The Indian drugmaker will pay the largest ever drug safety settlement for a generic manufacturer--$500 million--to put the case to rest.
The agency is providing a priority review for the therapy (TMC435) in combination with interferon and ribavirin, possibly speeding its way to the market.
Endo Health Solutions lost its bid to thwart generic makers copying its high-powered painkiller Opana ER. The FDA decided Endo's tamper-resistant formula doesn't prevent drug abuse significantly better than earlier versions that weren't designed to deter abuse. That's a blow for Endo, which took in almost $300 million from the drug last year, or 10% of its total sales.
Sorin picked up the FDA's blessing to market its SmartView remote monitoring system, which allows physicians to keep tabs on patients with implanted cardiac devices while they're at home.
Now that Aveo's share price has been badly mauled in the aftershock of an FDA panel vote rejecting its kidney cancer drug tivozanib, the class action suits are starting to pile up at the front door.
FDA has scrambled to get on top of the compounding pharmacy sector in the wake of the fungal meningitis outbreak, but last week admitted it still faces a fundamental problem--it is unsure of the scale of the problem.
Merck won the FDA's acceptance of a Biologics License Application for its investigational ragweed pollen allergy tablet to be delivered under the tongue.
Novartis has grabbed one of two new indications it was shooting for with its rare disease drug Ilaris, one step toward turning the drug into a blockbuster.
GlaxoSmithKline and Theravance have won FDA approval for their drug Breo Ellipta for treating chronic obstructive pulmonary disease, the third-biggest killer of Americans, the agency announced. The approval comes with an undesirable boxed warning from the agency that LABA therapies boost risk of asthma-related deaths.
Quest Diagnostics will fork over a $70,000 fine to settle claims in New York State that it pursued illegal hiring practices by automatically rejecting applicants with criminal records.