Topic:

Regulatory

Latest Headlines

Latest Headlines

AstraZeneca pay-to-delay could cost it and the industry billions of dollars

The U.S. Supreme Court last year refused to side with the industry in so-called pay-to-delay deals. Instead it pulled back the insulating legal blanket the industry had been wrapped in, ruling the deals must be fought on a case-by-case basis. Now AstraZeneca is first up to see how juries will respond, facing potentially billions of dollars in damages if it loses.

Roche and Novartis unable to kill €180M fine in Avastin vs. Lucentis case

An Italian regional court is upholding charges levied earlier this year against Roche and Novartis, fining the companies €180 million for manipulating sales of Lucentis, their drug for wet age-related macular degeneration.

Puma tanks on a fresh setback for its breast cancer drug

Puma Biotechnologies is walking back some bullish prognostications for its breast cancer treatment, delaying its planned FDA submission by as much as a year and lending weight to some creeping doubts about its top prospect.

NICE doesn't get the Soliris cost info it wants--but backs the drug anyway

Back in March, the U.K.'s cost watchdog went where it hasn't yet gone before, asking Alexion, maker of pricey orphan drug Soliris, to justify the drug's high sticker with information on the company's R&D costs. Now, it hasn't yet gotten the response it wants, it says, but it's backing Soliris regardless--once a few conditions are met.

Masimo wireless, wearable patient monitor cleared by FDA

Masimo has gained FDA clearance for its wireless, wearable patient monitor, Radius-7. The device connects to Root, Masimo's open architecture, patient monitoring and connectivity platform that links a variety of devices regardless of company origin, which the company expects to be ubiquitous.

FDA lifts a hold on Flexion pain drug

Burlington, MA-based Flexion says that the FDA has lifted its clinical hold on its lead pain drug candidate, FX006.

NICE changes its attitude on Roche's Gazyvaro

Months after the U.K.'s drug price watchdog the National Institute for Health and Care Excellence gave a preliminary thumbs-down to Roche's Gazyvaro for chronic lymphocytic leukemia, the agency is now set to recommend the drug in new draft guidance with a few strings attached.

Cepheid wins FDA nod for norovirus test

Cepheid scored an FDA OK to market its next-generation in vitro test for norovirus, helping the company generate some upward momentum as it ramps up its molecular diagnostic platform.

FDA approves Animas insulin pump, continuous glucose monitor combo device

The U.S. Food and Drug Administration has approved the Animas Vibe, a combination insulin pump and continuous glucose monitor. It allows patients with Type 1 diabetes to monitor blood glucose levels and adjust insulin delivery based on that data.

FDA slaps Dr. Reddy's with a Form 483

The FDA has slapped Dr. Reddy's Laboratories with a Form 483 letter, outlining concerns about the drugmaker's manufacturing plant in southern India, the company said.