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.
Novartis is acquiring Cambridge, Massachusetts-based neuroscience company Cadent Therapeutics for a $210 million upfront payment and potentially $560 million in milestone payments.
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.
Shares of Alkermes were up in trading after the Ireland-based company announced the experimental schizophrenia drug ALKS 3831 was overwhelmingly supported by an advisory committee for the U.S. Food and Drug Administration.
Sunovion Pharmaceuticals Inc. announced that results of a four-week pivotal study (SEP361-201) evaluating the safety and efficacy of SEP-363856 in patients with schizophrenia were published online in the New England Journal of Medicine.
Acadia Pharmaceuticals Inc.’s add-on treatment pimavanserin for schizophrenia failed to meet the main goal in a late-stage study.
Newron must delay a trial of the Swiss-listed drugmaker’s prospective schizophrenia medicine evenamide after the U.S. FDA raised concerns about CNS events that emerged in rats and dogs.