Topic:

Regulatory

Latest Headlines

Latest Headlines

FDA approves Sanofi's Menactra as meningococcal booster

The new nod could boost sales of the French drugmaker's vaccine, a lift it could use after Menactra's top-line haul in 2013 sank to €424 million in a 21.5% slide.

Takeda on track for dengue vaccine nods in 2017-18

Sanofi's dengue vaccine isn't slated to hit the market until late next year, pending approval, but it already has some competition on the horizon. Takeda has its eye on nods in the U.S. and Europe for its own candidate by the 2017-18 fiscal year, it says.

FDA fight with compounder tests its patience and its limits

For nearly two years, the FDA and a Texas compounder have been sparring over whether its products are safe and whether it will bend to the pressure the agency is exerting. The FDA sent a warning on Tuesday saying that the company cannot affirm its products are safe and that providers were taking a chance by using them.

UPDATED: Orexigen nabs long-awaited FDA approval for obesity drug Contrave

More than three long years after Orexigen was turned back at the FDA and forced to do a costly late-stage safety study of its weight drug Contrave, the agency has come back and given its seal of marketing approval to the drug.

Med tech M&A beware: Top Senate Democrats reveal plan to crack down on inversions

Amid growing action from U.S. lawmakers to curb corporate inversions, top Senate Democrats revealed a plan to rein in the deals that would allow med tech companies to shift their domiciles abroad for tax-paying purposes.

ACLA head makes case against FDA LDT regulation to Congress

Alan Mertz, president of the American Clinical Laboratory Association, ripped into the FDA's proposal to regulate lab-developed tests yesterday in testimony to Congress during a hearing of the 21st Century Cures initative. 

NPS jumps as FDA reviewers take little issue with orphan drug

NPS Pharma is moving toward FDA approval with its treatment for a rare disease, as agency staff applauded the drug's efficacy ahead of a make-or-break panel vote.

Attention market-access experts: NICE won't take pharma's word on cost-effectiveness anymore

Pharma companies devote a lot of resources to winning over the U.K.'s drug price watchdog, the National Institute for Health and Care Excellence (NICE). Now, NICE says it will start looking beyond pharma companies for data, to get a more complete picture of whether new drugs are really worth their high costs.

FDA panel spurns Actavis' cardio combo, jeopardizing its potential

A group of FDA advisers voted against recommending approval for a new combination blood-pressure treatment from Actavis, clouding the future of a prospect the company picked up in its $28 billion buyout of Forest Laboratories.

Low T products under FDA scrutiny over safety concerns

"Low T" products are characterized by a variety of different drug delivery technologies and mechanisms. In May, the FDA approved the first nasal gel for low testosterone. And in March, the agency finally approved Aveed as an injection given once to begin therapy, once four weeks later, and every 10 weeks after that.