Sanofi's rare disease-focused unit Genzyme picked up the FDA's coveted breakthrough-therapy designation for a drug designed to treat a form of Niemann-Pick disease.
Sanofi's rare disease-focused Genzyme picked up the FDA's coveted breakthrough-therapy designation for a candidate designed to treat a form of Niemann-Pick disease.
Major medical device makers haven't exactly rushed to integrate smartphones and tablets into their product lineups, despite their ubiquity and obvious potential medical utility. But now St. Jude Medical has gained a CE mark and launched the first app-based, wireless system for use during an initial patient trial period with an external neuromodulation chronic pain treatment device prior to receiving a permanent implant.
Shire shares slumped Thursday after a U.S. Appeals Court denied its latest attempt to fend off generic versions of its ulcerative colitis treatment Lialda. The drug is one of Shire's top sellers--and the case is one of the first reviewed under a U.S. Supreme Court patent-law ruling.
The Australian government is cracking down on some of the industry's top drugmakers by calling on companies to explain their tax-paying behavior in the country.
Calhoun Vision has been around a long, long time for a startup. But now it's got a massive infusion of $69 million that's following on the heels of the addition of a new, market-focused CEO from Bausch + Lomb to help catapult it into commercialization.
A line in the sand has been drawn by India's National Pharmaceutical Pricing Authority (NPPA) for 19 out of the top 100 drugmakers in the country to register on an online database by Friday.
Makers of generic drugs in India are expected to start producing local versions of Celgene's oncology drug Abraxane after a consecutive denial of a patent.
Japan has ramped up spending on healthcare as part of a broader effort by the government to spur innovation and revive economic fortunes for drug and device makers while at the same time trying to tame costs for reimbursement and hiking sales taxes.
St. Jude Medical got FDA approval to resume a U.S. trial of its transcatheter aortic valve system, a win for the company as it recovers from safety concerns tied to the device last year.