Topic:

Regulatory

Latest Headlines

Latest Headlines

Sanofi bags 'breakthrough' tag for new Genzyme rare disease med

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 snags a 'breakthrough' tag for a new rare disease drug

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.

St. Jude gains CE mark for first app-based pain neuromodulation patient trial system for use ahead of implant

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's bid to block Lialda copies hits another snag

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.

Australia lambasts Big Pharma for paying tiny taxes on multibillion-dollar revenue

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 raises $69M for light adjustable intraocular lens FDA approval, launch

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.

India's NPPA says it really means this deadline on registration

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.

Celgene's Abraxane denied by India patent office, local generics seen ahead

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 aims for high-end drug-device innovation and generics, but will it work?

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 gets FDA OK to resume trial of Portico TAVR

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.