The agreement covers the territories of mainland China (excluding Taiwan and Hong Kong) and Macau
Correvio suffers fresh blow as heart drug fails to win FDA panel backing
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. (NASDAQ: CORV) (TSX: CORV), a specialty pharmaceutical company focused on commercializing hospital drugs, today highlighted that the U.S. Food and Drug Administration (FDA) has accepted for review United Therapeutics Corporation's (NASDAQ: UTHR) New Drug Application (NDA) for Trevyent® (treprostinil) for the treatment of pulmonary arterial hypertension (PAH). The FDA assigned the NDA a Prescription Drug User Fee Act (PDUFA) target action date of April 27, 2020. Trevyent is a drug-device combination product that combines two-day, single use, disposable PatchPump® technology with treprostinil, for the subcutaneous treatment of PAH.
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.