Cardiome Pharma Corp.
Please contact Sales at: (212) 520-2765 or email PharmaNewsSales@informa.com
Latest From Cardiome Pharma Corp.
Deal Snapshot: Building portfolio and commercial infrastructure in Europe, Advanz gets both at a modest price in acquiring Correvio.
The latest news on novel drug approvals and complete response letters from our US FDA Performance Tracker.
Brinavess Rejected By Advisory Cmte., Leaving US FDA To Mull Lifting Clinical Hold On Correvio's AFib Drug
Cardiovascular and Renal Drugs Advisory Committee voted 11-2 against approval for Correvio's atrial fibrillation drug Brinavess over cardiovascular safety concerns; the agency would have to lift the long-standing clinical hold on the drug before the company can do any further study in humans.
Correvio's atrial fibrillation drug Brinavess will return to a US FDA advisory committee more than a decade after the agency first declined to approve the drug; FDA still has a series of cardiovascular safety concerns related to the drug and is not convinced by data from the European experience.