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Regulatory

Latest Headlines

Latest Headlines

Dexcom snags FDA approval for next-gen artificial pancreas tech for blood glucose monitoring system

As med tech outfits race to develop innovative, noninvasive technology for diabetes monitoring, Dexcom snagged FDA approval for a new artificial pancreas algorithm for its continuous glucose monitoring device.

Valeant labeling snafu affects Sanofi's Aplenzin, as well as Valeant's vaseretic

The 206,000 bottles of blood pressure medication vaseretic that Valeant has been recalling is not the only product affected by a packaging snafu that resulted in outdated package inserts. The drugmaker has also been retrieving 19 lots of the antidepressant Aplenzin that it makes for Sanofi.

Aeterna Zentaris bottoms out after a stinging FDA rejection

The FDA has rejected Aeterna Zentaris' orphan treatment, taking serious issues with its pivotal data and further battering the foundering biotech's share price.

FDA resumes its long search for a CIO

The FDA resumed its active search for a CIO late last month, more than one year after it first advertised the position, Regulatory Focus reports.

Ranbaxy manufacturing mess costs it approvals for Nexium, Valcyte

Ranbaxy said today that the FDA has withdrawn its 6-month exclusivity for Valcyte. It also said it had lost its tentative approval for AstraZeneca's heartburn blockbuster Nexium. Nexium went off patent in May and Valcyte went off patent last year.

Sanofi, Protein Sciences win flu jab nods in older adults

A couple of flu vaccine makers have new patient populations to target, thanks to a pair of recent FDA approvals in older adults.

Government report says medical device tax will not deter innovation

The Republican takeover of the Senate means the chances of a repeal of the medical device tax are improved, but the Congressional Research Service just gave supporters of the tax ammunition. This week it released to the public a report claiming the medical device tax will only result in a 0.2% decrease in device industry jobs and output.

Government watchdog promises to monitor device cybersecurity, reimbursement in FY 2015

The watchdog agency of the Department of Health and Human Services promised to crackdown on defective medical devices and  cybersecurity  in hospitals in its recently released agenda for fiscal year 2015. 

GlaxoSmithKline heads to the FDA with its next big respiratory bet

GlaxoSmithKline is racing to be the first on the market with a new approach to treating severe asthma, filing U.S. and European applications for the injectable mepolizumab as it jockeys with Teva and AstraZeneca.

FDA clears catheter for targeted drug delivery in peripheral vasculature

The FDA recently gave 510(k) clearance to a two-balloon catheter for the targeted delivery of diagnostic and therapeutic agents to the visceral vascular system. This subset of the peripheral vasculature consists of the arteries that supply blood to the intestines, spleen and liver.