Theravance may have to conduct another clinical trial to gain the nosocomial pneumonia indication for Vibativ (telavancin), which FDA approved for complicated skin and skin structure infections Sept. 11, 2009.
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Spurred by backing of physician opinion leaders, sales grow quickly ahead of first-line filing, which is expected in the second half of 2010.
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In an effort to maintain the leadership position of Enbrel in the psoriasis market amid fierce competition, Amgen has entered into a co-promotion agreement with GlaxoSmithKline under which GSK's Stiefel unit will promote the anti-tumor necrosis factor inhibitor to U.S. dermatologists.
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While acknowledging his "share of the blame" that reform hasn't been completed and expressing openness to any "better approaches," the president also urges: "Let's finish the job." Obama also wants to move forward on a deficit reduction commission.
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Gilead Sciences hopes to begin Phase III studies this year for its HIV “quad” pill – a fixed-dose combination containing two marketed and two experimental proprietary antiviral compounds, the company notes in its fourth-quarter sales and earnings report. Positive Phase II data for the quad pill and one of the compounds included in the quad will be unveiled next month at the Conference on Retroviruses and Opportunistic Infections.
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Novartis announces that Joe Jimenez, currently head of its pharma business, will become the CEO effective Feb. 1.
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Insurance coverage was an "obstacle to launch," for Rapaflo and Gelnique, but the outlook is much better for 2010, says Watson.
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