The FDA has sent Watson Pharmaceutical (NYSE:WPI) a complete response letter which elaborate its concerns over the company’s progesterone vaginal gel, which is designed to reduce the risk of preterm births. In an announcement confirming that it received the letter, Watson explained that the FDA found that the treatment doesn’t meet the level of statistical significance sufficient to support the approval of a product from a single trial.
In a statement released Monday, BioSante Pharmaceuticals’ (NASDAQ:BPAX) says that a clinical study of its Pancreas cancer vaccine shows positive results, indicating that the treatment increases the median survival rate for patients.
Investing Insights: Vitamin Shoppe Inc. Earnings: Beats Estimates.
An FDA advisory panel on Thursday recommended approval of Chelsea Therapeutics’ (NASDAQ:CHTP) Northera drug for treatment of symptomatic neurogenic orthostatic hypotension in patients with primary autonomic failure, such as Parkinson’s disease. Accordingly, Chelsea shares soar after the announcement.
Dendreon’s (NASDAQ:DNDN) guidance for a first quarter sales slump is probably what is causing shares to drop, even though the company beat fourth quarter estimates. The fall was not prevented by the fact that Street estimates had already forecast a sales drop
Canadian drug maker Valeant (NYSE:VRX) posts fourth quarter earnings per share of $0.18 vs. a loss of $0.10 a year earlier, and its adjusted earnings per share of $0.94 exceeds consensus. Acquisitions and better sales of key dermatology products are cited by the company as key to its revenue rising 34 percent, and it also supports earlier guidance for 2012 earnings per share of $3.95-$4.20.
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