Topic:

Regulatory

Latest Headlines

Latest Headlines

Clovis looks to rebuild the case for its cancer drug at FDA panel

Clovis Oncology, whose market value has plummeted by more than 80% over the past year, has secured a date with FDA advisers to make the case that its lung cancer treatment merits approval despite some disappointing data.

U.K. slaps GSK with $54.4M fine for decade-old pay-for-delay deal

The U.K.'s Competition and Markets Authority was only formed in 2014, but it didn't mind reaching back more than a decade for evidence to slap GlaxoSmithKline with a $54.4 million (£37.6 million) fine. In its first pay-for-delay decision, it said the U.K. company thwarted generic competition to its antidepressant drug Seroxat by paying off a handful of generic players.

U.K.'s NICE recommends Medtronic MiniMed auto-insulin shutoff for hypoglycemic Type 1 diabetics

The notoriously tight-fisted National Institute for Health and Care Excellence (NICE), which makes healthcare product payment decisions for the U.K. on what can be used in the country's National Health Service (NHS), has come out with a recommendation in support of the use of the MiniMed Paradigm Veo system from Medtronic. It's specifically for adults and children with Type 1 diabetes who have had disabling episodes of hypoglycemia even with continuous subcutaneous insulin infusion.

Burwell says HHS is considering 'march-in' on skyrocketing drug prices

Last month, a group of lawmakers urged the National Institutes of Health (NIH) and the U.S. Department of Health and Human Services (HHS) to take "extraordinary" action to fight rising drug prices. HHS got the note and is considering rolling out new guidelines to bring down skyrocketing prices.

Indian alliance tries to calm U.S. concerns over IP protections

Coming just a few days after the U.S. Pharmaceutical Research and Manufacturers of America called laws in India governing intellectual property "weak," a report out from the subcontinent says the Indian Pharmaceutical Alliance is making moves to assuage concerns from the U.S. Trade Representative over its IP laws.

Dreaded U.S. FDA Form 483s in the spotlight in China

While much of the news in recent months on warnings issued by the U.S. Food and Drug Administration centered on alerts issued to Indian pharmaceutical manfacturers, active pharmaceutical ingredient and drug manufacturers in China have also received their own set of alerts under the FDA's Form 483 regime, according to a report by the Regulatory Affairs Professionals Society.

Hong Kong's Chi-Med files amended U.S. SEC F-1 for Nasdaq IPO

Hong Kong-based Hutchinson China MediTech announced this week it filed an amended F-1 form with the U.S. Securities and Exchange Commission for its planned $100 million IPO in which it plans to sell American depositary shares under the symbol HCM.

After 2nd positive PhIII, AbbVie points endometriosis drug elagolix to a 2017 NDA

AbbVie says it has racked up a second set of positive Phase III data for its endometriosis drug elagolix, setting up a regulatory filing for sometime next year.

Intercept books a date with the FDA as buyout rumors simmer

After an FDA-mandated three-month delay, Intercept Pharmaceuticals is set for a meeting with agency advisers to discuss obeticholic acid, an in-development liver drug tabbed by analysts as a potential blockbuster.

Another win for 'gamification': FDA clears Microsoft Kinect-based physical therapy system

"Gamification" is the new buzzword in med tech. After all, playing games can make tasks fun and provide a source of motivation. In the latest example, the FDA cleared the Yugo Microsoft Kinect-based physical therapy system.