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'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.
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.
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.
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.
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 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.
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.
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.
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.