Topic:

Regulatory

Latest Headlines

Latest Headlines

Verizon jumps into med tech with FDA-cleared monitor

Verizon won FDA clearance for a cloud-based remote patient monitor, marking the wireless giant's first dealings with the agency as it further embraces healthcare and gets into the medical device market.

Ariad Pharma denied FDA's coveted 'breakthrough' stamp for lung cancer drug

Ariad Pharmaceuticals was unable to convince the FDA to pin a "Breakthrough Therapy" designation on its experimental drug for lung cancer patients with a specific genetic mutation. 

Zimmer owes Stryker $228M in patent lawsuit

Zimmer was already on the line to pay Stryker $70 million over patent infringement, and now a federal judge has more than tripled the award, ordering the company to fork over $228 million and barring it from selling the offending device.

Novo CEO: Correcting course after troubling setbacks

Novo Nordisk's quarterly sales hit 21.38 billion kroner, or about $3.8 billion. Profits amounted to 6.7 billion kroner. And now, the company expects 2013 sales to grow by 11% to 13%, with operating profits up 12% to 15%; previously it was looking for sales growth of 9% to 11%.

Recall expert takes services to Europe

Recalls are an unwanted expense for drugmakers, and if extensive enough, can be a drag on earnings. For Stericyle, which has a unit that helps companies manage recalls, they have been a moneymaker.

CareFusion saddled with yet another Class I recall

CareFusion's Alaris infusion pumps are back in the FDA's sights, as the agency has assigned its most serious warning to the company's latest malfunction, saying the problem could lead to serious injury or death.

UPDATED: FDA experts give Bayer's riociguat unanimous backing for lung disease

An FDA panel of outside experts has contributed a round of thumbs-up for Bayer's new drug for pulmonary arterial hypertension, to be sold as Adempas, sending the pharma giant on what appears to be another victory lap in the lead-up to a likely approval.

U.K. cost watchdogs nix Roche's new breast cancer drug Perjeta

The U.K.'s cost-effectiveness police have turned up their noses at Roche's new breast cancer drug Perjeta. The National Institute for Health and Care Excellence (NICE) says the drug's ability to extend patients' lives is unclear--and that it's far more costly than currently available treatments.

Ambry fires back at Myriad with antitrust suit

Myriad Genetics is using its legal budget and a misguided understanding of the law to monopolize the world of BRCA testing, according to a lawsuit from rival Ambry Genetics, the latest shot in a patent dispute with deep implications for the diagnostics industry.

Compounder issues nationwide recall of 45 products

The latest compounding pharmacy recall is from Beacon Hill Medical Pharmacy, which operates under the name of Rxtra Solutions. It is recalling all lots of 45 different products after the FDA "raised a question of sterility assurance."