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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.

Sanofi-aventis on Sunday made public its proposal to acquire Genzyme in a cash transaction valued at approximately $18.5 billion. The non-binding offer, initially submitted on July 29, was reiterated in a letter to Genzyme CEO Henri Termeer "after several unsuccessful attempts to engage Genzyme’s management in discussions.

Last Friday, members of the FDA's Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee overwhelmingly voted (20 to 2) against approving sodium oxybate (brand name Xyrem) for the treatment of fibromyalgia. While most of the panel members agreed that the drug was effective for some FM patients, their concerns centered around its safety. Sodium oxybate, also known as gamma-hydroxybutyrate (GHB) is known to have been used as a date rape drug.

Research published Tuesday in Circulation: Cardiovascular Quality and Outcomes identified no significant difference in the risk of death or cardiovascular events among patients taking GlaxoSmithKline's Avandia (rosiglitazone) or Takeda's Actos (pioglitazone). In this analysis, approximately 4 percent of patients taking either drug suffered a heart attack, heart failure, both or died over a 33-month period.

We wrote below about an unusual back-and-forth between advisory committee member Sid Wolfe and FDA Division Director Bob Rappaport over the relevance of a criminal case involving the marketing of Jazz Pharmaceuticals’ sodium oxybate to the discussion of a potential new indication.

Five days before a 2007 article in the New England Journal of Medicine showed that the diabetes drug Avandia was linked to a 43% increase in heart attacks compared with other medications or placebos, a group of scientists and executives from the drug's maker, GlaxoSmithKline (GSK), gathered in a conference room at the offices of the Food and Drug Administration in White Oak, Md. The GSK goal: to convince regulators that the evidence that the company's $3 billion-a-year blockbuster drug caused heart problems was inconclusive.

New drugs for hepatitis C and superhigh cholesterol  succeeded in late-stage clinical trials, the developers of the products announced on Wednesday. But both drugs have side effects that could dampen sales, analysts said.

Merck said that its drug boceprevir, when added to the existing therapy, effectively cured about two-thirds of patients with hepatitis C. That was far better than the cure rate with the existing therapy alone.