Topic:

Regulatory

Latest Headlines

Latest Headlines

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.

The pressure's on Novo's marketing force as FDA nod for liraglutide nears

Novo Nordisk may be nearing the regulatory finish line with an obesity-fighting dose of liraglutide, up for debate by the FDA's advisers this week.

With liraglutide nod nearing, Novo Nordisk girds for weight-loss marketing battle

Novo Nordisk is nearing the weight-loss finish line. Its obesity-fighting dose of liraglutide is up for debate by the FDA's expert advisors this week, and staff reviewers issued largely positive comments in documents filed Tuesday morning.

Judge: Merck must fight claims that it lied about mumps vaccine benefits

Merck tried to block two lawsuits claiming it lied about the efficacy of its mumps vaccine--but the pharma giant couldn't stop them. A federal judge in Pennsylvania refused to dismiss the lawsuits, filed by a pair of whistleblowers and a group of doctors and payers. Next stop: Trial.

Can Novo Nordisk and Orexigen finally open up a blockbuster weight-loss market?

Over the next few days two new contenders for the heavyweight title for weight control drugs face critical regulatory hurdles. After a long and expensive repeat voyage through a late-stage safety study, Orexigen is slated to get the FDA's marketing decision on Contrave by Thursday. And on the same day Novo Nordisk will run through a gamut of questions at an FDA independent panel review of liraglutide 3 mg, with the pharma player betting that it can ultimately get a green light that will open up a new market for its drug that will be worth billions of dollars in added annual sales.