Topic:

Regulatory

Latest Headlines

Latest Headlines

EMA hands Novartis good news on Xolair but a rebuke for serelaxin

Swiss drugmaker Novartis got a mixed bag of news from European regulators Friday. It got a recommendation for its asthma drug Xolair to treat a chronic form of hives. Regulators, however, slapped down its new heart drug serelaxin, a product that Novartis is counting on bringing in more than a billion dollars a year.

Ranbaxy falls further into regulatory quagmire with latest FDA ban

Every time Ranbaxy Laboratories seems to be making some progress, it stumbles over manufacturing problems that should have been resolved years ago. The FDA Thursday said it was banning a fourth of Ranbaxy Indian plant from exporting to the U.S. This one makes a majority of the active pharmaceutical ingredients for its U.S. drugs.

H. Lundbeck is facing questions about stalling competition at home

Denmark-based H. Lundbeck, which was fined in the EU last year for its effort to keep generics of antidepressant blockbuster Celexa off the market, is now facing questions in its home country. The health minister there is telling local jurisdictions they should bring legal action if they think they can prove they have been harmed by any drugmaker's effort to prevent competition.

With FDA rejection, Amag loses out on broader use of anemia drug Feraheme

The FDA dashed Amag Pharmaceuticals' hopes for its anemia drug Feraheme. The agency rejected Amag's application for broader use of the treatment for iron deficiency, citing a lack of evidence of its safety.

Cohera Medical's surgical sealants attracted a $26.3M Series D

Cohera Medical has $26.3 million in series D cash in hand to fuel regulatory approvals for its surgical adhesives and sealants. That's a jump of $9.3 million more from initial funding the Pittsburgh company nailed down for the round last February.

Covidien gets the FDA's OK for its LigaSure laparoscopic surgical device

Covidien won U,S. FDA 510(k) clearance and a CE mark for a combination laparoscopic surgical device.

Appeals court gives GSK another shot at AbbVie in HIV drug-pricing fight

GlaxoSmithKline has another chance to wrangle with AbbVie over HIV drug prices. A federal appeals court ordered a new trial for GSK, which had sued Abbott Laboratories for jacking up the price of its AIDS treatment Norvir, because Abbott excluded a gay man from the jury.

U.K. mulls a 'breakthrough' drug program of its own

Impressed by the success of the FDA's breakthrough therapy designation, U.K. regulators are considering a similar effort to speed the path for promising drugs.

On the long list of device industry challenges, insurance codes rise to the top

A continued decline in venture capital may be hampering the advance of medical device startups, but the absence of new insurance reimbursement codes is becoming a far bigger issue.

Yale researchers chide the FDA for failing to enforce high R&D standards

Some researchers at Yale want the world to know that there is no firm FDA standard for proving whether a drug is safe and effective--and they see that as a serious problem that needs to be addressed.