Topic:

Regulatory

Latest Headlines

Latest Headlines

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.

Abbott wins Medicare coverage, new tech add-on payments for MitraClip cardiology device

Abbott secured Medicare coverage for its MitraClip System to reduce the backward flow of blood through the heart's mitral valve (mitral regurgitation), the company announced Aug. 12. Earlier this month the federal Centers for Medicare and Medicaid services also approved the device for additional reimbursement in the form of new technology add-on payments due to its innovative nature. 

Exact Sciences bags FDA approval and proposed CMS coverage for colorectal cancer screening test

Exact Sciences won FDA approval for its stool-based colorectal cancer diagnostic, charting a regulatory milestone and picking up proposed national coverage for its product along the way.

Celltrion targets J&J's Remicade as biosimilars loom in the U.S.

South Korea's Celltrion is aiming to be second in line when biosimilars make their U.S. landfall, filing an FDA application to market a knockoff of Johnson & Johnson's blockbuster Remicade.

NICE says social values, along with cost, need to be factored into decisions

The U.K.'s National Institute for Health and Care Excellence wants to know what "societal values" should be considered, along with cost and efficiency, when making decisions. Now an appointed group of 30 people have given it that feedback, PMLive reports.