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Regulatory

Latest Headlines

Latest Headlines

Pfizer beats out Novartis with FDA MenB nod

We have a winner. In a two-horse race to grab the first-ever U.S. approval for a meningitis B vaccine, Pfizer has emerged victorious, nabbing the FDA's blessing Wednesday.

Daiichi Sankyo gains some in-house FDA support for a-fib drug edoxaban

Daiichi Sankyo's campaign to win approval for its atrial fibrillation drug edoxaban gained some support from regulators at the FDA who were clearly won over by the efficacy data in the NDA. But the internal review of the drug also includes recommendations for limiting its use to patients with abnormal kidney function. And they include a few cautionary notes on the competing drugs that have already made it to the market.

Ranbaxy's New Jersey plant comes through for drugmaker

Despite FDA bans on four Ranbaxy Laboratories plants in India, the drugmaker managed to realize a profit in the last quarter as its plant in New Jersey was able to come through for it.

FDA grants bioMérieux emergency authorization for one-hour Ebola Dx

BioFire, a subsidiary of French diagnostics outfit bioMérieux, was granted emergency authorization from the FDA for two of its Ebola tests.

One-hour Ebola test from bioMérieux receives FDA emergency use authorization

The U.S. Food and Drug Administration has given a temporary thumbs up to Ebola test FilmArray BioThreat-E from BioFire Defense, a bioMérieux company. The test offers results in one hour rather than the one to two days required by existing methods.

St. Jude Medical snags FDA approval for next-generation ablation catheter

St. Jude Medical snagged FDA approval for its next-generation ablation catheter for atrial fibrillation, bolstering the company's presence in a growing electrophysiology market and strengthening its footprint in the cardiac rhythm management sector.

Attorney: FDA final guidance on product recalls not helpful

FDA's final guidance on medical device recalls and associated reporting requirements omits the most pernicious proposal of the draft guidance, but is of little utility and "will probably soon be forgotten," according to the  FDA Law Blog, written by Hyman, Phelps & McNamara attorneys.   

U.S. Attorney asks Novo Nordisk about plant in Denmark

Novo Nordisk says the U.S. Attorney in Massachusetts has subpoenaed it for information about potential manufacturing issues at a plant in Kalundborg.

UPDATED: Sarepta plunges as CEO moves goal line on Duchenne MD drug downfield

Following a meeting with regulators in September, Sarepta spelled out a new set of data that the FDA is looking for in the application for its closely watched Duchenne muscular dystrophy drug eteplirsen, and the biotech says it will have to delay filing--another dramatic turning point for the company this year, which saw its shares plunge 30% on the news this morning.

Merck grabs another 'breakthrough' in PD-1 lung cancer race with Bristol-Myers

With the goal line for lung cancer in sight at the FDA as it races with an ambitious R&D team at Bristol-Myers Squibb, Merck has grabbed bragging rights to the agency's breakthrough drug designation for the checkpoint inhibitor pembrolizumab (Keytruda) for that golden market opportunity.