Topic:

Regulatory

Latest Headlines

Latest Headlines

FDA clearance of Medtronic's scoliosis implant a much-needed victory for pediatric devices

Pediatric devices are in short supply because of the prevalence of rare diseases in children, as well as their unique physiology. So, FDA's 510(k) clearance of Medtronic's Shillla Growth Guidance System for the treatment of scoliosis in children less than 10 years old has particular significance.

FDA says Aegerion has satisfied its demands over chatty CEO

Comments by Marc Beer, CEO of Aegerion Pharmaceuticals, got the company slapped with an FDA warning letter for exaggerating the benefits of its cholesterol-lowering drug Juxtapid during a television appearance on CNBC's "Fast Money" program. Beer had nothing to say Wednesday when the company announced the FDA had closed the matter out, satisfied with the "corrective actions" the company had taken.

Pfizer's C. diff vaccine gains on Sanofi with FDA fast-track nod

Look out, Sanofi. Pfizer's Clostridium difficile candidate has just nabbed an FDA fast-track designation that should help it pick up some ground in the race to bring the first vaccine for the disease to market.

FDA clears Glaxo Ebola vaccine for speedy human trials

GlaxoSmithKline's vaccine candidate for the deadly Ebola virus is ready to roll in human trials.

Cost watchdogs bar Boehringer, Lilly's diabetes med Jardiance--for now

Just as Eli Lilly and Boehringer Ingelheim's new diabetes drug Jardiance hit store shelves in the U.S., cost-effectiveness watchdogs in the U.K. were considering whether to give it their blessing. The verdict as of Thursday morning? Nay.

FDA lifts a hold on one of OncoMed's cancer drug programs

Shares of OncoMed Pharmaceuticals took a nasty tumble a couple of months ago when it hit the brakes on a pair of early-stage programs for two of its treatments after investigators noted trouble with some bone-related adverse events. Today, the biotech says it adjusted its protocols on vantictumab, a Wnt pathway inhibitor program, to the satisfaction of the FDA, which lifted its partial hold on the program.

PCSK9 race heads to the finish line with Amgen's evolocumab application

Amgen has taken another big step in its head-to-head race with Sanofi and Regeneron, filing its application for the prospective cholesterol blockbuster evolocumab and backing it up with more positive data from the latest in a long string of major clinical studies.

U.K.'s cancer drugs fund gets £160M--and power to push for lower prices

The U.K. has a workaround for expensive cancer drugs that its cost-effectiveness gatekeepers don't approve: a special fund to pay for those therapies, provided doctors jump through the hoops required to gain access.

The Ebola vaccine game plan takes shape as GSK, agencies hit the gas

Initially, GSK officials had sounded distinctly skeptical about whether the vaccine could be ready in time to help contain the outbreak. But this morning there was a distinct can-do attitude in its approach to the crisis.

NAFTA says FDA was in its rights to ban Apotex plants

It's tough luck for Canada's Apotex in its international slug fest with the FDA. An arbitration panel has tossed its claim that the FDA violated the North American Free Trade Act when it banned products from its plants in Toronto and Quebec from 2009 to 2011.