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Tag Archives: FDA
What OxyContin Tells Us About the Value of “Evergreening” and Patents
A few weeks ago, the FDA announced that they would not allow generic versions of older versions of OxyContin. The original formulation of OxyContin goes off patent today. The original formulation did not have “tamper-resistant qualities” that prevent people from “crushing, breaking, and dissolution using a variety of tools and solvents.” The article reports that the decision will keep Teva Pharmaceuticals and Impax Laboratories from making the older version which the FDA has determined is too dangerous Read More >
Legislative Hopes, Fears
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 >
Approving Drugs for Alzheimer’s Disease
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 >
Orphan Drugs: Making Rare Diseases Rarer
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 >
Simpson Bowles Keynote to Address Debt, Taxes, Government Services and Politics
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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Tags: 2013 BIO International Convention, BIO Events, BIO International Convention, budget deficit, debt ceiling, Events, FDA, federal budget, finance policy, Food and Drug Administration, Health Care, Medicaid, medicare, National Institutes of Health, NIH, simpson-bowles
Tags: 2013 BIO International Convention, BIO Events, BIO International Convention, budget deficit, debt ceiling, Events, FDA, federal budget, finance policy, Food and Drug Administration, Health Care, Medicaid, medicare, National Institutes of Health, NIH, simpson-bowles
