Legal/Regulatory

US Treasury takes action on tax inversions

US Treasury takes action on tax inversions

The Treasury announced Monday it would eliminate certain techniques companies use to facilitate so-called tax inversions, which a number of drug companies have undertaken in the past six months.

Five things for pharma marketers to know: Tuesday, September 23

Five things for pharma marketers to know: Tuesday, September 23

Treasury Department takes action against corporate tax inversions; CDC pegs Ebola worst case scenario at 1.4 million infected by new year; NIH allocates $10 million in grants to increase female clinical trials.

OPDP slams cholesterol drug's e-mail claims

OPDP slams cholesterol drug's e-mail claims

The Office of Prescription Drug Promotion took aim at Cipher Pharmaceuticals and its marketer Kowa, in an Untitled Letter over an e-mail alert making what it said were unsubstantiated assertions.

FDA panel votes against taking drugs for "low-T"

FDA panel votes against taking drugs for "low-T"

An FDA advisory panel voted overwhelmingly against the use of testosterone-replacement drugs for "low-T" Wednesday, saying the label should narrow and that more safety information is needed.

Five things for pharma marketers to know: Thursday, September 18

Five things for pharma marketers to know: Thursday, September 18

FDA panel votes overwhelmingly against Low-T drugs; Stenda approved for fast-acting ED treatment; and Bayer hones life-sci focus, spins off material sciences business.

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."

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