Aspire Bariatrics has nabbed a $12 million loan facility from Hercules Technology Growth Capital to wrap up its ongoing U.S. pivotal trial and submit a PMA in mid-2015. The company hopes to launch its stomach content-aspirating product in the U.S. in early 2016.
India's National Pharmaceutical Pricing Authority has told drugmakers that failure to hand in drug price and sales data by next week is not an option.
China's market for medical devices is expected to pass Japan's this year to become the world's second-largest, topped only by the United States. A consulting firm forecast China's market would pass the $55 billion mark this year.
Intercept Pharmaceuticals has nabbed the FDA's breakthrough therapy designation for obeticholic acid, a closely watched therapy in the pipeline for a blockbuster NASH indication.
Zeltiq Aesthetics gained 4% after it said FDA cleared a new applicator that uses lower temperatures to cut the one-hour treatment time almost in half. Zeltiq's CoolSculpting procedure is cleared by FDA for noninvasive fat reduction in the abdomen, flank and thighs.
It's no secret that branded drugmakers often rely on price hikes to keep U.S. sales growth coming, especially on older meds whose patents are close to the ends of their lives. But according to new data, prices spiked more than 10% last year--a trend that may fuel the payer backlash that's been steadily mounting.
IBM's artificial intelligence tool Watson is an expert at Jeopardy, but it can't answer the question as to whether the technology should be regulated as a medical device. That decision rests with Congress and the FDA, or perhaps lobbyists.
The European Medicines Agency recommended 20 new veterinary drugs for approval in 2014--the highest number of positive opinions it has issued in the past 5 years in animal health.
The FDA issued an administrative order requiring PMA approval for new and existing automated external defibrillators, citing manufacturing issues and pointing to the recall of 2 million of the devices since 2005 as justification for the more stringent regulation.
India's Central Drugs Standard Control Organization wants to tweak the rules on its presubmission process with agency staff and experts.