Tag Archives: United States

Prix Galien Push for Private/Public Collaboration

Preceding the presentation of the 2009 Prix Galien USA prizes, last Tuesday, a round table discussion was conducted at the American Museum of Natural History on the subject of how public and private collaboration can increase innovation and contribute to saving lives around the world. The talk included Leonard Bell of Alexion Pharmaceuticals, Barry Bloom […]
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FDA Readies More Warning Letters, Fast Enforcement Action

Image by Getty Images via Daylife FDA officials have been promising stiffer enforcement of manufacturing and marketing requirements for several months, and commissioner Margaret Hamburg is moving full-speed ahead to fulfill those predictions. Last month, FDA announced it will issue warning letters quickly when it finds violations and will require manufacturers to respond promptly. Too […]
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Tauzin to Boehner: Don’t “Bully” Me

Image via Wikipedia PhRMA chief Billy Tauzin so far shows no sign of waving the white flag in response to an accusatory missive from House Minority Leader Rep. John Boehner bludgeoning his former Republican colleague for leading the drug industry’s support of President Obama’s healthcare reform effort. Pointedly CC’d to pharma CEOs – Tauzin’s employers—and […]
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GSK Signs $120M Deal to Market DMab Overseas

Image via Wikipedia In an effort to boost its sales force without hiring more sales reps, Amgen announced on Tuesday that it has signed a deal with GlaxoSmithKline to co-market its osteoporosis treatment denosumab—currently pending FDA approval. GSK will paying $120 million up front (along with royalties) to mutually market denosumab, or DMab, in regions […]
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Hamburg Shifts Boxes at FDA

Image via Wikipedia Typical of new administrations, FDA commissioner Margaret Hamburg is moving around some staff functions and bringing in new faces, but holding off on major reorganizational changes at the agency. There will be a new “food czar”—a deputy commissioner of food—but not a comparable official in charge of drugs, biologics and medical devices. […]
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