Lawmakers float generic drug legislation

The bill proposes fining branded drugmakers for not complying.

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


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


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


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


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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