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Renewing the Project BioShield Act: What Has It Bought and Wrought?

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In the next several months, the U.S. Government will decide whether to continue the funding and authorities associated with Project BioShield, which expanded the U.S. stockpile of medical countermeasures (MCMs) for potential chemical, biological, radiological and nuclear (CBRN) attacks. Congress established Project BioShield in 2004 and provided $5.68B for procurement over 10 years. Two years later, it created the Biomedical Advanced Research and Development Authority (BARDA) to oversee BioShield’s advanced development and procurement efforts. To Read More >

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CDC Addresses Flu Vaccine Shortage

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Did you get your flu shot this year? With 48 states reporting widespread influenza activity, flu season has come on fast and strong. As of the second week in January, according to data released by the Center for Disease Control (CDC), 29 children have died and 5,249 Americans have been hospitalized for flu-associated conditions. What’s been most worrisome, GEN’s Alex Philippidis writes, is that there have been spot shortages of the vaccine despite manufacturers producing 145 Read More >

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FDASIA: A Step Forward for Patients

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Earlier this year, Congress passed and President Obama signed the FDA Safety and Innovation Act (FDASIA) which included a re-authorization of the Prescription Drug User Fee Act (PDUFA). PDUFA provides essential funding to the FDA by authorizing the agency to charge user fees to companies seeking to have products reviewed. Originally enacted in 1992, it must be reauthorized every 5 years. Sara Radcliffe, executive vice president of health at BIO, moderated a panel of experts and advocates Read More >

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Delivering on the Promise of Personalized Medicine

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As sequencing moves out of the lab and into the clinic, a host of players must get involved to make our collective promises of personalized medicine a reality. CEOs, entrepreneurs, researchers, clinicians, regulators and payers need to work together to take on the next challenges in the implementation of personalized medicine. Some of those challenges include: Cost vs. Benefit: How do we define and benefit from transformational technologies? Form vs. Function: What about the less Read More >

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The Future of Biodefense: Will Public-Private Partnerships Continue?

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Ten years ago, in the wake of the 2001 anthrax attacks, the U.S. government set out on a bold path to improve the country’s preparedness for bioterrorism by developing and stockpiling new drugs and vaccines to protect Americans from health emergencies.  Individuals from both political parties – many who had experienced bioterror first hand – worked together to harness the power of innovative science and tackle this national security threat. The ten year initiative was Read More >

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