Topic:

Regulatory

Latest Headlines

Latest Headlines

FDA approves ear inserts to reduce TMJ pain

The FDA has approved TMJ NextGeneration, custom ear canal inserts that increase the volume of the ear canal when the jaw is closed, thereby discouraging the user from clenching the jaw and the surrounding muscles.

NICE Zytiga snub is 'plainly illogical,' critic says

U.K.'s National Institute for Health and Care Excellence has delivered a blow to Johnson & Johnson's Zytiga in final draft guidance recommending against the prostate cancer pill as a treatment for prostate cancer before chemotherapy. And nobody seems very happy about it--including NICE itself.

Top U.S. senator urges Hospira to abandon inversion plans

Amid growing regulatory action to crack down on corporate tax inversions, a top U.S. senator is urging Hospira to keep its operations at home and abandon plans to move abroad for taxpaying purposes.

Roche's Avastin nabs quick FDA nod for cervical cancer use

After promising last month to fast track its review of Roche's Avastin in cervical cancer, the FDA has come back with a positive verdict--a full two months before its deadline. The agency approved the blockbuster drug to be used in combination with chemotherapy in women with advanced cervical cancer.

FDA launches pilot program for qualification of medical device development tools

Medical device evaluation can only be as effective as the tools used to conduct the evaluation. The FDA has begun seeking applications for the Medical Device Development Tools Pilot Program to validate and review such tools in preparation for a final guidance on the topic.

Pfizer, Merck pick up hefty vax sales bump with CDC nod in seniors

Pfizer's Prevnar 13, the world's best-selling vaccine, scored a big win Wednesday, nabbing a CDC committee nod for universal use in adults over the age of 65. And once payer coverage kicks in, that's a nod that could be worth $2 billion for Pfizer, analysts say--with Merck's Pneumovax getting a boost, too.

For sale: One Swiss biotech with an antibiotic and a low tax rate

With the FDA insisting on more studies before it will consider approval of its new antibiotic and needing money to pay for them, Switzerland-based Basilea figures it might sell some assets to raise the money.

Skeptical U.K. watchdogs decide to back Gilead's hep C star Sovaldi

As Gilead's multibillion-dollar sales figures show, insurers and government payers are covering the highly effective--but highly pricey--hep C treatment. Now, if NICE's latest coverage proposal goes through, the U.K.'s National Health Service will officially be one of them.

Shire takes over production of Buccolam after contractor fails

After the MHRA hammered another SCM Pharma site for failing standards, the small CDMO came up short of cash to fix the problems and went into administration. Now Ireland's Shire, its largest customer, has taken over some operations to prevent interruption of production of an epilepsy drug it picked up with its acquisition of ViroPharma.

Prefer a Swiss tax rate? Basilea chief says he's ready to parley

Basilea CEO Ronald Scott offered that the next best step for the biotech may be to just sell the Basel-based company to a U.S.-based biopharma company interested in a quick tax inversion deal that would allow a buyer the chance of trading American taxes for a sweeter deal in Switzerland.