Topic:

Regulatory

Latest Headlines

Latest Headlines

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.

Merck's sleep drug suvorexant overcomes hurdles to win FDA approval

Merck scored a muted victory on Wednesday when the FDA approved its insomnia remedy suvorexant at four doses--the largest of which is half what the company initially hoped to be able to market.

Canada says GSK flu vaccine plant is on track; the FDA remains mum

GlaxoSmithKline's plan of action for its troubled Quebec flu vaccine has gotten the thumbs up from regulator Health Canada, but that is only a part of the puzzle for meeting its contracts to produce tens of millions of doses of four-strain and three-strain seasonal flu shots for the impending season.

Indian regulator lays down new standards for its inspectors

India's Central Drugs Standard Control Organization has issued new guidelines for state inspectors on how to prepare for and handle inspections of drug manufacturing facilities, Regulatory Focus points out.

Merck wins FDA nod for a weaker form of its embattled sleep drug

A year after enduring a stinging FDA rejection, Merck has convinced the agency to sign off on lower doses of its suvorexant, a novel sleep drug once predicted to become a blockbuster.