Legal/Regulatory

Regeneron's Eylea scores Breakthrough label

The designation is for diabetic retinopathy for patients with diabetic macular edema.

NY sues over Forest Alzheimer's medication

NY's attorney general alleges that a formulation switch is an attempt to create monopoly.

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.

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