Tag Archives: FDA

Biosimilars at the Federal Circuit – Can the Parties Be Compelled to Dance?

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In 2009, Congress passed the Biologics Price Competition and Innovation Act (“BPCIA”), which for the first time provided for biosimilar or interchangeable biological drug products.  But it was not until March 6, 2015, that the FDA approved the first biosimilar application – an application by Sandoz to market a version of Amgen’s NEUPOGEN® (filgrastrim) biologic drug product.  Nevertheless, there is still a question as to when Sandoz will be able to begin selling its drug product, Read More >

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New PhRMA Report: A Decade of Innovation in Rare Diseases

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Today, the Pharmaceutical Research and Manufacturers of America (PhRMA) released “A Decade of Innovation in Rare Diseases,” which highlights 10 years of progress in understanding rare diseases and drug development resulting in groundbreaking therapies. According to the report, more than 230 new medicines to treat rare or “orphan” diseases were approved by the U.S. Food and Drug Administration (FDA) in the last decade, and there are currently more than 450 orphan drugs in development. The Read More >

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The Administration Focuses on Improving Food Safety

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The Obama administration wants to establish a new agency that would be housed within the Department of Health and Human Services and serve as the primary voice on food safety standards and compliance with those standards. The Agency would be named the Food Safety Administration, the Obama administration said in its new budget request. The New York Times covered the story here: …At least 15 government agencies — from the Environmental Protection Agency to the National Oceanic and Atmospheric Administration — have Read More >

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How Industry Rates Interactions with the FDA

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Kicking off day one of the BIO CEO & Investor Conference in New York City, panelists in the ‘How Industry Rates Interactions with the FDA’ session brought attendees good news – communication with the FDA has improved overall. “The improvements we have seen in increased communications between FDA and sponsors is based on a continuous dialogue that has been established over the past several years in which BIO has been at the forefront,” said Jonathan Read More >

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Survey Shows Americans Support Labeling Foods Containing DNA

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A recent survey by the Oklahoma State University Department of Agricultural Economics finds that over 80 percent of Americans support “mandatory labels on foods containing DNA,” about the same number as support mandatory labeling of GMO foods “produced with genetic engineering.” Washington Post reported on the survey:   If the government does impose mandatory labeling on foods containing DNA, perhaps the label might look something like this: WARNING: This product contains deoxyribonucleic acid (DNA). The Surgeon General has Read More >

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