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A joint FDA advisory committee wіƖƖ meet here Friday tο consider whether tһе narcolepsy drug sodium oxybate (Xyrem) ѕһουƖԁ receive аח additional indication tο treat fibromyalgia. Sodium oxybate, currently approved аt a 500 mg/ml dose fοr narcolepsy-associated cataplexy аחԁ excessive daytime sleepiness, іѕ a central nervous system depressant аחԁ carries a boxed warning against іtѕ υѕе іח amalgamation wіtһ additional similar drugs.

Late-stage results presented Tuesday at the European Society of Cardiology Congress demonstrated that Bristol-Myers Squibb and Pfizer's apixaban reduced the risk of stroke in patients with atrial fibrillation by more than half compared with aspirin. Lead trial investigator, Stuart Connolly, called the data "truly impressive," adding that the results leave "no competition for apixaban in the foreseeable future" for patients that are unsuited to treatment with warfarin.

GlaxoSmithKline and partner Valeant Pharmaceuticals International have suffered a slight setback with the news that regulators in the USA need another three months to evaluate new data, and decide on final approval, of the firms' new epilepsy treatment Potiga.

Biotechnology company Genzyme Corp. said Monday it rejected Sanofi-Aventis SA's $18.5 billion buyout offer because it undervalues the company. On Sunday, French drug developer Sanofi-Aventis ( SNY - news - people ) offered $69 per share for Genzyme ( GENZ - news - people ), which has been struggling in the aftermath of manufacturing problems for key drugs.

(Reuters) - The U.S. Food and Drug Administration has released its latest list of possible drug safety concerns, citing Roche's breast cancer drug Herceptin and Sanofi Aventis' heart drug Multaq, among others.