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 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.
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.
Thanks to an FDA ruling, a fleet of Medtronic pacemakers and defibrillators are now cleared for use in patients with less severe heart failure.
Smith & Nephew, the U.K. orthopedic giant, has agreed to pay $12 million to settle a shareholder lawsuit blocking its $1.7 billion acquisition of ArthroCare, according to a SEC filing.
After a manufacturing problem irked the FDA and scared off partner GlaxoSmithKline, Impax Laboratories is resubmitting its investigational drug for Parkinson's disease, hoping it can clear an agency inspection and finally get its treatment on the market.
A strong regulatory agency and the patient confidence it inspires are essential for both patients and the industry as a whole, Sanofi CEO Chris Viehbacher said Thursday. And while the FDA has made recent strides in restoring the patient trust the agency depends on, Commissioner Margaret Hamburg says it still has some work to do.
San Diego-based Celladon has nabbed a "breakthrough" drug designation from the FDA for its heart failure drug Mydicar. The gene therapy uses a benign virus to insert the Serca2a gene into heart cells.
The French Competition Authority has stepped up its probe of potential Lucentis price-fixing. As The Times of London reports, the antitrust regulators said they raided local offices of Roche and Novartis, looking for evidence of collusion.
Sun Pharmaceutical execs acknowledge it will be no easy task to repair Ranbaxy Laboratories' damaged reputation with the FDA and the public. But Sun managing director Dilip Shanghvi and his lieutenants came in with a laundry list of actions to be taken quickly to jump-start the process, sources tell Reuters.