Topic:

Regulatory

Latest Headlines

Latest Headlines

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.

Edwards wins a battle in its ongoing TAVR patent war with Medtronic

Edwards Lifesciences scored a major victory against competitor Medtronic in an ongoing patent war over the companies' transcatheter aortic valve replacement products. A U.S. District Court issued a preliminary injunction against Medtronic's CoreValve system, limiting sales of the device in the U.S.

Vivus needs more than boardroom shuffling to keep up with Arena's Belviq

One pre-First Manhattan Co.-settlement Vivus director standing for re-election at the company's annual meeting, that is. The Mountain View, CA-based drugmaker announced Tuesday in a regulatory filing that J. Martin Carroll, Mark Logan and Robert Wilson would not seek to retain their board positions.