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Regulatory

Latest Headlines

Latest Headlines

FDA nod for LifeWatch wireless, patch-based vital signs monitoring system

Swiss remote diagnostic monitoring company LifeWatch has secured a clearance from the FDA for its wireless, patch-based vital signs monitoring system. It's expected to be used first in medical facilities such as hospitals and nursing homes, but eventually the company expects to target the ambulatory care market as well.

FDA says drug delivery devices need human factors validation testing

Several drug delivery devices are on a draft list of med tech that will be subject to a final guidance calling for the application of human factors and usability engineering to medical devices.

Top Senate Democrat grills HHS about opioid panel's alleged ties to industry

About a third of panelists at a Department of Health and Human Services (HHS) meeting on painkiller prescribing had financial ties to companies that make the drugs, a recent report showed. A top Senate Democrat is not pleased with those findings, and he's grilling the HHS about the members' relationships with the industry.

Japan continues to see generics as way to ease healthcare costs

The government of Japan is changing the lucrative brand-name healthcare market as its population ages and requires more drugs with a push to make at least 80% of the government's drug spending be for generics.

Hospitals, CMS rail against update to FDA device safety reports amid duodenoscope pushback

Last month, senators pointed to problems with duodenoscopes linked to superbug outbreaks and partly blamed an outdated FDA reporting system for not adequately monitoring the devices' safety. The lawmakers want to give the system a facelift, but they could face obstacles from hospitals and Medicare officials who are railing against some of the proposed changes.

UPDATED: NICE, in reversal, OKs Amgen's Repatha while snubbing Sanofi and Regeneron's Praluent

Amgen's Repatha is in a market brawl with Sanofi and Regeneron's Praluent as the competitors rush to sew up as many OKs around the world as possible for the new-gen cholesterol fighters following their FDA approval last year within weeks of one another. Now Amgen has pulled ahead in England after the country's drug pricing watchdog has both changed course to cover Repatha for some patients, while dealing its competitors a blow with a rejection for Praluent.

Sarepta faces another FDA delay with its much-scrutinized DMD drug

Sarepta Therapeutics, hoping to win approval with a treatment for Duchenne muscular dystrophy, will have to endure a three-month FDA delay before getting final word on its drug.

Omega diet-aid ad banned in U.K.; summer slimming promos not 'socially responsible'

Omega Pharma's advertising for its diet pill XLS Medical found itself in the middle of a dust-up in Britain, with hundreds of complaints flying about the swimsuit-season promos. And now, the campaign is banned altogether.

Baxalta partner CTI plunges after FDA slaps partial hold on PhIII myelofibrosis drug

The FDA has slapped a partial clinical hold on CTI BioPharma's late-stage myelofibrosis drug pacritinib after patients in the drug arm of a Phase III study began to die at a higher rate than those in the placebo group. The drug arm also registered a higher number of adverse events, further raising concerns about the safety of the drug.

Novo says China price pressures may go into 2017

With approval for Tresiba in China potentially years out, Novo Nordisk expects continued price competition from domestic companies that will show up on the books more widely in the coming year and into 2017.