Alkermes plc today presented new research from its psychiatry portfolio at the 2022 Congress of the Schizophrenia International Research Society (SIRS).
The U.S. Food and Drug Administration approved BioXcel Therapeutics Inc.’s IGALMI (dexmedetomidine) sublingual film for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.
On the strength of data from Alzamend Neuro’s Phase I study of its lead compound AL001 being developed for the treatment of Alzheimer’s disease, the company is looking to commence a Phase II multiple ascending dose study for that indication during the second quarter of 2022.
The U.S. Food and Drug Administration approved Intra-Cellular Therapies Inc.’s Caplyta for the treatment of depressive episodes associated with bipolar I or II disorder in adults, as monotherapy and as adjunctive therapy with lithium or valproate.
New York-based Intra-Cellular Therapies published the results of the company’s Study 404 phase III trial of lumateperone as monotherapy for major depressive episodes associated with bipolar I or bipolar II disorder.
Sage Therapeutics ended two late-stage studies of the depression drug zuranolone after discussions with the U.S. Food and Drug Administration led the company to believe they were unnecessary for potential regulatory approval.
Alkermes Plc said on June 1 the U.S. Food and Drug Administration approved the company’s Lybalvi for the treatment of schizophrenia and bipolar I disorder.
Several biopharmaceutical companies submitted New Drug Applications (NDAs) to the U.S. Food and Drug Administration in recent weeks, covering treatment indications ranging from an opioid overdose to bipolar disorder and rare disease.
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.