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New BIO Survey on Effective FDA – Sponsor Communication During Drug Development

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BIO is surveying members on their interactions with the FDA during the various stages of drug development prior to submitting an NDA/BLA. The survey can be accessed here. In an increasingly competitive and fiscally-constrained environment, it is more important than ever for all stakeholders to work together to promote effective R&D for innovative medicines. This initial survey is designed to assist in the implementation of the Prescription Drug User Fee Act (PDUFA V) program on Read More >

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Ellmers’ Cancer Bill Marks 100 Co-Sponsors

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Today, Congresswoman Ellmers announced that 100 bipartisan cosponsors have signed on to support her bill – The Cancer Patients Protection Act of 2013 (H.R. 1416). The bill aims to ‘protect cancer patients from the harmful effects of the misallocated sequestration cuts.’  The bill also protects patients suffering from other diseases too.  In a statement from the Congresswoman, she points out that the focus of sequestration is to reduce spending, but treating patients in hospitals is Read More >

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Unraveling the Mystery of Alzheimer’s Disease

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Preeminent researchers from around the world gathered recently to tackle the science behind one of medicine’s toughest problems – Alzheimer’s – and elevating the disease as a top global priority. The Global CEO Initiative on Alzheimer’s Disease (CEOi) – a coalition of corporations from the fields of biotechnology, pharmaceuticals, diagnostics, finance, and healthcare – hosted a dinner during the Alzheimer’s Association International Convention (AAIC) in Boston. The CEOi had already taken strides to achieve this Read More >

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Separating Science from Fiction

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The Atlantic recently published a story on the dangers of anti-vaccine rhetoric, “Destabilizing the Jenny McCarthy Public-Health Industrial Complex.” The article describes the hysteria around the alleged link between autism and vaccines, which has since been scientifically discredited. The public campaign created fear among parents, some of whom chose not to vaccinate their children. As the author states, “Anti-vaccinators risk not only the lives of their own children, but also those of others who are Read More >

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Sen. Grassley Raises Concerns over 340B Program

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In a memo written this week, Sen. Chuck Grassley (R-IA) responded to a recent Kaiser Health News report by asking whether 340B-eligible hospitals are ‘doing everything possible to help uninsured patients receive health care, including affordable prescription drugs.’ 340B is an important safety net program designed to help uninsured indigent patients gain greater access to prescription medicines.  While there remains a need for this safety net program, there are emerging concerns about the program in Read More >

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