Tag Archives: Food and Drug Administration

Legislative Hopes, Fears

PNNL Research Scientist Heather Brown

Biotechnology advances are poised now more than ever to help policymakers achieve their goals of supporting innovation in health care, renewable energy, and green technologies. How can they help us? Here are our six hopes (and one big concern) for the term ahead. HOPE 1: Cultivate an atmosphere for patient access to our products While the Congress considers finding savings, do it in a way that does not threaten patient access to drug products by Read More >

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Approving Drugs for Alzheimer’s Disease

Russ Katz

BIOtechNOW delves into the current state of Alzheimer’s disease research with today’s feature on regulatory challenges. Tomorrow, we cover the first Alzheimer’s prevention trial, and on Wednesday, we will explore the societal and economic impact of this devastating disease. The therapies currently approved for Alzheimer’s disease work by treating the patients’ symptoms, improving their cognitive and overall functions. Increasingly, however, experts are intent on slowing or halting the disease process—before it has ravaged patients’ brains. In February, the U.S. Food Read More >

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Orphan Drugs: Making Rare Diseases Rarer

Panel

A panel at the BIO CEO & Investor Conference provided an analysis of the thriving orphan drug market opportunity featuring industry, clinical and regulatory experts specializing in rare diseases. The signing of FDASIA by President Obama in July reinforces the country’s commitment to fostering innovation for rare diseases. With a record 460 medicines in late-stage clinical trials, biopharmaceutical companies have embraced rare disease medicine and are rapidly developing the pipeline with hopes of achieving the Read More >

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Simpson Bowles Keynote to Address Debt, Taxes, Government Services and Politics

Jim Greenwood

I was recently asked what the single biggest threat to the biotechnology industry is today.  My answer was immediate – the biggest threat to biotech innovation is the unsustainable mismatch of spending and revenue in the U.S. federal budget. The enormous national debt and the huge annual budget deficits that feed it endanger America’s entire economic future – but the nation’s dire fiscal situation is particularly threatening to our industry. Part of the reason for Read More >

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FDASIA: A Step Forward for Patients

fdasia-panel

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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