Topic:

Regulatory

Latest Headlines

Latest Headlines

23andMe capitulates, yanking all health-related gene tests pending FDA review

California's 23andMe has capitulated to the FDA, agreeing to regulators' demands to stop selling all health-related genetic tests while it submits them for a formal regulatory review.

The day after its Lemtrada snub, NICE blesses Sanofi's Aubagio

Thursday, Sanofi's multiple sclerosis drug Lemtrada was stymied by the U.K.'s cost-effectiveness gatekeeper, which asked for more data on the med before it could determine its worth. But just one day later, the regulatory body gave Sanofi's MS franchise a boost: It has recommended Aubagio, its oral treatment, for use in Britain's National Health Service.

Jarvik Heart's Japan regulatory win gives Thoratec a new heart pump challenge

Jarvik Heart won Japanese regulatory approval for its left ventricular assist device, bringing its heart pump rivalry with Thoratec to Asia. Japan's Pharmaceuticals and Medicines Devices Agency signed off on the Jarvik 2000 Heart based on Japanese and U.S. clinical trial data, approving it as a bridge to transplant.

FDA questions the safety of Takeda's blockbuster-hopeful bowel disease drug

FDA staff has taken issue with Takeda Pharmaceutical's vedolizumab, warning that the treatment for inflammatory bowel diseases could put patients at risk for a rare but deadly brain infection, possibly outweighing its benefits.

Medtronic's new version of Symplicity gets a green light in EU and Australia

Medtronic announced Thursday it has approval in the EU and Australia to market its new system for renal denervation to treat uncontrolled hypertension.

Sanofi's MS drug Lemtrada tripped up again, this time in U.K.

Less than a month ago, Sanofi's multiple sclerosis treatment Lemtrada ran into problems with FDA staffers who were unconvinced of the drug's safety and efficacy. Now, it looks as if the U.K. may share some of those doubts. Its cost-effectiveness gatekeeper has asked the French pharma for more data, giving the company just over a month to submit the supplementary information.

Tyrx wins FDA's nod to use its antibacterial envelope for neuromodulator implants

Tyrx won FDA clearance to expand the use of its next-generation antibacterial envelope for spinal cord neuromodulator implants. In doing so, it is staking claim to an infection control market with a product line that has few, if any, competitors.

BioDelivery Sciences pushes diabetic pain gel to PhIII with FDA nod

It looks like BioDelivery Sciences is on its way to a Phase III clinical trial of its topical gel treatment for painful diabetic neuropathy following a "positive" meeting with the FDA.

FDA warning letter tasks Wockhardt with global plant assessment

When the FDA finds deep flaws at a manufacturing plant, it questions practices at all other facilities in the network. Hospira found this out in 2010 when a second warning letter in 8 months prompted the FDA to ask it to do a global review, and Wockhardt has now been given a similar regulatory to-do list.

23andMe pulls ads after FDA warning, but sales roll on

23andMe has stopped advertising its personal genetic test after a strongly worded rebuke from the FDA, Reuters reports, but the company is still selling its $99 kit despite the agency's demands.