Topic:

Regulatory

Latest Headlines

Latest Headlines

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.

NICE to bypass drugmakers in search of data to support pricey drugs

The U.K.'s drug price watchdog, the National Institute for Health and Care Excellence, says that from now on, NICE will request clinical trial data directly from European regulatory authorities whenever it feels a company isn't providing adequate information to make sound coverage decisions, according to a statement.

Lilly and Boehringer snag EU nod for Lantus knockoff, but stateside hopes stay on ice

Eli Lilly and Boehringer Ingelheim won European clearance for their biosimilar of Lantus, Sanofi's top-selling insulin product, but the treatment's full potential remains hamstrung by a U.S. patent challenge.

Boston Scientific dealt $73M blow in vaginal mesh case

Boston Scientific was dealt a crushing blow in its vaginal mesh saga, as a Texas state jury ordered the devicemaker to pay $73 million to a woman who claimed chronic pain and injury from the company's vaginal mesh implant.

Free speech, PhRMA? Not in this off-label marketing case, feds say

The pharma industry's free speech stand in a whistleblower lawsuit against Millennium Pharmaceuticals? Not so fast, says the Department of Justice. The First Amendment doesn't protect speech that spawns illegal conduct, federal prosecutors say in their own brief in the case.