients. We are committed to continuing this reinvestment in innovation if the tax is suspended on a long-term basis going forward.

“However, while we applaud this proposed five-year suspension, it is a only a first step toward the ultimate goal to fully repeal the medical device tax and unleash the full promise of job growth and medical innovation for American patients.”

12/13/2017

Animal vaccine company expanding Athens footprint as part of $80M investment

Tue, 02 Jul 2019 18:27:53 GMT

Athens' health-care economy is getting a booster shot.

Boehringer Ingelheim, a provider of animal health products for pets and livestock, said it will invest more than $80 million to expand its existing facilities in Athens and St. Joseph, Missouri to accommodate increased production of animal vaccines.

Enlarge

Boehringer Ingelheim’s facility in Athens, Georgia.

The company said its Athens facility will grow from its current footprint of approximately 350,000 square feet to 400,000 square feet and will nearly double its filling capacity for companion animal and avian vaccines. Construction is slated to begin in the fourth quarter of 2017 and will continue through 2019, with commercial production anticipated to begin in the second half of 2019, according to a news release. The facility, which was established in 1989, currently employs approximately 400 people, including Research and Development operations also based there. It is expected that an additional 50 positions will be added over the next three years to support the expansion.

In a major deal announced last June, Boehringer Ingelheim acquired Sanofi’s Atlanta-based animal care subsidiary, Merial, valued at $13.53 billion, and Sanofi took over Boehringer Ingelheim’s consumer health care business unit, valued at $7.98 billion, as well as cash compensation of $5.54 billion. The merger made Boehringer Ingelheim the second largest animal health business in the world, with more than 10,000 employees worldwide.

Boehringer Ingelheim has a significant presence in Georgia, with its manufacturing and R&D facility in Athens, an additional manufacturing site located in Gainesville and the headquarters for its U.S. Animal Health business based in Duluth.

12/06/2017

Gilead Sciences, Emory and others launch $100 million initiative to address HIV/AIDS crisis in South

Tue, 02 Jul 2019 18:25:00 GMT

A group of scientific institutions are teaming up to take aim at the growing HIV/AIDS crisis in the southern United States.

Gilead Sciences Inc. (NYSE: GILD), Emory University Rollins School of Public Health, the Southern AIDS Coalition and the University of Houston Graduate College of Social Work on Dec. 4 announced the Gilead COMPASS Initiative, a $100 million commitment of financial resources and support for organizations working to end HIV/AIDS.

The South lags behind other parts of the country in terms of HIV prevention and care indicators, according to the Atlanta-based U.S. Centers for Disease Control and Prevention. Eight of the 10 states with the highest rates of new HIV diagnoses are in the South, and 45 percent of those who live with the disease live in a South, though it is home to only one-third of the U.S. population.

Fulton County's diagnosis rates are also five times the national average, and Foster City, Calif-based Gilead biotech recently has shown a big commitment to helping address the epidemic. Grady Health System's Ponce Center for HIV/AIDS treats one of every four HIV/AIDS cases in Georgia, and Gilead donated $2 million to help it and build a surgical center across the street from its main campus. Read more about that here.

12/06/2017

The 2017 SEBIO’s Deal of the Year Award Winners Announced

Tue, 02 Jul 2019 18:25:59 GMT

PINEHURST, NC – The winners of Southeast BIO’s (SEBIO) Deal of the Year awards were announced in a ceremony held at its 19th Annual Investor Forum in Pinehurst, North Carolina on November 15, 2017. Companies competed in the following categories:

IPO
VC Transaction
Initial Funding
Strategic Transaction
Strategic Investment
SEBIO Leadership Award

“Southeast BIO’s Awards Program recognizes the companies and individuals that are driving the growth of the Southeast’s life sciences industry,” said David Day, Executive Director, SEBIO. “SEBIO award winners are a measure of the strong companies, exciting new technologies, and executive leadership contributing to the development of a robust industry across the region.”

The winners of the 2017 Deal of the Year Awards are:

G1 Therapeutics, a Research Triangle-based clinical-stage oncology company, for the SEBIO Deal of the Year: IPO. G1 Therapeutics, became a publicly traded company in May with a $105 million initial public offering of seven million shares of stock priced at $15 a share. G1, a spinout from the University of North Carolina at Chapel Hill, is developing novel therapies that address significant unmet needs in people with various cancers.

NeuroTronik a medical technology company based in Research Triangle Park, N.C. and Dublin, Ireland for the SEBIO Deal of the Year: Strategic Investment. NeuroTronik Limited and NeuroTronik, Inc. announced closing on a $23.1 million Series B Preferred Stock Financing, tranched in line with project plan milestones. The funding was led by Boston Scientific Group, plc. Other major investors include Hatteras Venture Partners, Synergy Life Science Partners, Lord Baltimore Investment Partners, Mountain Group Capital, and Sovereign’s Capital.

Femasys, Inc., a developer of innovative medical devices based in Atlanta, Georgia, for the SEBIO Deal of the Year: VC Transaction. In December, 2016, Femasys closed $40 million in Series C financing. The transaction was arranged by Salem Partners, a Los Angeles-based investment bank which also participated as a principal investor.

HemoShear Therapeutics, LLC, a drug-discovery company based in Charlottesville, VA., for the SEBIO Deal of the Year: Strategic Transaction. Takeda Pharmaceutical Company Limited (TSE: 4502) and HemoShear Therapeutics, LLC, a privately held biotechnology company, announced a partnership to discover and develop novel therapeutics for liver diseases, including nonalcoholic steatohepatitis (NASH).

Intezyne Technologies, a Tampa, FL.-based clinical-stage oncology company focused on cancer therapies, for the SEBIO Deal of the Year: Initial Funding. Intezyne Technologies raised $10 million in an oversubscribed Series A round led by Gaston Capital. McAllister said Intezyne has just launched a $30 million pre-IPO Series B Preferred round which he plans to close by mid-2018.

Ken Tindall for the SEBIO Leadership Award. Ken Tindall is a responsible for the North Carolina Biotechnology Center’s Science and Business Development efforts, which include the Business and Technology Development, the Science and Technology Development, and the Centers of Innovation programs as well as Library and Information Technology. These programs currently administer 10 grants or loans and since 2000 have provided more than $87 million in support of North Carolina research, educational activities and biotechnology businesses. As for Ken’s service to SEBIO, simply put, he has done everything for SEBIO that has been asked of him and more. Ken has served on the Board for a very long time. He has chaired the conference, led the raising of sponsorship dollars and provided wise leadership over the years.

The 2018 SEBIO Awards Ceremony will be held in November during the 20th Annual Southeast BIO Investor Forum in Atlanta, Georgia. Further details coming early 2018.

About Southeast BIO

Southeast BIO (SEBIO) is a regional nonprofit organization that fosters the growth of the life sciences industry in the Southeastern United States through efforts that promote entrepreneurship and bring together the key players active in the development of the industry. SEBIO’s geographic footprint includes Alabama, Florida, Georgia, North Carolina, South Carolina, Tennessee and Virginia. SEBIO focuses on key industries within the life sciences, including: bio/pharma, medical devices and technology, agricultural biotechnology, animal health, bioinformatics and biomaterials. Visit www.sebio.org for more information.

http://ow.ly/vdR730gFceD

11/20/2017

BIO Applauds Sens. Tillis and Peters for Introducing the Fostering Innovation Act

Tue, 02 Jul 2019 18:26:49 GMT

The Fostering Innovation Act would build on the success of the JOBS Act and further reduce regulatory costs for biotech small businesses.

Washington, DC (November 15, 2017) – Today, the Biotechnology Innovation Organization (BIO) applauds Sens. Thom Tillis (R-NC) and Gary Peters (D-MI) for introducing the Fostering Innovation Act. This vital legislation would build on the success of the JOBS Act and further reduce regulatory costs for biotech small businesses.

The JOBS Act provides emerging growth companies (EGCs) with a five-year exemption from the costly auditor attestation requirements of Section 404(b) of Sarbanes-Oxley (SOX). The Fostering Innovation Act would extend the JOBS Act’s SOX 404(b) exemption for an additional five years for pre-revenue small businesses. The additional five years of cost-savings would allow growing companies to focus their capital on life-saving R&D rather than one-size-fits-all regulatory burdens.

The following statement may be attributed to BIO President & CEO Jim Greenwood:

“BIO commends Sens. Tillis and Peters for introducing the Fostering Innovation Act. More than 230 emerging biotechs have gone public under the JOBS Act, and this bill would further support their growth. By allowing innovative small businesses to focus their investment capital on science rather than compliance, the Fostering Innovation Act would allow these emerging innovators to remain focused on delivering groundbreaking cures and treatments to patients.

“The targeted nature of the Fostering Innovation Act, which would only benefit pre-revenue companies, represents an important move away from one-size-fits-all regulations. BIO strongly supports this vital legislation, and we applaud Sens. Tillis and Peters for their efforts to reduce compliance costs for emerging biotechs and support small business capital formation.”

The Fostering Innovation Act has also been introduced in the House by Reps. Kyrsten Sinema (D-AZ) and Trey Hollingsworth (R-IN). It was approved by the House Financial Services Committee on October 12 by a bipartisan 48-12 vote.

11/20/2017

Aviragen, Vaxart merge to develop oral vaccines for influenza, norovirus and RSV

Tue, 02 Jul 2019 18:27:29 GMT

For some antigens like norovirus and RSV, there are no approved vaccines. For others, like the seasonal flu, immunization rates are often far from ideal. Now, a new company, the product of a merger between Aviragen Therapeutics and Vaxart, aims to develop oral vaccines against these diseases.

After the transaction, which executives believe will close early next year, the combined company will take Vaxart’s name. Vaxart CEO Walter Latour will lead the combined company and shares will trade on Nasdaq under the proposed ticker “VXRT.”

The new Vaxart will have about $30 million in cash, which it will use to advance several key candidates in the company’s pipeline, Wouter Latour, M.D., CEO of Vaxart, said during a conference call on Monday about the transaction. Recent positive clinical data have derisked Vaxart’s platform, Aviragen CEO Joseph Patti, Ph.D., said on the call, leading the Nasdaq-listed company to pursue the merger after an extensive review of about 60 strategic options.

10/31/2017

Shire Receives Orphan Drug Designation for Gene Therapy Candidate SHP654 (BAX 888) for the Treatment

Tue, 02 Jul 2019 18:29:06 GMT

Lexington, MA – October 25, 2017 – Shire plc (LSE: SHP, NASDAQ: SHPG), the global biotechnology leader in rare diseases, today announced the U.S. Food and Drug Administration (FDA) awarded Orphan Drug Designation to Shire’s gene therapy candidate SHP654 (also designated as BAX 888), an investigational factor VIII (FVIII) gene therapy for the treatment of hemophilia A. The regulatory agency also granted Shire investigational new drug (IND) status for SHP654.

Orphan Drug Designation is intended to advance drug development for rare diseases.1 The FDA provides Orphan Drug Designation to drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S.1 Hemophilia A is the most common type of hemophilia, a bleeding disorder that causes longer-than-normal bleeding due to a lack of clotting factor VIII (FVIII) activity in the blood.2 It is estimated that approximately 14,000 people in the U.S. suffer from hemophilia A.3

“This important Orphan Drug Designation highlights Shire’s commitment to patients with rare diseases; and for hemophilia patients specifically our aim is to help them achieve zero bleeds,” says Paul Monahan, M.D., Senior Medical Director, Gene Therapy, Shire. “We know that hemophilia care is not one-size-fits-all and that every patient is unique, which is why we continue to focus on optimizing personal outcomes for hemophilia patients by developing innovations to transform care.”

Gene therapy is the delivery of a functional copy of the defective gene.4 For hemophilia, this is the gene for factor VIII or factor IX so the body can produce its own factor instead of relying on exogenous factor administration.5 The goal of hemophilia gene therapy is to provide a constant level of factor expression over several years and eliminate the peaks and troughs associated with factor replacement therapy.6 Shire is studying SHP654 as a potential treatment for hemophilia A patients through the delivery of a long-term, constant level of factor VIII expression.7

Shire also received FDA clearance for the IND application it submitted earlier this year to initiate a global multi-center study with SHP654 to evaluate the safety and optimal dose needed to boost factor VIII activity levels and affect hemophilic bleeding. The company anticipates that the SHP654 Phase 1/2 study will begin by the end of 2017.

About SHP654 (BAX 888)
Shire is developing SHP654, which includes technology acquired from Chatham Therapeutics, LLC, a spin-out of Asklepios Biopharmaceutical, Inc. SHP654 is an investigational factor VIII (FVIII) gene therapy intended to treat hemophilia A using a adeno-associated virus serotype 8 (AAV8) vector to deliver a codon-optimized, B-domain deleted FVIII (BDD-FVIII) specifically to a patient’s liver, where FVIII would then be produced and used to manage bleeds.7,8

About Hemophilia A
Hemophilia A, the most common type of hemophilia, is a rare bleeding disorder that causes longer-than-normal bleeding due to lack of clotting factor VIII activity in the blood.2 The severity of hemophilia A is determined by the amount of factor in the blood, with more severity associated with lower amounts of factor activity.9 More than half of patients with hemophilia A have the severe form of the condition.9 Hemophilia A primarily affects males, with an incidence of one in 5,000 male births.9,10

References

U.S. Food and Drug Administration. Developing Products for Rare Diseases & Conditions FDA website. https://www.fda.gov/forindustry/developingproductsforrarediseasesconditions/default.htmAccessed October 17, 2017
World Federation of Hemophilia. “What is hemophilia?” World Federation of Hemophilia website. http://www.wfh.org/en/page.aspx?pid=646. Accessed October 17, 2017.
World Federation of Hemophilia. Report on the Annual Global Survey 2015. World Federation of Hemophilia website. http://www1.wfh.org/publication/files/pdf-1669.pdf. Accessed October 17, 2017.
U.S. Food and Drug Administration. What is Gene Therapy? FDA website https://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ucm573960.htm Accessed October 17, 2017.
National Hemophilia Foundation. Future Therapies. National Hemophilia Foundation website. https://www.hemophilia.org/Bleeding-Disorders/Future-Therapies Accessed October 17, 2017
Herzog R. “Hemophilia Gene Therapy: Caught Between a Cure and an Immune Response.” Molecular Therapy. 2015;23(9):1411-1412.
Falkner et al. “Development of SHP654 a highly efficient AAV8-based BDD-FVIII gene therapy vector for treatment of hemophilia A.” Available at: http://onlinelibrary.wiley.com/doi/10.1111/rth2.2017.1.issue-S1/issuetoc
Hoellriegl et al. “Dose response and long-term expression of a human FVIII gene therapy construct in hemophilia A mice.” Available at: http://onlinelibrary.wiley.com/doi/10.1111/rth2.2017.1.issue-S1/issuetoc
National Hemophilia Foundation. “Hemophilia A.” National Hemophilia Foundation website. https://www.hemophilia.org/Bleeding-Disorders/Types-of-Bleeding-Disorders/Hemophilia-A. Accessed October 17, 2017.
Centers for Disease Control and Prevention. “Hemophilia.” Centers for Disease Control and Prevention website. http://www.cdc.gov/ncbddd/hemophilia/facts.html. Accessed October 17, 2017.

For further information please contact:

Investor Relations
Ian Karp	ikarp@shire.com	+1 781 482 9018
Robert Coates	rcoates@shire.com	+44 1256 894874
Media
Gwen Fisher	gfisher@shire.com	+1 781 482 9649
Molly Poarch	molly.poarch@shire.com	+1 312 965 3413

NOTES TO EDITORS

About Shire
Shire is the leading global biotechnology company focused on serving people with rare diseases. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.

www.shire.com

Forward-Looking Statements

Statements included herein that are not historical facts, including without limitation statements concerning future strategy, plans, objectives, expectations and intentions, the anticipated timing of clinical trials and approvals for, and the commercial potential of, inline or pipeline products, are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire’s results could be materially adversely affected. The risks and uncertainties include, but are not limited to, the following:

Shire’s products may not be a commercial success;
increased pricing pressures and limits on patient access as a result of governmental regulations and market developments may affect Shire’s future revenues, financial condition and results of operations;
Shire conducts its own manufacturing operations for certain of its products and is reliant on third party contract manufacturers to manufacture other products and to provide goods and services. Some of Shire’s products or ingredients are only available from a single approved source for manufacture. Any disruption to the supply chain for any of Shire’s products may result in Shire being unable to continue marketing or developing a product or may result in Shire being unable to do so on a commercially viable basis for some period of time;
the manufacture of Shire’s products is subject to extensive oversight by various regulatory agencies. Regulatory approvals or interventions associated with changes to manufacturing sites, ingredients or manufacturing processes could lead to, among other things, significant delays, an increase in operating costs, lost product sales, an interruption of research activities or the delay of new product launches;
certain of Shire’s therapies involve lengthy and complex processes, which may prevent Shire from timely responding to market forces and effectively managing its production capacity;
Shire has a portfolio of products in various stages of research and development. The successful development of these products is highly uncertain and requires significant expenditures and time, and there is no guarantee that these products will receive regulatory approval;
the actions of certain customers could affect Shire’s ability to sell or market products profitably. Fluctuations in buying or distribution patterns by such customers can adversely affect Shire’s revenues, financial conditions or results of operations;
Shire’s products and product candidates face substantial competition in the product markets in which it operates, including competition from generics;
adverse outcomes in legal matters, tax audits and other disputes, including Shire’s ability to enforce and defend patents and other intellectual property rights required for its business, could have a material adverse effect on the Company’s revenues, financial condition or results of operations;
inability to successfully compete for highly qualified personnel from other companies and organizations;
failure to achieve the strategic objectives, including expected operating efficiencies, cost savings, revenue enhancements, synergies or other benefits at the time anticipated or at all with respect to Shire’s acquisitions, including NPS Pharmaceuticals Inc., Dyax Corp. or Baxalta Incorporated may adversely affect Shire’s financial condition and results of operations;
Shire’s growth strategy depends in part upon its ability to expand its product portfolio through external collaborations, which, if unsuccessful, may adversely affect the development and sale of its products;
a slowdown of global economic growth, or economic instability of countries in which Shire does business, as well as changes in foreign currency exchange rates and interest rates, that adversely impact the availability and cost of credit and customer purchasing and payment patterns, including the collectability of customer accounts receivable;
failure of a marketed product to work effectively or if such a product is the cause of adverse side effects could result in damage to Shire’s reputation, the withdrawal of the product and legal action against Shire;
investigations or enforcement action by regulatory authorities or law enforcement agencies relating to Shire’s activities in the highly regulated markets in which it operates may result in significant legal costs and the payment of substantial compensation or fines;
Shire is dependent on information technology and its systems and infrastructure face certain risks, including from service disruptions, the loss of sensitive or confidential information, cyber-attacks and other security breaches or data leakages that could have a material adverse effect on Shire’s revenues, financial condition or results of operations;
Shire incurred substantial additional indebtedness to finance the Baxalta acquisition, which has increased its borrowing costs may decrease its business flexibility; and

a further list and description of risks, uncertainties and other matters can be found in Shire’s most recent Annual Report on Form 10-K and in Shire’s subsequent Quarterly Reports on Form 10-Q, in each case including those risks outlined in “ITEM 1A: Risk Factors”, and in Shire’s subsequent reports on Form 8-K and other Securities and Exchange Commission filings, all of which are available on Shire’s website.

10/25/2017

Biden Cancer Initiative President & FasterCures Executive Director to Keynote Georgia Bio Innovation Summit October 24

Tue, 02 Jul 2019 18:34:05 GMT

Atlanta, GA (October 20, 2017) – The Georgia Bio Innovation Summit will welcome patient advocate and visionary strategist Greg Simon, who leads the Biden Cancer Initiative, and Kim McCleary, Acting Executive Director at FasterCures, a center of the Milken Institute, as the plenary speakers for the October 24, 2017 event at Cobb Galleria.

Immediately following her remarks, Ms. McCleary will moderate a panel discussion on “Engaging for Success: Patient Centricity Comes of Age” with: Robert K. Coughlin, President & CEO of the Massachusetts Biotechnology Council and a cystic fibrosis patient advocate, and Jason Spangler MD, MPH, FACPM, Executive Director for Value, Quality, & Medical Policy at Amgen.

The Summit is the largest gathering of life science leaders in the state. According to a 2016 TEConomy report, the bioscience industry in Georgia is sizable and growing, reaching nearly 30,000 jobs across 2,047 business establishments. Georgia’s bioscience and biomedical research complex is large with nearly $967 million in bioscience academic R&D.

This year’s conference will offer the opportunity to hear about developments in the bioscience start-up community. The Company Investor Presentations features several Georgia-based startups describing their technologies, products and recent developments. To get a glimpse of emerging technologies from Georgia’s universities and companies, stop by the Innovation Stageduring the exhibition breaks. The always popular Life Science Leader Chats provide the opportunity to learn from seasoned executives about the skills every entrepreneur needs.

The Summit serves as the only life sciences exposition in Georgia with an Exhibit Hall featuring the latest research, technology and services at companies, universities and other organizations. The Summit also features a Scientific Poster Contest where representatives from Georgia-based academia, research institutes and industry alike will showcase their research.

The event will close with a Casino Night Gala and Silent Auction where attendees can network and raise funds for the Georgia BioEd Institute, which provides K-12 STEM programming in bioscience and medtech throughout the state. Casino Night tickets are available onsite.

Georgia Bio (www.gabio.org) is the state’s private, non-profit life sciences association. Members include pharmaceutical, biotechnology and medical device companies, medical centers, universities and research institutes, government groups and other business organizations involved in the development of life sciences related products and services.

Editor’s Note: Registration is complimentary for credentialed members of the news media. To request media registration, please contact Maria Thacker at mthacker@gabio.org | 404-920-2042.

10/20/2017

The future of drug pricing: Value over volume

Tue, 02 Jul 2019 18:35:12 GMT

Doctors and hospitals are increasingly being paid not for the quantity of care they provide, but for the outcome or quality of care patients receive. The emerging trend in health care is about rewarding value, rather than volume. This is the future, where there is less focus on the number of tests or treatments a patient receives and more focus on whether a patient’s health is improving.

While value-based pricing is showing great promise in other areas of health care, expanding this approach to prescription drugs is restricted by outdated federal rules. Yet this hasn’t stopped critics from labelling this innovative approach a failure before it has been given a chance to succeed.

With a new wave of breakthrough cures and therapies expected in the coming years, ensuring prescription drugs are accessible and affordable will remain an important concern for drugmakers, policymakers, and the broader public. As the drug pricing debate continues, there are some key facts to keep in mind about a value-based model that highlight why it’s important for patients and the future of biomedical innovation.

Outcomes-based pricing is already happening.

This approach may be limited in the area of prescription drugs, but it isn’t new. Current value-based agreements cover patients with rheumatoid arthritis, hepatitis C, diabetes, congestive heart failure, and even a form of cancer in children and young adults.

Roughly 20 agreements have been announced in recent months, and each is developed with differing details. For example, some result in larger rebates or lower prices if a drug does not lead to its intended results. Other arrangements let patients “try before you buy” and only require payment if the therapy works. Still others promote “pay for performance” in which a drug’s cost is tied to its effectiveness.

These efforts are answering important questions and providing insights that will help expand this approach to more patients.

Future treatments will be more accessible and affordable.

While nearly 90 percent of all drugs on the market are low-cost generic medicines, roughly 5 percent of patients take so-called “specialty” drugs to treat serious or life-threatening diseases. These drugs represent one-third of all drug spending, and this trend is expected to continue with the discovery of new treatments for rare diseases and other highly personalized medicines.

Because drugmakers are accountable for patient outcomes, a value-based approach encourages insurers to ease coverage restrictions on more costly, innovative medicines. This occurs when an insurer places a drug on a lower cost-sharing tier, which reduces a patient’s out-of-pocket costs and encourages better medication adherence. What does this mean for patients? It means they have affordable access to the treatments they need and greater opportunity to enjoy healthier lives.

This will bend the cost curve in health care.

Biomedical innovation not only saves and improves the lives of patients, it also reduces other forms of health care spending. For example, every $1 spent on medicine for congestive heart failure for adherent patients saves an estimated $8 in other health services.

Further, the creation of the Medicare Part D prescription drug program reduced annual hospitalization costs by roughly $1.5 billion. It has been estimated that if researchers could develop a treatment to delay the onset of Alzheimer’s by five years, it would generate $367 billion in annual health care savings by 2050.

The facts show that prescription medicines — when taken as prescribed — reduce the need for more costly health services (like hospital stays and doctor visits). By ensuring future cures are accessible and patients adhere to their medications, value-based pricing will lower the trajectory of health care spending.

Outdated federal policies are standing in the way.

Over the years, policymakers have adopted several policies designed to protect patients and taxpayers, such as the Medicaid “Best Price” rule and restrictions on communications between drugmakers and payers. These policies may have been appropriate for the old payment model based on volume or consumption, but they also act as barriers to a value-based approach.

Providing more legal and regulatory flexibility — while maintaining strong protections for patients and taxpayers — will expand the use of outcomes-based drug pricing, and more importantly, advance patient health by providing better access to the treatments they need.

It’s one part of a broader effort to address drug costs.

Often policymakers respond to drug costs with calls for heavy-handed government intervention that would stymie innovation and harm patients who rely on new cures and treatments. That’s why the Council for Affordable Health Coverage — a coalition including drugmakers, insurers, pharmacy benefit managers, patient groups and employers — introduced a set of consensus reforms to tackle affordability of prescription drugs. These solutions leverage the power of the free market to promote greater access to affordable medicines and will protect biomedical innovation that saves lives.

In 2016, Congress passed the 21st Century Cures Act. The law reflects years of bipartisan work to deliver new hope to patients by accelerating the discovery of new cures and treatments. To achieve the full promise of the law, policymakers will need to think creatively about how the country pays for prescription drugs.

For the sake of patients and the future of biomedical innovation, value-based drug pricing will need to be at the center of this important effort.

Jim Greenwood, a former six-term member of Congress from Bucks County (Pa.), is the CEO of the Biotechnology Innovation Organization (BIO), the world’s largest biotechnology trade association.

10/19/2017

Intent Solutions™ Well Positioned to Address U.S. Opioid Crisis

Tue, 02 Jul 2019 18:36:12 GMT

ATLANTA (Oct. 17, 2017) — Intent Solutions™, creator of the breakthrough medical device technology, TAD™, has rounded out its executive team in preparation for going commercial later this year, which puts the company in a promising position to address the ongoing national opioid crisis. The commercialization efforts follow the company’s successful $1.5 million seed round capital raise in 2016 and an additional $1.5M in 2017.

“Even with great doctors and groundbreaking medications, patient results will be ineffective if they don’t take their medication as directed,” said Sam Zamarripa, Intent Solutions CEO. “We have a mission inside healthcare and research — we’re looking to alter the very definition of what it means to be adherent.”

In addition to helping address the national opioid crisis as reported by the Atlanta Journal Constitution, the medication dispenser helps facilitate clinical trials with its ability to record adherence data, which is sent to a cloud database for analysis, reducing errors and simplifying data reconciliation.

Since his promotion to CEO from his previous post as president, Zamarripa has led the development of Intent Solutions’ market strategy, helped to attract serious investments, and hired experienced executives to complete its management team, giving the company an edge as it looks to go commercial.

“The board’s mandate to me is to grow the company and successfully take it to market,” Zamarripa said. “With the addition of new key executive members, Intent Solutions is poised for commercial success in the areas of addiction, pain treatment, clinical trials, and beyond.”

Recent staff additions include:
Ward Broom, chief operating officer: Broom co-founded a healthcare business and has experience in taking a product from development to an exit. Broom has two degrees from the Georgia Institute of Technology and is currently completing his MBA with a focus in management of technology.
Paul Quiner, chief strategy officer and general counsel: Having spent his entire career in healthcare, both on the law and business development sides, Quiner most recently oversaw acquisitions for his former employer, McKesson, a Fortune 5 company. He brings a unique perspective on regulatory issues and overall strategy. His role with Intent Solutions will include helping to prioritize all the opportunities the company has in healthcare, putting together a solid strategy for success.

With the new energy and expertise of its additional hires, Intent Solutions is pushing into the final frontier of medicine. Knowing the need for a solution in addition and clinical trials, the company also is studying other markets including oncology drugs, specialty pharma, chronic pain, and tracking medication for adolescents and the elderly.
For more information on Intent Solutions or the TAD device, visit www.IntentSolutions.com or contact Sam@Intentsolutions.com.

About Intent Solutions:
Headquartered in Atlanta, Georgia, Intent Solutions is a technology, software, and data service company focused on developing solutions for clinical research, pain management, and specialized pharmacy. Its products markedly improve the monitoring and management of medication adherence and provide real time behavioral data to more accurately measure compliance and efficacy. For more information, visit: intentsolutions.com.

10/17/2017

Atlanta biomedical company @CryoLife buying German company for $225M

Tue, 02 Jul 2019 18:37:26 GMT

CryoLife has entered into a definitive agreement to acquire JOTEC AG (“JOTEC”). JOTEC is a German-based, privately-held developer of technologically differentiated endovascular stent grafts, and cardiac and vascular surgical grafts, focused on aortic repair. The combination of CryoLife and JOTEC will create a Company with a broad and highly competitive product portfolio focused on aortic surgery, and will position CryoLife to compete strongly in the important and growing endovascular surgical markets.

Pat Mackin, Chairman, President, and Chief Executive Officer of CryoLife, said, “We believe this acquisition will enable CryoLife to deliver sustained, high single-digit revenue growth, while also diversifying our revenues into a significantly larger addressable market. JOTEC has a technologically differentiated product portfolio addressing the $2 billion global market for stent grafts used in endovascular and open repair of aortic diseases. Their advanced product portfolio has allowed them to achieve a 17 percent revenue CAGR over the past five years, significantly outpacing the growth in the overall European market. We expect the acquired portfolio to continue to post double-digit growth outside of the United States for at least the next five years. In addition, the acquisition will leverage our global infrastructure and accelerate our ability to go direct in Europe, and will foster considerable cross-selling opportunities between the CryoLife and JOTEC product portfolios. The transaction will also drive gross margin expansion and accelerate our trajectory towards 20 percent or higher operating margins. We believe this will position CryoLife to deliver growth in non-GAAP EPS at a CAGR of at least 20 percent over the next five years.”

Mr. Mackin added, “We also expect the JOTEC new product pipeline and R&D capabilities to drive longer-term growth beyond the five year horizon, particularly as their most innovative products enter the U.S. market. We plan to utilize CryoLife’s clinical and regulatory expertise to gain FDA approval for these products, which we believe will allow for entry into the U.S. market.”

Thomas Bogenschütz, Chief Executive Officer of JOTEC, commented, “CryoLife is ideally positioned to accelerate adoption of our products through its highly complementary and global cardiac and vascular surgery business. We are looking forward to working with CryoLife’s team to drive growth of our existing business, expand into new geographies, and accelerate our R&D initiatives in key markets such as the U.S.”

JOTEC generated revenue of approximately €41 million in 2016, representing compound annual growth of approximately 17 percent over the preceding five years. JOTEC generated revenues of €43 million, or approximately $51 million at current currency exchange rates, for the twelve months ended June 30, 2017.

Strategic Rationale for the Transaction

Provides CryoLife with:
- Technologically advanced and highly competitive product portfolio that is taking market share
- A strong new product pipeline and outstanding R&D capabilities
- Near-term and longer-term revenue growth drivers through 2028; and
- Access to the $1.2 billion U.S. stent graft market, which is expected to grow to approximately $1.5 billion by 2021
Increases CryoLife’s addressable market opportunity via access to the current $2.0 billion global stent graft market, which is expected to grow to approximately $2.5 billion by 2021
Accelerates CryoLife’s direct sales strategy in key European markets
Creates significant cross-selling opportunities by leveraging CryoLife’s and JOTEC’s existing direct sales organizations
Drives projected high single-digit revenue growth, expands gross margin, and yields 20 percent plus operating margin over a five-year period

Terms of the Agreement

Under terms of the definitive agreement, CryoLife will acquire JOTEC for an upfront payment of $225 million, subject to certain adjustments, consisting of 75 percent in cash and 25 percent in CryoLife common stock issued to JOTEC’s shareholders. CryoLife expects to finance the transaction and related expenses, as well as refinance its existing $69 million term loan, with new $255 million senior secured credit facilities, consisting of a $225 million institutional term loan B and a $30 million undrawn revolving credit facility, $56.25 million in CryoLife common stock, and available cash on hand. The senior secured credit facilities are fully underwritten by Deutsche Bank, Capital One and Fifth Third Bank, and are expected to be syndicated to investors prior to closing of the acquisition.

The definitive agreement has been approved by both companies’ boards of directors. The transaction is expected to close later this year, subject to customary closing conditions.

Financial Commentary

Third quarter revenues were adversely affected due to the impact of the recent hurricanes on our business in Florida and Texas, which we estimate to be approximately $1.0 million, and additionally due to the continued delay in obtaining the re-certification of our AAP. Including the impact of these factors, third quarter revenue was approximately $45.1 million, compared to our third quarter revenue guidance of between $46.5 and $47.5 million. In addition, in connection with the transaction, CryoLife notified certain of its distributors that it had elected to terminate its relationship with those distributors based on a decision to distribute product through the to be combined Company’s direct sales channel. As a result of this decision, at the end of the respective contract terms, CryoLife will be buying back a portion of the inventory that was previously sold to these distributors, which will result in a $1.1 million third quarter reversal of previously recorded revenues. Considering all of these factors, preliminary third quarter revenues were approximately $44.0 million. Additional revenue reversals and revisions to the third quarter estimates are possible in subsequent quarters.

Management expects to update its 2017 financial guidance in its third quarter financial conference call and to issue initial financial guidance for the combined Company in its year-end conference call.

Moving forward, the Company expects pro forma compound annual revenue growth in the high single-digits on a percentage basis over the next five years. Non-GAAP earnings per share is expected to be dilutive in 2018 and accretive in 2019. Over the next five year period, the Company expects 20 plus percent compound growth in non-GAAP earnings per share.

Advisors

In connection with the transaction, Vinson and Elkins is acting as lead legal counsel to CryoLife. Walder Wyss Ltd is acting as lead legal counsel to JOTEC.

Webcast and Conference Call Information

CryoLife will hold a teleconference call and live webcast tomorrow at 8:30 a.m. Eastern Time to discuss the proposed transaction, followed by a question and answer session hosted by Mr. Mackin.

To listen to the live teleconference, please dial 201-689-8261 a few minutes prior to 8:30 a.m. A replay of the teleconference will be available October 11 through October 18 and can be accessed by calling (toll free) 877-660-6853 or 201-612-7415. The conference number for the replay is 13671595.

The live webcast and replay can be accessed by going to the Investor Relations section of the CryoLife website at www.cryolife.com and selecting the heading Webcasts & Presentations.

About CryoLife

Headquartered in suburban Atlanta, Georgia, CryoLife is a leader in the manufacturing, processing, and distribution of medical devices and implantable living tissues used in cardiac and vascular surgical procedures. CryoLife markets and sells products in more than 80 countries worldwide. For additional information about CryoLife, visit our website, www.cryolife.com.

About JOTEC

Headquartered in Hechingen, Germany, JOTEC develops, produces, and markets medical devices for aortic and peripheral vascular disease. JOTEC’s product portfolio encompasses conventional vascular grafts and interventional implants for vascular and cardiac surgery and radiology and cardiology. JOTEC was founded in 2000. For additional information about JOTEC, visit the website, www.jotec.com/en/.

10/11/2017

Recro Pharma Announces PDUFA Date for IV Meloxicam 30mg

Tue, 02 Jul 2019 18:38:30 GMT

PDUFA Date Set For May 26, 2018

MALVERN, Pa., Oct. 05, 2017 (GLOBE NEWSWIRE) -- Recro Pharma, Inc. (Nasdaq:REPH), a revenue generating specialty pharmaceutical company focused on therapeutics for hospital and other acute care settings, today announced that the U.S. Food and Drug Administration (FDA) has set a PDUFA date of May 26, 2018 for its decision on the New Drug Application (NDA) for for intravenous (IV) meloxicam 30mg for the management of moderate to severe pain.

About IV/IM Meloxicam 30mg

Meloxicam is a long-acting, preferential COX-2 inhibitor that possesses analgesic, anti-inflammatory and antipyretic activities, which are believed to be related to the inhibition of cyclooxygenase (COX) and subsequent reduction in prostaglandin biosynthesis. IV meloxicam 30mg was designed using the NanoCrystal® platform, a technology that enables enhanced bioavailability of poorly water-soluble drug compounds. NanoCrystal® is a registered trademark of Alkermes Pharma Ireland Limited (APIL).

About Recro Pharma, Inc.

Recro Pharma is a specialty pharmaceutical company that operates through two business divisions, an Acute Care, hospital product division and a revenue-generating contract development and manufacturing, or CDMO division, located at the Company’s Gainesville facility. The Acute Care division is primarily focused on developing innovative products for hospital and other acute care settings. The Company’s lead product candidate is a proprietary injectable form of meloxicam, a long-acting preferential COX-2 inhibitor. IV meloxicam 30mg has successfully completed two pivotal Phase III clinical efficacy trials in patients following bunionectomy and abdominoplasty surgeries, a large double blind Phase III safety trial, four Phase II clinical trials for the management of moderate to severe post-operative pain, as well as other safety studies. As injectable meloxicam is in the non-opioid class of drugs, the Company believes it will overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential while maintaining meaningful analgesic effects for relief of pain. The Company’s CDMO division leverages its formulation expertise to develop and manufacture pharmaceutical products using its proprietary delivery technologies and other manufacturing services for commercial partners who commercialize or plan to commercialize these products. These collaborations can result in revenue streams including royalties, profit sharing, research and development and manufacturing fees, which support continued operations for its CDMO division and it contributes non-dilutive funding for the development and pre-commercialization activities of its Acute Care division.

Cautionary Statement Regarding Forward Looking Statements

This press release contains forward-looking statements that involve risks and uncertainties. Such forward looking statements reflect Recro's expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words "anticipate," "believe," "estimate," "upcoming," "plan," "target", "intend" and "expect" and similar expressions, as they relate to Recro or its management, are intended to identify such forward-looking statements. These forward looking statements are based on information available to Recro as of the date of this press release and are subject to a number of risks, uncertainties, and other factors that could cause Recro’s performance to differ materially from those expressed in, or implied by, these forward looking statements. Recro assumes no obligation to update any such forward-looking statements. Factors that could cause Recro’s actual performance to materially differ from those expressed in the forward-looking statements set forth in this press release include, without limitation: the ability to obtain and maintain regulatory approval of injectable meloxicam and the labeling under any such approval; regulatory developments in the United States and foreign countries; results and timing of the clinical trials of injectable meloxicam, the Company’s ability to achieve its financial goals, including financial guidance; the Company’s ability to raise future financing for continued development and the payment of milestones; the Company’s ability to pay its debt; customer product performance and ordering patterns, the performance of third-party suppliers and manufacturers; the Company’s ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection; and the successful commercialization of injectable meloxicam. In particular, there can be no assurance that the FDA will complete its review by the PDUFA goal date, that the FDA will not require changes or additional data, or that the FDA will approve the NDA. The forward looking statements in this press release should be considered together with the risks and uncertainties that may affect Recro’s business and future results included in Recro’s filings with the Securities and Exchange Commission at www.sec.gov. Recro assumes no obligation to update any such forward looking statements.

CONTACT:

Investor Relations Contact:
Argot Partners
Susan Kim/Natalie Wildenradt
(212) 600-1902
susan@argotpartners.com
natalie@argotpartners.com

Recro Pharma, Inc.
Michael Celano
(484) 395-2413
mcelano@recropharma.com

Media Contact:
Argot Partners
Eliza Schleifstein
(973) 361-1546
eliza@argotpartners.com

10/05/2017

Emory University research funding breaks new record, $628M for FY 2017

Tue, 02 Jul 2019 18:39:33 GMT

Emory University reported Monday that it pocketed $628 million in external research funding in fiscal year 2017, an increase from $574.6 million the year before and a new record high.

Emory attributed the big increase to "groundbreaking results and the promise of future discoveries with the potential to change the face of science and medicine."

Researchers in Emory's Woodruff Health Sciences Center (WHSC) received more than $584.8 million in FY17, or more than 93 percent of the university total. The WHSC includes schools of medicine, public health, nursing, Yerkes National Primate Research Center, Winship Cancer Institute and Emory Healthcare.

Of the 2017 total, more than 61 percent, or $384 million, came from federal agencies. Read the full story here.

09/26/2017

Georgia Clinical & Translational Science Alliance receives $51 million NIH state-wide grant

Tue, 02 Jul 2019 18:40:24 GMT

After a decade of research collaboration, the Atlanta Clinical & Translational Science Institute (ACTSI) will welcome a new partner and change its name, reflecting a new statewide focus. The University of Georgia will officially become the fourth academic partner and ACTSI will now be known as the Georgia Clinical & Translational Science Alliance (Georgia CTSA)

This alliance is celebrating 10 years of research advancement by expanding across the state through a five-year, $51 million Clinical and Translational Science Award (CTSA) from the National Institutes of Health (NIH). The Emory-led Georgia CTSA will focus on transforming the quality and value of clinical research and translating research results into better outcomes for patients.

The Georgia CTSA unites the strengths of its academic partners, Emory University, Morehouse School of Medicine, the Georgia Institute of Technology and the University of Georgia (UGA). Emory is a national leader in health care and biomedical research as well as an outstanding leader in clinical and translational research training and education. Morehouse School of Medicine is a nationally recognized historically black institution that brings ethnic diversity to biomedical research, addresses health disparities through successful community engagement research, and serves as a pipeline for training minority researchers. Georgia Tech is a national leader in biomedical engineering, bioinformatics, and the application of innovative systems engineering to health care solutions. UGA has a proven track record in outstanding basic and translational research and, as the state's land-grant institution, offers a robust statewide network that enhances community outreach, service and research.

"Continuing such an alliance and involving these leading state institutions is extremely important and in-line with Georgia's goals for the promotion of clinical and translational research, innovation and development," says Nathan Deal, Governor, State of Georgia. "Having an active Clinical & Translational Science Awardee in Georgia has brought our citizens cutting-edge cures and the latest in clinical and translational research."

Georgia CTSA is one of 64 Clinical and Translational Science Awards (CTSA) at major academic medical centers across the country, funded by the National Institutes of Health's National Center for Advancing Translational Science, and is the only CTSA in Georgia. The award will fund cores focused on improving quality, efficiency and collaboration of the research process, provide consultative support and new tools in bioinformatics and biostatistics, pilot funding for new research projects, training and workforce development, while integrating special populations and focusing on participant interactions, and creating local centers tackling clinical trial inefficiencies.

The Georgia CTSA welcomes contact principal investigator (PI) at Emory, W. Robert Taylor, MD, PhD, and a new multi-PI leadership structure:

W. Robert Taylor, MD, PhD
Contact Principal Investigator, Georgia CTSA
Interim Chair, Department of Medicine
Director, Division of Cardiology
Marcus Chair in Vascular Medicine
Professor of Medicine and Biomedical Engineering
Emory University School of Medicine

Elizabeth O. Ofili, MD, MPH
Principal Investigator, Morehouse School of Medicine, Georgia CTSA
Professor of Medicine, Cardiology
Senior Associate Dean of Clinical and Translational Research
Director, Clinical Research Center
Morehouse School of Medicine

Andrés J. García, PhD
Principal Investigator, Georgia Institute of Technology, Georgia CTSA
Rae S. and Frank H. Neely Endowed Chair and Regents' Professor, Woodruff School of Mechanical Engineering and Petit Institute for Bioengineering and Bioscience
Director, Interdisciplinary Bioengineering Graduate Program
Georgia Institute of Technology

Bradley G. Phillips, PharmD, BCPS, FCCP
Principal Investigator, University of Georgia, Georgia CTSA
Millikan-Reeve Professor and Head, Clinical & Administrative Pharmacy, College of Pharmacy
Director, Clinical and Translational Research Unit (CTRU), Office of Research
University of Georgia

Henry M. Blumberg, MD
Principal Investigator, KL2 and TL1, Georgia CTSA
Professor of Medicine and Epidemiology, Division of Infectious Diseases
Emory University School of Medicine

"The Georgia CTSA creates a unique opportunity for synergy among historic partners in health care, education and cutting-edge research, and has emerged as an innovative and integrated environment where clinical and translational researchers can flourish," says Taylor. "The Georgia CTSA is a catalyst and incubator for clinical and translational research across the state, with impacts throughout the Southeast and nation."

Georgia CTSA has improved health care and research for Georgia citizens through collaboration with the Grady Health System, Children's Healthcare of Atlanta, Atlanta VA Medical Center, Georgia Research Alliance, Georgia Bio, and multiple community medical groups throughout the state.

"Georgia CTSA continues established, strong clinical and research partnerships by leveraging the infrastructure support of the NIH-funded Research Centers at Minority Institutions (RCMI) at Morehouse School of Medicine. We will continue to implement innovative patient centered and participatory care delivery models, toward the elimination of health disparities," says Ofili.

"Georgia CTSA's innovative support of discovery and collaborative partnerships help to rapidly translate scientific discoveries and new technology, which positively impacts patient care in Georgia. This is an exciting story for the state," says Garcia. The new alliance is improving health care and clinical research for the citizens of Georgia and continues to create synergies that foster and accelerate new and emerging technologies and discoveries.

"The addition of UGA provides the Georgia CTSA a state-wide footprint to connect with every county in the state to address health and wellness needs, particularly in rural and underserved populations; opportunities for continued excellence in research by strengthening existing and expanding new research collaborations; and the ability to enrich interprofessional education to include students and trainees from pharmacy and other disciplines so that they can learn how to work together as a team to discover new approaches and treatments that improve health and patient care," says Phillips. "As a new member of the Georgia CTSA, faculty and students across our campus will have unique support and infrastructure that builds upon current capabilities and increases our trajectory in fostering clinical and translational science in the state and beyond."

09/26/2017

UCB’s anti-epileptic drug VIMPAT® (lacosamide) receives EU approval for paediatric use

Tue, 02 Jul 2019 18:41:57 GMT

UCB’s anti-epileptic drug VIMPAT® (lacosamide) receives EU approval for paediatric use

VIMPAT® is approved for monotherapy and adjunctive therapy of partial-onset (focal) seizures in children aged 4 years and older and now provides a new treatment choice for physicians and their paediatric patients with epilepsy.1
Epilepsy is the most common serious neurological disorder among children and young adults with the prevalence of paediatric epilepsy in Europe ranging from 3.2 – 5.1 per 1,000.2
Despite its high prevalence, approximately 10 – 29% of paediatric epilepsy patients experience inadequate seizure control with currently available anti-epileptic drugs.3,4

Brussels (Belgium), 21 September 2017 – 18:00 (CEST): UCB today announced that the European Commission (EC) approved expanding the use of its anti-epileptic drug (AED) VIMPAT® (lacosamide) as monotherapy and adjunctive therapy in the treatment of partial-onset seizures (also known as focal-onset seizures (FOS) according to ILAE terminology 5,6) with or without secondary generalisation in adults, adolescents and children from 4 years of age.1

The approval follows a positive opinion adopted in July by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), and provides a new treatment option to aid the management of childhood epilepsy.7

“Today’s approval of VIMPAT® for children aged 4 to 16 is an important step forward for the management of paediatric epilepsy, a condition which can present significant challenges to children and their families,” said Jeff Wren, Executive Vice-President, Head of UCB’s Neurology Patient Value Unit. “One of our key commitments at UCB is to improve the lives of people with epilepsy, and we are proud to be providing a proven treatment option for this highly impacted patient population.”

Epilepsy is a common, chronic neurological disorder, affecting approximately 65 million people worldwide,8 with almost half of incident cases diagnosed during childhood.9 There are a number of comorbidities in childhood that may be associated with epilepsy, including cognitive impairment and neuropsychiatric conditions, mood disorders, and physical comorbidities.10 The stigma associated with epilepsy, especially during adolescence, has been related to low self-esteem, worry, and negative feelings about life,11 with 12 – 26% of children with epilepsy reporting depression and anxiety.12 Paediatric patients may suffer from adverse events with currently available AEDs.13 As such, there is a need for additional treatment options that may provide seizure control with a low side effect profile.

“Paediatric patients with focal seizures can still experience poor seizure control with currently available treatment options, along with a reduced quality of life,” said Professor Alexis Arzimanoglou, Coordinator of the Epilepsy Program of the Epilepsy Unit at San Juan de Deu Barcelona Children's University Hospital and Director of the Paediatric Clinical Epileptology, Sleep disorders and Functional Neurology Department at the University Hospitals of Lyon, France. “With the approval of lacosamide, healthcare professionals and paediatric patients in the EU now have an additional treatment option for focal onset seizures, either as monotherapy or adjunctive therapy, representing a great advance to further help children aged 4 years and older suffering from epilepsy.”

The approval of VIMPAT is based on the principle of extrapolation of its efficacy data from adults to children, and is supported by safety and pharmacokinetics data collected in children. The EMA has established that focal epilepsies in children older than 4 years old have a similar clinical expression to that in adolescents and adults.14 The Food and Drug Administration (FDA) and EMA allow extension of indication to paediatric populations using extrapolated data provided the dose is established and the safety is demonstrated. The EMA states that, from the safety viewpoint, a minimum of 100 children treated by the study drug should be followed for at least one year.14

VIMPAT has over 1,056,500 patient-years of exposure.15 Its established efficacy, safety and tolerability of adjunctive therapy in adults with focal seizures has been demonstrated by three double-blind and three open-label extension studies.16,17,18,19,20,21 The efficacy, safety and tolerability profile of first-line VIMPAT monotherapy has been demonstrated in a phase 3, double-blind study and a related open-label extension study.22

VIMPAT is approved in 72 countries worldwide. In the EU, it is also approved as monotherapy and adjunctive therapy for the treatment of partial-onset seizures (POS) with or without secondary generalisation in adults and adolescents (16 – 18 years) with epilepsy.23 In the US, VIMPAT is approved as monotherapy or adjunctive therapy for the treatment of POS in adults with epilepsy (ages ≥ 17 years).24

About VIMPAT®

VIMPAT® (lacosamide) was first launched in the European Union in September 2008, as adjunctive therapy for the treatment of partial-onset seizures with or without secondary generalisation in adult and adolescent (16-18 years) patients with epilepsy. In countries of the EU, VIMPAT® is available as film-coated tablets, syrup and solution for infusion. VIMPAT® solution for infusion is an alternative for patients when oral administration is temporarily not feasible. VIMPAT® tablets and injection were launched in the U.S. in May 2009 as an add-on therapy for the treatment of partial-onset seizures in people with epilepsy who are aged 17 years and older. VIMPAT® injection is a short-term replacement when oral administration is not feasible in these patients. VIMPAT® oral solution was launched in the US in June 2010. The availability of the oral tablets, oral solution, and intravenous (IV) injection allows for consistent patient treatment. In Asia, VIMPAT® is available in Korea, Hong Kong, Malaysia, Philippines and Thailand, and was approved for use in Japan in 2016, where the product will be jointly commercialised by Daiichi Sankyo. VIMPAT® is not approved in China.

Important safety information about VIMPAT® is available below.

About Epilepsy 8,25

Epilepsy is a disease of the brain affecting approximately 65 million people worldwide. It is defined as either the occurrence of two or more unprovoked seizures >24 hours apart or one unprovoked (or reflex) seizure and a probability of further seizures occurring over the next 10 years that is similar to the general recurrence risk (at least 60%) after two unprovoked seizures or diagnosis of an epilepsy syndrome. Although epilepsy may be linked to factors such as health conditions, race and age, it can develop in anyone at any age, and approximately 1 in 26 people will develop epilepsy in their lifetime.

About UCB in Epilepsy

UCB has a longstanding commitment to improving the lives of people with epilepsy around the world. With over 20 years of experience in the research and development of antiepileptic drugs, our goal is to become a preferred partner for the global epilepsy community, improving knowledge about and access to effective solutions to help patients better manage their individual epilepsy journeys. We strive to partner and create super-networks with world-leading scientists and clinicians in academic institutions, pharmaceutical companies and other organizations who share our goals. At UCB, we are inspired by patients, and driven by science in our commitment to support people with epilepsy.

About UCB

UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 7500 people in approximately 40 countries, the company generated revenue of €4.2 billion in 2016. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news

Important Safety Information about VIMPAT® in the EU and EEA

VIMPAT® is indicated as monotherapy and adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy. VIMPAT® therapy can be initiated with either oral or IV administration. For the paediatric population, the physician should prescribe the most appropriate formulation and strength according to weight and dose. A single loading dose may be initiated in patients in situations when the physician determines that rapid attainment of lacosamide steady state plasma concentration and therapeutic effect is warranted. It should be administered under medical supervision with consideration of the potential for increased incidence of CNS adverse reactions. Administration of a loading dose has not been studied in acute conditions such as status epilepticus. Use of a loading dose is not recommended in adolescents and children weighing less than 50 kg. A maximum dose of 300 mg/day is recommended for paediatric patients weighing 50 kg or more and for adult patients with mild to moderate hepatic impairment. Based on data in adults, in paediatric patients weighing less than 50 kg with mild to moderate hepatic impairment, a reduction of 25 % of the maximum dose should be applied. Lacosamide should be administered to adult and paediatric patients with severe hepatic impairment only when the expected therapeutic benefits are anticipated to outweigh the possible risks. The dose may need to be adjusted while carefully observing disease activity and potential side effects in the patient. In adolescents and adults weighing 50 kg or more with mild to moderate hepatic impairment a loading dose of 200mg may be considered, but further dose titration (>200 mg daily) should be performed with caution. In paediatric patients weighing 50 kg or more and in adult patients with mild or moderate renal impairment a loading dose of 200 mg may be considered, but further dose titration (> 200 mg daily) should be performed with caution. In paediatric patients weighing 50 kg or more and in adult patients with severe renal impairment (CLCR ≤ 30 ml/min) or with end-stage renal disease, a maximum dose of 250 mg/day is recommended and the dose titration should be performed with caution. In paediatric patients weighing less than 50 kg with severe renal impairment (CLCR ≤ 30 ml/min) and in those with end-stage renal disease, a reduction of 25 % of the maximum dose is recommended. Contraindications: Hypersensitivity to the active substance or any of the excipients; known second- or third-degree atrioventricular (AV) block. Special warnings and precautions for use: Treatment with VIMPAT® has been associated with dizziness which could increase the occurrence of accidental injury or falls. Therefore, patients should be advised to exercise caution until they are familiar with the potential effects of the medicine. Dose-related prolongations in PR interval with VIMPAT® have been observed in clinical studies. Cases with second- and third-degree AV block associated with VIMPAT® treatment have been reported in post-marketing experience. VIMPAT® should be used with caution in patients with known conduction problems, severe cardiac disease (e.g. history of myocardial infarction or heart failure), in elderly patients, or when VIMPAT® is used in combination with products known to be associated with PR prolongation. In these patients it should be considered to perform an ECG before a VIMPAT® dose increase above 400mg/day and after VIMPAT® is titrated to steady-state. In the placebo-controlled trials of VIMPAT® in epilepsy patients, atrial fibrillation or flutter were not reported; however both have been reported in open-label epilepsy trials and in post-marketing experience. Patients should be made aware of the symptoms of second-degree or higher AV block (e.g. slow or irregular pulse, feeling of lightheaded and fainting) and of the symptoms of atrial fibrillation and flutter (e.g. palpitations, rapid or irregular pulse, shortness of breath). Patients should be counseled to seek medical advice should any of these symptoms occur. Suicidal ideation and behaviour have been reported in patients treated with antiepileptic medicinal products in several indications. Therefore patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge. The safety and efficacy of lacosamide in paediatric patients with epilepsy syndromes in which focal and generalised seizures may coexist have not been determined. VIMPAT® syrup contains sodium methyl parahydroxybenzoate (E219) which may cause allergic reactions (possibly delayed). It contains 3.7 g sorbitol (E420) per dose (200 mg lacosamide), corresponding to a calorific value of 9.7 kcal. Patients with rare hereditary problems of fructose intolerance should not take this medicine. The syrup contains aspartame (E951), a source of phenylalanine, which may be harmful for people with phenylketonuria. VIMPAT® syrup and the solution for infusion contain sodium, which should be taken into consideration for patients on a controlled sodium diet. Effects on ability to drive and use machines: VIMPAT® may have minor to moderate influence on the ability to drive and use machines. VIMPAT® treatment has been associated with dizziness or blurred vision. Accordingly patients should be advised not to drive a car or to operate other potentially hazardous machinery until they are familiar with the effects of VIMPAT® on their ability to perform such activities. Undesirable effects: The most common adverse reactions (≥10%) are dizziness, headache, diplopia, and nausea. They were usually mild to moderate in intensity. Some were dose-related and could be alleviated by reducing the dose. Incidence and severity of CNS and gastrointestinal (GI) adverse reactions usually decreased over time. Incidence of CNS adverse reactions such as dizziness may be higher after a loading dose. Other common adverse reactions (≥1% - <10%) are depression, confusional state, insomnia, balance disorder, coordination abnormal, memory impairment, cognitive disorder, somnolence, tremor, nystagmus, hypoesthesia, dysarthria, disturbance in attention, paraesthesia, vision blurred, vertigo, tinnitus, vomiting, constipation, flatulence, dyspepsia, dry mouth, diarrhoea, pruritus, rash, muscle spasms, gait disturbance, asthenia, fatigue, irritability, feeling drunk, injection site pain or discomfort (local adverse events associated with intravenous administration), irritation (local adverse events associated with intravenous administration), fall, and skin laceration, contusion. The use of VIMPAT® is associated with dose-related increase in the PR interval. Adverse reactions associated with PR interval prolongation (e.g. atrioventricular block, syncope, bradycardia) may occur. The safety profile of lacosamide in open-label studies in adjunctive therapy in children from 4 years to less than 16 years was consistent with the safety profile observed in adults. In the paediatric population the most frequently reported adverse reactions were vomiting (17.1 %), dizziness (16.7 %), somnolence (12.1 %), headache (11.7 %) and convulsion (10.1 %). Additional adverse reactions reported in children were decreased appetite (6.6 %), lethargy (4.3 %) and abnormal behaviour (1.9 %). Laboratory abnormalities: Abnormalities in liver function tests have been observed in controlled trials with VIMPAT® in adult patients with partial-onset seizures who were taking 1-3 concomitant antiepileptic medicinal products. Elevations of ALT to ≥3XULN occurred in 0.7% (7/935) of VIMPAT® patients and 0% (0/356) of placebo patients. Multiorgan Hypersensitivity Reactions: Multiorgan hypersensitivity reactions (also known as Drug Reaction with Eosinophilia and Systemic Symptoms, DRESS) have been reported in patients treated with some antiepileptic medicinal products. These reactions are variable in expression but typically present with fever and rash and can be associated with involvement of different organ systems. If multiorgan hypersensitivity reaction is suspected, VIMPAT® should be discontinued.

Refer to the European Summary of Product Characteristics for other adverse reactions and full prescribing information. Date of revision: 14th September 2017 http://www.ema.europa.eu/.

Forward looking statements

Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement.

For further information:

Corporate Communications

France Nivelle, Global Communications, UCB

T+32.2.559.9178, France.nivelle@ucb.com

Jim Baxter, Neurology Communications, UCB

T+32.2.473.78.85.01, jim.baxter@ucb.com

Investor Relations

Antje Witte, Investor Relations, UCB

T+32.2.559.94.14, antje.witte@ucb.com

Isabelle Ghellynck,

Investor Relations, UCB

T +32.2.559.9588, isabelle.ghellynck@ucb.com

References

Data on File (European Commission, dated 19 September 2017).
Pugliatti, M., Beghi, E., Forsgren, L., Ekman, M., Sobocki, P. Estimating the cost of epilepsy in Europe: A review with economic modelling. Epilepsia. 2007;48(12):2224–2233.
Ohtsuka, Y., Yoshinaga, H., Kobayashi, K. Refractory childhood epilepsy and factors related to refractoriness. Epilepsia. 2000;41(Suppl 9):14-17.
Berg, A., Shinnar, S., Levy, S., Testa, F., Smith-Rapaport, S., Beckerman, B. Early development of intractable epilepsy in children: a prospective study. Neurology. 2001;56(11):1445-1452.
Fisher, R.S., Cross, H.J., French, J.A., et al. Operational classification of seizure types by the International League Against Epilepsy: Position Paper of the ILAE Commission for Classification and Terminology. Epilepsia. 2017;58(4):522-530.
Berg, A.T., et al. Revised terminology and concepts for organization of seizures and epilepsies: Report of the ILAE Commission on Classification and Terminology, 2005–2009. Epilepsia. 2010;51:676-85.
European Medicines Agency Committee for Medicinal Products for Human Use (CHMP), 20th July 2017. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion/human/000863/WC500231716.pdf. Accessed 20 September 2017.
The Epilepsy Foundation of America. Who gets epilepsy? Available at: http://www.epilepsy.com/learn/epilepsy-101/who-gets-epilepsy. Accessed 20 September 2017.
Shinnar, S., Pellock, J.M. Update on the epidemiology and prognosis of pediatric epilepsy. J Child Neurol. 2002;17(1):S4-17.
Wei, S., Lee, W-T. Comorbidity of childhood epilepsy. J Form Med Assoc. 2015;114:1031-1038.
MacLeod, J.S., Austin, J.K. Stigma in the lives of adolescents with epilepsy: a review of the literature. Epilepsy Behav. 2003;4(2):112-117.
Caplan, R., Siddarth, P., Gurbani, S., Hanson, R., Sankar, R., Shields, W.D. Depression and anxiety disorders in pediatric epilepsy. Epilepsia. 2005;46(5):720-730.
Guerrini, R., Zaccara, G., la Marca, G., Rosati, A. Safety and Tolerability of Antiepileptic Drug Treatment in Children with Epilepsy. Drug Saf. 2012;35(7):519-533.
European Medicines Agency. Guideline on clinical investigation of medicinal products in the treatment of epileptic disorders. 2010. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070043.pdf. Accessed 20 September 2017.
Periodic Safety Update Report data lock point Dec 15th 2016.
Ben-Menachem, E., Biton, V., Jatuzis, D., Abou-Khalil, B., Doty, P., Rudd, G.D. Efficacy and safety of oral lacosamide as adjunctive therapy in adults with partial-onset seizures. Epilepsia. 2007;48(7):1308-1317.
Chung, S., Sperling, M.R., Biton, V., Krauss, G., Hebert, D., Rudd, G.D., Doty, P. Lacosamide as adjunctive therapy for partial-onset seizures: A randomied controlled trial. Epilepsia. 2010;51(6):958-967.
Halász, P., Kälviäinen, R., Mazurkiewicz-Beldzinska, M., Rosenow, F., Doty, P., Hebert, D., Sullivan, T. Adjunctive lacosamide for partial-onset seizures: Efficacy and safety results from a randomized controlled trial. Epilepsia. 2009;50(3):443-453.
Rosenfeld, W., Fountain, N.B., Kaubrys, G., et al. Safety and efficacy of adjunctive lacosamide among patients with partial-onset seizures in a long-term open-label extension trial of up to 8 years. Epilepsy Behav. 2014;41:164-170.
Husain, A., Chung, S., Faught, E., Isojarvi, J., McShea, C., Doty, P. Long-term safety and efficacy in patients with uncontrolled partial-onset seizures treated with adjunctive lacosamide: results from a Phase III open-label extension trial. Epilepsia. 2012;53(3):521-528.
Rosenow, F., Kelemen, A., Ben-Menachem, E., et al. Long-term adjunctive lacosamide treatment in patients with partial-onset seizures. Acta Neurol Scand. 2016;133(2):136-144.
Baulac, M., Rosenow, F., Toledo, M., Terada, K., Li, T., de Backer, M., Werhahn, K.J., Borck, M. Efficacy, safety, and tolerability of lacosamide monotherapy versus controlled-release carbamazepine in patients with newly diagnosed epilepsy: a phase 3, randomised, double-blind, non-inferiority trial. Lancet Neurology. 2017;16(1):43-54.
European Medicines Agency. VIMPAT® (lacosamide). Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000863/human_med_001139.jsp&mid=WC0b01ac058001d124. Accessed 20 September 2017.
U.S. Food and Drug Administration. VIMPAT® (lacosamide) Prescribing Information. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022255s026s027,022254s019s020,022255s012s013lbl.pdf. Accessed 20 September 2017.
Fisher, R.S., et al., ILAE Official Report: A practical clinical definition of epilepsy. Epilepsia. 2014;55(4):475-482.

09/26/2017

Georgia State Partners With American Cancer Society To Support National Tobacco-Free Campus Initiative

Tue, 02 Jul 2019 18:42:52 GMT

ATLANTA—Researchers at Georgia State University’s School of Public Health are partnering with the American Cancer Society (ACS) on a project to help colleges and universities across the United States develop and implement tobacco-free policies.

ACS started the Tobacco-free Generation Campus Initiative (TFGCI) in 2016 with funds from the CVS Health Foundation to help 120 colleges and universities advocate for, adopt and implement 100 percent smoke- and tobacco-free campus policies. ACS estimates that of the 20 million college and university students in the country, 1 million will die prematurely due to smoking. Cigarette smoking remains responsible for nearly a third of all cancer deaths in the nation, and 99 percent of smokers take up the habit by the age of 26, making college campuses an ideal target for efforts to curb tobacco use, according to the ACS website for the initiative.

“We look forward to helping the American Cancer Society and participating universities in creating a tobacco-free generation of young people,” said Dr. Michael Eriksen, dean of the School of Public Health and an internationally recognized expert in tobacco control.

“Tobacco use still cuts too many lives short and causes serious health problems that burden individuals and society as a whole,” Eriksen said. “We want to do everything we can to support efforts to keep young people from getting addicted, and to help those who have started smoking or using tobacco in other forms to quit before they develop a deeply entrenched habit that is hard to break.”

Researchers Pamela Redmon and Amelia Jazwa will evaluate the effectiveness of the Tobacco-free Generation Campus Initiative by assessing tobacco use on participating campuses, the intentions to quit among students who use tobacco products, perceptions of anti-tobacco policies and their enforcement, among other issues.

The work is designed to help ACS gauge progress on participating campuses. For the first two cohorts of the program, ACS selected 64 campuses ranging from community colleges to major research universities such as the University of Michigan and Penn State University. The campuses serve more than 950,000 students across 27 states.

“College is a time when young people are susceptible to starting or developing a tobacco addiction,” said Richard C. Wender, M.D., chief cancer control officer of the American Cancer Society. “With the expert support from Georgia State University, we can ensure we are effectively reducing tobacco use among college students, and in turn, reducing the number of people who get sick and die from tobacco-related diseases.”

09/25/2017

New Infographic: A Response to “A Better Deal” on Drug Pricing

Tue, 02 Jul 2019 18:43:36 GMT

The United States is the global leader in biomedical innovation, discovering more new cures than the rest of the world combined. We have brilliant scientists, world-class research institutions, and dedicated investors. But what sets us apart is a commitment to free-market policies that reward innovation and recognize the inherent costs and risks of discovering new treatments.

As BIO President and CEO Jim Greenwood says, “The only thing that can stop the next wave of new cures is bad policy.” That’s why BIO created a video to “follow the pill” and launched DrugCostFacts.org to explain how drug prices are set, who determines what patients pay out of pocket for prescription drugs, and what are the real drivers behind health care spending. Our goal is to ensure the right policies are in place to protect patients and the future of biomedical innovation.

That effort continues with the release of a new infographic. Recently, Democratic leaders released an economic agenda called “A Better Deal.” This agenda includes numerous claims on prescription drug costs and outlines policy proposals that would harm biomedical innovation and patients. It’s important for policymakers and the public to have all the facts, and that is precisely what this new infographic is intended to do.

09/21/2017

Immune Cells Produce Wound Healing Factor, May Lead To New IBD Treatment Immune Cells Produce Wound

Tue, 02 Jul 2019 18:44:29 GMT

ATLANTA—Specific immune cells have the ability to produce a healing factor that can promote wound repair in the intestine, a finding that could lead to new, potential therapeutic treatments for inflammatory bowel disease (IBD), according to a new research study.

The research team, led by Georgia State University and the University of Michigan, wanted to understand how a wound heals in the intestine because in IBD, which includes Crohn’s disease and ulcerative colitis, damage to the intestinal epithelial barrier allows bacteria in the intestine to go across the barrier and stimulate the body’s immune system. This can lead to excessive inflammation and IBD. Efficient repair of the epithelial barrier is critical for suppressing inflammation and reestablishing intestinal homeostasis.

In this study, the researchers found that a specific population of immune cells called macrophages have the ability to secrete or produce a protective or healing factor known as Interleukin-10 (IL-10), which can interact with receptors on intestinal epithelial cells to promote wound healing. The findings are published in The Journal of Clinical Investigation.

“Understanding how wounds can be healed is believed to be very important and a potential therapeutic avenue for the treatment of inflammatory bowel disease,” said Dr. Tim Denning, associate professor in the Institute for Biomedical Sciences at Georgia State. “In this study, we tried to understand some of the cellular mechanisms that are required for optimal wound healing in the intestine. To do this, we used a cutting-edge system, a colonoscope with biopsy forceps, to create a wound in mice. This is analogous to colonoscopies in humans. This cutting-edge system allowed us to begin to define what cells and factors contribute to wound healing in the mouse model.”

The researchers used a small, fiber optic camera and forceps to pinch the mouse’s intestine and take a small biopsy, just as how colonoscopies are done in humans. This small pinch created a wound, which the researchers observed as it healed. The study compared intestinal wound healing in two groups of mice: 1) typical mice (wild type) found in nature and 2) mice genetically deficient in the healing factor IL-10, specifically in macrophages, which impairs their ability to have normal wound repair.

The team also analyzed the effects of IL-10 on epithelial wound closure in vitro using an intestinal epithelial cell line.

They concluded that macrophages are a main source of IL-10 in the wound bed, and IL-10 stimulates in vitro intestinal epithelial wound healing and increases in expression during in vivo intestinal epithelial wound repair. In vitro, exposure to IL-10 increased wound repair within 12 hours and the response was further enhanced after 24 hours.

“Basically, you have a wound, and you have an immune cell that comes in,” Denning said. “That’s the macrophage. The macrophage can produce a factor (IL-10), and that factor can then cause the cells that are around the wound to start closing the wound.”

In addition, the researchers defined some of the signaling pathways that IL-10 uses to orchestrate wound repair. They found IL-10 promotes intestinal epithelial wound repair through the activation of cAMP response element-binding protein (CREB) signaling at the sites of injury, followed by synthesis and secretion of the WNT1-inducible signaling protein 1 (WISP-1).

“The implications are that understanding these cells, the factors and the pathways may offer us the ability to modulate this pathway during inflammatory bowel disease, which could lead to treatment and promote healing and recovery from inflammatory bowel disease,” Denning said. “There are different ways we think about it, but perhaps we could deliver the beneficial compounds (IL-10 and the downstream signaling pathways) to those patients, orally or even intravenously, or somehow drive the natural production of those compounds.”

Co-authors of the study include Dr. Asma Nusrat and Dr. Charles A. Parkos of the Department of Pathology at the University of Michigan, as well as researchers from Emory University, Technische Universität München and Ludwig-Maximilian University.

The study was funded by the National Institutes of Health, the Crohn’s and Colitis Foundation and the German Research Foundation.

To read the study, visit https://www.jci.org/articles/view/90229.

09/20/2017

Neuroscience Professor Chassaing Receives $100,000 Innovator Award

Tue, 02 Jul 2019 18:45:21 GMT

ATLANTA—Dr. Benoit Chassaing of Georgia State University’s College of Arts and Sciences has received a $100,000 Innovator Award from the Kenneth Rainin Foundation, part of $3 million awarded for Inflammatory Bowel Disease (IBD) research.

The grants will support researchers across the world as they study new ideas that could lead to breakthrough discoveries about IBD. Those who demonstrate significant progress are eligible for additional years of support.

Chassaing’s research involves the role of gut microbiota—which are known to be involved in a number of chronic inflammatory diseases—in intestinal inflammation. Chassaing and Dr. Andrew Gewirtz in the Institute for Biomedical Sciences have previously demonstrated in animal studies that food additives known as dietary emulsifiers, commonly found in processed foods to improve texture and extend shelf life, alter the composition of bacteria residing in the gut. They found such changes allowed bacteria to penetrate the mucus layer that lines and protects the intestine, which is normally sterile.

Chassaing will use the grant to study the impact of dietary emulsifiers on human microbiotas taken from IBD patients. The study will help advance scientific understanding of the non-genetic factors that contribute to IBD, and may result in new dietary advice for IBD patients.

“This year’s grantees are pursuing research that has the potential to yield important insights into this chronic disease.” said Dr. Laura Wilson, director of health strategy and ventures at the Kenneth Rainin Foundation. “Our Innovator Awards provide critical initial support to high-risk research that will help us improve the prevention and prediction, as well as better management, of the disease by doctors and patients.”

09/20/2017

New indication for BRIVIACT® (brivaracetam): UCB’s newest antiepileptic drug approved by FDA as monotherapy treatment of partial-onset seizures in adults

Tue, 02 Jul 2019 18:46:49 GMT

RIVIACT® CV provides a new monotherapy treatment option for epilepsy patients 16 years of age and older with partial-onset (focal) seizures, which can be initiated at a therapeutic dose at day one.
Approval applies a newly established regulatory pathway which allows monotherapy treatment options to reach epilepsy patients sooner.
New indication comes just 18 months after launch of BRIVIACT® in the U.S.

Atlanta, Georgia (U.S.) & Brussels (Belgium), 15 September, 2017 – 0700 (CEST): UCB announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for BRIVIACT® (brivaracetam) CV as monotherapy for partial-onset (focal) seizures (POS) in patients 16 years and older with epilepsy.1

This is a new indication for BRIVIACT, which is already approved in the U.S. as adjunctive treatment for POS in patients in this age group. As a result, adults and adolescents aged 16 years and older with POS in the U.S. can now be initiated on BRIVIACT as monotherapy or adjunctive therapy.

BRIVIACT is the newest antiepileptic drug (AED) in the ‘racetam’ class of medicines and demonstrates a high and selective affinity for synaptic vesicle protein 2A (SV2A) in the brain, which may contribute to its anticonvulsant effects. Gradual dose escalation is not required when initiating treatment with BRIVIACT for monotherapy or adjunctive therapy, allowing clinicians to initiate treatment at a therapeutic dose from day one.1

The most common adverse reactions (at least 5% for BRIVIACT and at least 2% more frequently than placebo) are somnolence and sedation, dizziness, fatigue, and nausea and vomiting symptoms1.

Please see additional BRIVIACT Important Safety Information below.

“This new monotherapy indication builds on an already strong and compelling clinical profile for BRIVIACT, providing doctors the flexibility to tailor their choice of AED to match individual patient needs and circumstances,” explained Dr. Pavel Klein, director of the Mid-Atlantic Epilepsy and Sleep Center. “In helping to progress their journey towards seizure freedom by providing a choice of treatment which can be initiated as monotherapy, at a therapeutic dose, from day one, BRIVIACT provides an additional treatment choice for neurologists and their patients.”

UCB submitted a supplemental application for a BRIVIACT monotherapy indication taking into account a recent General Advice Letter, issued by the FDA,2 which stated it is acceptable to extrapolate the efficacy and safety of drugs approved as adjunctive therapy for the treatment of POS to their use as monotherapy for the treatment of POS. As a result of the FDA’s approach to assessing extrapolated data, UCB was able to support its BRIVIACT monotherapy submission with a wealth of brivaracetam clinical trials data, which involved more than 2,400 adult patients with POS.1

“We are delighted that, with this new monotherapy indication for BRIVIACT, we can support people with epilepsy to reach their treatment goals. Coming just 18 months after our launch in the U.S., this is evidence of our commitment to increasing the speed at which our therapies are approved and made available to as many patients as possible,” explained Jeff Wren, Executive Vice-President, Head of UCB’s Neurology Patient Value Unit. “Discovering, validating and improving access to new and innovative solutions to support people living with epilepsy has been, and will continue to be, a core UCB mission. With this BRIVIACT monotherapy indication, we build on our longstanding commitment to help people with seizure disorders at every point of their journey.”

About Epilepsy3,4,5,6

Epilepsy is a chronic neurological disorder of the brain. It is the fourth most common neurological condition worldwide and affects approximately 65 million people. In the U.S., more than 3 million people have epilepsy. Anyone can develop epilepsy; it occurs across all ages, races and genders, and is defined as one or more unprovoked seizures with a risk of further seizures. Around one third of patients with epilepsy currently live with uncontrolled seizures.

About UCB in Epilepsy

UCB has a rich heritage in epilepsy with over 20 years of experience in the research and development of antiepileptic drugs. As a company with a long-term commitment to epilepsy research, our goal is to address unmet medical needs. Our scientists are proud to contribute to advances in the understanding of epilepsy and its treatment. We partner and create super-networks with world-leading scientists and clinicians in academic institutions, pharmaceutical companies and other organizations who share our goals. At UCB, we are inspired by patients, and driven by science in our commitment to support patients with epilepsy.

About BRIVIACT 1,7

BRIVIACT (brivaracetam) is a new molecular entity that was rationally designed and developed by UCB.

In the U.S., BRIVIACT is approved as monotherapy and adjunctive therapy (a therapy used together with primary treatment) for the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy. BRIVIACT is available in three formulations (film-coated tablets, oral solution, and injection).

Important Safety Information about BRIVIACT® in the U.S.1

Warnings and Precautions

Suicidal Behavior and Ideation: Antiepileptic drugs, including BRIVIACT, increase the risk of suicidal behavior and ideation. Monitor patients taking BRIVIACT for the emergence or worsening of depression; unusual changes in mood or behavior; or suicidal thoughts, behavior, or self-harm. Advise patients, their caregivers, and/or families to be alert for these behavioral changes and report them immediately to a healthcare provider.
Neurological Adverse Reactions: BRIVIACT causes somnolence, fatigue, dizziness, and disturbance in coordination. Somnolence and fatigue-related adverse reactions were reported in 25% of patients taking at least 50 mg per day of BRIVIACT compared to 14% of patients taking placebo. Dizziness and disturbance in gait and coordination were reported in 16% of patients taking at least 50 mg per day of BRIVIACT compared to 10% of patients taking placebo. The risk is greatest early in treatment but can occur at any time. Monitor patients for these signs and symptoms and advise them not to drive or operate machinery until they have gained sufficient experience on BRIVIACT.
Psychiatric Adverse Reactions: BRIVIACT causes psychiatric adverse reactions, including non-psychotic and psychotic symptoms. These events were reported in approximately 13% of patients taking at least 50 mg per day of BRIVIACT compared to 8% of patients taking placebo. A total of 1.7% of adult patients taking BRIVIACT discontinued treatment due to psychiatric reactions compared to 1.3% of patients taking placebo. Advise patients to report these symptoms immediately to a healthcare provider.
Hypersensitivity: BRIVIACT can cause hypersensitivity reactions. Bronchospasm and angioedema have been reported. Discontinue BRIVIACT if a patient develops a hypersensitivity reaction after treatment. BRIVIACT is contraindicated in patients with a prior hypersensitivity reaction to brivaracetam or any of the inactive ingredients.
Withdrawal of Antiepileptic Drugs: As with all antiepileptic drugs, BRIVIACT should generally be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus.

Dosing Considerations

Dose adjustments are recommended for patients with all stages of hepatic impairment.
When BRIVIACT is co-administered with rifampin, an increase in the BRIVIACT dose is recommended.

Adverse Reactions

The most common adverse reactions (at least 5% for BRIVIACT and at least 2% more frequently than placebo) are somnolence and sedation, dizziness, fatigue, and nausea and vomiting symptoms.

BRIVIACT is a Schedule V controlled substance.

Please refer to full Prescribing Information at http://www.briviact.com/briviact-PI.pdf.

For more information on BRIVIACT®, contact 844-599-CARE (2273).

BRIVIACT® is a registered trademark of the UCB Group of Companies.

For further information:

Corporate Communications

France Nivelle, Global Communications, UCB

T+32.2.559.9178, France.nivelle@ucb.com

Jim Baxter, Neurology Communications, UCB

T+32.2.473.78.85.01, jim.baxter@ucb.com

Investor Relations

Antje Witte, Investor Relations, UCB

T+32.2.559.94.14, antje.witte@ucb.com

Isabelle Ghellynck, Investor Relations, UCB

T +32.2.559.9588, isabelle.ghellynck@ucb.com

About UCB

UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 7 500 people in approximately 40 countries, the company generated revenue of € 4.2 billion in 2016. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news

Forward looking statements - UCB

References:

Briviact® U.S. Prescribing Information. Brussels, Belgium: UCB, 2017. https://www.briviact.com/briviact-PI.pdf accessed 15th September 2017.
Data on File (FDA General Advice Letter, dated 09/13/2016)
The Epilepsy Foundation of America. About epilepsy basics http://www.epilepsy.com/learn/about-epilepsy-basics accessed 15th September 2017.
The Epilepsy Foundation of America. What is epilepsy? http://www.epilepsy.com/learn/epilepsy-101/what-epilepsy accessed 15th September 2017.
The Epilepsy Foundation of America. Who gets epilepsy? http://www.epilepsy.com/learn/epilepsy-101/who-gets-epilepsy accessed 15th September 2017. The Epilepsy Foundation of America. Who gets epilepsy ?http://www.epilepsy.com/learn/epilepsy-101/who-gets-epilepsy accessed August 30, 2017
Centers for Disease Control and Prevention, Epilepsy Fast Facts https://www.cdc.gov/epilepsy/basics/fast-facts.htm accessed 15th September 2017.
Briviact® EU Prescribing Information. Brussels, Belgium: UCB, 2016. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003898/WC500200206.pdf accessed 15th September 2017.

09/15/2017

FDA to Close Loophole Allowing Companies to Skirt Pediatric Study Requirements

Tue, 02 Jul 2019 18:47:41 GMT

FDA commissioner Scott Gottlieb announced Tuesday that the agency will release guidance to close a loophole that allows companies to avoid their obligation to study pharmaceuticals in pediatric populations.

The situation, according to Gottlieb, arises if sponsors received an orphan designation for a pediatric subtype of an otherwise common and non-orphaned adult disease.

For example, with a condition like inflammatory bowel disease (IBD), a drug may be approved to treat the large population of adults with the condition but then the same drug may be granted an orphan designation to treat a subset of children suffering from IBD.

"But once a drug receives an orphan designation for a pediatric population of the adult disease, the drug then becomes statutorily exempt from the requirements" of the Pediatric Research Equity Act (PREA), Gottlieb explains.

"It’s a loophole that is in direct opposition to what Congress intended," he wrote. "Nobody envisioned this unintended conflict between the original ODA [Orphan Drug Act] and the provisions outlined in PREA. In effect, by letting sponsors designate pediatric subpopulations of drugs intended to treat adult diseases, the drug makers receive an unintended ‘free pass’ from having to study drugs in these or other pediatric uses. Thus, rather than ensuring more pediatric research, as Congress envisioned, we can end up with fewer pediatric studies. FDA will soon issue a draft guidance document that’s aimed at closing this inadvertent loophole."

Nancy Goodman of Kids v Cancer, whose RACE for Children's Act was included in the FDA user fee reauthorization law (FDARA), explained to Focus that the language on closing the loophole was initially going to be included in FDARA.

A public meeting announced by Gottlieb will also address some of the statute from FDARA and get input on complex scientific and regulatory issues, such as those raised by molecularly targeted drugs and biologics and the appropriate application of orphan incentives.

In addition to closing that loophole and the meeting, Gottlieb said FDA has now reviewed all orphan drug designation requests older than 120 days and will put in place new policies to improve the efficiency of FDA’s review process to ensure that we meet our new 90-day mandate to prevent new backlogs.

Source: raps.org

09/14/2017

Georgia Tech-led group gets $20M federal grant to fund biomedical engineering research center

Tue, 02 Jul 2019 18:48:36 GMT

A Georgia Tech-led research consortium received a nearly $20 million National Science Foundation grant to fund a new engineering research center.

The NSF Engineering Research Center for Cell Manufacturing Technologies (CMaT) will develop tools and technologies to help clinical facilities reproducibly manufacture efficient, safe and affordable cell-therapy products, Georgia Tech said in a statement.

Enlarge

The Georgia Tech-led CMaT lab

ROB FELT

Examples of these highly promising therapies include T cell-based immunotherapies for blood cancers and a gene-modified stem cell therapy recently approved in Europe for a form of the so-called “bubble boy” syndrome.

Unlike pharmaceuticals and other products now used in medical treatments, cells are living entities whose properties can change depending on the way they are grown, stored or manipulated, CMaT Director Krishnendu Roy said in the statement.

“The center will develop new engineering tools and scalable methods to better characterize, expand, differentiate, separate, transport and store high-quality cells so they provide consistent therapeutic effects, allowing them to be used in standardized therapies by clinicians to serve large numbers of patients worldwide,” Roy said.

CMaT will develop models for a supply chain, storage and distribution system for these therapeutic cell products. The public-private initiative will also help develop a skilled bio-manufacturing workforce through education and training activities at the K-12, technical college, undergraduate, graduate and postdoctoral levels.

The Georgia Tech led partnership includes the University of Georgia, the University of Wisconsin-Madison and the University of Puerto Rico, Mayaguez Campus. Affiliate partners include University of Pennsylvania, Emory University, the Gladstone Institutes and Michigan Technological University.

CMaT is expected to speed up the development of new therapies and the testing needed to bring them into the clinic, said Steven Stice, director of the University of Georgia’s Regenerative Bioscience Center.

Regenerative medicine applications could offer new ways of treating diseases for which there are now essentially no treatments, including Parkinson's, Alzheimer’s, heart disease and stroke.

“There are a significant number of cell therapy clinical trials and investments in the field,” Stice noted. “But there is little or no investment in a set of consistent standardization methods to optimize how these therapies should work."

09/13/2017

Spaser Can Detect, Kill Circulating Tumor Cells to Prevent Cancer Metastases, Study Finds

Tue, 02 Jul 2019 18:49:28 GMT

ATLANTA—A nanolaser known as the spaser can serve as a super-bright, water-soluble, biocompatible probe capable of finding metastasized cancer cells in the blood stream and then killing these cells, according to a new research study.

The study found the spaser can be used as an optical probe and when released into the body (possibly through an injection or drinking a solution), it can find and go after circulating tumor cells (CTCs), stick to them and destroy these cells by breaking them apart to prevent cancer metastases. The spaser absorbs laser light, heats up, causes shock waves in the cell and destroys the cell membrane. The findings are published in the journal Nature Communications.

The spaser, which stands for surface plasmon amplification by stimulated emission of radiation, is a nanoparticle, about 20 nanometers in size or hundreds times smaller than human cells. It has folic acid attached to its surface, which allows selective molecular targeting of cancer cells. The folate receptor is commonly overexpressed on the surface of most human cancer cells and is weakly expressed in normal cells.

The discovery was made by researchers at Georgia State University, the University of Arkansas for Medical Sciences, the University of Arkansas at Little Rock and the Siberian Branch of the Russian Academy of Science.

“There is no other method to reliably detect and destroy CTCs,” said Dr. Mark Stockman, director of the Center for Nano-Optics and professor of physics at Georgia State. “This is the first. This biocompatible spaser can go after these cells and destroy them without killing or damaging healthy cells. Any other chemistry would damage and likely kill healthy cells. Our findings could play a pivotal role in providing a better, life-saving treatment option for cancer patients.”

Metastatic cancer occurs when cancer spreads to distant parts of the body, often to the bone, liver, lungs and brain, through a process called metastasis. Many types of cancers refer to this as stage IV cancer. Once cancer spreads, it can be difficult to control, and most metastatic cancer can’t be cured with current treatments, according to the National Institute of Health’s National Cancer Institute. One of the most dangerous ways metastasizing occurs is through the CTCs, which this study aims to detect and destroy using spasers.

The spasers used in this study measure just 22 nanometers, setting the record for the smallest nanolasers. A nanometer is one-billionth of a meter. Most results were obtained with a gold, spherical nanoparticle surrounded by a silica shell and covered with a uranine dye, which is widely used for tracing and biomedical diagnostics.

The researchers studied the spaser’s capabilities in vitro in human breast cancer cells with high folate receptor expression and endothelial cells with low folate receptor expression, as well as in mouse cells in vivo.

They found cells with spasers demonstrated high image contrasts with one or many individual “hot spots” at different laser energies above the spasing threshold. The presence of spasers was confirmed with several optical and electron microscopy techniques, which revealed an initial accumulation of individual spasers on the cell membrane followed by their entrance into the cell cytoplasm.

The study also found low toxicity of the spasers for human cells. At the same time, the spasers subjected to laser irradiation selectively killed the tumor cells without damaging the healthy ones.

Based on the study’s results, spaser-based therapeutic applications with high-contrast imaging is a promising field. The data suggest spasers have high potential as therapeutic and diagnostic agents that integrate optical diagnosis and photothermal-based cell killing, using just a few laser pulses to kill cancer cells.

The study is funded by the National Institutes of Health, the National Science Foundation, the University of Arkansas for Medical Sciences and the U.S. Office of Naval Research.

To read the paper, visit https://www.nature.com/articles/ncomms15528.

08/30/2017

Augusta University researcher gets $12.8 million grant to lead consortium on diabetic complications

Tue, 02 Jul 2019 18:50:31 GMT

Augusta University researcher Dr. Richard A. McIndoe received a $12.8 million grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), a division of the National Institutes of Health.

The funds will allow McIndoe, a bioinformatics expert and associate director of the Center for Biotechnology and Genomic Medicine at Augusta University,to continue leading a national research initiative that aims to reduce diabetic complications.

Enlarge

Augusta University researcher Dr. Richard A. McIndoe received a $12.8 million grant from… more

AUGUSTA UNIVERSITY

This is the fourth time McIndoe has been chosen to lead the Diabetic Complications Consortium, an NIKKD program.

The consortium is focused on advancing science and patient care, including funding studies in animals and humans to better understand and prevent complication.

It also supports summer programs for medical students.

According to Atlanta-based Centers for Disease Control and Prevention, nearly 10 percent of the U.S. population has diabetes. Complications from the disease are the leading reason to diabetes-related deaths.

08/24/2017

Amgen and Humana Partner for Improved Health Outcomes and Efficiency

Tue, 02 Jul 2019 18:51:43 GMT

THOUSAND OAKS, Calif. and LOUISVILLE, Ky. (Aug. 17, 2017) -- Two of the nation’s leading health organizations, health and well-being company Humana Inc. (NYSE: HUM) and biotechnology company Amgen (NASDAQ:AMGN), have teamed up to identify opportunities to improve health outcomes and improve efficiency by unlocking new insights from the real world health care experiences of Humana’s 13 million members.

In the collaboration agreement between Amgen and Humana, six projects are currently underway or planned, with more expected over the term of the agreement. Both organizations are committed to expanding the work into further therapeutic areas where the partnership can bring value to both Amgen and Humana. The goal is the same across all projects: deliver increased value to patients and the health care system by focusing on working to improve quality and outcomes in the context of total health care costs.

The collaboration will initially target multiple serious conditions, including cardiovascular disease, osteoporosis, neurologic disorders, inflammatory diseases and cancer. Researchers will combine available sources of real world evidence (RWE) with data from wearable technology, digital apps and Bluetooth-enabled drug delivery devices. Prospective observational studies are also planned.

Planned research will identify patients whose serious medical conditions are likely to result in an adverse patient outcome, which may lead to development of algorithms that can predict risk and drive to early intervention. The partnership will also dive deeply into specific therapeutic areas, from defining the burden of osteoporatic fractures to understanding the impact of wearable technology on medication adherence for inflammatory diseases.

“The rising cost of disease is challenging the sustainability of our health care system in the U.S., and is motivating innovators to urgently develop new therapeutic options and partner on opportunities to improve the quality and efficiency of care and reduce financial burden to the system,” said Joshua Ofman, M.D., M.S.H.S., senior vice president of Global Value, Access & Policy at Amgen. “It is our hope that this collaboration with Humana, a first of its kind for Amgen, will cultivate value-based, integrated approaches to care that will focus on patients and benefit the healthcare system more broadly.”

“Humana is focused on the holistic health of our members and by teaming up with Amgen we can study new ways to improve the health outcomes for our members,” said Laura Happe, Pharm.D. M.P.H., chief pharmacy officer for Humana. “At the same time, we hope this research results in new tools and technology that support our provider partners who are on the journey to population health and value-based care.”

Amgen and Humana have proven experience in value-based initiatives. Globally, Amgen has engaged in more than 75 distinct value-based programs that have focused on improving clinical outcomes, patient experience and population health.

As of June 30, 2017, Humana has 1.8 million individual Medicare Advantage members and 142,000 commercial members who are cared for by 50,700 primary care providers, in more than 900 value-based relationships across 43 states and Puerto Rico. By focusing on quality and health, Humana experienced 20 percent lower costs in total in 2015 for members who were treated by providers in a value-based reimbursement model setting versus an estimation of original fee-for-service Medicare costs using CMS Limited Data Set Files.

About Amgen

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing, and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.

Amgen and Value-Based Programs

As a collaborative partner within the healthcare system, Amgen believes that engaging in value-based programs with stakeholders creates mutually beneficial opportunities to improve costs, quality of care and the patient experience

Globally, Amgen is engaged in over 75 distinct, value-based projects, spanning disease state collaborations, risk sharing, cost-cap guarantee, pay-for-performance and outcomes-based agreements.

About Humana

Humana Inc. is committed to helping our millions of medical and specialty members achieve their best health. Our successful history in care delivery and health plan administration is helping us create a new kind of integrated care with the power to improve health and well-being and lower costs. Our efforts are leading to a better quality of life for people with Medicare, families, individuals, military service personnel, and communities at large.

To accomplish that, we support physicians and other health care professionals as they work to deliver the right care in the right place for their patients, our members. Our range of clinical capabilities, resources and tools – such as in-home care, behavioral health, pharmacy services, data analytics and wellness solutions – combine to produce a simplified experience that makes health care easier to navigate and more effective.

More information regarding Humana is available to investors via the Investor Relations page of the company’s web site at www.humana.com, including copies of:

• Annual reports to stockholders

• Securities and Exchange Commission filings

• Most recent investor conference presentations

• Quarterly earnings news releases and conference calls

• Calendar of events

• Corporate Governance information

###

CONTACT:

Amgen, Thousand Oaks
Kristen Neese, 805-313-8267 (media)
Arvind Sood, 805-447-1060 (investors)

Humana

Marina Renneke, 602-760-1758, mrenneke@humana.com

08/22/2017

Metro Atlanta's MiMedx to spin out subsidiary to focus on biopharma

Tue, 02 Jul 2019 18:52:44 GMT

Marietta-based MiMedx Group, Inc. (NASDAQ: MDXG) has signed an agreement to divest the company's subsidiary, Stability Biologics LLC, back to its original stockholders.

MiMedx's said its transition into a biopharmaceutical company was an impetus for this divestiture initiative.

MiMedx was founded in 2008 by serial Atlanta entreprenuer Pete Petit.

JOANN VITELLI

MiMedx Group is developing and marketing regenerative and therapeutic biologics with human placental tissue allografts and patent-protected processes for multiple sectors of health care. In January of 2016, the company acquired Stability Biologics, which developed and processed bioactive bone graft products and tissue allografts. MiMedx disclosed that it acquired Stability Biologics with a combination of cash and stock paid at closing, with future contingent consideration to be paid through a two-year earn-out arrangement.

MiMedx CEO Parker "Pete" Petit, said in a press release that Stability Biologics' business is not a strategic fit with the company's new focus on biopharmaceuticals.

"We remain very confident in our growth trajectory continuing and in our ability to meet or exceed the revenue projections we have previously set for 2017," Petit said in a press release. He added that as of July 26, the company raised its annual revenue guidance to the range of $309 million to $311 million. "Assuming this transaction closes in the third quarter, we will maintain our full year revenue guidance. Even without the Stability Biologics revenue contribution in the fourth quarter, we are confident in our ability to meet our increased revenue guidance for the year...

"... While we believe the potential of Stability Biologics products continues to be significant, we expect to have better return on investment (ROI) opportunities in biopharma compared to those in the cadaver tissue category," Petit added in the release. "A major incentive for the MiMedx acquisition of Stability Biologics was its independent sales representative organization. As part of the transaction, MiMedx will retain access to this sales rep organization via a distributor agreement with Stability. This group of sales reps will continue to focus on certain areas of our surgical business."

08/22/2017

T3 Labs sets gold standard in preclinical testing for CorAmi

Tue, 02 Jul 2019 18:53:54 GMT

Dr. Rebecca Levit

Dr. Levit is Assistant Professor of Cardiology at Emory University in Atlanta, GA and adjunct faculty in the Department of Biomedical Engineering at the Georgia Institute of Technology. She is also the Chief Scientific Officer of CorAmi Therapeutics. CorAmi is working in partnership with Emory University to develop a combination hydrogel delivery catheter and therapeutic hydrogel focused on cardiac applications, leading with a treatment for AF.

Dr. Levit engaged regional medtech industry resources early in order to streamline the considerable developmental pathway for a Class III device: including GCMI and its subsidiary T3 Labs.

Medtech innovation requires a healthy ecosystem
“The resources here are endless,” she says. “Between meetings with multiple electrophysiologists from Emory and PhDs from Georgia Tech, administrative support and animal study expertise at T3, guidance from the Emory/Georgia Tech Coulter Translational Partnership Fund, working with SEMDA, securing office space at GCMI (not to mention utilizing their fabrication equipment), and funding from multiple organizations, there must be more than 100 people in this area who have touched this product. Needless to say, we are appreciative of the ecosystem!”

Team testing the CorAmi device in the T3 Labs Cathlab (from L to R) : Dr. Gautam Kumar, Dr. Andres Garcia, Peter Campbell, Juline Deppen, Dr. Jose Garcia, Dr. Rebecca Levit

What would you tell a physician innovator in your position when you started?
“Other physician innovators should understand the work it is going to take and that there are some elements that no one can do for you. They can’t write the grant, present the poster or network with people. It takes time and you need to be willing to give that time up. It also takes an ecosystem. This is not at all possible without a healthy medtech development ecosystem. Know that medtech innovation is impossible to do by yourself.”

You can read the full story here.

If you are a physician innovator, researcher, or medical device company of any size, and want to bring your new product to life as efficiently as possible, T3 Labs and GCMI can help from concept to cure through design & development, preclinical testing, bioskills training to commercialization. Contact us today.

The photo of Dr. Rebecca Levit, as well as the CorAmi catheter, were taken by Emory Photo.

08/17/2017

Bard Shareholders Approve Proposed Merger With Becton, Dickinson

Tue, 02 Jul 2019 18:54:42 GMT

MURRAY HILL, N.J. and FRANKLIN LAKES, N.J., Aug. 8, 2017 /PRNewswire/ -- C. R. Bard, Inc. (NYSE: BCR) ("Bard") and Becton, Dickinson and Company (NYSE: BDX) ("BD") today announced the results of Bard's special meeting of shareholders, held on August 8, 2017 and at which a quorum was present, for Bard shareholders to consider and vote upon the proposed merger of Bard with BD. Bard shareholders approved the definitive merger agreement, with approximately 99% of shares voting cast in favor of the proposal.

As previously announced on April 23, 2017, Bard and BD entered into a definitive agreement pursuant to which BD would acquire Bard in a stock and cash transaction. Bard shareholder approval was a condition to the transaction. The proposed transaction remains subject to certain other conditions and approvals, and is presently expected to close in the fourth calendar quarter of 2017.

Click here for more information: http://investorrelations.crbard.com/phoenix.zhtml?c=91501&p=irol-newsArticle&ID=2292793

08/14/2017

Georgia State names football field for Atlanta business leader Pete Petit

Tue, 02 Jul 2019 18:55:39 GMT

Georgia State University said Tuesday it will name its new football field at Georgia State Stadium -- formerly Turner Field -- in honor of Atlanta businessman Parker H. “Pete” Petit.

Petit is chairman and CEO of Marietta, Ga.-based MiMedx Group Inc. (Nasdaq: MDXG), a maker of biomaterial products and bioimplants processed from human placental tissue, skin and bone. A serial entrepreneur and long-time supporter of the university, he has made a $10 million gift to the university to support the athletics program.

MiMedx was founded in 2008 by serial Atlanta entreprenuer Pete Petit.

JOANN VITELLI

“Pete Petit has been a long-time generous benefactor of Georgia State,” Mark P. Becker, president of Georgia State, said in a statement, “and his impact on our university cannot be overstated. We are extremely proud to name the playing field in Georgia State Stadium in his honor.”

Georgia State is holding separate talks over naming rights for the stadium itself, but that deal could be months away.

Petit has long-standing ties to Georgia State. He earned his MBA in finance in the university’s J. Mack Robinson College of Business and is chair of the steering committee for Georgia State’s $300 million Burning Bright fund-raising campaign. He has been a generous supporter of the university over the years, giving $5 million to build the Parker H. Petit Science Center and making gifts to the Robinson College and athletics. To read a 2009 Atlanta Business Chronicle profile of Petit, click here.

“This field and stadium are just one of the many successes Georgia State has accomplished in a matter of a few years,” Petit said in a statement. “Georgia State is destined to become one of the most respected urban universities in this country because of this series of successes, which have been a result of its leadership.” Read the full announcement here.

08/08/2017

ATDC Companies See Record Investment Year So Far

Tue, 02 Jul 2019 18:56:47 GMT

If there’s one area of the Atlanta startup ecosystem lagging behind the growth of the rest, it’s local capital. Talent, startup activity, public support for entrepreneurship, and corporate innovation are all consistently strong, but the region lacks the investment resources of many of its fellow top-ranked Global Cities.

But investment activity in the city may be picking up. One sign is just-released figures by the Advanced Technology Development Center (ATDC), the state of Georgia’s technology incubator and the oldest startup incubator in the country, which shows that its portfolio companies raised more than double the amount of capital in the first half of 2017 than in the comparable period a year ago.

From January to June 2017, ATDC startups raised more than $50 million in Seed and Series A funding. That’s an over 145 percent increase from the $20.6 million raised during the same amount of time in 2016.

“Both local and out-of-state early stage investors (Seed and Series A) are gaining more confidence and taking higher risks on Georgia-based companies. More money is flowing into Atanta than ever before,” says ATDC investor relations manager Michael Maziar. “Because our companies are getting stronger, the deal sizes are getting larger. Outside investors spur local investors and vice versa.”

ATDC, which is based at Georgia Tech but has six locations throughout the state, helps facilitate those investor connections for its startups through an Invest Connect program, says Mazier.

“We proactively facilitate connections between our companies and the investment community in Georgia and throughout the U.S.,” says Maziar. Those connections include hosting meetings for investors and companies at ATDC, as well as traveling with 11 startups to Silicon Valley for meetings and pitches with over 30 venture capitalists and firms.

Much of the investment activity was for startups in the region’s traditionally-strong fields, such as Fintech. Just two Fintech companies — First Performance and Greenlight — raised $25 million.

“Being a part of ATDC has been critical to Greenlight’s growth,” says Tim Sheehan, CEO of Greenlight. The incubator facilitated a meeting with a firm that contributed to their $7.5 million Series A raise.

Startups in the healthcare, manufacturing, and predictive analytics industries also raised capital.

“Being a part of ATDC and the coaching we received set the foundation to help us build a great business,” says Amari Ruff, CEO of logistics technology company Sudu. Sudu recently joined the ranks of ATDC’s Signature companies, the top tier of the program.

“If we weren’t a part of this program, we wouldn’t be where we are today,” says Ruff.

Article originally appeared on Hypepotamus.

08/04/2017

vMiMedx Files With The FDA To Initiate Its Investigational New Drug Achilles Tendonitis Phase 3

Tue, 02 Jul 2019 18:57:36 GMT

MARIETTA, Ga., Aug. 4, 2017 /PRNewswire/ -- MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare, announced today that the Company has filed with the Food and Drug Administration (FDA) to initiate its Investigational New Drug (IND) Phase 3 Achilles Tendonitis clinical study.

The Achilles Tendonitis clinical trial will study MiMedx's AmnioFix® Injectable in a Phase 3, Prospective, Double Blinded, Randomized Controlled Trial of the Micronized dHACM Injection as Compared to Saline Placebo Injection in the Treatment of Achilles Tendonitis. The Company expects patient enrollment to commence in the next few months.

The trial will enroll approximately 158 study patients with moderate to severe pain due to Achilles Tendonitis with failed conservative treatment for at least one month. The IND Phase 3 clinical study objective is to determine the safety and effectiveness of AmnioFix Injectable as compared to the 0.9% Sodium Chloride USP placebo injection control for the treatment of moderate to severe pain due to Achilles tendonitis.

The filed primary efficacy endpoint of this study will be the change in Visual Analog Scale (VAS) score for patients between baseline and Day 90 expressed as the difference in means between the AmnioFix Injectable versus placebo-treated group. The primary safety endpoint will be the incidence of Adverse Events, Serious Adverse Events, and Unanticipated Adverse Events during the first 180 days post injection in the AmnioFix Injectable group versus the placebo-treated group.

The Achilles Tendonitis study will be the second IND Phase 3 trial for MiMedx AmnioFix Injectable. MiMedx plans to submit a Biologic License Application (BLA) to the FDA for tendonitis when the Company's Plantar Fasciitis Phase 3 trial completes.

Parker H. "Pete" Petit, CEO, said, "In addition to this IND study, we are planning to file for another IND study by the end of this quarter. This additional IND study will be for the use of our micronized dHACM in the treatment of Osteoarthritis Knee Pain. With the commencement of the Osteoarthritis study, we will have three IND studies ongoing. We are excited about our progress in moving our focus into the biopharmaceutical market, and we look forward to keeping our shareholders appraised on our future study results. We will continue to keep shareholders very well informed of our new biopharmaceutical initiatives. Later this year, we will hold a meeting in New York that will include presentations by MiMedxexecutives and the physicians involved with our various IND studies to better inform analysts and our shareholders of these important activities."

MiMedx previously reported that the Company will be hosting a webcast on Monday, August 7, 2017 beginning at 2:00 p.m. Eastern Time. This Achilles Tendonitis study will also be included in the presentation. As previously announced, a listen-only simulcast of the shareholder call will be available on-line at the Company's website at www.mimedx.com beginning at 2:00 p.m. eastern time, August 7, 2017. A 30-day on-line replay will be available approximately one hour following the conclusion of the live broadcast on the Company's website at www.mimedx.com.

About MiMedx
MiMedx® is a biopharmaceutical company developing and marketing regenerative biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. "Innovations in Regenerative Medicine" is the framework behind our mission to give physicians products and tissues to help the body heal itself. We process the human placental tissue utilizing our proprietary PURION® Process among other processes, to produce safe and effective allografts. MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization. MiMedx is the leading supplier of placental tissue, having supplied over 900,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. For additional information, please visit www.mimedx.com.

Important Cautionary Statement
This press release includes forward-looking statements, including statements regarding the timing, results, and publication of clinical studies; and the potential safety and efficacy, and additional approved uses and markets for our products. These statements also may be identified by words such as "believe," "except," "may," "plan," "potential," "will" and similar expressions, and are based on our current beliefs and expectations. Forward-looking statements are subject to significant risks and uncertainties, and we caution investors against placing undue reliance on such statements. Actual results may differ materially from those set forth in the forward-looking statements. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include the risk that unexpected concerns may arise from additional data or analysis from our clinical trials; regulatory submissions may take longer or be more difficult to complete than expected; and that regulatory authorities may require additional information or further studies or may fail to approve or may delay approval or grant marketing approval that is different than anticipated. For more detailed information on the risks and uncertainties associated with new product development and commercialization activities, please review the Risk Factors section of our most recent annual report or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statement.

View original content:http://www.prnewswire.com/news-releases/mimedx-files-with-the-fda-to-initiate-its-investigational-new-drug-achilles-tendonitis-phase-3-clinical-trial-300499995.html

SOURCE MiMedx Group, Inc.

08/04/2017

BIO: Senate Passage of FDA User Fee Package Important Victory for Patients, Medical Innovation

Tue, 02 Jul 2019 18:58:26 GMT

Biotechnology Innovation Organization (BIO) President and CEO James C. Greenwood issued the following statement regarding passage of the Food and Drug Administration Reauthorization Act (FDARA) by the U.S. Senate today: “The user fee program reauthorization package passed by the Senate today is an important victory for patients and for the next generation of medical innovation. This legislation will advance patient involvement in drug development and bring patient perspectives more clearly to bear on regulatory decisions. It also ensures that the FDA continues to have the resources necessary to carry out its critical human drug review programs, and takes steps to modernize and improve the clinical trial process, which remains the most time-consuming, complex and expensive stage of drug development.

“The reauthorization of the biosimilars user fee program, including steps to improve communication between the FDA and Sponsors throughout application review, will create a more robust and competitive marketplace for biosimilar therapies, following an appropriate period of exclusivity for innovator biologic products.”

“The legislation also contains a number of provisions that will accelerate and incentivize the entry of generic medicines to the market, which will help to contain costs through increased competition while improving consumer choice. These provisions are consistent with proposals endorsed by BIO to drive smarter spending within our healthcare system without harming incentives for innovation.

“We commend the leadership of Senate HELP Committee Chairman Lamar Alexander and Ranking Member Patty Murray for their tireless bipartisan efforts in advancing this important legislation, as well as that of their counterparts on the House Energy and Commerce Committee, Chairman Greg Walden and Ranking Member Frank Pallone.

“We look forward to working with the FDA and other stakeholders to ensure that the important patient-centric advances contained in this legislation are most effectively implemented.”

08/03/2017

Georgia State Sets Research Funding Record For Sixth Consecutive Year

Tue, 02 Jul 2019 18:59:31 GMT

ATLANTA—Georgia State University received $147 million in research funding in fiscal year 2017, setting a record for the sixth consecutive year.

The total exceeds last year’s record of $120.1 million. Externally funded research activity at the university has climbed 81 percent over the past three years. This year one of the largest funding increases came from industry research grants and contracts, which grew nearly fivefold.

The university experienced a particularly large spike in funding for health and biomedical research. Of the $147 million, more than $20 million went toward research in the Institute for Biomedical Sciences and more than $16 million to research in the School of Public Health.

“As one of the nation’s fastest growing research institutions, Georgia State has rapidly developed a reputation for scientific innovation,” said James Weyhenmeyer, vice president for research and economic development at Georgia State. “Achieving this funding benchmark shows that we’ve been adept at cultivating monetary support for our innovative work, which helps drive economic development and transformative research at the university and throughout the metro Atlanta region.”

This year’s key awards included:

A $7.7 million grant from the National Institutes of Health awarded to Margo Brinton (College of Arts and Sciences) to investigate the consequences of West Nile and Zika virus infections on the human central nervous system.
More than $4 million from the NIH awarded to Christopher Basler (Institute for Biomedical Sciences) to develop a drug targeting the Ebola virus.
A $3.9 million grant from the Laura and John Arnold Foundation awarded to Tim Sass and Dan Kreisman (Andrew Young School of Policy Studies) to create the Georgia Center for Education Policy, which will work to improve academic, career and life outcomes for students across the state.
More than $3 million from the NIH awarded to Kathleen Baggett (School of Public Health) to test the effectiveness of Mom and Baby Net, a mobile phone app combining two programs to decrease maternal depression and build parenting skills.
A $2.8 million grant from NIH awarded to Zhoglin Xie and Ming-Hui Zou (Center for Molecular and Translational Medicine) to study diabetic cardiomyopathy, changes in the heart’s structure and function related to diabetes.
A $1.8 million grant from the NIH awarded to Andrew Gewirtz (Institute for Biomedical Sciences) to study how changes in gut bacteria could lead to obesity and metabolic syndrome.
A $1.8 million grant from the NIH awarded to Anne Murphy (Neuroscience Institute) to investigate pain management therapies for people age 65 and older.
An $867,000 grant from Pfizer Inc. awarded to Michael Eriksen and the School of Public Health to continue their work to implement tobacco control programs in five major Chinese cities.

“Georgia State’s record-high levels in research funding validate the strategy of long-term investment in talent and technology,” said Mike Cassidy, president and chief executive officer of the Georgia Research Alliance (GRA). “The GRA stands committed to helping Georgia State continue to expand its capacity to discover more and launch more enterprises around the most promising inventions.”

Georgia State earned its designation as a major research institution in 1995, and it now ranks among the nation’s top 108 public and private universities in the Carnegie Foundation’s elite category of Highest Research Activity.

For more information about research at Georgia State, visit research.gsu.edu.

08/02/2017

Biomedical Researcher Gets $1.9 Million To Study Influenza Vaccines

Tue, 02 Jul 2019 19:00:32 GMT

ATLANTA—Dr. Sang-Moo Kang, professor in the Institute for Biomedical Sciences at Georgia State University, has renewed a four-year, $1.9 million federal grant to develop influenza vaccines that offer enhanced protection against a broad range of influenza virus strains.

This is the second grant renewal from the National Institute for Allergy and Infectious Diseases of the National Institutes of Health. The project will explore novel approaches to improve the cross-protective properties of licensed seasonal influenza vaccines, with results expected to be applicable to the clinic and have a significant impact on public health.

Dr. Richard Plemper, a professor in the Institute for Biomedical Sciences, will be a co-investigator for the research project.

Influenza, a contagious respiratory illness caused by influenza viruses, can cause mild to severe illness and even lead to death. Influenza vaccines, such as inactivated split virus vaccines and live attenuated influenza virus vaccines, that are based on immunity to the hemagglutinin (HA) hypervariable protein, do not provide effective cross protection against new influenza virus strains that develop through changes in the virus’ genes as it replicates over time. Developing a novel vaccine that improves the efficacy and extent of cross protection is a high priority.

“With this project, we’ve proposed groundbreaking approaches to increase the capacity of current influenza vaccine platforms to give cross protection against new influenza virus strains,” Kang said. “We will achieve this by incorporating M2e epitopes, which are found among all influenza strains, into HA and engineering a M2e-HA molecule.”

This project has three aims. First, the researchers will test the hypothesis that recombinant seasonal inactivated split virus vaccines and live attenuated influenza virus vaccines with M2e-HA molecules will enhance the efficacy of cross protection by inducing immunity to M2e and HA.

Secondly, the research team will study recombinant influenza virus vaccines and investigate the role of cellular and humoral immune mechanisms in cross protection in mice. Lastly, the researchers will validate the efficacy of cross protection by recombinant influenza virus vaccines in ferrets, the most relevant small-animal model for the assessment of influenza vaccines, in collaboration with a team led by Dr. Ian York at the Centers for Disease Control and Prevention in Atlanta.

An abstract of the grant, 2R01AI093772-07A1, is available at NIH’s Project RePORTer website.

For more information about the Institute for Biomedical Sciences, visit http://biomedical.gsu.edu.

07/31/2017

New Workflow Is First End-to-End Solution For Extrusion-Based Drug Implant Production

Tue, 02 Jul 2019 19:01:26 GMT

KARLSRUHE, Germany (JULY 26, 2017) – To meet growing demand for innovative drug delivery systems in the pharmaceutical industry, drug formulation scientists can now use the first commercially available, fully-integrated solution for polymer-based drug implant development and production using hot melt extrusion (HME). This new drug development workflow provides pharmaceutical manufacturers with a complete end-to-end manufacturing line from a single supplier.

The Thermo Scientific Pharma mini implant line is built around the Thermo Scientific Pharma mini HME twin-screw micro compounder. It provides drug developers, process manufacturing scientists and engineers with a continuous and fast production process designed to improve product quality, maximize operator safety and reduce the risk of contamination. This integrated production line is also designed to allow contract research and manufacturing organizations (CRO/CMO) to develop and optimize small-scale formulations before engaging in larger-scale production.

“With a single subcutaneous injection, advanced drug implants can release a therapeutic substance that can provide patients with improved drug compliance, effective disease treatment or controlled hormonal regulation for weeks or even months,” said Hanna Granö-Fabritius, senior business director, material characterization for Thermo Fisher Scientific. “Pharmaceutical manufacturers are seeking fast, reliable solutions for continuous production of novel drug delivery systems. Our new, automated implant line offers a hot melt extrusion solution designed to minimize formulation development time.”

The Thermo Scientific Pharma mini implant line incorporates a range of components in an innovative configuration. In addition to the Pharma mini HME micro compounder, components include:

• A containment valve to add the active pharmaceutical ingredient (API) and the polymer, designed to protect the operator from exposure to the API and preventing contamination of the API;
• A gravimetric feeder to deliver the API/polymer into the micro compounder for heating and mixing before the melt is extruded through a die that creates a continuous filament;
• New bi-axial lasers that measure the thickness or diameter of the filament to adjust the stretching or “take-off” speed of the conveyor belt; and
• Proprietary equipment that cuts the filament to a desired implant length while maintaining “roundness” without deforming the implant shape.
For more information on the Thermo Scientific Pharma mini implant line, please visit www.thermofisher.com/implantline.

About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with revenues of $18 billion and more than 55,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support. For more information, please visit www.thermofisher.com.

07/27/2017

NIH Awards NeurOp $3.5 Million to Support Phase 1 Clinical Trial of NMDA Inhibitor NP10679

Tue, 02 Jul 2019 19:02:22 GMT

NeurOp, Inc. today announced that it has received a $3.5 million award from the National Institute of Neurological Disorders and Stroke (NINDS), a division of the NIH, to begin clinical testing of the Company’s drug candidate NP10679, a GluN2B subunit-specific NMDA (N-methyl-D-aspartate) inhibitor. NeurOp is investigating NP10679 for the prevention of ischemic damage during a stroke or subarachnoid hemorrhage (SAH).

“We designed NP10679 with great care to incorporate the attributes we believe differentiate this molecule from other NMDA inhibitors in development,” said Barney Koszalka, PhD, NeurOp CEO. “For example, the binding of the molecule is enhanced in an acidic environment, a property other NMDA inhibitors lack. This property of pH dependence improves the chance of achieving efficacy at dose levels devoid of side effects. We would like to partner with a pharmaceutical company in future trials to fully explore this advantage in an array of disorders such as stroke, treatment-resistant depression and neuropathic pain.”

NP10679 is bioavailable by either the oral or IV route, and it will initially be evaluated in a Phase 1 study in healthy human volunteers by the IV route. The study is expected to start in early 2018. Pre-clinical studies have shown efficacy in treating complications associated with SAH. An IND for NP10679 was opened in 2016.

NeurOp’s Chief Scientific Officer, Robert Zaczek, PhD, added, “The safety profile of NP10679 allows for prophylactic use in patients at risk for an ischemic event, such as those suffering an SAH. This is important because extensive data has shown that early intervention is key for robust efficacy of neuroprotective therapy. Our prophylactic intervention strategy will place NP10679 at its site of action before an SAH-driven delayed cerebral ischemia event takes place. This eliminates the time-of-dosing caveat that might, in part, have led to previous failures of clinical tests involving glutamatergic agents in stroke and head trauma.”

Note: Research reported in this news release is supported by the National Institute of Neurological Disorders and Stroke of the National Institutes of Health (NIH) under Award Number R44NS071657. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

About NeurOp
NeurOp, Inc. is an Atlanta-based biopharmaceutical company developing new medicines for central nervous system disorders, including depression, neuropathic pain, ischemia (stroke), schizophrenia and Parkinson’s disease. Its research targets specific subunits of neuronal NMDA receptors to identify and evaluate small molecule modulators for potential therapeutic benefit. Multi-year funding from the NIH supports the Company’s research and development programs for NP10679 for the prevention of ischemic damage during a stroke or subarachnoid hemorrhage. For more information, please visit www.neuropinc.com.

07/24/2017

Skin Vaccination with Microneedle Patch, Influenza Fusion Protein Improves Efficacy of Seasonal Flu Vaccines, Study Finds

Tue, 02 Jul 2019 19:03:17 GMT

ATLANTA—A boosting skin vaccination with a biodegradable microneedle patch and protein constructed from sequences of influenza virus subtypes could improve the effectiveness of conventional influenza vaccines, according to a study led by Georgia State University.

To increase the protection offered by standard influenza vaccines, Dr. Baozhong Wang’s group made a fusion protein (4M2e-tFliC) with four different sequences of M2e from four different influenza subtypes. M2e is a peptide, a compound of two or more amino acids linked in a chain, found among all influenza strains. The fusion protein also contains flagellin (FliC), a peptide found in nearly all bacteria with flagella (lash-like appendages) that acts as a strong catalyst when administered together with other antigens, or foreign substances that induce an immune response in the body.

The researchers condensed the protein into the microneedle patch through a collaboration with Dr. Mark R. Prausnitz of the Georgia Institute of Technology. The microneedle patch is generated from a biocompatible polymer, and the tiny needles arrayed on the patch dissolve and release vaccine into the skin rapidly.

The study found mice receiving a conventional inactivated vaccine, a vaccine consisting of pathogens grown in culture and then killed, followed by a skin-applied dissolving 4M2e-tFliC microneedle patch boost could better maintain the humoral immunity antibody response against influenza virus infection compared to when they received the conventional vaccine alone. The findings, published in the Journal of Controlled Release, offer a new perspective for universal influenza vaccines.

“Our study demonstrates that M2e-based vaccines greatly improve immune responses and strengthen protective functions against influenza virus infection,” said Wang, associate professor in the Institute for Biomedical Sciences at Georgia State. “We found that a skin-applied 4M2e-tFliC microneedle patch boosted immunization to seasonal vaccine recipients and may be a rapid approach to increasing the protective efficacy of seasonal vaccines in response to influenza virus challenges. Thus, the M2e antigen is a promising candidate for the development of universal influenza vaccines.”

Influenza virus is one of the most serious respiratory pathogens affecting humans and causes about five million illnesses and 250,000 to 500,000 deaths each year worldwide. It’s estimated that a sudden emergence of an influenza pandemic could kill about 60 million people globally.

Vaccination is an effective method to prevent influenza virus infection, but circulating viruses can rapidly undergo antigenic changes, or small changes in the genes of influenza viruses that happen over time as the virus replicates, that can reduce or eliminate the efficacy of seasonal flu vaccines. To combat an influenza pandemic caused by antigenic drift, a fast, cost-efficient vaccination method is required to provide broader cross-protection against seasonal and pandemic influenza virus infection and promote long-term immunity.

The biodegradable microneedle patch, which is designed to deliver vaccines into the epidermis and dermis of the skin, is a novel technology for vaccine delivery and could improve the vaccine’s ability to provoke an immune response in the body. The skin is a potent site for vaccination because it has an abundance of blood vessels and lymphatic vessels, as well as many different immune cell types. Also, many cells in skin express TLR5, a receptor for FliC that activates the innate immune system. Combining the skin delivery of the M2e antigen with tFliC as a catalyst creates a strong synergy.

In this study, mice were immunized with inactivated influenza vaccines, and four weeks later they were given one of the following boosting immunizations: intramuscular injection of 4M2e-tFliC fusion protein, microneedle patch skin vaccination of 4M2e-tFliC or a placebo microneedle patch without the antigen.

The researchers tested whether a 4M2e-tFliC boosting immunization could affect the immune responses induced by inactivated influenza vaccines. The mice were challenged with H1N1 and H3N2 influenza viruses and monitored daily for body weight changes and survival over 14 days. The levels of influenza virus titers in the lungs of animals whose bodies had built up antibodies against influenza virus were measured, and samples of blood, lungs, spleens and bone marrow were collected and processed.

Mice that received the microneedle patch boost showed significantly enhanced survival and cellular immune responses. The results also indicated skin vaccination with 4M2e-tFliC aided a long-term antibody-mediated immunity.

Co-authors of the study include Drs. Wandi Zhu, Chao Wang, Yuan Luo, Gilbert X. Gonzalez and Teena Mohan of Georgia State and Drs. Winston Pewin and Mark R. Prausnitz of the Georgia Institute of Technology.

The study is funded for $2.6 million by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health. Wang is the principal investigator.

To read the study, visit http://www.sciencedirect.com/science/article/pii/S0168365917306806.

07/19/2017

Tech Square Labs scores $1 million from Invest Georgia

Tue, 02 Jul 2019 19:04:09 GMT

Atlanta-based Tech Square Labs Fund has received a $1 million investment from Invest Georgia, a state-run venture capital fund.

The $25 million Tech Square Labs Fund has made 12 investments so far, totaling $4 million. Investors in the fund include family offices and high net worth individuals. Invest Georgia is the first institutional money in the fund.

Tech Square Labs was launched by a duo of serial entrepreneurs Paul Judge and Allen Nance. The venture, which operates out of a 15,000-square-foot former Office Depot building at Tech Square, aims to build the next generation of information security, marketing automation, and business-to-consumer (B2C) companies.

The General Assembly created Invest Georgia back in 2013, an initiative of Lt. Gov. Casey Cagle, to boost investment in Georgia-based growth and early-stage companies.

The VC fund was allocated $20 million out of an allowed $100 million to date from the state.

Earlier this year, Invest Georgia plowed $3.25 million into Mosley Ventures. The $31 million Mosley Ventures fund has invested in nearly 20 companies since launching four years ago. The fund invests in seed-and-early stage companies in cybersecurity, digital media, machine learning and mobility.

In 2015, Invest Georgia invested $3 million in TTV Capital IV, a financial services-focused venture capital fund.

07/13/2017

AdvaMed Urges House Passage of MDUFA Reauthorization Bill

Tue, 02 Jul 2019 19:05:01 GMT

WASHINGTON, D.C. – The Advanced Medical Technology Association (AdvaMed) issued the following statement from President and CEO Scott Whitaker regarding the planned vote in the U.S. House on the FDA Reauthorization Act of 2017:

"AdvaMed is pleased the full House will be taking up the FDA Reauthorization Act this week. Passage of this legislation will help patients everywhere as it will bring us one step closer to helping FDA fulfill its crucial mission to ensure the availability of safe and effective medical devices and diagnostics.

"The robust performance goals, process improvements, increased accountability and additional resources built into the new user fee agreement mean that patients will benefit from more timely access to the latest medical innovations and companies will benefit from greater certainty as they plan for the next-generation of advancements.

"We encourage members of the House to vote in favor of this important legislation and urge their Senate colleagues to follow suit as soon as possible."

07/11/2017

Medical device company raises $12.3 million, plans move to Atlanta

Tue, 02 Jul 2019 19:05:41 GMT

Dune Medical Devices, a metro Philadelphia-based company dedicated to identifying microscopic residual cancer, is moving its U.S. headquarters to Atlanta.

The company also closed a $12.3 million funding round on July 6. Investors included Canepa Healthcare, ATON Partners and the Kraft Group.

Dune's MarginProbe System is used during breast cancer lumpectomy procedures to test whether the surgery has removed all the cancerous cells.

Typically, women must wait at least five to seven days after the procedure to see if physicians "got it all," and currently 20 to 30 percent of those who undergo lumpectomies will need a second surgery.

"That's really the challenge that's out there, and it's a huge cost to the health-care system as well as a pretty big stress to the patient," said Lori Chmura, CEO of Dune Medical Devices. "It's really important to get all the cancer out the first time."

MarginProbe has shown to reduce re-excision rates up to 79 percent. The U.S. Food and Drug Administration approved the device in 2012, and it already has been used on 10,000 patients.

MarginProbe uses a proprietary radiofrequency spectroscopy platform that also has potential to be applied to a variety of other cancers.

"It essentially uses radio frequency fields to reflect what the differences are between cancer and non-cancer," Chmura said. "."[The device] looks like a pen. You put it up to the tissue once the specimen is removed and the system acquires and delivers a signal that says whether it's cancerous or not."

Dune's technology has attracted attention worldwide, and last year it received a grant of three million euros from EU Horizon 2020 to continue developing the technology.

"Our goal is to make this a standard of care in breast conservation surgery," Chmura said. "We're in the process right now of developing technology to be able to detect microscopic residual cancer for other types of cancer as well."

After breast cancer, Dune will focus on prostate cancer. The company's goal is to expand MarginProbe's capabilities to endoscopic, laparoscopic and robotic surgeries for cancers like pancreatic, lung, gastrointestinal and colon cancers.

Originally founded in Israel, Dune is in the process of moving its U.S. headquarters from metro Philadelphia to Alpharetta, where it has leased office space on Windward Parkway. The office will start with five to seven full-time employees and grow with time, Chmura said.

"Atlanta has shown to be very open to working with Israeli startup companies, which is important to us," Chmura said. "We are moving our headquarters to Alpharetta to really capitalize on the health IT market as well as the benefits of [the Southeastern Medical Device Association, located in Norcross, Ga.], the Global Center for Medical Innovation and some of the other great medical device organizations in Atlanta."

Source: https://www.bizjournals.com/atlanta/news/2017/07/11/medical-device-company-raises-12-3-million-plans.html?ana=e_du_prem#i1

07/11/2017

BIO Adopts Principles on Workplace Development, Diversity, and Inclusion; Launches Board WDDI Commit

Tue, 02 Jul 2019 19:06:31 GMT

WASHINGTON--(BUSINESS WIRE)--Today, the Biotechnology Innovation Organization (BIO) released a set of principles on workforce development, diversity, and inclusion (WDDI) for the biotechnology industry. Concurrent with the adoption of these principles, BIO established a board-level WDDI Committee charged with working to foster workforce development, diversity, and inclusion at BIO and throughout the biotech industry. The Committee will be chaired by Helen Torley, President & CEO of Halozyme, who is succeeding Julie Gerberding, Executive Vice President & Chief Patient Officer at Merck, who led the Committee as it developed BIO’s WDDI principles over the last year.

“As a leader of the 21st century innovation economy, it is critical that the biotech industry also be at the forefront of efforts to develop an effective, diverse and talented global workforce,” said BIO President & CEO Jim Greenwood. “BIO is proud to announce the formation of the WDDI Committee, which will lead our efforts to attract the best and brightest talents from diverse backgrounds to biotech careers, foster an inclusive industry culture, and, most importantly, enable biotech companies and their employees to understand, interact with, and ultimately provide treatment to a diverse patient population with the cultural competency required for success.”

The principles on WDDI adopted today by BIO’s Board of Directors state that BIO considers diversity to be essential to the success of the biotechnology industry. BIO commits itself to, and encourages the industry to follow, these principles on workforce development, diversity, and inclusion:


1.	BIO believes that our members’ products and services should be intended to address the needs of a diverse population.

2.	BIO believes that diversity in all aspects of business operations will optimize the continued growth and success of the biotechnology industry.

3.	BIO will champion workforce development, diversity and inclusion as a way to attract, develop and retain the employee talent pool within the globally competitive biotechnology industry.

4.	BIO will lead by example and be outward-facing in our diversity efforts, and will incorporate diversity and inclusion into all aspects of BIO operations: in communications and membership engagement, at BIO events through programming and education, and in the composition of the Board of Directors and its committees.

5.	BIO will engage with external partners to broaden the reach and incorporation of diversity throughout the biotechnology ecosystem.

6.	Definitions. For purposes of these Principles, the following terms shall have the meanings set forth below:

		a.	Diversity is defined as the wide-range of similarities and differences among persons and perspectives, and follows guidelines established by the U.S. Equal Employment Opportunity Commission.

		b.	Inclusion is defined as the process of creating a business culture and environment that recognizes and effectively leverages the talents, skills, and perspectives of diverse employees.

		c.	Workforce development is defined as the process of ensuring all employees have the opportunities to develop the capabilities and skills required to meet the challenging needs in the biotechnology industry.

“Adopting these principles is an important first step in BIO’s work to ensure that the biotechnology industry is an employer of choice for talented individuals from all backgrounds,” said Julie Gerberding, Executive Vice President and Chief Patient Officer at Merck. “This week, the BIO International Convention will showcase the breadth and depth of talent our industry has to offer, and the Convention programming reflects that diversity. Going forward under Helen’s leadership, the Committee will work with professionals within the biotech industry, BIO staff, and partner organizations to fulfill our mission to create a more globally competitive biotechnology industry by promoting and enhancing workforce development, diversity, and inclusion.”

The 2017 BIO International Convention features three panels on the importance of WDDI in the biotechnology industry:

Invest in Diversity to Drive Innovation – Wednesday, June 21 at 10:45 am
An Issue Not to be Ignored: Diversity in Clinical Trials – Wednesday, June 21 at 1:45 pm
Career and Personal Paths to the Corporate Boardroom, presented by Women in Bio – Thursday, June 22 at 11:00 am

To learn more about BIO’s WDDI efforts, visit bio.org/diversity.

07/05/2017

It’s a Wrap-BIO 2017 Delivers Again

Tue, 02 Jul 2019 19:07:38 GMT

Breaking all previous records, BIO 2017 hosted over 41,400 partnering meetings during this year’s event. Facilitated by BIO’s unique One-on-One Partnering™ system, these invaluable connections form the foundation of innovative industry collaborations and scientific breakthroughs. That word—breakthrough—was heard and seen throughout the Convention Center in San Diego from June 19 – 22. “Breakthrough” reflects the innovation and exciting advancement in the biotech sector.

The annual event drew 16,123 biotech leaders from around the globe and provided attendees with unique perspectives on the immense opportunities and complex challenges ahead for the industry.

David Cameron, the former Prime Minister of the UK, and Ann Romney, the wife of Mitt Romney and a staunch patient advocate delivered keynote addresses that touched on challenges in both the political and health arenas.

BIO 2017 included over 1,800 exhibitors, more than 800 speakers at 400 educational sessions and company presentations, and seven fireside chats. The breadth and depth of offerings and the networking opportunities afforded by having thousands of industry stakeholders continue to make the Convention the premiere event for the biotechnology industry.

This year’s International Convention was co-hosted by Biocom, California Life Sciences Association (CLSA) and Southern California Biomedical Council (SoCalBio).

The 2018 BIO International Convention will return to Boston, MA from June 4 – 7 to celebrate 25 years of innovation.

Philadelphia, PA will host the 2019 BIO International Convention from June 3 – 6.

In 2020, BIO returns for the fourth time to San Diego from June 8 – 11!

07/05/2017

One Health Holds the Key to Preventing the Next Pandemic

Tue, 02 Jul 2019 19:08:44 GMT

Can we combat disease threats before they even emerge? In the fight against infectious diseases, understanding where outbreaks are most likely to happen and under which circumstances can help us develop tools to address risk to potentially prevent the next pandemic.

This theme was explored at BIO’s International Convention on Monday, June 19, during its “One Health Day” programming, which brought together different parts of the BIO family with sessions focused on issues linking human, animal and environmental health.

The One Health concept examines the connectivity between infectious diseases, the health of plants and animals, the health and safety of the environment and food security issues. All of these play a role in contributing to or controlling and preventing the threat of disease outbreaks. To be effective, prevention mechanisms need to address all of these areas and be put in place cooperatively by government, industry and academia on a global scale.

“Seventy-five percent of emerging diseases such as Ebola or Zika come from animals,” said Senator Al Franken (D-Minn.) via video message. Franken is a sponsor of legislation aimed at breaking down silos between human and animal health programs. “The biotechnology industry has an important role to play here. And your convention is a great example of One Health in action.”

In addition to Senator Franken, session speakers included:

Dr. William Karesh, Executive Vice President for Health and Policy at EcoHealth Alliance
Dr. Carsten Brunn, Bayer’s Head of Pharmaceuticals, Americas Region
Frank Terhorst, Bayer’s Global Head of Seeds
Dr. Eddie Sullivan, President, CEO and Co-Founder, SAB Biotherapeutics Inc., and Chairman, BIO Food & Ag Section Governing Board (moderator)
Dr. Laura Kahn, Research Scholar, Woodrow Wilson School of Public and International Affairs, Princeton University and Co-Founder, One Health Initiative
Dr. Nikos Gurfield, Adjunct Professor of Pathology, UC San Diego and County Veterinarian, San Diego County Vector Disease and Diagnostic Laboratory
Adrianne Massey, Managing Director for Science and Regulatory Affairs, Food & Agriculture, BIO
Phyllis Arthur, Managing Director, Infectious Diseases and Diagnostics Policy, BIO
Joanne Duncan, President, Membership and Business Operations Division, BIO

Dr. Carsten Brunn, Phyllis Arthur, Dr. Adrianne Massey, Dr. William Karesh and Frank Terhorst.

“One Heath action requires the efforts of more than just policymakers, academics and practitioners. It is dependent on engagement, and often leadership, from civil society and the private sector,” said Dr. Karesh, who pointed to international efforts such as The Global Virome Project, a global cooperative scientific initiative aimed at massively lowering the risk of harm from future viral outbreaks over 10 years.

“One Health impacts economic health,” explained Karesh. “The costs associated with a disease outbreak aren’t just healthcare costs, but also the costs associated with loss of trade and social disruption.”

At BIO, we’re working to breakdown the silos between plant, animal and human health to leverage the potential of One Health.

“Biotechnology is inherently interdisciplinary,” said BIO’s Adrianne Massey, “and BIO is a logical home for exploring the One Health concept and addressing the connectivity between animal health and human health.

07/05/2017

BIO Applauds Bipartisan Introduction of Renewable Chemicals Tax Credit

Tue, 02 Jul 2019 19:09:34 GMT

Washington, D.C. (June 30, 2017) – The Biotechnology Innovation Organization (BIO) today thanked Rep. Bill Pascrell (D-NJ) and Reps. Ryan Costello (R-PA), Brian Fitzpatrick (R-PA) and Linda Sánchez (D-CA) for introducing the Renewable Chemicals Act of 2017. The legislation, if enacted, would create a targeted, short-term tax credit for production of qualifying renewable chemicals from biomass or investment in production facilities. Applicants for the tax credit would be evaluated on job creation, innovation, environmental benefits, commercial viability and contribution to U.S. energy independence.

Brent Erickson, executive vice president of BIO’s Industrial & Environmental Section, stated, “The Biotechnology Innovation Organization and its members thank Representatives Pascrell, Costello, Fitzpatrick and Sanchez for supporting innovation and helping U.S. companies compete in a rapidly growing global renewable chemicals market. Industrial biotechnology is helping renewable chemical producers innovate, revitalize domestic manufacturing, and bring new energy efficient products to market. That in turn is creating millions of new jobs and opportunities for economic growth. This new legislation will help U.S. companies capture their fair share of worldwide growth in renewable chemical production.”

Mark Schweiker, Senior Vice President of Renmatix, located in King of Prussia, Pa., commented, “There is clear momentum for the biobased industry to commercialize cost-competitive pathways to bio-materials and renewable chemicals. This bill will help leverage a variety of under-utilized, non-food biomass in America for conversion into renewable materials. Stimulating the nascent U.S. renewable chemicals market will reinvigorate rural economies and create sustainable jobs.”

Hugh Welsh, President of DSM NA, headquartered in Parsippany, N.J., added, “We are grateful for Congressman Pascrell’s continued leadership and vision on innovation, renewable chemicals and a US manufacturing renaissance as reflected in his sponsorship of the Renewable Chemicals Act of 2017. This legislation will further support employment, economic growth and continue to encourage global companies like DSM to make additional investments in New Jersey and the entire United States.”

About BIO

07/05/2017

Sanpower Group Closes Acquisition of Dendreon

Tue, 02 Jul 2019 19:10:42 GMT

SEAL BEACH, Calif.--(BUSINESS WIRE)--Dendreon Pharmaceuticals LLC (“Dendreon”) today announced the close of a transaction in which Sanpower Group, a private Chinese conglomerate, acquired Dendreon from an affiliate of Valeant Pharmaceuticals International, Inc. for $819.9 million in cash.

By operating as a standalone company, under the ownership of Sanpower Group, Dendreon will strive to further accelerate and expand access to its flagship immunotherapy product PROVENGE® (sipuleucel-T) to prostate cancer patients worldwide. This is an important goal as the global incidence of prostate cancer continues to climb.

“The first order of business is to work to accelerate the growth trajectory we’ve established over the last two years. PROVENGE remains a groundbreaking therapy, with a demonstrated overall survival benefit and a manageable safety profile,” said Dendreon CEO James Caggiano. “Having treated over 20,000 metastatic prostate cancer patients since PROVENGE was approved, our aim now is to treat a larger percentage of the more than 40,000 men who are afflicted with this disease each year.”

Since being purchased by Valeant two years ago, Dendreon has achieved consistent growth in the use of PROVENGE. Enrollments (prescriptions) of PROVENGE grew by more than 10 percent from 2015 to 2016.

The Dendreon leadership, commercial, sales, manufacturing and operations teams will remain in place following closing, focusing on the continued delivery of life-extending cancer immuno-oncology treatments to those in need.

The acquisition of Dendreon is a milestone for Sanpower Group, its first in the U.S. healthcare sector. “PROVENGE is the first immunotherapy approved and marketed in the U.S. We will work with the relevant authorities to bring PROVENGE to other markets, especially to China and SE Asia. We also plan to evaluate PROVENGE usage in early-stage prostate cancer, with the hope of curing more men of the disease,” remarked Sanpower Chairman Yuan Yafei. “Dendreon brings unique strategic value to our portfolio, and coupled with the largest cord blood bank in the world, our goal is to become a leader in stem cells and immune-oncology. We also plan to add on adjacent assets to Dendreon to enrich its pipeline.”

PROVENGE was the first U.S. Food and Drug Administration-approved personalized immunotherapy for cancer – and remains the only autologous immunotherapy in the world approved for human use.

About PROVENGE® (sipuleucel-T)

PROVENGE® (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone refractory) prostate cancer.

IMPORTANT SAFETY INFORMATION

Acute Infusion Reactions: Acute infusion reactions (reported within 1 day of infusion) may occur and include nausea, vomiting, fatigue, fever, rigor or chills, respiratory events (dyspnea, hypoxia, and bronchospasm), syncope, hypotension, hypertension, and tachycardia.

Thromboembolic Events: Thromboembolic events, including deep venous thrombosis and pulmonary embolism, can occur following infusion of PROVENGE. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events. PROVENGE should be used with caution in patients with risk factors for thromboembolic events.

Vascular Disorders: Cerebrovascular events (hemorrhagic/ischemic strokes and transient ischemic attacks) and cardiovascular disorders (myocardial infarctions) have been reported following infusion of PROVENGE. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events.

Handling Precautions: PROVENGE is not tested for transmissible infectious diseases.

Concomitant Chemotherapy or Immunosuppressive Therapy: Chemotherapy or immunosuppressive agents (such as systemic corticosteroids) given concurrently with the leukapheresis procedure or PROVENGE has not been studied. Concurrent use of immune-suppressive agents may alter the efficacy and/or safety of PROVENGE.

Adverse Reactions: The most common adverse reactions reported in clinical trials (≥ 15% of patients receiving PROVENGE) were chills, fatigue, fever, back pain, nausea, joint ache, and headache.

For full Prescribing Information, please visit http://www.dendreon.com/Products.

About Dendreon

Dendreon is a healthcare company whose mission is to transform lives through the discovery, development, commercialization and manufacturing of novel personalized immune-therapeutics for cancer. Dendreon manufactures PROVENGE® (sipuleucel-T), which was approved by the U.S. Food and Drug Administration in April 2010. Dendreon is exploring the application of additional product candidates for the potential treatment of a variety of cancers. Dendreon is headquartered in Seal Beach, Calif. For more information, please visit http://www.dendreon.com.

About Sanpower Group

Established in 1993, Sanpower Group has become one of the largest private conglomerates in China. Headquartered in Nanjing, it offers a global platform for its three primary sectors: Healthcare, Retail and Financial Services. Sanpower Group has controlling stakes in more than 100 subsidiaries and has a 100,000-strong global workforce, including 40,000 based internationally. Sanpower Group currently generates over RMB 120 billion in annual revenue. For more information, please visit http://en.sanpowergroup.com/.

About Sanpower Group Healthcare Sector

In recent years, Sanpower Group has determined the direction for Healthcare sector's growth, including health care, home care, genetic testing, precision medical and other fields.

In fact, Sanpower Group previously acquired AnKangTong, Natali and A.S. Nursing Company. In 2016, the group announced the acquisition of China Cord Blood Corporation and Shandong Cord Blood Bank, this means that it has emerged as the world's largest cord blood banking operator. The group also owns many medical and health institutions.

The acquisition of PROVENGE is an important step in the area of precision medical treatment for Sanpower Group. The big data from its cord blood bank provides the foundation for precise medical care. The acquisition of PROVENGE has allowed the group to expand its umbilical cord blood bank from the basics to its practical application, and has taken a strategic step in further laying out precise medical care.

The incidence of prostate cancer increases significantly in China. According to a sampling survey, the incidence of prostate cancer in China increased by 10 times within 20 years. Therefore, PROVENGE in China will have a broad market and prospects for development. "We aim to introduce one of the most advanced medical technologies and treatments to China and also other major Asian markets, and make Sanpower Group a leading Chinese enterprise in cellular immunotherapy," said Yuan Yafei, Chairman of Sanpower Group.

07/05/2017

Gilead Sciences Makes Lead Gift for HIV/AIDS Clinic Modernization

Tue, 02 Jul 2019 19:11:53 GMT

The Grady Health Foundation is pleased to announce a $2 million donation from Gilead Sciences that will help fund a comprehensive renovation of Grady Health System’s Ponce de Leon Center, which houses one of the nation’s largest and most comprehensive programs for the treatment of advanced HIV and AIDS.

The donation underscores an ongoing partnership between Grady and Gilead to address the needs of people living with HIV.

“Grady has been on the front lines of HIV and AIDS treatment and research since the early 1990s and continues to lead the fight against this disease, which has reached epidemic proportions in Atlanta and throughout the south. We are grateful to Gilead Sciences for this generous donation, which will be used to modernize our Ponce de Leon Center so that we can more effectively implement new approaches to care and accommodate the high volume of patients who come through our doors for testing, treatment and support,” said John Haupert, President and CEO of Grady Health System.

One in four patients with HIV in Georgia receives treatment at Grady, including adult men and women as well as young children. The Ponce de Leon Center provides multidisciplinary support for patients including testing, diagnosis, primary care, acute care, dental care, and mental and behavioral health services.

Gilead’s leadership gift supports a planned $23 million renovation that will allow for more efficient delivery of services and increase the clinic’s capacity so that Grady can meet increasing demand with innovative, patient-centered programs.

“Gilead and Grady share the goal of providing life-saving care for patients living with HIV and AIDS. Given its location at the epicenter of the current HIV epidemic in the southeast, we are confident that this investment in the future of the Ponce de Leon Center will allow Grady to have an even greater impact on the care received by thousands of people in the region,” added Gregg Alton, Executive Vice President, Corporate and Medical Affairs, Gilead Sciences.

The Ponce de Leon Center was first opened in 1993 and today serves 6,000 patients annually from a 20-county area including Fulton and DeKalb, which have the highest prevalence of HIV in Georgia and are among the highest in the United States. Research at the Ponce de Leon Center is conducted in partnership with The Center for AIDS Research at Emory.

06/29/2017

Metro Atlanta Chamber Bioscience Leadership Council Asks ‘What’s Next?’

Tue, 02 Jul 2019 19:13:17 GMT

This article is part of a continuing series of posts on the Metro Atlanta Chamber’s council groups. Learn more about the Chamber’s work by exploring these leadership councils and the impact they have on the metro region. The previous entry covered MAC’s Supply Chain Leadership Council and the industry’s digital transformation.

Chaired by industry trailblazers from Morehouse School of Medicine, athenahealth and Spencer Stuart, the Metro Atlanta Chamber’s Bioscience Leadership Council brings together the most advanced research programs, world-class universities and both public and private organizations. With partners across the region and businesses from FORTUNE 500 companies to startups, the council provides a platform to present breakthrough technologies, address skill gaps, market our region and create awareness specific to industry expansion opportunities.

The second quarter meeting included What’s New, What’s Next & What’s Needed for the bioscience industry. The discussion highlighted new innovations in digital health, hospitals, vaccines and healthcare delivery. Next, Patientory Founder and CEO Chrissa McFarlane shared her challenges and triumphs navigating the innovation ecosystem, including how her company recently raised $7.2 million in just three days to expand their blockchain technology.

Todd Haedrich, vice president and general manager of small groups at athenahealth, closed the meeting by highlighting advancing technologies in artificial intelligence, blockchain, cloud storage and wearables. The major discussion point involved what it will mean to move these technologies into consumers’ homes and how Atlanta can make an impact addressing global needs.

“Readmission, immune response, patient satisfaction and data storage are a few of the technologies Atlanta will continue to move the needle on. The Metro Atlanta Chamber will continue to bring together thought leaders who will leverage the advantages and assets in our region and truly make a global impact,” said Kornelius Bankston, MAC’s director of bioscience ecosystem expansion.

Recognized as the center of global health and health IT capital of the U.S., metro Atlanta is a powerhouse for the rapidly growing bioscience industry. With more than 200 life science companies employing more than 30,000 people, the state’s bioscience industry is anchored by world-class organizations like the Centers for Disease Control and Prevention, American Cancer Society, Arthritis Foundation, CARE, The Carter Center, Task Force for Global Health and many more.

The next Bioscience Leadership Council meeting will be held September 12 at the Metro Atlanta Chamber.

If you have any questions on how your organization can engage with MAC, please contact Jack Murphy.

06/29/2017

Impact Cryotherapy Commits to European Markets with CE Certification

Tue, 02 Jul 2019 19:14:09 GMT

ATLANTA--(BUSINESS WIRE)--Impact Cryotherapy announces it has met the requirements to certify and display the highly-respected CE Mark on their entire line of Impact Cryosaunas.

The CE mark is mandatory for certain products sold in the European Economic Area (EEA) and indicates the product conforms with a wide array of standards for safety, health, environmental protection and quality assurance. It is required in the EEA for electrical equipment, medical devices, most machinery and many other products.

The CE mark is also found on products sold outside of the EEA, making it a recognizable and valuable standard throughout the world. “Designed, manufactured and distributed from the U.S., we are committed to delivering and supporting our cyrosaunas in markets worldwide,” said Richard Otto, Chief Executive Officer of Impact Cryotherapy.

Cryotherapy is the practice of using cold temperatures to promote wellness. Whole body cryotherapy is the modern experience which stimulates rejuvenating and refreshing benefits at a new level of cold, in just three minute sessions. Reaching temperatures as low as -120º Celsius (-184º Fahrenheit), participants say they experience a multitude of benefits from cryotherapy sessionsand is the driving force behind a new lifestyle of wellness.

Additional information related to the self-certification CE Mark standards met by Impact Cryotherapy may be obtained by contacting Impact.

06/29/2017

Visioneering Technologies, Inc. Names Mark Rapoport as New CFO

Tue, 02 Jul 2019 19:14:55 GMT

ATLANTA--(BUSINESS WIRE)--Visioneering Technologies, Inc. (VTI), an innovative leader in developing products that redefine vision, announced today that it has appointed Mark Rapoport to the position of Chief Financial Officer (CFO).

“Mark is an exceptionally accomplished financial leader, and we are excited to have a seasoned executive of his caliber on the VTI team,” said Stephen Snowdy, PhD, CEO of VTI. “He has a long and successful track record of strong financial management and contributing at the executive level to revenue and organizational growth.”

Rapoport brings more than three decades of experience in diverse industries, including healthcare technology. He has also served as the financial leader for several venture capital funded companies. As CFO, he will be responsible for overseeing the financial management of the company as it undergoes significant national and global sales and manufacturing expansions.

In his most recent position, Rapoport served as the CFO for Capsule Technologie SAS, a Private Equity funded provider of Medical Device Information System solutions acquired by Qualcomm Life, Inc. Prior to that, Rapoport’s healthcare experience included President & CEO for Thomas, Thomas & Walsh, Inc., a venture-capital-funded provider of Medicaid eligibility services to hospitals; and COO and CFO for Landacorp, Inc. a publicly traded Nasdaq company providing medical management software solutions and technology-based disease management programs to hospitals and managed care organizations.

Rapoport earned his Master of Business Administration in Finance and Accounting from Emory University in Atlanta, Georgia and his Bachelor of Arts in Economics from State University of New York at Binghamton.

“I’m excited to be part of a team that is so passionate about bringing VTI’s revolutionary NaturalVue® portfolio of contact lenses to market,” said Rapoport. “This is a dynamic and rapidly growing company and I look forward to using my skills to help VTI reach and exceed their goals.”

Rapoport may be reached at mrapoport@vtivision.com or 1-844-VTI-LENS (1-844-884-5367).

06/29/2017

UGA joins initiative to advance biotech manufacturing in the U.S.

Tue, 02 Jul 2019 19:15:41 GMT

Athens, Ga. - The University of Georgia is partnering in a biopharmaceutical innovation institute that aims to boost market production of cell-based therapies and develop a skilled workforce trained for the biotechnology and pharmaceutical industry.

The new public-private partnership, called the National Institute for Innovation of Manufacturing Biopharmaceuticals, or NIIMBL, will focus its efforts on driving down the cost and risks associated with manufacturing advanced cell and gene therapies for biopharmaceutical production.

Steven Stice, director of the UGA's Regenerative Bioscience Center, is the UGA lead in the partnership, which is coordinated by the University of Delaware.

NIIMBL represents a total investment of $250 million, including $129 million in private cost-share commitments from the NIIMBL consortium of 150 companies, nonprofits, educational institutions and state partners across the country, combined with at least $70 million in federal funding from the U.S. Department of Commerce.

NIIMBL is the 11th institute under the Manufacturing USA National Network for Manufacturing Innovation initiative created to advance manufacturing leadership and restore jobs to the U.S.
This recent success follows an announcement in 2016 by the U.S. Department of Defense that an MIT-led team involving UGA was selected for funding as the eighth NNMI institute.

"We are pleased to have UGA participate in these high-profile public-private partnerships that are aimed at advancing U.S. leadership in key manufacturing sectors," said UGA Vice President for Research David Lee. "We are eager to assist industry partners in meeting their goals through the development of new and existing intellectual property, and the training of an appropriate workforce."

Biopharmaceuticals are increasingly showing promising results in treating some of the most prevalent and debilitating diseases affecting human health. But manufacturing of biopharmaceuticals is not without large-scale operational and technological challenges, Stice said.

These biologically sourced drugs are different from traditional small molecule, synthesized drugs. For example, he said, the synthesized drug ibuprofen can be precisely copied and characterized, and result in varied generic versions. In contrast, biopharmaceuticals like vaccines are much more complex and rely on the use of a biological transformation. As living cells, they are highly sensitive to their conditions and surroundings.

Technical projects, which will be designed by the industry partners of the institution, will be selected through a competitive process and funded via subaward agreements with NIIMBL members.

Stice, a Georgia Research Alliance Eminent Scholar and D.W. Brooks Distinguished Professor in the College of Agricultural and Environmental Sciences, will facilitate team assembly for response to the project calls, leveraging years of collective experience in regenerative medicine and technology development.

He is co-director of the Regenerative Engineering and Medicine research center, or REM, a collaboration of Emory University, the Georgia Institute of Technology and UGA, which will play a pivotal role in developing new ideas and technologies.

"There is a crippling regulatory gap, which is commonly referred to as ‘the valley of death' in moving biotech products from discovery to commercialization," Stice said. "What NIIMBL presents is an opportunity to help improve government regulation, minimize failure, create job growth and improve health care quality, all while reducing costs in the U.S."

The Regenerative Bioscience Center at the University of Georgia links researchers and resources collaborating in a wide range of disciplines to develop new cures for devastating diseases that affect animals and people. With its potential restorative powers, regenerative medicine could offer new ways of treating diseases for which there are currently no treatments-including heart disease, Parkinson's, Alzheimer's and stroke. For more information, see www.rbc.uga.edu.

06/26/2017

Priority Generic Drug Reviews: New FDA Draft Guidance

Tue, 02 Jul 2019 19:16:35 GMT

In preparation of its commitments under the second Generic Drug User Fee Amendments (GDUFA II), the US Food and Drug Administration (FDA) on Monday released a draft guidance laying out how sponsors can qualify for shorter review times for priority generic drugs.

Under GDUFA II, FDA agreed to shorten its review of eligible priority generics by two months if sponsors submit a complete and accurate pre-submission facility correspondence (PFC) two months ahead of their abbreviated new drug application (ANDA), prior approval supplement (PAS) or amendment.

"This critical 2-month lead time provides the agency the opportunity to determine whether facility inspections will be needed, and, when they are, to initiate inspection planning earlier in the review of the ANDA, enabling FDA to meet the shorter review timeframe," FDA writes.

In the draft guidance, FDA details the information and format it says sponsors must include in their PFCs, which includes:

General information, including the planned ANDA pre-assignment number (which the applicant must request from FDA before submitting the PFC), PFC submission date, and the applicant's identifying information;
Statement of ANDA eligibility for priority review;
Manufacturing process and testing facility information; and
Bioequivalence summary and site/organization information.

To attest that an ANDA is eligible for priority review, FDA says sponsors must include a statement detailing which criteria for priority review the submission meets, pointing sponsors to its Manual of Policies and Procedures (MAPP) on ANDA prioritization.

Under the MAPP, FDA lays out eight criteria that may qualify an ANDA for an expedited review, such as applications for sole-source generics, products in shortage, first generics and generics that could help address public health emergencies.

However, FDA cautions sponsors to ensure they get everything right in the PFC the first time around, or else risk receiving a standard review timeframe.

"Absent extraordinary circumstances, FDA does not expect to utilize its limited resources to review a second PFC on the same submission if the first one is deficient," FDA writes.

The agency also says that PFCs must be submitted between two and three months before the planned ANDA submission, as submitting the PFC less than two months would give the agency too little time to assess the information and more than three months ahead would put the information at risk for being out-of-date.

06/22/2017

110 Women Who Are Making Their Mark In The Medtech Industry

Tue, 02 Jul 2019 19:17:28 GMT

There is quite a network of women leading the medical technology industry- such an impressive network that Becker’s Hospital Review recently published a list of 110 medtech women executives and leaders to know. Each woman on the list is leaving their mark on the medtech field in health IT, medical devices and technology and acting as a driving force for their organizations and industries.

Among the list of rockstar medtech ladies is GCMI and T3 Labs CEO Tiffany Wilson. Tiffany is a real mover and shaker in the Southeast’s medical device community, spending over a decade bringing innovative medical technology from bench top to bedside.

“She (Tiffany) joined the Global Center of Medical Innovation in 2011 to launch the Southeast’s first medical device innovation center,” says Laura Dyrda, Becker’s Hospital Review contributor. “Her team works with inventors and companies to accelerate the development, testing, training and commercialization of innovative medical products. She serves as Past-President of the Board of the Southeast Medical Device Association (SEMDA), Founding Member of Medtech Women@SEMDA, the Georgia Bio Board of Directors and a member of the National Advisory Council on Innovation and Entrepreneurship the U.S. Department of Commerce.”

Congratulations Tiffany!

To see the full list and read about the other 109 ladies making strides for medtech, click here.

Stay up to date with the latest news from GCMI and T3 Labs by following us on Linkedin and Twitter.

About GCMI and T3 Labs
The Global Center of Medical Innovation (GCMI) and its wholly owned subsidiary T3 Labs, is the world’s leader in driving efficient medical product innovation. Using our proven high-quality processes, our expert staff works alongside physician innovators, hospital teams, Fortune 500s, start-ups, academic and government funded innovators every day to commercialize innovative medical devices and products, including drugs and biologics, that improve quality based outcomes and delivery of healthcare for patients.

Are you a physician innovator or engineer with an innovative medtech idea seeking a quality partner to help navigate the pathway from concept to cure to commercialization? GCMI and T3 Labs can help. Contact GCMI and T3 Labstoday!

06/22/2017

Georgia State Hosts First International Triple Negative Breast Cancer Conference

Tue, 02 Jul 2019 19:18:14 GMT

ATLANTA—Georgia State University will host the First International Triple Negative Breast Cancer Conference from Sept. 18 to 20.

The two-day conference is focused on advancing scientific knowledge about the aggressive triple negative breast cancer (TNBC) subtype with the goal of improving patients’ lives and eliminating racial breast cancer-related disparities. The conference theme is “Illuminating Actionable Biology.”

Conference topics will include “The Biology of Triple Negative Breast Cancer,” “Predictive and Prognostic Biomarkers,” “Strategies for Reducing Disparities,” “Therapeutic Targets and Treatment Strategies” and “Epidemiology and Precision Oncology.”

Speakers include Dr. Ian O. Ellis of the University of Nottingham, United Kingdom; Dr. Charles M. Perou of the University of North Carolina, Chapel Hill; and Dr. Otis Brawley of the American Cancer Society.

“We envision this conference as representing the confluence of scholarship, research talent, excellence in medicine and compassion,” said Dr. Ritu Aneja, conference chair and Distinguished University Professor and director of the Molecular Basis for Disease Program at Georgia State. “It will bring together patients, researchers, clinicians and students to brainstorm, learn and conceive innovative ideas to tackle the challenges associated with TNBC management and breast cancer-related racial health disparities. In doing so, it will catalyze the transformation of Georgia State into a premier international hub for breast cancer research.”

Conference co-chairs are Dr. Emad A. Rakha, chair of the Department of Histopathology of Nottingham University, United Kingdom, and Dr. Mylin A. Torres, director of the Glenn Family Breast Center and the Louisa and Rand Glenn Family Chair in Breast Cancer Research at Winship Cancer Institute of Emory University.

The last date for abstract submission is July 15. Travel awards are available for minority student researchers.

The conference is supported by the Glenn Family Breast Center at Winship Cancer Institute of Emory University, the International Consortium for Advancing Research on Triple-Negative Breast Cancer and the Georgia Center for Oncology Research & Education.

The conference is open to the public. For details about registration and eligibility criteria for travel awards, visit www.tnbcconference.org.

06/22/2017

Georgia State Spin-Off, Inlighta Biosciences LLC, Receives $2 Million Grant To Develop Enhanced MRI Contrast Agents For Liver Cancers And Metastasis

Tue, 02 Jul 2019 19:18:55 GMT

ATLANTA—A local start-up, life sciences company founded by Dr. Jenny Yang, Regents’ Professor of Biochemistry at Georgia State University, has received a $2 million federal grant to develop improved magnetic resonance imaging (MRI) contrast agents for the early detection of liver cancers and other cancers, such as uveal melanoma or eye cancer, that have metastasized to the liver.

Yang, who is also the director of the Center for Diagnostics and Therapeutics, is the principal investigator for the grant from the National Cancer Institute of the National Institutes of Health (NIH) via the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs. The research and development work will be done through a collaboration among startup company Inlighta, Georgia State and Emory University. The focus of the project is on optimizing a novel, protein-based contrast agent called ProCA32, the company’s first candidate for clinical development. Next-generation agents that target cancer cells will also be developed.

The funding will support fine-tuning of in vivo imaging protocols, validating the benefit of the agent and conducting animal toxicology studies needed to support an application to the United States Food & Drug Administration for human clinical trials.

“We are very excited by receiving this Phase II STTR funding to support our Investigational New Drug enabled studies,” Yang said. “Our proposed studies in precision imaging address major medical gaps, including early detection of small lesions and biomarker expression, especially for high-risk patients, and monitoring the dynamic changes of biomarkers during disease progression and following therapeutic treatment. Success in our proposed studies will have immediate clinical implications in the diagnosis of liver metastasis from various cancers, primarily liver cancer, and other liver diseases’ accurate staging and follow-up of high-risk patients, evaluating treatment effect and image-guided interventions. We are also very grateful for the previous support from Georgia State, Georgia Research Alliance and funding of STTR Phase I from the National Cancer Institute.”

The innovative design of ProCA32 allows it to bind tightly with two gadolinium (Gd3+) ions, resulting in a 10-fold increase in relaxivity and significantly enhanced MRI image contrast compared to conventional MRI contrast agents.

Yang has previously conducted preclinical studies in collaboration with clinicians and other researchers, including Drs. Hans Grossniklaus and Pardeep Mittal at Emory, investigating uveal (eye) cancer, which is treatable in the eye but often fatal if it metastasizes to the liver. In rodents, conventional contrast agents are unable to detect liver tumors smaller than 1 cm, while ProCA32 has detected liver tumors as small as 0.24 mm. By detecting tumors earlier, clinicians will be able to pursue better treatment options for their patients and potentially improve their odds of recovery.

Yang has also found ProCA32 can be modified to detect other types of cancers, as the contrast agent may be linked with a receptor-targeting moiety so that it can bind to disease biomarkers such as CXCR4 on liver tumors, HER2 on breast tumors and collagen at liver fibrosis. Further modifications of the agents will allow for mapping of heterogeneously expressed biomarkers that are often missed by blind biopsy, enabling early detection and characterization of metastatic tumors and distinguishing among different types of liver metastases (nodular or invasive).

Georgia State, in downtown Atlanta, is rapidly becoming a hub for research in the Southeast, and administrators at Georgia State are focused on providing a supportive environment for basic and applied research and translational studies aimed at developing marketable products.

“Supporting innovative and entrepreneurial Georgia State investigators’ efforts to access funds critically needed to advance early-stage technology toward the market is a high priority for Georgia State,” said Dr. James Weyhenmeyer, vice president for research and economic development at Georgia State. “We expect a substantial increase in the number of Georgia State investigators applying to the small business research programs sponsored by NIH and other federal agencies to support the further development of their technology.”

For more information about Inlighta Biosciences LLC, visit http://www.inlighta.com/.

06/21/2017

GeoVax Awarded NIH Grant for Zika Vaccine

Tue, 02 Jul 2019 19:19:36 GMT

GeoVax Labs, Inc. (OTCQB: GOVX), a biotechnology company developing innovative human vaccines, announced today that the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has awarded the Company a Small Business Innovative Research (SBIR) grant of $600,000 in support of its novel Zika vaccine development program.

The grant, entitled “Advanced Preclinical Testing of a Novel Recombinant Vaccine Against Zika Virus”, will support preclinical testing of GeoVax’s vaccine candidates in non-human primates in preparation for the initiation of a Phase 1 human clinical study.

GeoVax is developing two novel Modified Vaccinia Ankara (MVA) vaccine candidates against Zika virus (ZIKV): one expressing the ZIKV NS1 protein (designated GEO-ZM02), and a second expressing the ZIKV Envelope protein. In the studies supported by this grant, GeoVax will evaluate the immunogenicity and protective efficacy of these two vaccine candidates in non-human primates.

Farshad Guirakhoo, Chief Scientific Officer at GeoVax, commented, “The studies funded by this grant will build upon previous work that demonstrates the protective efficacy of recombinant vaccines using GeoVax’s MVA live viral vector. We are particularly excited about GEO-ZM02, which recently demonstrated 100% single-dose protection in normal mice against a lethal dose of ZIKV delivered by intracerebral inoculation. GEO-ZM02 not only has the potential of a single-dose vaccine, which is practical to combat epidemics in resource-strained countries, but also does not bear the risk of enhancing other flavivirus infections, such as Dengue and West Nile viruses, in vaccinated subjects. This phenomenon, called Antibody Dependent Enhancement (ADE) of infection, has been shown to increase severity of DENV infection in vivo, and is a safety concern for other Zika vaccines under development that utilize the structural Envelope (E) protein of ZIKV for their vaccine construct. GEO-ZM02 is based on the non-structural-1 (NS1) protein of ZIKV, which is not packaged into the virions and is not involved in ADE. Moreover, the NS1 protein is abundantly secreted into the blood of a ZIKV-infected individual and plays a critical role in flavivirus acquisition by mosquitoes by overcoming the immune barrier of the mosquito midgut. Therefore, GEO-ZM02 has the potential to protect both humans and mosquitoes from ZIKV infection; a novel vaccination strategy that could stem epidemics at a low vaccine coverage.”

About GeoVax
GeoVax Labs, Inc., is a clinical-stage biotechnology company developing human vaccines against infectious diseases using its Modified Vaccinia Ankara-Virus Like Particle (MVA-VLP) vaccine platform. The Company’s development programs are focused on preventive vaccines against HIV, Zika Virus, hemorrhagic fever viruses (Ebola, Sudan, Marburg and Lassa fever), and malaria, as well as therapeutic vaccines for chronic Hepatitis B infections and cancers. GeoVax’s vaccine platform mimics a natural infection, stimulating both the humoral and cellular arms of the immune system to recognize, prevent, and control the target infection. For more information, visit www.geovax.com.

06/21/2017

Quest Diagnostics to Form Precision Oncology Center of Excellence Through Acquisition of Two Texas..

Tue, 02 Jul 2019 19:20:23 GMT

MADISON, N.J., June 12, 2017 /PRNewswire/ -- Quest Diagnostics (NYSE: DGX) today announced that it has signed definitive agreements to acquire two laboratory businesses in Lewisville, Texas, with the aim to establish a center of excellence providing diagnostic services to aid the detection and management of cancer for oncologists and patients nationwide.

The two businesses, Med Fusion and Clear Point, together provide a full range of diagnostic services to physicians and provider networks. Baylor Scott & White Health (BSWH), the largest not-for-profit health care system in the state of Texas; The US Oncology Network (The Network), supported by McKesson Specialty Health, a division of McKesson Corporation; Texas Oncology; and Pathologists Bio-Medical Laboratories (PBM) are co-owners of one or both businesses.

Upon the completion of the transaction, Quest will become a preferred provider of advanced oncology diagnostics for The Network, including Texas Oncology. The Network is the largest of its kind, consisting of more than 400 locations across the United States and over 1,400 independent, community-based physicians. The advanced diagnostics Quest will provide include genomic and pathology testing, such as tumor sequencing, typically used by oncologists to select and monitor treatment and predict disease progression. Inherited genetic testing, such as for BRCA breast cancer screening, typically offered by non-oncologists, will not be part of a preferred provider relationship.

In addition, Quest will be a preferred provider of a full range of inpatient and outpatient diagnostic services for 12 hospitals of Baylor Scott & White Health in North Texas. Quest will provide these services from the center of excellence site in Lewisville upon close of the transaction. Quest and PBM will also have a preferred provider relationship for several services assuming the completion of the transaction.

"Precision medicine is changing the way we treat cancer and giving new hope to people living with the disease, but too often advanced diagnostics that facilitate the best possible care are out of reach of community oncologists and their patients," said Steve Rusckowski, chairman, president and CEO, Quest Diagnostics. "By partnering with McKesson Specialty Health and The Network, we will make Quest's state-of-the-art genomic analysis readily available to community oncologists everywhere. We also look forward to working with BSWH, a leading health system, to deliver broad access to high quality, high value services. This transaction will not only accelerate Quest's growth in cancer diagnostics, but also holds the promise of improving care for patients with cancer in Texas and the entire United States."

The transaction is expected to be completed in the third quarter of calendar year 2017, subject to the satisfaction of customary closing conditions, including obtaining required regulatory approvals. Additional terms were not disclosed.

Precision medicine diagnostics are intended to help guide personalized treatment, based on genomic, proteomic or other characteristics unique to the patient. Following the closing of the transaction, Quest Diagnostics and McKesson Specialty Health, with The Network and Texas Oncology, will collaborate on the development of standardized, evidence-based services for guiding treatment decisions within the electronic patient record and care plan workflow, building off a model spearheaded by Med Fusion. Quest expects to be able to offer versions of these services, once developed, to other providers in the United States with the goal to advance better cancer outcomes.

The center will complement Quest's existing centers of excellence in San Juan Capistrano and Valencia, California; Chantilly, Virginia; and Marlborough, Massachusetts. These laboratories generally specialize in advanced diagnostic services for marquee health systems and specialty physicians. In Texas, Quest Diagnostics also operates full-service laboratories in Irving and Houston.

Nearly 1.7 million people are expected to be diagnosed with cancer in the United States in 2017, according to the American Cancer Society.

Ziegler, a specialty investment bank, acted as the financial advisor to Med Fusion on the transaction.

Additional Executive Quotes
"The US Oncology Network will benefit from our collaboration with Quest Diagnostics, a leader in innovative oncology and genomic testing," said Kirk Kaminsky, president, The US Oncology Network and Practice Management, McKesson Specialty Health. "We're excited about the opportunity for enhanced access to advanced diagnostic tools for the community-based oncology practices that we support."

"Quest is well positioned to expand med fusion's vision, helping deliver precision medicine in an unrelenting environment of value improvement for patients, physicians and other stakeholders," said John McWhorter, chief operating officer at Baylor Scott & White Health.

"By joining forces with Quest Diagnostics, Med Fusion will speed the development and adoption of its novel framework for precision medicine diagnostics developed in recent years by our team," said Jon L. Hart, chief executive officer, Med Fusion. "This relationship has tremendous potential to generate value and better outcomes and care for cancer patients."

About Baylor Scott & White Health
Formed from the 2013 merger between Baylor Health Care System and Scott & White Healthcare, the system referred to as Baylor Scott & White Health is the largest not-for-profit health care system in the state of Texas. With total assets of $10.8 billion* and serving a population larger than the state of Georgia, Baylor Scott & White Health has the vision and resources to provide its patients continued quality care while creating a model system for a dramatically changing health care environment. The system now includes 48 hospitals, more than 1,000 access points, 5,500 active physicians, and 44,000 employees, plus the Scott & White Health Plan, Baylor Scott & White Research Institute and Baylor Scott & White Quality Alliance — a network of clinical providers and facilities focused on improving quality, managing the health of patient populations, and reducing the overall cost of care. For more information visit: bswhealth.com
* based on audited 2016 fiscal year statements

About Quest Diagnostics
Quest Diagnostics empowers people to take action to improve health outcomes. Derived from the world's largest database of clinical lab results, our diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve health care management. Quest annually serves one in three adult Americans and half the physicians and hospitals in the United States, and our 43,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives. For more information, please visit www.QuestDiagnostics.com.

About Med Fusion
Headquartered in Lewisville, Texas, Med Fusion is an integrated, advanced diagnostics laboratory and clinical trials service organization providing support to a wide range of healthcare providers through a patient-centric support model. The company is positioned to introduce more targeted diagnostics, reduce episode of care costs and enhance healthcare delivery system efficiencies. Based in a 200,000 square foot facility, the company's full service clinical laboratory includes a dedicated staff of over 450 well-trained healthcare professionals, For more information, please visit www.medfusionservices.com.

About Clear Point
Clear Point serves healthcare providers with core and STAT laboratory testing and services, as well as certain advanced esoteric testing along with anatomic and reference tests through collaboration with Pathologists Bio-Medical Laboratories and Med Fusion. Clear Point optimizes patient care delivery through its focus on efficient turnaround of test results, specimen preservation and tracking protocols, and integrated information systems with highly accurate and detailed reports. For more information, please visit www.ClearPointlabs.com

About Texas Oncology
Texas Oncology delivers high-quality cancer care with leading-edge technology and advanced treatment and therapy options available to help patients achieve "More breakthroughs. More victories."® in their fights against cancer. Texas Oncology, a pioneer in community-based cancer care, is an independent oncology practice with sites of service throughout Texas and southeastern Oklahoma. Texas Breast Specialists and Texas Urology Specialists, which focus on all areas of breast and urologic care, as well as Texas Center for Proton Therapy, are a part of Texas Oncology.

Texas Oncology patients have the opportunity to take part in some of the most promising clinical trials in the nation for a broad range of cancers. Texas Oncology is affiliated with US Oncology Research, which has played a role in nearly 60 FDA-approved cancer-fighting drugs, about one-third of all cancer therapies approved by the FDA to date.

Texas Oncology is a member of The US Oncology Network, one of the nation's largest community-based cancer treatment and research networks in America. For more information, visit www.TexasOncology.com.

06/21/2017

Vertera Spine raises $3.1 million

Tue, 02 Jul 2019 19:21:13 GMT

Atlanta-based Vertera Spine Inc. raised more than $3 million, according to documents filed with the U.S. Securities and Exchange Commission.

The company, located at 739 Trabert Avenue Northwest, began raising money Feb. 7.

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Atlanta-based Vertera Spine Inc. raised more than $3 million, according to documents… more

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Vertera CEO Christopher Lee could not immediately be reached for comment.

Vertera is a privately held medical device company that manufactures spinal implants. One of its products is the COHERE Cervical Interbody Fusion Device, which was named one of the top 10 best spine technologies of 2016 by Orthopedics This Week.

Founded in 2013, the company also has received funding from the National Science Foundation, Georgia Research Alliance and Duke Angel Network.

05/31/2017

New chair named for Coulter Department of Biomedical Engineering

Tue, 02 Jul 2019 19:23:05 GMT

Susan Margulies, PhD, has been named the Wallace H. Coulter Chair of the Coulter Department of Biomedical Engineering (BME) at Georgia Tech and Emory University, and a Georgia Research Alliance Eminent Scholar in Injury Biomechanics. Her appointments are effective August 1.

Margulies is currently professor of bioengineering at the University of Pennsylvania. She is a Fellow of the American Institute for Medical and Biological Engineering, Fellow of the Biomedical Engineering Society and Fellow of the American Society of Mechanical Engineers.

"Dr. Margulies will be an outstanding addition and leader for our joint Department of Biomedical Engineering," says David S. Stephens, MD, interim dean, Emory University School of Medicine and vice president for research, Woodruff Health Sciences Center. "Throughout her career, she has distinguished herself as an educator, scientist, mentor, and a national and international leader in the biomedical sciences, and I look forward to working with her in our many shared initiatives."

As the new chair, Margulies will oversee a department that is consistently ranked as one of the nation's most prominent programs of its kind in both graduate and undergraduate education. Currently, U.S. News & World Report ranks the joint Georgia Tech/Emory biomedical engineering graduate program #3 in the United States and the undergraduate program #1. It is the largest BME department in the country, with 72 faculty at Georgia Tech and Emory and more than 1,500 undergraduate and graduate students.

"Without a doubt, Susan is the very best person to lead the joint biomedical engineering department into the future," says Gary S. May, dean of the Georgia Tech College of Engineering. "She is an active researcher and highly regarded educator. Susan has the vision, scholarship and experience in fields critical to the department that make her ideally suited and prepared to lead."

The Coulter Department, which was launched in 1997, is a visionary partnership between a leading public engineering school and a highly respected private medical school. The department uses the latest engineering technologies, clinical insights and biological approaches to address unmet clinical challenges in pediatric bioengineering, immunoengineering, regenerative medicine, cardiovascular and neural engineering, imaging and biomedical computing.

"I speak for all Wallace H. Coulter Department members in stating how delighted we are to welcome Susan Margulies as our incoming chair," says Ross Ethier, interim chair, Wallace H. Coulter Department of Biomedical Engineering and a GRA Eminent Scholar. "Susan has a remarkable track record as a scholar, teacher, academic leader and role model. She brings a deep understanding of both engineering and medicine, and how they can work synergistically in the field of biomedical engineering for the benefit of patients and society. She will further strengthen the Emory-Georgia Tech relationship, and will sustain the strong tradition of excellence and innovation that have characterized the Coulter Department since its establishment."

Margulies earned her BSE in Mechanical and Aerospace Engineering at Princeton University and PhD in Bioengineering from the University of Pennsylvania. After a postdoctoral fellowship and faculty appointment at Mayo Medical School, she joined the faculty at the University of Pennsylvania in 1993. Her research program spans the micro-to-macro scales in two distinct subfields: traumatic brain injury in children and ventilator-induced lung injury. Margulies focuses on prevention, intervention and treatments. She has pioneered new methods for measuring functional effects of large or repeated tissue distortions; identified injury tolerances and response cascades, and translated these basic research discoveries to preclinical therapeutic trials to mitigate and prevent brain and lung injuries in children and adults.

Over the years, as principal investigator she has secured over $34 million in federal funding from the National Institutes of Health, National Science Foundation, Centers for Disease Control and Prevention, Department of Transportation, and private foundations. Her recent engagement and negotiations with industry have led to $1.5 million in corporate research agreements. Her scholarship has been disseminated in over 350 papers, abstracts, and book chapters and numerous media features.

While directing a large, translational, interdisciplinary research program, she has taught more than fifteen undergraduate and graduate courses and has had a broad range of administrative roles at the departmental, school, and institutional levels. She has received honors for improving the lives of women faculty, and for excellence in teaching and mentoring. Margulies has created new programs improve faculty and student diversity, access, engagement and professional development, as well as leading initiatives to enhance cross-campus research, training, and education, and engagement with industry and alumni.

"The Coulter BME Department is uniquely situated in two excellent institutions," says Margulies. "As Chair of BME, my goal is to enrich the impact of BME on both campuses by enhancing interdisciplinary research and education; expanding access to educational opportunities in biomedical applications of engineering; creating synergies within the department; and working with faculty, student, staff and alumni communities to catalyze strategic research and translational initiatives with federal, corporate and foundation partners."

05/31/2017

Aziyo Continues Building New Breed of Regenerative Medicine Company

Tue, 02 Jul 2019 19:23:47 GMT

SILVER SPRING, MD. – Aziyo Biologics, Inc. a fully integrated regenerative medicine company, today announced it has completed an asset purchase agreement with CorMatrix® Cardiovascular, Inc. for the purchase of all CorMatrix commercial assets and related intellectual property.

With the acquisition, Aziyo will:

Add 5 commercially marketed products
Double topline revenue
Add 50 employees, including a direct sales organization of 37 professionals
Welcome 2 highly experienced executives to its leadership team
Add a xenogeneic platform which is highly complementary to the Company’s existing differentiated human tissue platform

“Since Aziyo Biologics was created late 2015, we have focused on creating a new breed of regenerative medicine company,” said Lode Debrabandere, Ph.D., President and Chief Executive Officer of Aziyo. “Our goal has always been to take leading edge research and science and make it commercially viable. By combining our existing manufacturing, commercial and research capabilities with the CorMatrix people and products, we have made a huge step towards that goal, literally overnight.”

The CorMatrix platform includes natural tissue products derived from porcine extracellular matrix for cardiac and vascular repair, as well as CanGaroo®, a biomaterial pouch that secures cardiovascular implantable devices such as pacemakers and defibrillators. CorMatrix products have received FDA 510(k) clearance and European CE mark. They have been used at more than 1,000 hospitals in the U.S. and around the world and been successfully implanted in over 155,000 cardiac and vascular procedures.

Andrew Green, former Chief Executive Officer of CorMatrix, commented, “I enjoyed being a part of CorMatrix and am excited to be joining the Aziyo team. From the very beginning, we recognized similar cultures and dedication to advancing regenerative medicine between our organizations. For example, CanGaroo is currently being evaluated in a prospective study of 1,000 patients, which we expect will demonstrate improved outcomes of CanGaroo, particularly the reduction of pocket infections. Aziyo saw this opportunity and immediately began asking how to take this product to the next clinical and commercial level.” Mr. Green will join the Aziyo leadership team as the Company’s Chief Business Officer and Patrick Ferguson will be Vice President of Sales.

Aziyo plans to expand the CanGaroo platform into new indications, invest in additional clinical studies to demonstrate the benefits of this biologic implantable device and grow its sales force. In addition, Aziyo’s differentiated vascular human tissue products combined with CorMatrix’s vascular repair products will enhance the efficiency of the sales force.

Rich Ferrari, Executive Chairman of CorMatrix, also commented. “This agreement will allow CorMatrix to focus on its leading earlier stage development programs for the prevention and treatment of congestive heart failure, heart valve replacement and certain vascular grafts. CorMatrix was originally formed to pursue these treatments and is now positioned to create significant value from these milestones in the near future.”

About CanGaroo
CanGaroo® is a 510(k) FDA cleared medical device envelope that differs from competitive synthetic devices because it is natural tissue derived from porcine extracellular matrix. The biologic material leads to a healthy regenerative response permitting remodeling into neo-vascularized tissue, unlike synthetic materials that can trigger inflammation and scar formation.

About Aziyo Biologics, Inc.
Aziyo Biologics, Inc. was formed by HighCape Partners, Deerfield Management Co. and KeraLink International with the mission of restoring health and mobility to the greatest number of patients. Aziyo’s vision is to impact healthcare through innovation of new solutions realizing the commercial potential of regenerative medicine. KeraLink is one of the world’s leading eye banks with a mission to reverse corneal blindness through transplantation.

About HighCape Partners
HighCape Partners is a growth equity fund that invests in commercial-stage life sciences companies. The firm applies decades of investment and operational experience to transform its portfolio companies into sustainable businesses with multiple exit alternatives. Please visit www.highcape.com.

About CorMatrix
CorMatrix® Cardiovascular, Inc. was founded in 2001 as a privately held medical device company dedicated to developing and delivering innovative biomaterial devices that harness the body’s own innate ability to repair damaged cardiovascular tissues.

05/31/2017

Georgia State Researcher Receives $7.7 Million Federal Grant To Study West Nile And Zika Viruses

Tue, 02 Jul 2019 19:24:27 GMT

ATLANTA—A Georgia State University researcher, in collaboration with researchers at the University of Pennsylvania and Florida State University, has received a five-year, $7.7 million federal grant to study the consequences of West Nile and Zika virus infections on the human central nervous system.

The three-part study is funded by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health. It aims to develop three-dimensional human brain models called organoids. They will be used to study the parameters of brain infections with neurotropic flaviviruses, such as West Nile and Zika, screen candidate antiviral compounds and study novel therapeutic approaches.

Dr. Margo Brinton, Regents’ Professor in the Department of Biology, is leading one of the grant’s three projects, which will explore the effects of virulent and avirulent strains of West Nile virus on different types of human brain cells.

The grant will help Brinton determine which types of human neural cells can be infected by the West Nile virus, as well as how the virus infection affects the functions and gene expression of various types of brain cells and whether factors produced by infected cells can affect uninfected neighboring cells.

Brinton and her lab will use two-dimensional cultures of individual types of brain cells and three-dimensional organoids provided by the researchers at the University of Pennsylvania led by Dr. Guo-li Ming, professor of neuroscience in the Perelman School of Medicine. The 2D cell cultures and organoids are developed through tissue engineering of human skin cells to create pluripotent cells. The pluripotent cells are then differentiated into neural progenitor cells, which can differentiate into various types of brain cells. To create organoids, neural progenitor cells are placed in hammock-like slings suspended in specialized culture media where they assemble into a mini brain-like structure.

Florida State researchers, led by Dr. Hengli Tang, professor in the Department of Biological Sciences, will work on the Zika portion of the study. The Brinton and Tang laboratories will infect organoids with their respective viruses and compare the phenotypes and pathologies between the West Nile virus and Zika virus-infected organoids.

“Because of obvious ethical reasons, experimental studies of brain virus infections cannot be done in humans,” Brinton said. “The organoids provide a way to obtain good models of the human brain without using human embryos to obtain the initial cells. We have previously used animal models for studying virus infections of the human brain but these models do not accurately duplicate the conditions in human brains. The further development of brain organoids that represent different regions of the brain will provide more accurate human brain models that can be used to understand the differences between these two different neurotropic viruses that are members of the same virus family but have very different disease effects in humans.”

Researchers at Emory University, led by Dr. Zhexing Wen, assistant professor in the Department of Psychiatry and Behavioral Sciences, will work as the scientific core for the study, providing cells and analyzing cell gene expression.

05/31/2017

National Institutes Of Health $2.3 Million Renewal Grant To Study Enzyme In Diabetic Vascular Disease

Tue, 02 Jul 2019 19:25:37 GMT

ATLANTA—Dr. Ming-Hui Zou, director of the Center for Molecular & Translational Medicine and a Georgia Research Alliance Eminent Scholar in Molecular Medicine, has renewed a four-year, $2.3 million federal grant to study the role of an enzyme in causing diabetic vascular diseases and the molecular mechanism that leads to these diseases.

This is the third competitive renewal for this grant from the National Heart, Lung and Blood Institute of the National Institutes of Health. The diabetes-related research was initially funded in 2005.

Diabetes is the seventh leading cause of death in the United States. About 29.1 million Americans, one out of every 11 people, have diabetes, a disease in which blood glucose levels are above normal. Diabetes can cause serious health complications, including heart disease, blindness, kidney failure and lower-extremity amputations, according to the Centers for Disease Control and Prevention.

The grant will help Zou determine if adenosine monophosphate-activated protein kinase (AMPK), an essential energy and redox homeostasis sensor, maintains the balance of mitochondrial fission and fusion by promoting the autophagic degradation (the natural, destructive mechanism of the cell that gets rid of unnecessary or dysfunctional components) of dynamin-related protein 1 (DRP1). The findings could lead to a new treatment for diabetic vascular diseases.

Mitochondria are the power houses of cells, and a disruption in the balance between mitochondrial fusion and fission is associated with mitochondrial dysfunction in a variety of diseases, including neurodegenerative and cardiovascular diseases. Zou’s preliminary data found that inhibiting AMPK is accompanied by increases in mitochondrial fission, oxidative stress and endothelial dysfunction.

“The completion of this study will assess whether the inhibition of mitochondrial fission, a crucial step in the initiation of cardiovascular disease, can be a new strategy to protect against the development of vascular disease in diabetic patients,” Zou said.

The project has two aims. Zou’s research team will determine the essential role of AMPK in maintaining the balance between mitochondrial fission and fusion, and they will explain the molecular mechanisms by which AMPK inhibits DRP-1-dependent mitochondrial fission in endothelial cells, which line the inner walls of blood vessels and lymphatic vessels. The studies will be conducted in mice.

An abstract of the grant, 5R01HL080499-12, is available at NIH’s Project RePORTer website.

For more information about the Center for Molecular & Translational Medicine, visit http://medicine.gsu.edu.

05/25/2017

Cocrystal Pharma Receives Investment Through Private Placement

Tue, 02 Jul 2019 19:26:17 GMT

BOTHELL, WA and ATLANTA, GA -- (Marketwired) -- 04/24/17 -- On April 20, 2017, Cocrystal Pharma, Inc. (OTCQB: COCP) (the "Company") closed on proceeds of $3,000,000 in a private placement offering (the "Offering") of 12,500,000 shares of the Company's common stock at a purchase price of $0.24 per share. The purchasers included one of the members of the Company's board of directors, Chairman Dr. Raymond F. Schinazi. In addition, OPKO Health, Inc. invested in the Offering, of which the Company's director Dr. Phillip Frost is Chairman and Chief Executive Officer.

Cocrystal is a clinical stage biotechnology company. The Company has completed human clinical safety profiling of its pan-genotypic non-nucleoside hepatitis C virus (HCV) polymerase inhibitor (CC-31244) in healthy subjects and has completed enrollment in a trial in HCV infected subjects. The drug appears to be safe and well tolerated in both healthy and HCV-infected patients. HCV-infected subjects treated with CC-31244 had a rapid and marked decline in HCV RNA levels, slow viral rebound after treatment, and no viral breakthrough during treatment. Results of this study suggest that CC-31244 could be an important component in an all-oral limited duration HCV combination therapy.

The Company's influenza program has a lead compound and several other promising preclinical candidates under development. The lead compound CC-42344 showed excellent antiviral activity against various influenza A strains, including avian pandemic strains and Tamiflu resistant strains.

"It is an exciting time at Cocrystal as we continue to advance our science programs and clinical trials. We are grateful for the continued support of our dedicated staff and investors in helping us to achieve our goal of developing promising and novel antiviral pharmaceuticals," stated Dr. Gary Wilcox, Cocrystal Pharma's interim Chief Executive Officer.

About Cocrystal Pharma
Cocrystal is a clinical stage biotechnology company seeking to discover novel antiviral therapeutics as treatments for serious and/or chronic viral diseases. Cocrystal employs unique technologies and Nobel Prize winning expertise to create first- and best-in-class antiviral drugs. These technologies, including our nucleoside chemistry expertise and market-focused approach to drug discovery are designed to efficiently deliver small molecule therapeutics that are safe, effective and convenient to administer. The company has identified a promising clinical stage compound and preclinical stage antiviral compounds for several unmet medical needs, including hepatitis, influenza and norovirus infections. Cocrystal has previously received strategic investments from Teva Pharmaceuticals, OPKO Health (NYSE: OPK), Brace Pharmaceutical, LLC, and The Frost Group. For further information about Cocrystal, please refer to www.cocrystalpharma.com.

Forward Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding Cocrystal, they are forward-looking statements reflecting the current beliefs and expectations of management including statements regarding development plans for treatments related to Hepatitis C, influenza and norovirus. Forward-looking statements in this release involve substantial risks and uncertainties that could cause future results to differ significantly from what is expressed or implied by the forward-looking statements. For a description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see filings Cocrystal has made with the Securities and Exchange Commission including its Form 10-K filed on March 31, 2017.

05/23/2017

ATDC Names Michael Maziar Investor Relations Manager

Tue, 02 Jul 2019 19:27:09 GMT

The Advanced Technology Development Center, Georgia’s technology incubator, has named Michael Maziar investor relations manager.

Maziar, who had been chief operations officer of Atlanta Technology Angels, will manage ATDC’s Investor Connect program and its related activities, as well as develop and maintain relationships with angels, venture capitalists, and other sources of debt and equity financing for ATDC’s portfolio companies.

“Michael is an enthusiastic go-getter who has deep connections to Atlanta’s entrepreneurial and investment communities,” said Jennifer Bonnett, ATDC’s general manager. “He is results-oriented and a great addition to our team’s mission in providing the critical support our companies need for long-term success.”

As Atlanta Technology Angels’ COO, Maziar oversaw its day-to-day operations. His role included managing the deal flow process going from recruiting and screening through the due diligence phase. Additionally, he was responsible for angel investing education, managing the analyst program, and entrepreneurial and membership support.

Prior to that, he worked throughout the Atlanta startup technology ecosystem in sales, marketing, and operations.

“I love working with investors to help them vet and determine good deployments of their financial, professional, social capital. I equally enjoy working with entrepreneurs who preparing for high potential growth,” Maziar said. “My role here at ATDC allows me to do both while creating jobs and economic development for the high tech industry and the people of Georgia.”

In 2016 he joined as a partner at the Guild a residential co-living accelerator for change makers and social enterprises based in Atlanta’s East Lake neighborhood. Maziar earned his MBA from Georgia Tech’s Scheller College of Business and obtained his bachelor’s degree from the University of Colorado.

In his spare time, he volunteers on various nonprofit boards, including Startup Atlanta, and advises various other social entrepreneurs and civic innovators.

05/11/2017

Atlanta biotech firm GeoVax raises $1 million in stock sale

Tue, 02 Jul 2019 19:28:02 GMT

Atlanta biotech firm GeoVax Labs Inc. (OTCQB: GOVX) reported Tuesday it has raised $1 million by selling shares to an unidentified investor in a private placement transaction.

In the stock sale, GeoVax sold 1,000 shares of its Series D Convertible Preferred Stock which is initially convertible into 66,666,667 shares of its common stock.

Enlarge

Robert T. McNally, GeoVax’s president and CEO.

BYRON E. SMALL

The news came a day after GeoVax said it has made progress in each of its vaccine development programs.

GeoVax said May 8 it has obtained "very impressive preclinical results (100% protection) for our Zika vaccine from a highly rigorous lethal challenge model conducted by the Centers for Disease Control and Prevention (CDC)."

GeoVax also said it's initiated a new clinical trial for its preventive HIV vaccine for the developed world. The company was recently awarded a $658,000 grant from the National Institute of Allergy and Infectious Diseases to continue its work toward another HIV vaccine for the developing world.

GeoVax also recently initiated a new program to develop a malaria vaccine through a collaboration with The Burnet Institute in Australia.

GeoVax has also been working on vaccines for Ebola.

05/11/2017

VWR Enters into Definitive Agreement with Avantor

Tue, 02 Jul 2019 19:28:57 GMT

CENTER VALLEY, Pa. and RADNOR, Pa., May 5, 2017 /PRNewswire/ -- Avantor, a global supplier of ultra-high-purity materials for the life sciences and advanced technology industries, and VWR (NASDAQ: VWR), the major global independent provider of product, supply chain, and service solutions to laboratory and production customers, today announced that they have entered into a definitive agreement under which Avantor will acquire VWR for $33.25 in cash per share of VWR common stock, reflecting an enterprise value of approximately $6.4 billion. The purchase price represents an approximate 17% premium to the unaffected closing stock price on May, 2, 2017, the day prior to the start of market speculation regarding a potential sale of VWR. The purchase price also represents an approximate 20% premium to the 30 trading day volume weighted average price (VWAP), and an approximate 24% premium to the 90 trading day VWAP of VWR common stock as of May 2, 2017.

Combined Company Uniquely Positioned to Serve Customers Globally

Avantor's acquisition of VWR will create a major consumables-focused solutions and services provider to the high-growth life sciences and advanced technologies industries, as well as education, government, and research institutions across the globe. The acquisition will build on each company's strengths, including Avantor's cGMP manufacturing processes, significant exposure to emerging markets and VWR's significant position across the Americas and Europe. The combined company will be a vertically integrated organization, serving a global customer base in all areas of their activities, from research through production - a unique advantage in a fast growing marketplace.

Michael Stubblefield , Chief Executive Officer of Avantor, said, "Avantor's acquisition of VWR is both highly compelling and complementary. We will bring together our well-known expertise in ultra-high-purity materials and customized solutions with VWR's global scale, unparalleled channel access, and deep customer relationships. Collectively, this will create a larger, stronger and more diversified company with significantly enhanced scale and product breadth. The global customers that we plan to serve in a more high-touch manner will immediately benefit from the combination, as we will provide end-to-end solutions that offer increased quality, effectiveness, and productivity."

Mr. Stubblefield continued, "Avantor and VWR share a dedication to enabling the advancement of science worldwide and a commitment to quality, safety, innovation and customer service. Both of our companies have highly qualified employees who are dedicated to helping our customers succeed. We look forward to welcoming VWR's more than 10,000 employees to Avantor and to our continued success as one team upon the successful completion of the transaction. We expect that this acquisition will expand opportunities for our employees, as part of a larger, high-growth enterprise."

Agreement Reflects VWR's Strong Performance

Manuel Brocke-Benz , President and Chief Executive Officer of VWR, commented, "Since our IPO, VWR has made significant progress executing on our strategy to drive organic growth, and the first quarter 2017 results that we will announce today clearly show that VWR's growth story remains on track. Given the changing dynamics in the highly fragmented and diverse life sciences sector, we believe that combining Avantor's advanced materials and solutions with VWR's unparalleled distribution capabilities and breadth of offerings represents a compelling value proposition. I am confident that this acquisition will create a highly differentiated organization, one that is uniquely positioned to serve the growing needs of laboratory and production customers around the world."

New Mountain Capital to Continue as Lead Shareholder of the Combined Company

Matt Holt , Managing Director at New Mountain Capital, said, "We believe this combination creates significant value for all stakeholders including customers, partners and the employees. The combined company will have a strong position as a vertically integrated, global player in manufacturing and supply chain solutions for the life sciences, advanced technologies, and research industries."

The agreement followed the unanimous approval by the Board of Directors of both VWR and Avantor. Completion of the transaction is subject to the expiration of a "go-shop" period, the expiration or termination of the applicable waiting period under Hart-Scott-Rodino Antitrust Improvements Act and European Commission approval, obtaining any required clearance, consent or approval under applicable foreign antitrust laws, VWR shareholder approval, and other customary closing conditions. Varietal Distribution Holdings, LLC, the largest shareholder of VWR comprised of, among other parties, Madison Dearborn Partners (MDP), which has been a significant shareholder of VWR since 2007, and certain officers and directors of VWR, has signed a voting and support agreement committing it to vote in favor of the transaction, representing approximately 34.8% of the total issued and outstanding shares of common stock of VWR.

Following the closing of the acquisition, which is expected in the third quarter of 2017, New Mountain Capital will be the lead shareholder of the combined company, and MDP will not own any shares of common stock of the combined company. The combined company will be led by Mr. Stubblefield upon closing.

Goldman Sachs, Jefferies LLC, and Barclays are acting as financial advisors to Avantor, and Simpson Thacher & Bartlett LLP is serving as legal advisor to Avantor. BofA Merrill Lynch is acting as exclusive financial advisor to VWR, and Kirkland & Ellis LLP is acting as legal advisor. Fully committed financing of the acquisition has been provided by Goldman Sachs, Barclays, and Jefferies LLC.

VWR First Quarter Financial Results
VWR will report its first quarter 2017 financial results on May 5, 2017.

In light of the announcement of VWR's definitive agreement with Avantor, VWR no longer plans to provide or update financial guidance and will not hold the investor conference call on its first quarter 2017 results, previously planned for 8:00AM ET on May 5, 2017.

About Avantor
Avantor is a global supplier of ultra-high-purity materials for the life sciences and advanced technology markets. The company provides performance materials and solutions for the production and research needs of approximately 7,900 customers across the biotechnology, pharmaceutical, medical device, diagnostics, aerospace & defense, and semiconductor industries.

Avantor's product portfolio includes more than 30,000 products that meet increasingly stringent standards across technology driven and highly regulated markets. Avantor manufactures and markets its products around the world under several respected brand names. Avantor's brands of performance chemistries include the J.T.Baker®, Macron Fine Chemicals™, Rankem™, BeneSphera™, Puritan Products™, and POCH™ brands. Avantor's brands of advanced silicones include the NuSil™ and CareSil brands. For more information visit www.Avantorinc.com.

About VWR
VWR (NASDAQ: VWR), headquartered in Radnor, Pennsylvania, is a global independent provider of product and service solutions to laboratory and production customers. With sales in excess of $4.5 billion in 2016, VWR enables science for customers in the pharmaceutical, biotechnology, industrial, education, government and healthcare industries. With more than 160 years of experience, VWR has cultivated a value proposition delivering product choice, operational excellence and differentiated services to improve our customers' productivity from research to production. VWR's differentiated services provide innovative, flexible and customized solutions from scientific research services to custom-manufactured chemical blends. Our dedicated team of more than 10,200 associates is focused on supporting scientists, medical professionals and production engineers to achieve their goals. For more information on VWR please visit www.VWR.com.

About New Mountain Capital
New Mountain Capital is a New York-based investment firm that emphasizes business building and growth, rather than debt, as it pursues long-term capital appreciation. The firm currently manages private equity, public equity, and credit funds with approximately $15 billion in aggregate capital commitments. New Mountain seeks out what it believes to be the highest quality growth leaders in carefully selected industry sectors and then works intensively with management to build the value of these companies. For more information on New Mountain Capital, please visit www.newmountaincapital.com.

About Madison Dearborn Partners, LLC
Madison Dearborn Partners, LLC (MDP), based in Chicago, is a leading private equity investment firm in the United States. Since MDP's formation in 1992, the firm has raised seven funds with aggregate capital of approximately $23 billion and has completed approximately 130 investments. MDP is currently investing out of its most recent fund, $4.4 billion MDCP Fund VII, in businesses across a broad spectrum of industries, including health care; basic industries; business and government services; consumer; financial and transaction services; and telecom, media and technology (TMT) services. For more information, please visit http://www.mdcp.com.

Forward-Looking Statements
Statements about the expected timing, completion and effects of the proposed transaction and all other statements in this press release, other than historical facts, constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Readers are cautioned not to place undue reliance on these forward- looking statements and any such forward-looking statements are qualified in their entirety by reference to the following cautionary statements. All forward-looking statements speak only as of the date hereof and are based on current expectations and involve a number of assumptions, risks and uncertainties that could cause the actual results to differ materially from such forward- looking statements. The parties may not be able to complete the proposed transaction on the terms described above or other acceptable terms or at all because of a number of factors, including (1) the occurrence of any event, change or other circumstances that could give rise to the termination of the merger agreement, (2) the failure to obtain shareholder approval or the failure to satisfy the closing conditions, (3) the failure to obtain the necessary financing arrangements set forth in the debt and equity commitment letters delivered pursuant to the merger agreement, (4) risks related to disruption of the attention of Avantor's and VWR's managements from their respective ongoing business operations due to the proposed transaction, and (5) the effect of the announcement of the proposed transaction on the ability of each party to retain and hire key personnel and maintain relationships with its customers, suppliers, operating results and business generally.

Actual results may differ materially from those indicated by such forward-looking statements. In addition, the forward-looking statements represent the parties' views as of the date on which such statements were made. The parties anticipate that subsequent events and developments may cause their views to change. However, although the parties may elect to update these forward-looking statements at some point in the future, they specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing the parties' views as of any date subsequent to the date hereof.

Additional Information and Where to Find It

In connection with the proposed transaction, VWR will file with the Securities and Exchange Commission (the "SEC") and furnish to VWR's shareholders a proxy statement. BEFORE MAKING ANY VOTING DECISION, VWR'S SHAREHOLDERS ARE URGED TO READ THE PROXY STATEMENT IN ITS ENTIRETY WHEN IT BECOMES AVAILABLE AND ANY OTHER DOCUMENTS TO BE FILED WITH THE SEC IN CONNECTION WITH THE PROPOSED MERGER OR INCORPORATED BY REFERENCE IN THE PROXY STATEMENT (IF ANY) BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION AND THE PARTIES TO THE PROPOSED TRANSACTION. Investors and shareholders may obtain a free copy of documents filed by VWR with the SEC at the SEC's website at http://www.sec.gov. In addition, investors and shareholders may obtain a free copy of VWR's filings with the SEC from VWR's website at http://investors.vwr.com or by directing a request to: VWR Corporation, Radnor Corporate Center, Building One, Suite 200, 100 Matsonford Road, Radnor, Pennsylvania 19087, (610) 386-1700

VWR and certain of its directors, executive officers, and certain other members of management and employees of VWR may be deemed to be participants in the solicitation of proxies from shareholders of VWR in favor of the proposed merger. Information about directors and executive officers of VWR is set forth in the proxy statement for VWR's 2017 annual meeting of shareholders, as filed with the SEC on Form DEF 14A on March 31, 2017. Additional information regarding the interests of these individuals and other persons who may be deemed to be participants in the solicitation will be included in the proxy statement with respect to the merger that VWR will file with the SEC and furnish to VWR's shareholders.

05/09/2017

Invest Georgia: Lt. Governor Cagle Appoints Jeff Muir

Tue, 02 Jul 2019 19:30:30 GMT

Lt. Governor Casey Cagle has announced Jeff Muir to serve on the Invest Georgia Board of Directors. Invest Georgia is a unique, state-based capital access program, designed to drive business growth and job creation in Georgia.

“This innovative partnership has proven very effective, maximizing Georgia's existing assets and providing new possibilities for startups to capitalize on promising ideas and business plans,” said Lt. Governor Cagle. “Jeff’s extensive knowledge and experience adds immense value to Invest Georgia as we work to make Georgia the “Silicon Valley of the South.””

Established by the Georgia General Assembly in 2013, IG is a long-term investment program designed to grow and mentor current and new Georgia Venture Capital and Private Equity Investment Funds. The IG Program emphasizes return on investment as well as Georgia economic and social development. By working with local venture capital and private equity funds, the IG Program helps improve success opportunities for Georgia-based businesses incubated and growing within the state.

“Invest Georgia is a critical program to maintain and extend our state’s leadership position, and I am looking forward to serving on its board and working to close our current capital gap,” said Mr. Muir. “Georgia is blessed with all the ingredients for a robust entrepreneurial environment that enables small businesses to grow rapidly, except sufficient capital to fund the numerous promising ventures.”

Early and growth stage companies commonly encounter a capital access problem between initial business funding and institutional expansion funding. The IG program creates an environment where Georgia-based investment funds and Georgia-based companies can work together to solve this problem. IG enhances an already favorable business climate by fostering innovation, capital investment and the creation of new business entrepreneurs in the state.

05/01/2017

BD To Acquire Bard For $24 Billion

Tue, 02 Jul 2019 19:31:38 GMT

FRANKLIN LAKES, N.J. and MURRAY HILL, N.J., April 23, 2017 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, and C. R. Bard, Inc. (NYSE: BCR), a medical technology leader in the fields of vascular, urology, oncology and surgical specialty products, announced today a definitive agreement under which BD will acquire Bard for $317.00 per Bard common share in cash and stock, for a total consideration of $24 billion. The agreement has been unanimously approved by the Boards of Directors of both companies.

The combination will create a highly differentiated medical technology company uniquely positioned to improve both the process of care and the treatment of disease for patients and healthcare providers. The transaction will build on BD's leadership position in medication management and infection prevention with an expanded offering of solutions across the care continuum. Additionally, Bard's strong product portfolio and innovation pipeline will increase BD's opportunities in fast-growing clinical areas, and the combination will enhance growth opportunities for the combined company in non-U.S. markets.

This financially compelling transaction will be immediately accretive and is expected to generate high-single digit accretion to adjusted earnings per share (EPS) in fiscal year 2019. Approximately $300 million of estimated annual, pre-tax, run-rate cost synergies are expected by fiscal year 2020. Separately, BD also expects to benefit from revenue synergies beginning in fiscal year 2019. The transaction is expected to improve BD's gross margins by approximately 300 basis points in fiscal year 2018, increase BD's earnings per share growth trajectory to the mid-teens, and generate strong cash flow.

Vince Forlenza , BD's chairman and chief executive officer, said, "Combining with Bard will accelerate our ability to offer more comprehensive, clinically relevant solutions to customers and patients around the globe, creating a strong partner for healthcare providers who are increasingly focused on delivering better outcomes at a lower total cost. Our two purpose-driven organizations are well-aligned strategically, sharing a strong track record of performance and a deep commitment to addressing unmet needs in today's challenging healthcare environment. We expect the transaction to contribute meaningfully to BD's plans for revenue growth and margin expansion, and generate outstanding value both near- and long-term for shareholders. I am excited to welcome Bard's talented employees to our strong and dedicated team as we bring together two companies with such complementary capabilities, values and strong reputations for delivering superior results."

Tim Ring , Bard's chairman and chief executive officer, said, "We are confident that this combination will deliver meaningful benefits for customers and patients as we see opportunities to leverage BD's leadership, especially in medication management and infection prevention. We also believe that we can expand our access to customers and patients through BD's strategic selling capabilities, and that our fast-growing portfolio in emerging markets can significantly benefit from their well-established international commercial infrastructure. Our two companies share the conviction that a product leadership strategy focused on unmet needs and improved outcomes that provide economic value to the global healthcare system will provide long-term shareholder returns."

John Weiland , Bard's vice-chairman, president and chief operating officer, added, "BD and Bard share a common purpose with highly compatible organizations. We are very proud of the business and culture we have built over 110 years, focused on quality, integrity, innovation and service. We have long had great respect for BD and find in them a similarly strong, results-oriented culture that prioritizes execution and long-term value creation. In addition to significant benefits for our customers, patients, and shareholders, we believe this combination will provide our employees with new and exciting opportunities as part of a highly competent, dynamic global organization. We look forward to this next chapter in our company's great history."

Strategic Highlights

Will create new opportunities to build on BD's leadership position in medication management and infection prevention with an expanded offering of solutions across the care continuum.

Will bring together highly complementary product sets to create unmatched solutions for customers, enhancing growth opportunities for the combined company.
By combining Bard's strong leadership position and innovation pipeline in fast-growing vascular access segments – PICCs (peripherally inserted central catheters), midlines and drug delivery ports – with BD's leadership and innovation in IV drug preparation, dispensing, delivery and administration, the new company will be better positioned to provide end-to-end medication management solutions across the care continuum.
Will further expand BD's leadership in infection prevention, with offerings positioned to address 75 percent of the most costly and frequent healthcare associated infections (HAIs). Through the combined solutions set, the new company will have a more comprehensive, clinically relevant offering to address Surgical Site Infections (SSIs) and Catheter-Related Blood Stream Infections (CRBSIs).

Bard's strong product portfolio and innovation pipeline will increase BD's opportunities in fast growing clinical areas, including peripheral vascular therapy, oncology and bio-surgery.

Bard's clinically differentiated offerings create more meaningful scale and relevance for BD in high-growth categories of oncology and surgery.
Bard will expand BD's focus on the treatment of disease states beyond diabetes to include peripheral vascular disease, urology, hernia and cancer.

BD's leading global capabilities and infrastructure will further accelerate the combined company's growth outside of the U.S., creating more opportunities for patients and clinicians around the world to benefit from BD's and Bard's product technology.

Together, BD and Bard will bring to market an expanded portfolio of clinically relevant products, with opportunities to drive near-term revenue synergies outside of the U.S.
- Bard, which registered approximately 500 products internationally in 2016, has made significant progress expanding outside of the U.S. in recent years, particularly in emerging markets, where Bard is among the fastest growing medical technology companies.
Bard's strong presence in vascular access and surgery will also help drive sales of the highly complementary CareFusion portfolio outside of the U.S.
The combined company will have a large and growing presence in emerging markets, including $1 billion in annual revenue in China.

Transaction Highlights

Under the terms of the transaction, Bard common shareholders will be entitled to receive approximately $222.93 in cash and 0.5077 shares of BD stock per Bard share, or a total of value of $317.00 per Bard common share based on BD's closing price on April 21, 2017. At closing, Bard shareholders will own approximately 15 percent of the combined company.

BD expects to contribute approximately $1.7 billion of available cash to fund the transaction, along with, subject to market conditions, approximately $10 billion of new debt and approximately $4.5 billion of equity and equity linked securities issued to the market. Bard shareholders will also receive $8 billion of BD common stock. BD has also obtained fully committed bridge financing. At closing, BD estimates the combined company will have pro forma leverage of approximately 4.7x and is committed to deleveraging to below 3.0x leverage within three years of closing. BD expects to continue the suspension of its share repurchase program. BD is also committed to annual dividend increases while reinvesting in the business to continue to drive long-term growth.

The transaction is subject to regulatory and Bard shareholder approvals and customary closing conditions, and is expected to close in the fall of 2017.

Integration Plans

BD has a successful integration track record, as demonstrated by its 2015 acquisition and integration of CareFusion. BD has put in place a plan to ensure a seamless integration with Bard. A designated integration team, comprised of senior members of both organizations, will be led by Bill Tozzi , a seasoned BD executive who most recently served as worldwide president of the Medication and Procedural Solutions business and earlier was corporate controller for BD. At the closing of the transaction, Tim Ring , chairman and chief executive of Bard, and an additional Bard director, are expected to join the BD Board of Directors, which will be expanded by two directors. BD is confident in its ability to achieve synergies as it brings together two world class companies and expects to offer opportunities for talented employees to become part of an even more dynamic global leader.

BD Organizational Update

BD expects to create a third segment within the company – BD Interventional — where the Bard businesses will report both operationally and financially. BD is separately announcing today the appointment of Tom Polen , 43, currently executive vice president and president of the BD Medical Segment, as president of BD, effective immediately. In his new role, Mr. Polen will oversee BD's Medical and Life Sciences segments, as well as the new Interventional segment.

Transaction Conference Call and Webcast Information

BD and Bard will conduct a live conference call and webcast on April 24, 2017 at 8:00 a.m. (ET). The webcast of the conference call, along with related slides, will be accessible through BD's and Bard's websites. The conference call will also be available for replay through BD's and Bard's websites, or at (800) 585-8367 (domestic) and (404) 537-3406 (international) through the close of business on May 1, 2017, confirmation number 13011331.

BD Earnings Update

BD's earnings conference call, previously scheduled for Thursday, May 4, 2017, has been rescheduled for Tuesday, May 2, 2017, at 8:00 a.m. (ET). BD will issue a press release detailing the quarter's earnings earlier that morning. The webcast of the conference call, along with related slides, will be accessible through BD's website at www.BD.com/investors and will be available for replay through Thursday, May 9, 2017.

Bard Earnings Update

Bard separately today announced first quarter 2017 financial results, which are available on Bard's corporate website, and is canceling the previously scheduled earnings conference call on April 26, 2017.

Advisors

Perella Weinberg Partners LP is acting as lead financial advisor to BD. Citi is also serving as a financial advisor to BD and will be providing fully committed financing. Skadden, Arps, Slate, Meagher & Flom LLP provided legal counsel to BD. Goldman, Sachs & Co. served as financial advisor to Bard. Wachtell, Lipton, Rosen & Katz served as legal advisor to Bard.

About BD

BD is a global medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. BD leads in patient and health care worker safety and the technologies that enable medical research and clinical laboratories. The company provides innovative solutions that help advance medical research and genomics, enhance the diagnosis of infectious disease and cancer, improve medication management, promote infection prevention, equip surgical and interventional procedures, and support the management of diabetes. The company partners with organizations around the world to address some of the most challenging global health issues. BD has nearly 50,000 associates across 50 countries who work in close collaboration with customers and partners to help enhance outcomes, lower health care delivery costs, increase efficiencies, improve health care safety and expand access to health. For more information on BD, please visit bd.com.

About C. R. Bard, Inc.

C. R. Bard, Inc. (www.crbard.com), headquartered in Murray Hill, NJ, is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products.

FORWARD-LOOKING STATEMENTS

This press release contains certain estimates and other "forward-looking statements" within the meaning of the federal securities laws, including Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward looking statements generally are accompanied by words such as "will", "expect", "outlook" "anticipate," "intend," "plan," "believe," "seek," "see," "will," "would," "target," or other similar words, phrases or expressions and variations or negatives of these words. Forward-looking statements by their nature address matters that are, to different degrees, uncertain, such as statements regarding the estimated or anticipated future results of BD, and of the combined company following BD's proposed acquisition of Bard, the anticipated benefits of the proposed combination, including estimated synergies, the expected timing of completion of the transaction and other statements that are not historical facts. These statements are based on the current expectations of BD and Bard management and are not predictions of actual performance.

These statements are subject to a number of risks and uncertainties regarding BD and Bard's respective businesses and the proposed acquisition, and actual results may differ materially. These risks and uncertainties include, but are not limited to, (i) the ability of the parties to successfully complete the proposed acquisition on anticipated terms and timing, including obtaining required shareholder and regulatory approvals, anticipated tax treatment, unforeseen liabilities, future capital expenditures, revenues, expenses, earnings, synergies, economic performance, indebtedness, financial condition, losses, future prospects, business and management strategies for the management, expansion and growth of the new combined company's operations and other conditions to the completion of the acquisition, (ii) risks relating to the integration of Bard's operations, products and employees into BD and the possibility that the anticipated synergies and other benefits of the proposed acquisition will not be realized or will not be realized within the expected timeframe, (iii) the outcome of any legal proceedings related to the proposed acquisition, (iv) access to available financing including for the refinancing of BD's or Bard's debt on a timely basis and reasonable terms, (v) the ability to market and sell Bard's products in new markets, including the ability to obtain necessary regulatory product registrations and clearances, (vi) the loss of key senior management or other associates; the anticipated demand for BD's and Bard's products, including the risk of future reductions in government healthcare funding, changes in reimbursement rates or changes in healthcare practices that could result in lower utilization rates or pricing pressures, (vii) the impact of competition in the medical device industry, (viii) the risks of fluctuations in interest or foreign currency exchange rates, (ix) product liability claims, (x) difficulties inherent in product development, including the timing or outcome of product development efforts, the ability to obtain regulatory approvals and clearances and the timing and market success of product launches, (xi) risks relating to fluctuations in the cost and availability of raw materials and other sourced products and the ability to maintain favorable supplier arrangements and relationships, (xii) successful compliance with governmental regulations applicable to BD, Bard and the combined company, (xiii) changes in regional, national or foreign economic conditions, (xiv) uncertainties of litigation, and (xv) other factors discussed in BD's and Bard's respective filings with the Securities and Exchange Commission.

The forward-looking statements in this document speak only as of date of this document. BD and Bard undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date hereof, except as required by applicable laws or regulations.

IMPORTANT INFORMATION FOR INVESTORS

In connection with the proposed transaction, BD will file with the SEC a registration statement on Form S−4 that will constitute a prospectus of BD and include a proxy statement of Bard. BD and Bard also plan to file other relevant documents with the SEC regarding the proposed transaction. INVESTORS ARE URGED TO READ THE PROXY STATEMENT/PROSPECTUS AND OTHER RELEVANT DOCUMENTS FILED WITH THE SEC IF AND WHEN THEY BECOME AVAILABLE, BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. You may obtain a free copy of the proxy statement/prospectus (if and when it becomes available) and other relevant documents filed by BD and Bard with the SEC at the SEC's website at www.sec.gov. In addition, you will be able to obtain free copies of these documents by phone, e−mail or written request by contacting the investor relations department of BD or Bard at the following:

04/24/2017

IoT-Connected Baby Bottle nfant Reduces Hospital Time, Costs for Preemie Parents

Tue, 02 Jul 2019 19:32:24 GMT

Approximately 15 million babies — about 1 in 10— are born premature every year, and in the U.S., preterm births are actually rising. Though medical advances are allowing doctors to keep more and more of these babies alive, they often must spend an extended period of time in the Neonatal Intensive Care Unit (NICU), a stay that comes with a high price tag — the average cost for an infant to stay in the NICU is around $3,000 per day.

Often, what keeps a baby in the hospital is feeding issues — 70 percent of preemies have trouble feeding. Atlanta-based medical device company nfant, recently named a TAG Top 10 Most Innovative Company in Georgia, is tackling this problem with a high-tech, IoT-connected sensor that attaches to a baby bottle and can measure tongue motion on the nipple.

Developed by Tommy Cunningham, a biomechanical engineer by training, and clinician Dr. Gilson Capitlouto, the smart bottle connects wirelessly through nfant’s mobile app, which aggregates data from feeding and allows the doctor to view and analyze how the baby is progressing in real-time. The company is also developing a robust database of infant feeding stats — kicking off several partnerships with the best hospitals across the country.

This includes a partnership with Boston Children’s Hospital and Harvard Medical School, who are using nfant devices to investigate a link between infant feeding patterns and neurodevelopment — in other words, if how a baby sucks is indicative of brain damage and neurological progress. They also kicked off a new study at the largest NICU in the country, as well as one with the Marcus Autism Center to study the potential of the device for autism diagnosis and intervention.

Cunningham took some time away from white papers and clinical trial results to talk to Hype about how much the health and economic impact nfant can have for every member of the healthcare ecosystem, their major growth over the next year, and how nfant is a pioneer for the Southeast’s medical device industry.

04/19/2017

BIO Statement on MedPAC Vote

Tue, 02 Jul 2019 19:33:04 GMT

“The patients served under Part B include those fighting cancer, multiple sclerosis, and rheumatoid arthritis—those most vulnerable to disruptions in their treatment regimens. In advance of today’s vote, BIO and many other stakeholders expressed our concerns to MedPAC that the proposals being considered could threaten these vulnerable beneficiaries’ access to critical treatments. We are disappointed, therefore, that the Commission has voted to advance these proposals without addressing those concerns. Reducing provider reimbursement – particularly for small or rural practices – for Part B therapies can disrupt patient access, diminish their health outcomes, and increase overall healthcare expenditures by driving care to more costly and less convenient settings.

“We are also concerned that that the proposed “Drug Value Program” (DVP) leaves unanswered a number of critical questions, and could impose new restrictions on access to Part B therapies that will come between patients and their physicians when deciding upon the best course of treatment. In particular, the proposal to implement binding arbitration in the DVP would undermine the free-market negotiations that a robust and competitive marketplace requires and that the current ASP system currently benefits from.

“We hope that in the future the Commission will more fully consider the implications of their recommendations on patient’s health outcomes and access to care. We regret that the proposals advanced today threaten to undermine both by narrowly focusing on short-term savings that will put vulnerable patients at risk. We stand ready to work with the Commission and other stakeholders to develop patient-centric, value-driven reforms across the Medicare program.

“We urge Congress and the Centers for Medicare and Medicaid Services to consider the many concerns raised by BIO and other stakeholders in evaluating MedPAC’s proposals.”

04/06/2017

BIO Celebrates Five Years of the JOBS Act

Tue, 02 Jul 2019 19:33:51 GMT

Washington, D.C. (April 5, 2017) – Today the Biotechnology Innovation Organization (BIO) celebrates the fifth anniversary of the Jumpstart Our Business Startups (JOBS) Act, which was signed into law on April 5, 2012. The JOBS Act was designed to enhance capital formation for emerging companies, a vital imperative for growing biotechnology companies seeking to fund the substantial expenses of discovering and developing innovative new medicines.

“The extraordinary impact of the JOBS Act shows the dramatic effect that smart policymaking can have on the search for groundbreaking cures and treatments,” said BIO President and CEO Jim Greenwood. “BIO is proud to have supported this game-changing law, and we look forward to working with Congress to build on its success.

“Pre-revenue innovators undertaking the decades-long development process intrinsic to scientific advancement must raise vast sums of money to fund their research. The JOBS Act has increased the flow of capital to innovative small businesses while also decreasing capital diversions from the lab to unnecessary compliance burdens. BIO is excited to support legislative efforts like the Fostering Innovation Act and the Corporate Governance Reform and Transparency Act that would further enhance public capital formation for emerging biotechnology innovators.”

BIO has conducted a five-year review of the JOBS Act’s influence on biotech capital formation, revealing the breadth and depth of the law’s impact:

In the five years since the JOBS Act became law, there have been 212 biotech IPOs. The prior five years saw only 55 biotechnology companies going public.
The next generation of medical advances is being funded by capital raised through JOBS Act IPOs. Biotechnology companies using provisions of the JOBS Act to go public currently have 696 therapies currently in development, and the FDA has approved 18 new treatments from JOBS Act companies.
Emerging biotech companies raised $17 billion through JOBS Act IPOs – an average of $80 million per offering. These newly public innovators subsequently raised an additional $16 billion through follow-on offerings.
The success of the JOBS Act has supported a surge of financing for early-stage research. In the last five years, there have been 48 IPOs by biotechs in the earliest stages of research (pre-clinical R&D and Phase I clinical trials), compared to just 3 preclinical and Phase I IPOs in the five years before the JOBS Act.
The JOBS Act has supported IPOs from companies across a wide range of therapeutic areas. Oncology companies make up the largest share of JOBS Act IPOs (25%). The law also has led to increased funding for disease areas that have historically been difficult to finance, including diabetes and Alzheimer’s.
JOBS Act biotech companies currently employ over 27,000 people and have a market value of more than $111 billion.

BIO supports capital markets reforms that will build on the success of the JOBS Act and foster the continued growth of emerging public biotechnology companies, including:

The Fostering Innovation Act (H.R. 1645, sponsored by Reps. Kyrsten Sinema (D-AZ) and Trey Hollingsworth (R-IN)), which would extend the JOBS Act’s Sarbanes-Oxley (SOX) Section 404(b) exemption for an additional five years for certain pre-revenue companies;
The Corporate Governance Reform and Transparency Act (sponsored by Rep. Sean Duffy (R-WI) in the 114th Congress), which would provide for SEC oversight of proxy advisory firms and foster accountability, transparency, responsiveness, and competition in the proxy advisory firm industry;
Enhanced short selling transparency in order to shine a light on manipulative trading behaviors that disincentivize long-term investment in innovation, and;
Targeted capital formation provisions in the Financial CHOICE Act (sponsored by Rep. Jeb Hensarling (R-TX) in the 114thCongress), including the Fostering Innovation Act, the Corporate Governance Reform and Transparency Act, the Small Company Disclosure Simplification Act, the Small Business Capital Formation Enhancement Act, and the proposed Small Issuer Exemption from Internal Control Evaluation.

An infographic summarizing the impact of the JOBS Act on the biotech industry may be found at https://www.bio.org/sites/default/files/JOB-Act-at-5-FINAL.pdf

About BIO
BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world. BIOtechNOW is BIO's blog chronicling “innovations transforming our world” and the BIO Newsletter is the organization’s bi-weekly email newsletter. Subscribe to the BIO Newsletter.

04/05/2017

GaBio and GaBioEd Name Stratford Academy Junior as Georgia BioGENEius Finalist

Tue, 02 Jul 2019 19:34:36 GMT

Georgia Bio and the Georgia BioEd Institute today named Stratford Academy junior Tejas Athni of Macon, GA as the winner of the 2017 Georgia BioGENEius Challenge, the premier competition for high school students that recognizes outstanding research and innovation in the biotechnology field. As Georgia’s BioGENEius finalist, Athni will attend the 2017 BIOInternational Convention, the industry’s trade conference from June 18-21 in San Diego, where he will engage with leading companies, scientists and innovators currently transforming the scientific landscape in order to gain valuable insights into an industry making significant contributions to the world.

While in San Diego, Athni will compete against high school students from the U.S., Canada and Germany in the International BioGENEius Challenge. The student projects will represent a range of biotechnology topics such as healthcare, agriculture, and the environment.

Athni’s award-winning research is the first to report the effects of B. monnieri leaf extract in inhibiting the growth of human cancer cells. “Glioblastoma multiforme (GBM) is one of the most aggressive and deadly cancers found in the brain,” says Athni. “Unfortunately, patients have a very short median survival time as there are very few effective treatment modalities. This research presents a novel potential treatment option for such a lethal disease. With further research and testing, this avenue of work could possibly lead to an improvement in the prognosis of patients afflicted with GBM.”

The results, due to be published later this year in the journal NeuroTherapeutics, could lead to potential new therapies for this very aggressive form of brain cancer. Athni’s work was completed during a summer research experience at Fort Valley State University in Georgia and Karmanos Cancer Institute in Detroit, Michigan.

“The BioGENEius Challenge highlights the breakthroughs made when we invest in and encourage young people to pursue their ideas,” said Georgia Bio President and CEO Russell Allen. “Georgia Bio is thrilled that Tejas will represent our state at the upcoming BIO Convention. We are proud to support this Georgia scholar as he develops tomorrow’s healthcare innovations.”

Georgia Bio also congratulates the Georgia BioGENEius runner-up, Marissa McDonald of Union Grove High School in McDonough, GA. McDonald’s research characterizes the galectin-4 protein that binds to and kills certain bacteria that escape the human immune system. Better understanding of this protein may help scientists to design more targeted antibiotics so that harmful bacteria are killed without adversely affecting the helpful bacteria living naturally in our gut.

Judging the 2017 Georgia BioGENEius were Jamie L. Graham, Kilpatrick Townsend & Stockton; Kami McMillan, Chubb; Ashan Perera, VWR; Jordan Rose, Georgia BioEd Institute; and Scott Silverman, Arbor Pharmaceuticals.

The Georgia BioGENEius Challenge is made possible through the sponsorship of Arbor Pharmaceuticals.

National and International winners will be announced during June 18-21, 2017 BIO International Convention. Winners will receive cash scholarships.

# # #

Follow the BioGENEius Challenge: Throughout the challenge, @BiotechInstitut will be tweeting interviews, photos, and engaging with the biotechnology community by using the hashtag #BioGENEius.

Download this Press Release.

04/04/2017

AdvaMed’s Whitaker Urges Congressional Action on MDUFA

Tue, 02 Jul 2019 19:35:14 GMT

WASHINGTON, D.C. – Advanced Medical Technology Association (AdvaMed) President and CEO Scott Whitaker testified before the Senate HELP Committee today on reauthorization of the Medical Device User Fee Act (MDUFA), stressing the urgent need for Congress to move forward with the agreement as negotiated between FDA and industry.

“The MDUFA IV agreement lays the groundwork to build on recent FDA performance improvements through more ambitious goals, important process changes and increased accountability, supported by additional resources,” Whitaker said.

“We strongly support the vital improvements made by the new agreement and believe that a failure to act would have a destructive impact on our industry’s ability to bring new, innovative treatments, diagnostics and cures to patients,” he cautioned.

While focusing on the benefits of the negotiated MDUFA agreement for patients, FDA and innovation, Whitaker noted that there were additional legislative reforms Congress could consider outside the parameters of the negotiated agreement to “enhance and compliment the underlying user fee agreement” that will “maximize[s] the opportunity for success at the agency, which should be the shared goal of all involved.”

As one example, he cited bipartisan legislation recently introduced in both the House and Senate that designed to improve the consistency and transparency of FDA inspections and to move to a risk-based system for inspections. “These common-sense proposals will ensure that FDA’s inspections resources are best targeted to public health needs and that companies and FDA are working together,” Whitaker said.

He called on the Senate HELP Committee and its counterparts in the House to “act promptly to reauthorize this program, which is so critical to our industry, to the FDA, and to patients.”

A copy of Whitaker’s written testimony can be viewed here.

04/04/2017

Sanofi and Regeneron Announce FDA Approval of Dupixent

Tue, 02 Jul 2019 19:36:39 GMT

BRIDGEWATER, N.J. and TARRYTOWN, N.Y., March 28, 2017 /PRNewswire/ -- Sanofi and Regeneron Pharmaceuticals, Inc.announced today that the U.S. Food and Drug Administration (FDA) approved Dupixent® (dupilumab) Injection, the first and only biologic medicine approved for the treatment of adults with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.

View the Multimedia News Release: http://www.multivu.com/players/English/7951851-dupixent-regeneron-sanofi-fda-approval/

"People with moderate-to-severe atopic dermatitis cope with intense, sometimes unbearable symptoms that can impact them for most of their lives," said Julie Block, President and Chief Executive Officer, National Eczema Association. "To date, there have been few options available to treat people with moderate-to-severe atopic dermatitis who have uncontrolled disease. That's why today's approval of Dupixent is so important for our community. Now we have a treatment that is expected to help address patients suffering from this devastating disease."

Dupixent is a human monoclonal antibody that is designed to specifically inhibit overactive signaling of two key proteins, IL-4 and IL-13, which are believed to be major drivers of the persistent underlying inflammation in AD. Dupixent comes in a pre-filled syringe and can be self-administered as a subcutaneous injection every other week after an initial loading dose. Dupixent can be used with or without topical corticosteroids. It should not be used in patients who are allergic to dupilumab or any of the ingredients in Dupixent.

AD, the most common form of eczema, is a chronic inflammatory disease with symptoms often appearing as a rash on the skin. Moderate-to-severe AD is characterized by rashes often covering much of the body, and can include intense, persistent itching and skin dryness, cracking, redness, crusting, and oozing.i Itch is one of the most burdensome symptoms for patients and can be debilitating.ii Of the adults with uncontrolled moderate-to-severe AD in the United States, it is estimated that 300,000 are most in need of new treatment options.iii

"Dupixent is the result of years of tireless research by our scientists into the underlying causes of allergic and atopic diseases. In atopic dermatitis, Dupixent was shown to help clear the skin and manage the intense itch caused by the disease," said George D. Yancopoulos, M.D., Ph.D., Founding Scientist, President, and Chief Scientific Officer, Regeneron. "Today's approval would not be possible without the dedication of the clinical investigators and the participation of the patients who took part in the global LIBERTY AD clinical program."

Dupixent was evaluated by the FDA with Priority Review, which is reserved for medicines that represent potentially significant improvements in safety or efficacy in treating serious conditions. This followed the FDA's 2014 Breakthrough Therapy designation for Dupixent for inadequately controlled moderate-to-severe AD. Breakthrough Therapy designation was created by the FDA to expedite the development and review of drugs developed for serious or life-threatening conditions/ Dupixent represents the first time this designation was granted for a dermatological disease, other than in dermatologic cancers.iv

"We strive to transform scientific innovation into therapeutic solutions that make a meaningful difference to people's lives,"said Olivier Brandicourt, M.D., Chief Executive Officer, Sanofi. "The approval of Dupixent offers new hope for adults with moderate-to-severe AD in the United States, and we look forward to working with regulatory authorities around the world to bring this important new medicine to patients globally."

Sanofi Genzyme, the specialty care global business unit of Sanofi, and Regeneron will market Dupixent in the United States. Dupixent is expected to be available to patients and providers in the U.S. later this week.

Sanofi and Regeneron recognize that Dupixent can only help those uncontrolled moderate-to-severe AD patients that were prescribed the medicine if they can both access the medicine and use it properly. Therefore, the companies have launched Dupixent MyWay™, a comprehensive and specialized program that provides support and services to patients throughout every step of the treatment process.

Dupixent MyWay™ will help eligible patients who are uninsured, lack coverage, or need assistance with their out-of-pocket costs. Additionally, Dupixent MyWay™ offers personalized support from registered nurses and other specialists who are available 24/7 to speak with patients and help them navigate the complex insurance process. For more information, please call 1-844-Dupixent (1-844-387-4936) or visit www.Dupixent.com.

The Wholesale Acquisition Cost (WAC) of Dupixent in the United States is $37,000 annually. Actual costs to patients, payers and health systems are anticipated to be lower as WAC pricing does not reflect discounts, rebates or patient assistance programs.

LIBERTY AD Clinical Program and Results
The approval of Dupixent was based on data from the global LIBERTY AD clinical program, which included three randomized Phase 3 pivotal trials known as SOLO 1, SOLO 2 and CHRONOS (enrolled 2,119 total adult patients). The studies examined the use of Dupixent either alone (SOLO 1 or SOLO 2, 1,379 adult patients enrolled) or with topical corticosteroids (CHRONOS, 740 adult patients enrolled) in patients with inadequately controlled moderate-to-severe AD. In all these studies, Dupixent alone or with topical corticosteroids met the primary and key secondary endpoints, specifically:

In the SOLO 1 and SOLO 2 studies, treatment with Dupixent as monotherapy significantly improved measures of skin clearing and overall extent and severity of disease:
- At 16 weeks, for SOLO 1 and SOLO 2, respectively, 38 and 36 percent of patients who received Dupixent 300 mg every two weeks achieved clear or almost clear skin as measured by the 5-point Investigator's Global Assessment (IGA) scale (primary endpoint), compared to 10 and 9 percent with placebo.
- At 16 weeks, for SOLO 1 and SOLO 2, respectively, 51 and 44 percent of patients who received Dupixent 300 mg every two weeks achieved a 75 percent or greater reduction in their Eczema Area and Severity Index score (EASI-75) from baseline, a key secondary endpoint, compared to 15 and 12 percent with placebo.
- At 16 weeks, for SOLO 1 and SOLO 2, respectively, 41 and 36 percent of patients who received Dupixent 300 mg every two weeks achieved a greater than or equal to 4 point improvement in the daily intensity of patient-reported itch, as measured by the Pruritus Numerical Rating Scale (NRS), compared to 12 and 10 percent with placebo.
In the CHRONOS study, treatment with Dupixent with topical corticosteroids (TCS) significantly improved measures of overall disease severity at 16 and 52 weeks, when compared to placebo with TCS:
- At 16 weeks, 39 percent of patients who received Dupixent 300 mg every two weeks with TCS achieved clear or almost clear skin (IGA 0 or 1), the primary endpoint, compared to 12 percent of patients receiving placebo with TCS.
- At 16 weeks, 69 percent of patients who received Dupixent 300 mg every two weeks with TCS achieved EASI-75 (key secondary endpoint), a 75 percent reduction on an index measuring eczema severity, compared to 23 percent of patients receiving placebo with TCS.
- At 16 weeks, 59 percent of patients who received Dupixent 300 mg every two weeks with TCS achieved a greater than or equal to 4 point improvement in the daily intensity of patient-reported itch, as measured by the NRS, compared to 20 percent of patients receiving placebo with TCS.
- The study also met additional key secondary endpoints at 52 weeks, showing that 36 percent of patients who received Dupixent 300 mg every two weeks with TCS achieved clear or almost clear skin (IGA 0 or 1), compared to 13 percent of patients receiving placebo with TCS.

The most common adverse events that were noted to be greater than or equal to one percent with Dupixent treatment included injection site reactions, eye and eye lid inflammation including redness, swelling, and itching, and cold sores in the mouth or on the lips.

In December 2016, the European Medicines Agency accepted for review Sanofi's and Regeneron's marketing authorization application (MAA) for Dupixent for adults with uncontrolled moderate-to-severe AD.

Dupilumab Program Overview
Dupilumab is currently being evaluated in a comprehensive development program for AD that includes studies in children with severe AD (6 months to 11 years of age) and adolescents with moderate-to-severe AD (12 to 17 years of age). In October 2016, the FDA granted dupilumab Breakthrough Therapy designation for both populations. These potential uses are investigational and the safety and efficacy have not been evaluated nor confirmed by any regulatory authority.

Dupilumab is also being studied in other inflammatory diseases that are believed to be driven by IL-4 and IL-13 cytokines, including persistent uncontrolled asthma (Phase 3, results expected later this year), nasal polyposis (Phase 3) and eosinophilic esophagitis (Phase 2). These potential uses are investigational and the safety and efficacy have not been evaluated by any regulatory authority. For more information on dupilumab clinical trials please visit www.clinicaltrials.gov.

IMPORTANT SAFETY INFORMATION
Do not use if you are allergic to dupilumab or to any of the ingredients in Dupixent®.

Before using Dupixent, tell your healthcare provider about all your medical conditions, including if you:

have eye problems
have a parasitic (helminth) infection
have asthma
are scheduled to receive any vaccinations. You should not receive a "live vaccine" if you are treated with Dupixent.
are pregnant or plan to become pregnant. It is not known if Dupixent will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known whether Dupixent passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. If you have asthma and are taking asthma medicines, do not change or stop your asthma medicine without talking to your healthcare provider.

Dupixent can cause serious side effects, including:

Allergic reactions. Stop using Dupixent and go to the nearest hospital emergency room if you get any of the following symptoms: fever, general ill feeling, swollen lymph nodes, hives, itching, joint pain, or skin rash.
Eye problems. Tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision.

The most common side effects include injection site reactions, eye and eyelid inflammation, including redness, swelling, itching, and cold sores in your mouth or on your lips.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Dupixent. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Use Dupixent exactly as prescribed. If your healthcare provider decides that you or a caregiver can give Dupixent injections, you or your caregiver should receive training on the right way to prepare and inject Dupixent. Do not try to inject Dupixent until you have been shown the right way by your healthcare provider.

Please click here for the full Prescribing Information. The patient information is available here.

INDICATION

Dupixent is used to treat adult patients with moderate-to-severe atopic dermatitis (eczema) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. Dupixent can be used with or without topical corticosteroids. It is not known if Dupixent is safe and effective in children.

About Sanofi
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi is organized into five global business units: Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Consumer Healthcare. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

Sanofi Genzyme focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families.

About Regeneron Pharmaceuticals, Inc.
Regeneron (NASDAQ: REGN) is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.

03/30/2017

CiDrep Informatics Launches Cloud Services Platform

Tue, 02 Jul 2019 19:37:31 GMT

ATLANTA, Georgia – March 15, 2017. CiDrep Informatics, Inc., today announced the addition of Cloud Services to its portfolio of products and solutions. CiDrep Cloud, is a fully automated ecommerce solutions that allows hospitals, health systems, independent physicians’, dental, behavioral health offices and research organizations to purchase, provision and use HIPAA compliant cloud Software-as-a-Service and Infrastructures-as-a-Service with security and ease.

Built on a single, open cloud platform, CiDrep Cloud is a comprehensive digital business platform that offers Collaboration Software Tools, Device Management, Microsoft Office 365 Plans, IBM SoftLayer, Virtual Private Systems, Hyper-V based virtual machines running Windows 2012 64bit edition, Project Management and Healthcare specific software’s designed to help increase productivity, augment decision-making and become a digital health business beyond organizational boundaries with staffs, patients, partners and vendors.

“With the rise of today’s digital workplace, where information is abundant, we can provide the latest communication tools to help cut through the noise and achieve effective collaboration and quality workplace outcomes in client’s environments. CiDrep Cloud is designed to meet the unique workstyle of every IT department, technology use and managed IT services with purpose-built, integrated applications, infrastructures and software tools to reduce costs of ownership, risk and resource demands while delivering stronger support, reliability and operational efficiency with popular cloud infrastructure applications”, said Wayne Craige, CEO of CiDrep.

CiDrep cloud solutions include and number of Infrastructure as a Service (IaaS) and Software as a Service (SaaS) products, plus:

· Cloud Computing Infrastructure Platforms,

· Communications and Collaborations Software Tools,

· Acronis Cloud Backup and Disaster Recovery,

· Microsoft OneDrive for Business File Storage,

· Data and Email Migration Services,

· Custom Virtual Private Servers running Linux CentOS 6

· Custom Virtual Servers running Windows 2012 64bit

· IBM SoftLayer Dedicated Bare Metal, Power8 Servers, Virtual Servers, Storage and Networking

· Microsoft Office 365 Productivity Plans for Healthcare Business

· Microsoft Azure, SharePoint and Exchange Online Services for Business

About CiDrep Cloud

CiDrep cloud is a single platform for a whole new way of doing business with clients. We help transform their business, and be up and running in the cloud in minutes, with little to no investment, enabling them to deliver internal technology services, and manage their infrastructure most efficiently. To learn more about CiDrep Clouds Solutions, please visit https://www.cidrep.com

About CiDrep Informatics Inc.

At CiDrep, we are continuously developing intelligent solutions for the health care industry. CiDrep is an informatics (clinical, health, imaging and bioinformatics) services company providing a range of clinical, health, imaging and genomic informatics services and technology solutions for providers and researchers. CiDrep collaborates with clients with an aim to provide Better Technology to drive Better Outcomes and ultimately Better Care™. https://www.cidrep.com

03/15/2017

GCMI Launches New Medtech Accelerator

Tue, 02 Jul 2019 19:38:22 GMT

Media Release – February 28, 2017 (Atlanta, Ga.) – The Global Center for Medical Innovation (GCMI) announced today it is partnering with BD (Becton, Dickinson and Company) to support the launch of, and the first startup to enter, the new GCMI Medtech Accelerator.

The announcement harkens the arrival of a substantial new asset for the medtech ecosystem in Atlanta and the southeast.

“Too many medtech startups fail unnecessarily due to a lack of bridge, or seed funding, required to advance far enough in the commercialization process to attract investment by a larger device company,” says Tiffany Wilson, CEO of GCMI and its preclinical testing and training arm T3 Labs. “The new accelerator and BD’s support provides a new source of critically needed funding and support for local and regional medtech startups, and the ecosystem as a whole, to take a measurable step forward.”

According to Wilson, BD will support the first company to complete the GCMI Medtech Accelerator program through a milestone driven process and grant. Each startup or early stage company admitted to the accelerator will be selected by a team including GCMI, an industry partner, investor and other relevant subject matter experts.

BD, and other partnering companies to follow, will play key roles in milestone setting and mentoring for the accelerator’s startups. “Milestone” examples could include intellectual property (IP) protection, FDA 510(k) submission, preclinical studies or a startup’s first contract with a provider or hospital. Selected accelerator companies will live at GCMI for 6 to 12 months depending on the milestones created at admission and the tasks to be completed during their stay.

“In spite of best efforts, medtech startups still face ‘a valley of death’ when it comes to securing funding and bringing the first product to market”, stated Ellen Strahlman, MD, MHSc, Executive Vice President R&D and Chief Medical Officer for BD. “GCMI represents a unique way to address that issue and the program dovetails nicely with BD’s global accelerator partnerships.”

“From concept to development through clinical trials, the infrastructure needed to support successful medtech innovation resides within close proximity to our facilities,” says Wilson. “Our new accelerator fills a gap in the ecosystem which now enables us to locally support high potential young medtech companies and the associated economics gains – including new jobs – to Atlanta and the southeast.

According to Jason Rupp, executive director of the Southeastern Medical Device Association (SEMDA), the southeast led the country in [medtech] employment and establishment growth from 2012 – 2014. While overall U.S. employment in the medtech industry fell by 0.1%, employment in the southeast grew by 5.1%, adding 2,874 jobs. The region added 174 establishments during the same period, a 9.4% increase compared to a 5.5% increase nationally.

“GCMI’s Medtech Accelerator represents a profound step forward for the medtech ecosystem in the southeastern United States,” says Rupp. “It is precisely the kind of asset needed to increase regional medtech investment and maximize our local and regional resources’ capabilities to drive improvements in patient care and meaningful economic growth.”

“GCMI’s team has the track record, facilities, expertise, network and commitment to make this the first of what we believe will be many high-value partnerships for all concerned and a model for accelerating medtech innovation,” says Al Lauritano, BD’s Director, External Innovation & Partnerships.

“Medical device innovation is a complex, expensive process, yet there is a tremendous need for novel solutions to unmet clinical needs,” Wilson says. “These are the technologies that will ultimately benefit patients and lower healthcare costs by improving the way physicians diagnose and treat disease. Given Atlanta’s fantastic resources, which include expertise at GCMI, T3 Labs, Georgia Tech, Emory Healthcare, Piedmont Healthcare, Children’s Healthcare of Atlanta and now the GCMI Medtech Accelerator thanks to BD’s support, we can help de-risk many new medical technologies in a methodical way, making the process more transparent and predictable, decreasing the time required for a new device to get to market and attracting more investment.”

“GCMI levels the playing field for small medtech startups to get a toe hold, work through regulatory, make it to market and then scale. With their help, we were able to avoid millions of dollars in upfront costs,” says John O’Shaughnessy, Founder and CEO of Matrix Surgical USA.

About GCMI

The Global Center for Medical Innovation (GCMI) brings together core members of the medical device community, including universities, research centers, clinicians, established device companies, investors and startups, with the goal of accelerating the commercialization of innovative medical technology.

www.devices.net

03/13/2017

Giant deal for Atlanta-based Merial gets final U.S. government OK

Tue, 02 Jul 2019 19:39:15 GMT

A giant deal involving Atlanta-based animal health company Merial has gotten a final green light from U.S. regulators.

In the deal, announced last June, Boehringer Ingelheim has acquired Sanofi’s animal care subsidiary, Merial, valued at $13.53 billion, and Sanofi took over Boehringer Ingelheim’s consumer health care business unit, valued at $7.98 billion, as well as cash compensation of $5.54 billion.

Enlarge

The FTC's Feb. 24 order requires that Boehringer Ingelheim divest the canine, feline… more

The Federal Trade Commission on Feb. 24 approved a final order okaying the deal. The FTC had alleged that as originally structured, it would harm competition in the U.S. markets for various vaccines for pets and certain parasite control products for cattle and sheep. The FTC also charged the deal could lead to higher prices and reduced service in these markets, and could increase the likelihood of coordinated interaction between competitors.

The FTC's final order requires that Boehringer Ingelheim divest the canine, feline and rabies vaccines identified in the complaint to Eli Lilly and Co. and its Elanco Animal Health division, and the parasite control products to Bayer AG.

Merial's North American headquarters are located in Duluth, Ga. The company has 1,750 U.S. employees.

Source: Atlanta Business Chronicle

03/08/2017

Emory and AKESOgen Partner on Healthy Aging Study

Tue, 02 Jul 2019 19:40:13 GMT

ATLANTA February 28, 2016 – Emory University School of Medicine and AKESOgen announced today their collaboration on the Emory Healthy Aging Study. The largest clinical research study ever conducted in Atlanta, the Emory Healthy Aging Study is a game changing effort to further the scientific understanding of how we age. Aiming to identify predictive markers through cutting edge technologies, the study will enable the prediction of diseases occurring more commonly in later years.

Through recruitment of thousands of study participants over the next few years, the Emory Healthy Aging Study will build an extensive database of personal health information. The data collected may also help participants, through consultation with their physician, learn more about their overall health.

As an academic medical center, Emory’s mission includes providing care for patients and researching how to provide even better care in the future. AKESOgen shares this philosophy, and is well established as one of the top College of American Pathologists (CAP) accredited providers of high quality data to both research and medical institutions. Many important medical discoveries and groundbreaking new treatments have been made at Emory, thanks to the work of Emory researchers and the contributions of study participants.

“We are delighted to be working with leading scientists at Emory on this unique and outstanding long term study on health and wellbeing which will deliver enormous benefits to the participants and the community as a whole.” commented AKESOgen’s CEO Bob Boisjoli.

“We believe our strong relationship with Emory and our excellent scientific and technical prowess in precision medicine will allow us to make important contributions to new discoveries in this exciting landmark study.” says Mark Bouzyk PhD, AKESOgen’s Chief Scientific Officer.

Over time, Emory’s diverse team of researchers will study numerous age-related diseases. Examples of these include Alzheimer’s disease, heart disease, and diabetes. AKESOgen has deep experience in precision medicine approaches in these diseases among others.

"The Emory Healthy Aging Study is an ambitious clinical research endeavor that aims to improve the lives of people so they may live healthier lives as they age,” says James Lah, MD, PhD, the principal investigator of the study and associate professor and vice-chair of the Department of Neurology at Emory.

“A study of this scale, gathering large amounts of health data across a diverse participant population, will help us learn more about a host of age-related diseases,” adds Michele Marcus, PhD, Professor of Epidemiology at Emory and a lead investigator of the study.

About the Emory Healthy Aging Study

The Emory Healthy Aging Study is the largest clinical research study ever conducted at Emory University. It is an effort to further the scientific understanding of how people age, and to learn more about diseases that occur more commonly in later years. The Emory Healthy Aging Study seeks to enroll 100,000 people and anyone 18 years of age or older who is a U.S. resident is eligible to participate. For more information, visit https://healthyaging.emory.edu.

About AKESOgen, Inc.

AKESOgen is an integrated Clinical Laboratory Improvement Amendments (CLIA) compliant and College of American Pathology (CAP) accredited genomics, genetics and bio-banking company that services the pharmaceutical, biotechnology, clinical, academic, and government sectors for clinical trials, diagnostic clinical testing, and research. Based in Atlanta, GA, USA, the company’s main focus is oncology and personalized medicine. AKESOgen’s services include providing high-throughput, biomarker profiling, cytogenetic arrays, sequencing, and genomics analysis utilizing different types of markers (e.g. DNA, mRNA, miRNA, and methylation) and Pathology. For more information, visit www.akesogen.com.

02/28/2017

Senate Bill Would Modernize FDA MedTech Inspection Process

Tue, 02 Jul 2019 19:40:58 GMT

WASHINGTON, D.C. – The Advanced Medical Technology Association (AdvaMed) issued the following statement from President and CEO Scott Whitaker after introduction in the U.S. Senate of bipartisan legislation (S. 404) to modernize FDA’s medical device inspections process:

“Both the medical technology industry and FDA recognize the need for a robust inspections process to help ensure the continued availability of safe and effective devices and diagnostics for patients.

“However, the agency’s current inspections process suffers from a lack of consistency, predictability and transparency, preventing both FDA and industry from addressing quality and compliance issues in an efficient manner.

“The legislation introduced today by Sens. Johnny Isakson (R-Ga.) and Michael Bennet (D-Colo.) will help modernize FDA’s inspections process through a risk-based approach that will focus the agency’s limited resources on facilities that have the most potential to impact public health, improving overall patient safety.

The legislation would also:

Establish a process for companies to address deficiencies more quickly and robustly;
Create a more focused and efficient inspection process for FDA;
Harmonize the inspection process to eliminate regional variations; and
Improve communications between FDA and companies to ensure timely implementation of any remediation plans.

“This legislation will lead to a higher level of patient safety and more efficient use of inspector time and effort, while not taking away any of FDA’s authority to inspect device manufacturing facilities.

“We commend Sens. Isakson and Bennet for their leadership on this issue, and look forward to working with FDA, Congress and other stakeholders in advancing this important bill.”

02/22/2017

CorMatrix Cardiovascular Secures Fifty-six (56) Patents in 2016 Expanding Patent Protection for Extracellular Matrix (ECM®) Based Implantable Devices

Tue, 02 Jul 2019 19:42:01 GMT

(Roswell, GA –Jan 19, 2017) – CorMatrix® Cardiovascular, Inc., (www.cormatrix.com) a leading developer of biomaterial compositions and medical devices for regenerative medicine, today announced the issuance of 56 patents in 2016. The ongoing expansion of this patent portfolio continues to support the Company’s development of novel extracellular matrix (ECM®) based devices and compositions. Of the fifty-six patents, 19 were obtained internationally. CorMatrix currently holds 13 trademarks related to its Extracellular Matrix products and the Company has secured some 128 patents affording significant intellectual property protection in the area of regenerative medicine. CorMatrix ECM is a naturally occurring bioscaffold that remodels over time into healthy, organized tissue that is site specific.

“CorMatrix’s intellectual property portfolio is outstanding. We have very comprehensive coverage of not only the ECM devices we provide to our core markets, but also of the innovations that can find applications in other important areas of regenerative medicine,” said Robert Matheny, MD, CSO of CorMatrix. “From the beginning, we recognized the importance of developing and then protecting our technology. As a pioneer in the field of regenerative science since 2001, having our patents recognized by offices around the globe (United States, Europe, South America, Australia and others) is a source of pride for the entire Company, our Partners, and our Investors.”

Extracellular matrix has been used as a biologic scaffold in many different surgical applications including cardiac and vascular repairs, pelvic floor reconstructions, dental surgery, and veterinary medicine to identify a few. A steady production of both preclinical and clinical data support the need for organs and tissues to have an inductive scaffold for the cells, particularly stem cells, to be retained, restored, and to function normally.

Among the patents issued this year, CorMatrix secured US 9,352,070 for use as a tissue prosthesis which can be engineered into a variety of shapes and used to repair, reconstruct or replace damaged or diseased tissue and the associated biological structures. This includes seamless tubular uses (for vein and arterial replacements), heart valves, myocardium, pericardium and other significant aortic structures. Use of ECM as a prosthetic also could also be extended to esophageal, tracheal, and bronchial anatomy. The Company currently has 510(k) clearances for their implantable ECM devices used in adult and pediatric cardiac tissue repair, pericardial reconstruction, and vascular repair.

Two additional patents, US 8,980,296 and US 8,877,224; along with the issuance of European patent No. 2398502, may significantly address issues surrounding the prevention, reduction, and treatment of myocardial damage and arrhythmic sequelae. Atrial fibrillation, (AFib or AF) is the most common type of heart arrhythmia and affects an estimated 3-6 million people in the United States. More than 750,000 hospitalizations occur each year because of AFib and costs the United States approximately $6 billion each year. Through these patents, micronized extracellular matrix (with or without stem cells) is delivered via intra-myocardial injection into the area of infarct enabling regrowth and restoration of the native cardiac function. Medical costs for people with AFib are almost $9K higher per year than for people who do not have AFib.1, 2

“Our CorMatrix technology backed by the Company’s patents is harnessing the potential of stem cells and matrix factors working together to regenerate site specific tissue,” said Andrew Green, CEO of CorMatrix. “We now have preclinical and human evidence of regenerating heart muscle after myocardial infarctions and myocardial tissue replacement treatments. No other company, stem cell based or otherwise, has been able to demonstrate this concept. Now our goal is to make it available around the world.”

1 January CT, Wann LS, Alpert JS, Calkins H, Cigarroa JE, Cleveland JC Jr, et al. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation. Journal of the American College of Cardiology. 2014; 64(21):2246–80.

2 Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, et al. Heart disease and stroke statistics—2015 update: a report from the American Heart Association. Circulation. 2015; 131:e29–e322.

Source: CorMatrix

02/07/2017

MAP Announces Partnership with Intent Solutions to Assess Medication Compliance in Patients with ADD

Tue, 02 Jul 2019 19:42:56 GMT

MAP Health Management, LLC., announced today a partnership with Intent Solutions designed to track adherence to medication protocols for patients with a Substance Use Disorder diagnosis who are served by MAP’s patient engagement technology. Intent Solutions is the creator of the TAD™, a biometric pill dispensation device that can track in real-time who has or has not taken their medication.

The partnership will launch with a pilot program as early as March of this year wherein a number of patients whose risk for relapse is continuously measured by MAP’s technology will be provided a TAD™ device. The device will send real-time data to MAP’s platform when a patient takes their medication, or fails to do so. With this information, MAP can inform the appropriate members of collaborative care networks if a patient is overusing their medication, or failing to take their medication at all. This information is then leveraged to improve clinical outcomes and manage financial risk through facilitating early interventions and other modes of mitigating recidivism and costly treatment episodes.

86% of patients served by MAP’s technology have a co-occurring mental or behavioral health disorder in addition to Substance Use Disorder and 94% are prescribed at least one medication. Capturing actionable data regarding medication compliance is an essential component of improving clinical and financial outcomes for this demographic.

“The number one factor in improving outcomes is early intervention. Putting the TAD™ into the hands of people recovering from addiction who are prescribed medication will greatly enable MAP to better inform treatment providers, family members, and insurance carriers who are at high risk for relapse and readmission resulting from the lack of medication compliance”, said Jacob Levenson, CEO of MAP Health Management, LLC.

Currently, identifying who is properly taking their medication after acute addiction treatment episodes has been elusive. “We are excited to partner with MAP and empower their ecosystem with our TAD™ device. We know that our product has great efficacy for those with Substance Use Disorder and MAP knows how to leverage our device to improve outcomes for all of the stakeholders”, said Sam Zamarripa, President and Director of Intent Solutions.

MAP continues to add to its robust ecosystem of patients, providers, insurance companies, and technology products, all of which are integrated into MAP’s population health platform. MAP is generally recognized as possessing the most robust risk identification and reporting environment for insurance companies related to the addiction treatment space.

About MAP Health Management, LLC
MAP develops technology-enabled solutions that improve clinical and financial outcomes for chronic behavioral health illnesses such as Substance Use Disorder. MAP empowers treatment providers, health insurance companies, health systems, and patients with the right data at the right time in order to improve clinical and finical outcomes. For more information, visit https://www.thisismap.com. To download the recently released white paper, ‘The 5 Key Factors to Successful Behavioral Health Population Management’, visit: https://thisismap.com/insights/white-papers/5-key-factors-successful-behavioral-health-population-management.

About Intent Solutions
Headquartered in Atlanta, Georgia, Intent Solutions is a technology, software, and data service company focused on developing solutions, for clinical research, pain management and specialized pharmacy, designed to markedly improve the monitoring and management of medication adherence and provide real-time behavioral data to more accurately measure compliance and efficacy.

It is estimated that up to one-half of all prescriptions are not taken which results in deaths of over 125,000 from adherence related causes and a staggering economic burden in health care of $300B, and a global revenue loss of $564B to pharmaceutical companies. The adherence problem may include taking more or less than prescribed, skipping doses, and also the abuse, misuse, and diversion of medications.

02/02/2017

Lieutenant Governor Casey Cagle Named Georgia Bio Lawmaker of the Year

Tue, 02 Jul 2019 19:43:44 GMT

ATLANTA, GA (January 25, 2017) -- Georgia Bio has announced that Lieutenant Governor Casey Cagle has been selected as the 2017 Lawmaker of the Year for his support of the life sciences industry and university research in Georgia during the 2016 General Assembly.

Mr. Cagle is being recognized for his leadership in economic growth, innovation, education and workforce development. Mr. Cagle continues to champion legislation to support growth of innovative companies in biosciences and other sectors via programs like Invest Georgia, and he has collaborated with the Georgia BioEd Institute on STEM education and workforce development programs.

“Lieutenant Governor Cagle recognizes the importance of medical technology and life sciences to the future of our state. He is a leading advocate for improving education and positioning Georgia as one of the strongest states in the nation for innovation jobs,” said Russell Allen, president and CEO of Georgia Bio.

Lieutenant Governor Cagle will be honored at the Georgia Bio Annual Awards Dinner, January 26, 6 pm to 9 pm, at the Westin Atlanta Perimeter North. Other leading companies, executives, researchers and dedicated individuals will receive Georgia Bio Awards. Learn more and register at www.gabio.org/awards.

Biography of Awardee

Lieutenant Governor Casey Cagle

A successful entrepreneur and respected former State Senator, Casey Cagle made history in 2006 by becoming the first Republican elected to Georgia’s second highest office. In November of 2010 and 2014, in recognition of his outstanding efforts on behalf of the state his family has called home for seven generations, Georgia voters overwhelmingly re-elected Lieutenant Governor Cagle.

After a leg injury ended his dreams of playing college football, Casey returned to Gainesville in 1986 and became the proprietor of his first small business, a tuxedo rental company. At just twenty years old, Casey began realizing the American dream as his business expanded throughout North Georgia. After founding Southern Heritage Bank in 1999 and earning his reputation as a community and business leader in Gainesville, Casey focused his efforts on serving the citizens of Georgia.

In 1994, he was elected the youngest state Senator at just 28 years old, and was overwhelmingly reelected five times. In the Senate, Casey rapidly established himself as a capable and effective lawmaker. He was appointed to serve as Chairman of the Finance Committee, Vice Chairman of Science and Technology, and as a member of the Appropriations Committee and Natural Resources Committee. Casey’s ability to build consensus made him a successful leader in lowering taxes, protecting private property rights, and standing up for Georgia’s families.

In 2006, Casey Cagle became Georgia’s 11th Lieutenant Governor. As the first ever Republican in Georgia to serve in that office, Casey focused his conservative principles to help make Georgia a place where businesses could grow and families could prosper. Championing the Charter Systems Act, Casey improved education in our state while providing a path to career technical education for Georgia’s high school students.

Additionally, he launched the Georgia College and Career Academy Network, a partnership between local community leaders, school systems, and Georgia’s technical colleges. The college and career academies provide a relevant and rigorous curriculum aimed at preparing students for a highly skilled, 21st-Century economy upon graduation. Thanks to Casey’s leadership, Georgia has 37 College and Career Academies today with additional academies planned each year.

An avid triathlete, Casey leads Healthy Kids Georgia, an effort to encourage local partnerships that introduce children to healthy lifestyle options. Under the slogan of “Be Fit. Be Healthy. Be You.” the initiative helps acquaint children with ways to improve their health and wellness. Working together, local communities are beginning to stem the tide of childhood obesity in ways that are proven to increase academic achievement and reduce long-term healthcare costs.

Notwithstanding his many accomplishments in private and public life, Casey is most proud to be a husband, father and grandfather. He has been married to Nita, his high school sweetheart, for 30 years and they are the proud parents of three sons – Jared and his wife Kaylan, Grant and his way Meghan, and Carter – and grandparents of a beautiful granddaughter – Everette Grace. They live in Flowery Branch and are active members of Blackshear Place Baptist Church.

For a list of past Georgia Bio award recipients, click here.

Georgia Bio (www.gabio.org) is the state’s life science industry association whose members include pharmaceutical, biotechnology and medical device companies, medical centers, universities and research institutes, government groups and other business organizations involved in the development of life sciences related products and services.

01/25/2017

Marc Pedersen of Paulding County High School Named Biotech Teacher of the Year

Tue, 02 Jul 2019 19:44:20 GMT

ATLANTA, GA (January 24, 2017) – Marc Pedersen, Ed.S. of Paulding County High School in Dallas, GA has been selected as the 2017 Georgia Bio Biotechnology Teacher of the Year.

The Teacher of the Year award recognizes excellence in STEM teaching and support for the biotechnology pathway, part of Georgia’s Career Clusters, by a current high school biotechnology teacher. The award winner is nominated by peers and selected by the Georgia BioEd Institute Board of Advisors.

Marc Pedersen has been a science teacher at Paulding County High School for the past 12 years where he has taught science content ranging from biotechnology to chemistry, environmental science, and physics. Mr. Pedersen earned a B.S. in science education from Indiana University, a M.S. in biology from the University of Wisconsin-Milwaukee, and an Ed.S. in teacher leadership from Piedmont College.

As a published research scientist and former molecular ecologist, Mr. Pedersen brings his expertise and passion for biotechnology into the classroom. In addition to teaching the biotechnology pathway curriculum, his students are conducting exciting and innovative research. Currently, Mr. Pedersen’s students are using newly emerging molecular techniques such as environmental DNA, CRISPR-Cas9 genome editing, and DNA barcoding of Georgia aquatic species. His students are encouraged to publish their research and to enter various competitions throughout the year.

“Teachers like Mr. Pedersen are helping to prepare students to enter the STEM workforce and become tomorrow’s biotech industry leaders,” said Jordan Rose, Executive Director for the Georgia BioEd Institute. “His enthusiasm encourages young minds to see themselves improving the world through biotechnology.”

Mr. Pedersen has received numerous recognitions for his dedication and commitment to education. Having been named the 2013 Paulding County School District teacher of the year, he went on to become a 2015 Georgia Teacher of the Year finalist and he now serves as president-elect of the Georgia Teachers of the Year Association. Last June, Mr. Pedersen was recognized nationally by the Biotechnology Institute as the recipient of the 2016 BioGENEius Mentor Award, which was awarded during the Biotechnology Innovation Organization International Convention in San Francisco, CA. In September, Mr. Pedersen received the 2015 Presidential Award of Excellence in Science Teaching. This is the single highest honor a science teacher can receive in the United States. Most recently, Mr. Pedersen was named a 2016 Claes Nobel Top Ten National Educator of the Year, which is an award given through the National Society of High School Scholars.

Mr. Pedersen is dedicated to all facets of the teaching profession. He shares his pedagogical strategies and research with other educators at conferences and seminars nation-wide. He has also served on numerous committees and advisory boards, such as the Governor’s Teacher Advisory Committee and the State Superintendent’s Advisory Council. He is an inaugural member of the Georgia BioEd Institute’s Teacher Advisory Council.

Mr. Pedersen will be honored at the Georgia Bio Annual Awards Dinner, January 26, 2017 from 6 pm to 9 pm, at the Westin Atlanta Perimeter North. Other leading companies, executives, researchers and dedicated individuals will receive Georgia Bio Awards. Learn more and register at www.gabio.org/awards.

For a list of past Georgia Bio award recipients, click here.

01/24/2017

GeoVax draws a bead on hep B with therapeutic vaccine deal

Tue, 02 Jul 2019 19:45:23 GMT

GeoVax has partnered with Georgia State University to try to pursue an elusive goal—the development of an effective therapeutic vaccine for hepatitis B virus (HBV) infections.

The treatment of chronic hepatitis B has improved dramatically in recent years thanks to new antiviral drugs, but efforts to develop a therapeutic vaccine have largely ended in disappointment. Recent casualties among therapeutic HBV vaccines include GlobeImmune's GI 13020/GS-4774 which failed a Phase II trial causing partner Gilead to terminate a license for the candidate last November.

A therapeutic vaccine could boost chances for a functional immunological cure of the disease that could do away with the current need for lifelong suppression of the virus using nucleoside analog drugs like Gilead's tenofovir and Bristol-Myers Squibb's entecavir and interferon.

Chasing that goal, GeoVax and Georgia State say they are working on developing several vaccine candidates. The biotech—also based in Georgia—will contribute its modified vaccinia Ankara virus technology platform, which can be used to stimulate virus-like particles (VLPs) against specific antigens in patients and is already being used in vaccines against Zika and other serious diseases.

The university will contribute VLP design and functional assays developed by professor of chemistry Dr. Ming Luo, with assistance from Peking University Shenzhen Graduate School in China. Luo's work has focused on teasing out the molecular mechanisms that come into play during immune responses to HBV.

"The combined technologies and already defined functional assays will serve to rapidly test this innovative concept," said GeoVax' chief scientific officer Farshad Guirakhoo.

Hepatitis B is spread through blood and body fluids, attacking the liver and resulting in an estimated 650,000 deaths each year—most of them in low- and middle-income countries, according to the World Health Organization (WHO).

In the U.S. there are somewhere between 700,000 and 1.4 million people infected with HBV, say the Centers for Disease Control and Prevention (CDC), with 20,000 new infections every year.

Other companies in pursuit of therapeutic HBV vaccines include Abivax, whose ABX203 candidate is in mid-stage clinical testing, and Inovio Pharma with INO 1800 in Phase I testing, although that program took a knock when former partner Roche handed rights back last August. Altimmune has its HepTcell immunotherapy in Phase I, while another candidate from Chinese firm Kangtai Biologicals Products is also reported to have reached the clinical testing stage.

Aside from therapeutic vaccines, hopes of achieving a functional cure in HBV could also be met by new drug classes, including encapsidation inhibitors, entry inhibitors and TLR7 agonists, which are in various stages of development.

Source: Fierce Biotech

01/23/2017

UCB files BRIVIACT® (brivaracetam) CV in the U.S. as monotherapy treatment for adult epilepsy patient

Tue, 02 Jul 2019 19:46:18 GMT

Brussels (Belgium), Atlanta (Georgia, USA), 19 January 2017 – 18:30 (CET): UCB has today announced the filing of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for BRIVIACT® (brivaracetam) CV as monotherapy in the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy within the U.S.

BRIVIACT® is currently approved in the U.S. as adjunctive therapy in the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy1. The most common adverse reactions (at least 5% for BRIVIACT® and at least 2% more frequently than placebo) in adjunctive therapy clinical trials were somnolence and sedation, dizziness, fatigue, and nausea and vomiting symptoms. Please see additional BRIVIACT® Important Safety information below. Brivaracetam is not currently approved as monotherapy.

UCB submitted its supplemental application taking into account a recent General Advice Letter issued by the FDA2 which stated that it is “acceptable to extrapolate the efficacy and safety of drugs approved as adjunctive therapy for the treatment of partial onset seizures (POS) to their use as monotherapy for the treatment of POS”. The communication stipulates that, to support extrapolation, proposed dosages of a drug when used as monotherapy should result in exposures similar to those demonstrated to be safe and effective when the drug is used as adjunctive therapy and that adequate pharmacokinetic information must be provided “to demonstrate such similarity, taking into consideration possible drug-drug interactions (inhibition or induction) that may alter the metabolism of the drug”. UCB has included this information within its BRIVIACT® monotherapy supplemental application.

“We are very pleased to be able to submit a label change for brivaracetam to the FDA, to include its use as monotherapy for partial-onset seizures. The FDA’s agreement to the principle of extrapolation from existing data in their assessment of antiepileptic drugs has enabled us to base this submission on the existing wealth of brivaracetam data, less than a year after its launch as an adjunctive therapy in the U.S., and could improve patient access to the medicine if approved,” said Professor Dr. Iris Loew-Friedrich, UCB’s Chief Medical Officer. “This submission, under the FDA’s extrapolation principle, allows us to use the strength of our brivaracetam clinical trials data, involving more than 2,400 adult patients with partial-onset seizures, and reinforces our longstanding commitment to develop and make available meaningful treatment solutions to improve the lives of people living with epilepsy.”

While the supplemental application of BRIVIACT® as monotherapy in the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy in the U.S. has been accepted by the FDA, acceptance of this submission does not necessarily mean BRIVIACT®will be approved for this indication.

About Epilepsy3,4
Epilepsy is a chronic neurological disorder of the brain. It is the fourth most common neurological condition worldwide and affects approximately 65 million people. In the U.S., 3 million people have epilepsy. Anyone can develop epilepsy; it occurs across all ages, races and genders, and is defined as one or more unprovoked seizures with a risk of further seizures. One third of patients with epilepsy live with uncontrolled seizures.

About UCB in Epilepsy
UCB has a rich heritage in epilepsy with over 20 years of experience in the research and development of antiepileptic drugs. As a company with a long-term commitment to epilepsy research, our goal is to address unmet medical needs. Our scientists are proud to contribute to advances in the understanding of epilepsy and its treatment. We partner and create super-networks with world-leading scientists and clinicians in academic institutions, pharmaceutical companies and other organizations who share our goals. At UCB, we are inspired by patients, and driven by science in our commitment to support patients with epilepsy.

About BRIVIACT®1,5

BRIVIACT® is a new molecular entity that was rationally designed and developed by UCB. Brivaracetam displays a high and selective affinity for synaptic vesicle protein 2A (SV2A) in the brain, which may contribute to the anticonvulsant effect. However, the precise mechanism of action by which BRIVIACT® exerts its anticonvulsant activity is not known. In the U.S. and European Union, BRIVIACT® is approved as adjunctive therapy (a therapy used together with primary treatment) in the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy. BRIVIACT® is available in three formulations (film-coated tablets, oral solution, and injection).

Source: UCB

01/19/2017

Flow MedTech Announces Vice President of Medical Affairs (VPMA)

Tue, 02 Jul 2019 19:47:01 GMT

DALLAS, TX — JANUARY 9, 2017 — Flow MedTech — Today Flow MedTech, Inc., an early-stage company developing an implantable medical device to prevent strokes in people with irregular heart rhythms, announces the appointment of Senthil Thambidorai, MD, FHRS, as Vice President of Medical Affairs.

Dr. Thambidorai completed a Cardiac Electrophysiology Fellowship at Cleveland Clinic in Ohio and a Cardiology Fellowship at the Creighton University-Department of Medicine in Nebraska. Dr. Thambidorai received his Doctor of Medicine, Bachelor of Medicine, Bachelor of Surgery from Kilpauk Medical College in India.

“With Dr. Thambidorai’s extensive training in left atrial appendage closures and experience with left atrial appendage closure devices, he is an incredible addition as well as a strong asset for our team,” said Arnab Chakraborty, Chief Product Officer and Chairman, Flow MedTech.

Dr. Thambidorai will lead Flow MedTech’s efforts by providing clinical input and vision during the research and development phase. He will also facilitate strategic partnerships to strengthen and further Flow MedTech’s position in the left atrial appendage closure market. His leadership to the Flow MedTech team will ensure the delivery of key objectives.

“We are thrilled to have Dr. Thambidorai join the Flow MedTech team. He brings a tremendous amount of perspective due to his experiences of implanting left atrial appendage closure devices in the Dallas/Fort Worth area,” said Christine Hang, Chief Executive Office, Flow MedTech. “It was important to us to bring someone on board who has the hands-on clinical experience to lead our medical affairs. Dr. Thambidorai will add profound value as we continue the development of Flow MedTech’s technology.”

Dr. Thambidorai will also continue his roles as the Regional Director of Electrophysiology for HCA North Texas, cardiologist and cardiac electrophysiologist in Fort Worth, TX, and a part of the academic core faculty for the Internal Medicine Residency Program at the University of North Texas in Fort Worth, TX. Dr. Thambidorai is a member of the American College of Cardiology and American Heart Association. He is the author of more than 13 peer-reviewed articles and more than 25 scientific presentations at national and international forums.

Source: Flow MedTech

01/09/2017

Athenahealth to Add 500 Jobs in Atlanta, Double Footprint

Tue, 02 Jul 2019 19:47:41 GMT

Healthcare tech company Athenahealth (Nasdaq: ATHN) will add about 500 jobs in Atlanta.

As part of the expansion, Athenahealth will double its office footprint, taking an additional 40,000 square feet at Ponce City Market in Atlanta's Old Fourth Ward, where it currently leases 98,000 square feet.

Athenahealth provides Internet-based electronic health records, practice management, and care coordination services to medical groups, hospitals and health systems. The company takes on non-core functions, such as claims processing, billing, patient communication and medical records management, allowing providers to focus on patient care.

Watertown, Mass.-based Athenahealth exceeded its projected employee growth rate by 40 percent in Atlanta, though it reportedly laid off 40 people in Atlanta in October 2016 due to restructuring efforts.

Athenahealth has already invested nearly $20 million in Georgia. It created 500 new jobs when it expanded into Georgia in June 2013.

Source: Atlanta Business Chronicle

01/04/2017

Zika Vaccine Developer Names New Chief Scientific Officer

Tue, 02 Jul 2019 19:48:48 GMT

A Smyrna-based developer of vaccines against Zika, Ebola, HIV and other infectious diseases has named a new chief scientific officer.

Farshad Guirakhoo was promoted to the C-suite role at GeoVax Labs Inc. from senior vice president of research and development, his title upon joining the company in 2015. The promotion was effective Jan. 1.

His predecessor as CSO, company co-founder Harriet L. Robinson, will remain as chief scientific officer emeritus, the company said in a statement.

"For the past year, Farshad has been a driving force behind the growth of our vaccine development pipeline, and we are pleased to expand his role at this critical time for our company," GeoVax President and CEO Robert T. McNallysaid in the statement. "In the role of Chief Scientific Officer, Dr. Guirakhoo will lead the scientific advancement of GeoVax's technology pipeline as the Company identifies and pursues new opportunities to address significant medical needs."

Robinson will continue to direct the company's HIV vaccine program and to serve as principal investigator on National Institutes of Health grants to GeoVax, McNally said. Robinson will also continue to serve as a member of the GeoVax Board of Directors.

Before joining GeoVax in 2015, Guirakhoo served in senior management and scientific roles with biotechnology companies included Vaxess Technologies, Hookipa Biotech, Sanofi Pasteur, Acambis Inc. and OraVax Inc. He earned his Ph.D. in virology at the Medical University of Vienna in Vienna, Austria, and he holds a M.Sc. degree in genetics and a B.Sc. degree in biology. His post-doctoral training included a stint at the Centers for Disease Control and Prevention'sDivision of Vector-Borne Infectious Diseases in Fort Collins, Colo. Guirakhoo has filed over 90 patent applications in his scientific career, according to the statement, and was instrumental in the development and commercialization of the Imojev Japanese encephalitis virus vaccine and the Dengvaxia vaccine for Dengue virus.

GeoVax Labs Inc., is a clinical-stage biotechnology company developing human vaccines against infectious diseases. Its development programs are focused on vaccines against HIV, Zika, and hemorrhagic fever viruses (Ebola, Sudan, Marburg, and Lassa).

In February 2016, The University of Georgia and GeoVax announced a collaboration to develop and test a possible Zika virus vaccine. Read more about GeoVax's work on an Ebola vaccine here and here.

Source: Atlanta Business Chronicle

01/03/2017

Excellence in Biotech Education Awarded at 2016 BIO International Convention

Tue, 02 Jul 2019 19:49:42 GMT

WASHINGTON--(BUSINESS WIRE)--The BioGENEius Challenges and Leadership Awards are organized by the Biotechnology Institute, a U.S. based organization dedicated to biotechnology education, and will be announced during the 2016 BIO International Convention, which is being held June 6-9 in San Francisco. Generous support from sponsors include Johnson & Johnson Innovation and the Biotechnology Innovation Organization.

The Biotechnology Institute recognizes that its important constituencies aren’t just students that will be the future leaders of biotechnology, like the BioGENEius Challenge participants, but also those teachers, mentors and learning ecosystems that shape students’ education, and with them, their future and the future of biotechnology.

The Biotechnology Institute formally recognizes those who expand our collective horizons of opportunity by inspiring the next generation of biotechnology innovators:

The BioGENEius Hall of Fame Award honoring past finalists with a track record of outstanding accomplishments
The BioGENEius Mentor Award honoring a STEM teacher or other significant influencer in the participating communities that serve the BioGENEius program
The BioSTEM Leader Award honoring an outstanding K-12 school for their promotion and support of biotechnology education

This year, the BioGENEius Hall of Fame Award, honoring past finalists with a pioneering spirit and determination to use biotechnology to make a difference in our lives was presented to Johnny Fells from New York. A past 2007-2009 BioGENEius finalist, Johnny just graduated from Columbia University with a B.S. in Industrial Engineering. He embodies the BioGENEius spirit by “giving back” - a BioGENEius who dedicates his free time to engage, excite and inspire young researchers in biotechnology by acting as a science fair judge, student mentor, inspirational speaker and personally granting special awards for students in less advantaged STEM educational environments.

The BioGENEius Mentor Award recognizes STEM teachers and members of the BioGENEius community for their impact on the future growth of the biotechnology industry through career development. This year’s awardee, Marc Pedersen from Paulding County High School in Dallas, Georgia exemplifies it best. Marc has been recognized at the national, state and local levels for his excellence as a teacher and “covers it all” at Paulding from biotechnology to biology, chemistry, environmental science and AP physics. As a career mentor, he focuses students to utilize technology to investigate real problems within their own community. The value of their original research is reflected in their achievements at the Georgia Science and Engineering Fair and nationally at events such as the Siemens Math, Science and Technology Competition. To his students, Marc is simply “the best teacher!”

The Institute’s BioSTEM Leader Award honors outstanding K-12 schools for supporting biotechnology learning and the BioGENEius community through their “bio” STEM programs. This year, the Institute recognized Abraham Lincoln High School, in San Francisco, CA for the excellence of its STEM education programs and the dedication of its administration in its support of Lincoln’s Biotechnology Academy founded in 1995. The Academy has grown to 180 participating students who successfully compete nationally and internationally at events such as iGEM before moving on to college and career opportunities in many of California’s biotechnology companies. An essential lesson at the Academy is learning both the promise and limitations of biotechnology in order to develop the best solutions to real world problems.

“The success of today’s STEM students, the future leaders of the biotechnology industry, rests on our ability to inspire, engage and promote their desire to realize the solutions that science can offer,” said Dr. Lawrence Mahan, President of Biotechnology Institute. “This year’s awardees are exceptional and we are delighted to honor them at BioGENEius during the 2016 BIO International Convention.”

For additional information about the 2016 Leadership Awardees, visit www.biotechinstitute.org.

About the Biotechnology Institute

The Biotechnology Institute is an independent, national non-profit organization dedicated to education about the present and future impact of biotechnology. Its mission is to engage, excite and educate the public, particularly students and teachers, about biotechnology and its immense potential for solving human health, food and environmental problems. For more information, visit www.biotechinstitute.org.

Contact

For the Biotechnology Institute
Alexia Sikora (202) 295-8788
alexia.sikora@harbourgrp.com

05/30/2016

News from Georgia Life Sciences

ArunA Bio Raises $13 Million in Common Stock Financing

Freenome Closes $160 Million Series B Financing to Advance Its Multiomics Blood Testing Platform for Early Cancer Detection

Contacts

CenExel Clinical Research Establishes Clinical Trial Centers Of Excellence Company

Sharecare names Quest Diagnostics its preferred laboratory partner to advance digital health management

Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection

New pharma boss: Next EU Commission should be clear on how to protect innovation

BIO Applauds Enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act

FDA’s Atlanta lab relocating from Midtown to Fort Mac

Georgia Bio to Deliver Life Science Teacher Training Program to Rural Georgia

Pfizer acquisition suggests more deals on the horizon

New BIO Chair Vows Crackdown on Biopharma’s “Bad Actors”

High School Student from Pennsylvania Receives Top Honor at International BioGENEius Challenge: Students from California and Georgia named runners-up

UGA startup gateway generates $531M in economic value

Celgene's Revlimid combo OK'd for certain lymphomas

ArunA Bio to Provide Corporate Update and Participate on a Panel at the 2019 BIO International Convention

-- Panel Discussion Will Highlight Impact of Exosomes as Therapeutics and Drug Delivery Vehicles --

FDA OKs extended use of Takeda's Gattex

Celgene's lenalidomide recommended by NICE for multiple myeloma

Multiple Myeloma

New Georgia Research Alliance report shows $6B economic impact

GeoVax Reports 2019 First Quarter Financial Results and Highlights Corporate Development Progress

Takeda promises more cost savings from Shire acquisition

New BIO Report: More Progress Needed in Innovation of Alzheimer’s Disease Therapeutics

J&J’s Ethicon to acquire Takeda’s TachoSil surgical patch for $400m

Novartis buys dry eye drug from Takeda for up to $5.3 billion

BLOCKBUSTER BOUND?

National Institutes of Health Awards Moonlight Therapeutics with a $2.5 Million Grant to Advance Development of Peanut Allergy Treatment

Funding to support company’s preclinical development of a breakthrough allergy treatment

Emory plans $475M cancer tower at Emory University Hospital Midtown

Skyhawk signs neuro deal with Takeda as it prepares to expand its partnered indications

Emory files plans for $1 billion Executive Park campus

Takeda Inks Licensing Option Agreement with Gene Editing Platform Developer Emendo

Augusta University Medical Center moving forward on $150M hospital, medical campus

Recro, Teva Extend License and Supply Agreement

CDMO Recro Gainesville will continue to supply Verapamil SR capsules through 2024

Georgia Bio CEO: Investment in life sciences has produced 14.9% growth in jobs

Boehringer Ingelheim, PureTech to Partner on Cancer Immunotherapies

Gwinnett Chamber Announces New President & CEO

House Bill Targets Looming $20 Billion Tax On MedTech Industry

Georgia Bio Names Westminster School Junior as Georgia BioGENEius Winner

FDA Approves EVENITY™ (romosozumab-aqqg) For The Treatment Of Osteoporosis In Postmenopausal Women At High Risk For Fracture

Alpharetta biopharma company names board member as interim CEO

Congressman Collins Honored as Innovator in Biotechnology

Congressman Collins pictured (center) with Jed Perry, Head, U.S. Public Affairs, UCB (left) and Joseph Santoro, VP of External Affairs, Georgia Bio (right).

Senator Isakson Honored as Innovator in Biotechnology

EMA accepts Takeda application for subcutaneous Entyvio

UCB's inflammatory arthritis drug gains FDA approval

MiRus receives FDA Approval for First Medical Implant with New Superalloy- MoRe®

Related Links

Alcon announces $285M acquisition of PowerVision

ArunA Bio Appoints Al Medwar as Executive Vice President, Corporate and Commercial Development

Takeda receives U.S. FDA Approval to Manufacture FLEXBUMIN® at New Plasma Manufacturing Facility near Covington, Georgia

CSI Laboratories Begins Offering VENTANA PD-L1 (SP142) Assay as Companion Diagnostic Test for Triple Negative Breast Cancer as a Result of FDA Approval for TENCENTRIQ® (atezolizumab)

Advantage Capital Invests $6.5 Million in Danimer Scientific, Supporting Company’s Growth in Rural Georgia

BIO Statement on President’s Proposed 2020 Budget

Emory Technology Transfer presents 13th Celebration of Technology & Innovation

Senate Moves to Stop $20 Billion Tax Increase on MedTech Industry

GeoVax and Leidos Expand Collaboration to Malaria Vaccines

Georgia Research Alliance 'at a pivot point,' refocusing for the future

An inside look at the policy issues Georgia Bio is tackling in 2019

Statement re ECO Animal Health and University of Georgia sign second poultry vaccine development licencing deal

Animal Health company pledges $120M Georgia investment, 225 new jobs

Georgia Bio Names Maria Thacker-Goethe President and CEO

Boehringer Ingelheim Animal Health USA promotes CFO to president

BIO Statement on New Proposal for Lowering Out-of-Pocket Costs for Medicines

GeoVax Zika Vaccine Study Published in the Atlas of Science

Georgia Bio to Celebrate 30 Years at Annual Awards Dinner

Georgia Bio Bolsters Policy Resources Naming Joseph Santoro New VP of Business Development and External Affairs

Georgia bio company names new CEO

Deal: BioIQ to locate headquarters in Cobb County

Diversity in Clinical Trials: Preparing Physicians to Make a Difference

GeoVax and Enesi Pharma to Collaborate on Development of Multiple Vaccines Administered by ImplaVax(R), a Novel Needle-Free Vaccine Delivery Platform

The right way to address prescription drug costs

Avanos Medical, Inc. Appoints David Ball as Senior Vice President, Global Supply Chain & Procurement

Avanos Among Winners of FDA's Opioid Innovation Challenge

BIO Applauds Bipartisan 2018 Farm Bill

AdvaMed Statement on Medical Device Tax Moratorium

MiMedx Announces Organizational Realignment Program