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Alpharetta biopharmaceutical company names GC & chief compliance officer


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.

The Georgia Research Alliance Names Russell Allen as President and CEO


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.

GeoVax Comments on Recent Vaccine Development Study Funded by the Gates Foundation


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.

NIH $3M Grant Will Enable Emory, Georgia Tech Researchers to Tackle Sickle Cell Disease with New Technologies


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.

Wright to absorb Cartiva and its arthritis cartilage implant in $435M deal


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.

GeoVax and PharmaJet to Collaborate on Development of Needle-Free Vaccine for Zika Virus


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 Announces Appointment of David Dodd as Chairman, President and Chief Executive Officer


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.”

Clinical Research Pathways Organization Unveils New Patients' Guide to Clinical Trials and Expanded Access


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.

Celtaxsys Announces Results of Phase 2 Trial Showing Clinically Meaningful Improvement in Pulmonary Exacerbations in Cystic Fibrosis Patients


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.”

GeoVax and Emory University to Collaborate on HPV Therapeutic Program for Head and Neck Cancers


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.

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