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Overseas
Drugs Hit U.S. Regulatory Snags
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March
26, 2008--Several new drugs that
have entered the European market within the past two years have yet to
obtain approval from the US FDA. These products include Novartis’
diabetes drug Galvus (vildagliptin);
Sanofi-Aventis’ obesity drug rimonabant (known in Europe as Acomplia);
and GlaxoSmithKline’s cervical-cancer vaccine Cervarix. Novartis, which
submitted Galvus in both the US and Europe in 2006, may drop its bid to
market Galvus in the US; the FDA has twice postponed deciding on the drug.
The
Wall Street Journal (Subscription required)
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Genstruct: Patience, Persistence, and Payoff
By John Russell |
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Finding the right business model for systems biology (SB) technology providers has been challenging — that’s hardly a new theme in biotech.
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