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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
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. 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."
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."
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.
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.”
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.
Shire Receives U.S. FDA Approval for New State-of-the-Art Plasma Manufacturing Facility Near Covington, Georgia
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.”
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.
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.
Cambium Enrolls First Patient in Phase I/II Study to Evaluate Platelet Lysate Biologic for Graft-vs.-Host Disease Dry Eye
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.
SLAS DISCOVERY Publishes Ground-Breakig New Article – “Clinical Trials in a Dish: A Perspective on the Coming Revolution in Drug Development”
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.”
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