Topic:

Regulatory

Latest Headlines

Latest Headlines

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.

Wockhardt's run-ins with the FDA cost it most of its profits for a quarter

With two Indian plants on the FDA import alert list and a U.S. facility recently written up, India's Wockhardt reported this week that its April-June net profit was off 94% compared to the same quarter a year ago, producing 199.5 million rupees ($3.26 million), down from 3.23 billion rupees ($52.9 million) a year earlier.

Indian regulators punch up standards as FDA action takes a toll on the industry

Until very recently, no serious consequences had been dealt out by India's Central Drugs Standard Control Organization (CDSCO), even for Ranbaxy Laboratories, which last year pled guilty to criminal charges in the U.S. for selling subpar drugs. But CDSCO appears to be turning over a new leaf--at least a little.

Apple HealthKit data-sharing plans must overcome HIPAA privacy regs

Apple has discussed collaboration with several promiminent healthcare players as it prepares to roll out its HealthKit service, which is anticipated to be an element of the iPhone 6 that's planned for this fall. The players include Mount Sinai Hospital, the Cleveland Clinic, Johns Hopkins and electronic health records company Allscripts, according to  Reuters.

Tarsa picks up $10M to get its osteoporosis pill to the FDA

Philadelphia's Tarsa Therapeutics has nailed down a $10 million credit facility to help bankroll an FDA submission for Ostora, the company's treatment for postmenopausal osteoporosis.

FDA approves lung preservation device

Expectations are high for the recently FDA-approved, donated lung preservation device, XVIVO Perfusion System with STEEN Solution.