The U.S. Food and Drug Administration issued a Complete Response Letter for Alkermes’ New Drug Application for ALKS 3831 (olanzapine/samidorphan) for the treatment of adults with schizophrenia and bipolar 1 disorder, and a CRL for Adamis Pharmaceuticals’ NDA for the high-dose naloxone injection product ZIMHI for the treatment of opioid overdose.
A Paris-based prosecutor initiated an investigation into Sanofi over the company’s drug Depakine, which is on the market for epilepsy and bipolar disorder.
Intra-Cellular Therapies Inc.’s lead drug failed to meet the main goal of a late-stage study in patients with major depressive episodes associated with bipolar disorder.
Allergan Plc’s Vraylar won U.S. regulatory approval to treat depressive episodes of bipolar I disorder, expanding the scope of treatment to a full spectrum of symptoms related to the condition.
Denmark’s H. Lundbeck and Japan’s Otsuka Pharmaceutical announced that the antipsychotic drug Rexulti (brexpiprazole) failed to meet the primary endpoint in two Phase III clinical studies to treat manic episodes in patients with bipolar I disorder.
Seattle-based Impel NeuroPharma closed on a Series D financing totaling $67.5 million, co-led by KKR and Northwest Venture Partners.
Mental health disorders are on the rise in every country in the world and could cost the global economy up to $16 trillion between 2010 and 2030 if a collective failure to respond is not addressed, according to an expert report.
Alkermes, headquartered in Dublin, Ireland, received a $50 million milestone payment from Cambridge, Massachusetts-based Biogen.
An estimated 25 percent of adults in the United States will deal with some form of mental illness within a given year. It’s also estimated that many of the people who experience these problems may never report it or seek help – despite a number of available therapies.
The FDA approved a supplemental NDA that expands the use of Sunovion’s Latuda to include treating major depressive episode associated with bipolar I disorder in pediatric patients.