U.S. Food and Drug Administration staffers reviewing Correvio Pharma Corp’s heart drug said on Friday they did not believe the benefits of the therapy outweighed its risks, sending the company’s shares down nearly 38%.
Correvio Pharma Corp., formerly Cardiome Pharma Corp., announced that its partner Eddingpharm has enrolled the first patient in a randomized, double-blind, placebo-controlled, phase 3 clinical study evaluating Brinavess versus placebo in patients with recent onset atrial fibrillation (AF). Approximately 240 patients are expected to be enrolled at an estimated 30 clinical trial sites in China.
Cipher Pharmaceuticals and Cardiome Pharma Announce Strategic Transaction for Canadian Business Portfolio of Cardiome
Nine years after the FDA threw Cardiome $CRME for a loop, rejecting its IV atrial fibrillation drug Brinavess (vernakalant), the biotech is no closer to changing the agency’s decision.