Topic:

Regulatory

Latest Headlines

Latest Headlines

Roche gets FDA green light for quick C. difficile test

Roche got an FDA OK for its rapid test for Clostridium difficile, picking up another regulatory gold star as it broadens its offerings on its cobas 4800 system.

Valeant, Actavis on verge of FDA nods in IBS for Xifaxan, eluxadoline

Get ready for a showdown in the irritable bowel syndrome market.

FDA approves long-acting formulation of J&J schizophrenia med

The FDA gave the green light to Johnson & Johnson's Invega Trinza, which is injected four times a year, making it the longest-acting schizophrenia drug on the market.

Amicus' rare disease drug lines up for a quick EU approval

Amicus Therapeutics has landed on the European regulatory fast track, potentially shortening the review time for its orphan drug as it prepares filings at home and abroad.

EU's medicines agency stands by recommendation to suspend drugs studied at GVK India facility

The European Medicines Agency is standing by its original recommendation made earlier this year to suspend a number of medicines that received European Union clearance based on clinical studies conducted by GVK Biosciences in India.

Cipla pulls levalbuterol on FDA warning; Wockhardt removes other drugs on concerns

Cipla announced a drug recall of its asthma inhalant levalbuterol from the U.S. market following an FDA warning, and Wockhardt withdrew about a dozen drugs on manufacturing concerns at two of its plants in India.

FDA to allow midstream changes to device trials as part of effort to speed up approvals

The FDA issued draft guidance this week on adaptive designs for medical device clinical studies. Similar to a prior guidance on the incorporation of patient preference data in clinical trials, the latest guidance should help companies perform trials faster, and signals greater flexibility on the behalf of the FDA.

Merck's Keytruda, BMS' Opdivo score European nods to keep immuno-oncology race blazing

Merck's Keytruda gained some regulatory ground in Europe on Friday, nabbing a melanoma recommendation that Opdivo snagged last month. But Opdivo continued to charge ahead, too, winning a nod in lung cancer to help preserve its lead.

England's Cancer Drugs Fund keeps Bayer's Stivarga, axes Eisai and Lilly meds

England's Cancer Drugs Fund has drawn a hard line when it comes to its list of covered meds, axing cancer treatments despite pushback from drugmakers. But Bayer scored a victory for its cancer med Stivarga, getting the fund to reverse its decision and keep the drug on its list even as rival companies lose similar battles.

Want the U.K.'s NHS to quickly adopt new products, drugmakers? There's an office for that

Drugmakers want market access and reimbursement for their new products as fast as possible, and now, the U.K.'s National Institute for Health and Care Excellence is setting up an office with the same goal.