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Exploring New Solutions For Neglected Diseases in Developing Countries

SBIR Reauthorization Moves Forward

On Tuesday, BIO Ventures for Global Health (BVGH) announced the completion of the 30th research agreement as part of its partnership with the World Intellectual Property Organization (WIPO) to better enable drug companies to assist researchers in addressing infectious diseases worldwide. The partnership aims to accelerate development of drugs, diagnostics and vaccines for more than 1.5 billion people suffering from malaria, tuberculosis, and other neglected tropical diseases including dengue in developing nations. A recent publication in Read More >

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CTTI: Use of Central IRBs in Multi-Center Trials to Streamline Clinical Research

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Multi-center clinical trials can provide high-quality, statistically-sound evidence to answer medical questions. Earlier this year, the Clinical Trials Transformation Initiative (CTTI) launched a new tool and provided recommendations to improve the efficiency and quality of multi-center clinical trials. Typically, each participating center submits the study protocol to its institutional review board (IRB). Thus in a multi-center trial, the same protocol is submitted to as many IRBs as there are sites. The process of multiple reviews Read More >

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New PhRMA Report: Nearly 300 Vaccines Currently in Development

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Today, the Pharmaceutical Research and Manufacturers of America released a report, Medicines in Development: Vaccines – A Report on the Prevention and Treatment of Disease Through Vaccines. The report shows that U.S. biopharma companies are currently developing 271 vaccines to prevent and treat numerous conditions, including infectious diseases and various forms of cancer and neurological disorders. Vaccines have successfully prevented devastating infectious diseases such as smallpox, measles and polio. According to data from the Centers Read More >

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NCATS R&D Day Aimed At Linking Investors to Preclinical Drug Development Projects

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On behalf of the National Center for Advancing Translational Sciences (NCATS), I invite BIO stakeholders to join us for our inaugural “Research & Development Day” September 12 in Cambridge, Mass. Novartis Institutes for Biomedical Research will host the event at which researchers will showcase therapeutic candidates for indications such as sickle cell disease, hereditary inclusion body myopathy, Duchenne muscular dystrophy and cryptococcal meningitis to potential partners. To register and view the agenda, visit https://events-support.com/events/NCATS_RandD_Day. The Read More >

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New FDA Final Guidance on Clinical Trial Institutional Review Boards

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On Tuesday, August 27th, the FDA finalized its Guidance for Institutional Review Boards, Clinical Investigators and Sponsors on Institutional Review Board Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an Investigational New Drug/Investigational Device Exemption is Needed.  In an article published earlier today, the Pink Sheet’s Sarah Karlin summarized the goals of this guidance as strengthening human subject protection during clinical research and increasing the efficiency of Read More >

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