Topic:

Regulatory

Latest Headlines

Latest Headlines

GlaxoSmithKline wins an FDA nod for its GLP-1 diabetes drug albiglutide

After a three-month delay pushed pause on its commercial plans, GlaxoSmithKline has secured FDA approval for albiglutide, a new diabetes treatment that will contend for market share in a fast-crowding space.

UPDATED: FDA puts import alert on Baxter plant that makes saline solution

Baxter International, which has had a series of recalls in the last few months, has had a plant in Canada banned by the FDA from shipping products, including saline solution, which is already in serious short supply in the U.S.

Devices approved for pediatric use weren't tested in children first, new study finds

As the pediatric medical device sector grows, lawmakers are pushing for the development of innovative products that can treat younger patients and address an unmet need. But most devices that were recently approved for pediatric use were not tested on children first,  Reuters  reported.   

Impax believes manufacturing issues are fixed

Impax Laboratories had its future sidelined by manufacturing problems that set off a domino effect. Now, it says it is ready to get back in the game.

Merck bags FDA approval for its grass pollen pill Grastek

Merck picked up an expected FDA approval for the first of three immunotherapies in its allergy pipeline, gearing up to launch a grass pollen-fighting treatment with hopes of cracking a market dominated by injections.

Medtronic strikes back in its TAVR patent battle with Edwards

Medtronic is striking back in its latest battle with competitor Edwards over patents for the companies' transcatheter aortic valve replacement products. The company filed an emergency motion in a U.S. Circuit Court of Appeals to prevent an injunction against its CoreValve system from going into effect.

Lupin recalls more Suprax on purity problems, adding to Indian pharma's quality questions

In the latest black eye for India's pharma industry, Lupin is recalling some 10,000 bottles of its Suprax antibiotic in the U.S. The pills fell short of standards for purity, the FDA said in a statement on its website.

Covidien snags FDA OK for a camera-equipped feeding tube

Covidien is gearing up to launch its Kangaroo feeding tube in the U.S. after picking up FDA clearance for the device, which is outfitted with a camera that provides real-time images to physicians.

Abbott wins FDA nod for diabetes blood test

Abbott Laboratories has secured the FDA's blessing to launch its latest diabetes diagnostic, a test that can help diagnose and monitor diabetics as well as flag patients at risk for developing the disease.

Big Pharma tries to short-circuit France's move toward biosimilar substitution

Late last year, French legislators quietly slipped a measure into the country's 2014 budget legislation that would allow pharmacists to substitute inexpensive biosimilar drugs for pricier biotech brands. While not a full-out assault on branded biologics, it would make France the first European country to substitute the cheaper drugs, and the pharma industry is doing everything it can to derail that move before France's Administrative Supreme Court decrees it into effect.