UCB’s Fintepla (fenfluramine) oral solution CIV was approved in the United States for the treatment of seizures associated with Lennox-Gastaut syndrome in patients two years of age and older. Additionally, the FDA granted pediatric exclusivity for the product.
Shares of Ovid Therapeutics soared in trading after the company announced pharma giant Takeda signed a licensing agreement valued at $856 million to secure global rights to the investigational medicine soticlestat for the treatment of two forms of rare epilepsy.
Jazz Pharmaceuticals is beefing up its neurology pipeline with a $7.2 billion buyout of GW Pharmaceuticals, the only company yet to score U.S. regulatory approval for a cannabis-derived product.
Takeda Pharmaceutical and Ovid Therapeutics announced that the companies have gathered positive data from their Phase II ELEKTRA study of soticlestat in children with Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS).
The medical cannabis market in the United States, even with all of its restrictions, continues to be a fertile area not only for dispensaries, but pharma companies developing cannabis-derived drugs; and proponents say further growth can be generated by educating physicians about medical cannabis.
Emeryville, California-based Zogenix announced positive topline data from the company’s Phase III trial of Fintepla (fenfluramine) in Lennox-Gastaut Syndrome.
Eton Pharmaceuticals Inc. announced that Aucta Pharmaceuticals Inc.’s New Drug Application for ET-105, an innovative formulation of lamotrigine which Eton acquired the U.S. marketing rights to in June 2019, was accepted for review by the U.S. Food and Drug Administration.
GW Pharmaceuticals’ marijuana-based treatment Epidyolex won a positive recommendation for marketing approval from a European Medicines Agency (EMA) panel for use as an additional treatment for two types of seizures.
The U.S. Food and Drug Administration declined to approve Aquestive Therapeutics Inc.’s erectile dysfunction treatment tadalafil and sought additional data.
Rockville, Maryland-based Supernus Pharmaceuticals is acquiring Biscayne Neurotherapeutics, which is located in Miami.