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Biotech / Medical : Theravance - THRX

THRX 9.810

+0.4%

Jan 8 4:00 PM EST

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From: tnsaf	1/10/2008 12:40:53 PM
	of 74

FDA Sets Meeting for Theravance Drug Thursday January 10, 11:35 am ET FDA Experts Will Review Theravance's Skin Infection Antibiotic at February Meeting WASHINGTON (AP) -- A panel of government experts will meet in late February to review Theravance Inc.'s antibiotic to treat skin infections caused by "superbug" bacteria. The Food and Drug Administration said its panel of antibiotic experts will meet Feb. 27 to consider approval of telavancin, which has already been delayed once by regulators. In October, Theravance received a letter from the FDA requesting additional information before it would consider approving the injectable drug. The letter asked Theravance to submit revised labeling for the drug and reanalyzed or updated patient data. Regulators also raised questions about manufacturing practices at a third-party facility where the drug would be produced. South San Francisco-based Theravance told investors late last month that the FDA would likely hold a panel meeting to review its drug. The agency only calls in its outside panelists when its own scientists have lingering questions about a drug's safety or effectiveness. Shares of the company fell to a two-year low after the announcement on speculation that the drug's chances for approval could be lower than originally thought. However, at least one analyst pointed out that new regulations require the FDA to hold a panel meeting on every first-of-a-kind drug it reviews. Theravance developed telavancin in cooperation with Japanese drug maker Astellas Pharma. Shares of Theravance Inc. rose 18 cents Thursday to $20.68 in morning trading.

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