REMS

Business briefs: GlaxoSmithKline, Adverse Event reporting, Elan

GSK's Avandia woes continue, study finds a new way to identify adverse events, and Royalty ups its bid for Elan.

FDA opioid plan directs funding for CME

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The FDA's opioid REMS safety plan is challenged on two fronts: getting CME providers to offer courses and getting doctors to attend them. Can the agency's scheme educate enough physicians to curb an epidemic?

Company news: REMS for Purdue, Pfizer and Janssen painkillers

A potentially dangerous and oft-abused class of painkillers will be required to have REMS risk management programs in place under an FDA edict covering all extended release and long-acting opioid analgesics, a category covering 30 drugs manufactured by 20 companies.

Humira on solid ground, analysts say, despite vote on Pfizer hopeful

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The general consensus surrounding the FDA advisory panel's 8-2 vote in favor of Pfizer's rheumatoid arthritis hopeful tofacitinib yesterday was that Abbott's Humira doesn't have to watch its back.

FDA approves BMS skin cancer biologic Yervoy

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The FDA approved Bristol-Myers Squibb's cancer biologic Yervoy (ipilimumab) for the treatment of late-stage melanoma, a particularly deadly form of skin cancer for which treatment options are few. One analyst projected that sales of the drug could top $1.7 billion by 2015.

Covidien launches opioid patient safety alliance

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Covidien launched a patient safety organization - the Collaborating & Acting Responsibly to Ensure Safety (CARES) Alliance - today, featuring tools and resources for patients, physicians and pharmacists.

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