Topic:

Regulatory

Latest Headlines

Latest Headlines

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.   

UPDATED: 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.

Polish prosecutors hit GlaxoSmithKline with third round of bribery charges

GlaxoSmithKline has now hit a trifecta in bribery investigations: First China, then Iraq, and now, Poland. According to the BBC, a former GSK sales rep says the company was trading cash for prescriptions in the country in a wink-wink sort of way, by disguising the script incentives as speaking fees.

U.S. lawmakers join Lilly's attacks on Canada's patent attitude

U.S. lawmakers have asked the U.S. Trade Representative's office to put Canada on a "priority watch list" because it has invalidated patents on drugs made by Eli Lilly and others.