Topic:

Regulatory

Latest Headlines

Latest Headlines

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.

Feds eyed GlaxoSmithKline's Chinese consumer biz for bribery, too

GlaxoSmithKline may have a bigger problem in China than previously thought. Before news about potential corruption in its pharma business surfaced, U.S. officials were already looking into possible bribery in its consumer healthcare unit. And so was GSK.

NICE says 'too pricey' to Celgene's Abraxane combo for pancreatic cancer

The U.K.'s cost-effectiveness watchdogs are cracking down on expensive cancer treatments yet again. This time the ax is falling on Celgene, which learned today that the National Institute for Health and Care Excellence (NICE) won't back the company's drug Abraxane to treat metastatic pancreatic cancer.

FTC takes after AbbVie, Teva for pay-for-delay deal on AndroGel

Even as the FDA is questioning the widespread use of testosterone-boosting drugs for men, the Federal Trade Commission has sued AbbVie and Teva Pharmaceutical Industries for keeping a generic of one out of their reach for years. It is one of the first actions brought by the FTC since the Supreme Court last year said that so-called pay-for-delay deals are not inherently illegal.

Europe opens up big new market for Roche's RA therapy RoActemra

Roche just won access to a larger market for its RoActemra treatment for rheumatoid arthritis.

U.K. watchdogs hope to tap social media for drug-safety purposes

Now, it's U.K. drug regulators who are devising plans to eavesdrop on social media. But unlike the FDA, which plans to monitor the world of online sharing to see whether its communications are hitting their targets, the Medicines and Healthcare Products Regulatory Agency plans to search for drug safety info.