Legal/Regulatory

AbbVie ceded generic Tricor to protect AndroGel: FTC suit

AbbVie ceded generic Tricor to protect AndroGel: FTC suit

The FTC is suing AbbVie and two other firms in a pay-for-delay case that could have wider implications for pharma

FDA sanctions don't kill a business

Bloomberg reports that India's Wockhardt has become an M&A target.

FDA lifts OncoMed partial hold

The FDA froze the clinical trial of anti-Fzd7 vantictumab in July over concern about "bone-related adverse events."

GSK Ellipta franchise expands

GSK Ellipta franchise expands

The FDA has approved Arnuity Ellipta for asthma.

India's Marck gets FDA Warning Letter

Inspectors of Marck Biosciences found an array of problems during a October-November 2013 inspection, including mold near a sterile area that was so bad "the room had 'partially caved in.'"

Doctors back unique biosimilar names

A host of doctors has asked FDA Commissioner Margaret Hamburg to back a naming convention that would require biologics and biosimilars to have different names.

Roche has no rights to Sovaldi, panel rules

Despite a collaboration with original Sovaldi owner Pharmasset in 2004, a panel ruled Roche has no rights to HCV treatment Sovaldi.

Eisai sues FDA for more patent life

The Japanese drugmaker is looking to add as much as a year onto the patent life of some of its drugs after the DEA dragged out their scheduling decisions.

FDA wants more info on Acura pain drug

FDA wants more info on Acura pain drug

FDA feedback will influence a new clinical trial design, but the regulator's recent reaction was a bit of a surprise.

Five things for pharma marketers to know: Friday, August 15

Five things for pharma marketers to know: Friday, August 15

UK drug-cost watchdog backs Sovaldi, Achillion touts HCV interim results, Avastin's latest cancer indication, Ebola outbreak worsens, COPD drug gets panel nod, and study links quick reviews and black-box warnings.

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