Following a meeting with the U.S. Food and Drug Administration, SAGE Therapeutics is seeing the goal line for potential expedited approval of the company’s major depressive disorder and postpartum depression treatment, SAGE-217.
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.
Janssen Pharmaceuticals is eying a potential breakthrough in treating refractory major depressive disorder.
The U.S. FDA accepted Alkermes’ New Drug Application (NDA) for ALKS 5461, a treatment for major depressive disorder
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.
Alkermes plc announced the initiation of its rolling submission of a New Drug Application to the U.S. Food and Drug Administration, seeking marketing approval of ALKS 5461. The once-daily, oral vestigational medicine with a novel mechanism of action is intended for the adjunctive treatment of major depressive disorder MDD).
One day after the abrupt resignation of Chief Executive Officer Uli Hacksell, Cerecor Inc. announced that the company was divesting a drug therapy for major depressive order to Janssen Pharmaceuticals for up to $45 million.
23andMe, working in collaboration with the Milken Institute and Lundbeck, announced that they have commenced enrollment for a first-of-its kind genetic study designed to gain understanding of the underlying biology of major depressive and bipolar disorders.
In meeting with industry analysts, J&J indicated it expects to have 10 new products approved between 2017 and 2021 that have blockbuster potential.
Alkermes’ experimental anti-depression drug ALKS-5461 significantly reduced symptoms in major depressive disorder patients not helped by standard treatments.