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).
Special Feature: Medical Cannabis Continues To GrowAnalysts, August 2020, Canada, Cannabidiol (CBD), Cannabis, Colorado, Coronavirus Disease (COVID-19) Pandemic, Coronavirus Disease 2019 (COVID-19), Doctors, Dravet syndrome, Drug Schedules, Europe, Florida, Healthcare Communications Agencies, Healthcare Communications Networks, Issue Archives, Lennox-Gastaut Syndrome (LGS), Marketing & Advertising, Med Ad News, Medical Cannabis, Minnesota, New Jersey, New Mexico, Oklahoma, Schedule I Drugs, Schedule II Drugs, Schedule III Drugs, Special Features, Synthesized Molecules, Tetrahydrocannabinol (THC), United States, Washington
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.
The U.S. Food and Drug Administration approved Zogenix Inc.’s Fintepla (fenfluramine) oral solution, CIV for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older.
FDA Action AlertAcromegaly, Blockbusters, Checkpoint Inhibitors, Clinical Trials, Cutaneous Squamous Cell Carcinoma (CSCC), Diffuse Large B-Cell Lymphoma (DLBCL), Dravet syndrome, FDA/Regulatory, NDA Resubmission, New Drug Applications, Non-alcoholic steatohepatitis (NASH), Postoperative Pain, R&D, Seizures, Supplemental Biologics License Application, Supplemental New Drug Application (sNDA), Therapeutics
Wrapping up June and ahead of the July 4 holiday, the U.S. Food and Drug Administration has a busy two-week period coming up for drug approval reviews.
The U.S. Food and Drug Administration has a busy week of possible drug approvals on the regulatory agency’s calendar, including Celgene’s ozanimod for relapsing forms of multiple sclerosis.
Zogenix Reports Positive Results from Phase III Trial of Rare Childhood Epilepsy StudyChildren, Clinical Data, Clinical Trials, Dravet syndrome, European Commission, European Medicines Agency (EMA), FDA, FDA/Regulatory, Lennox-Gastaut Syndrome (LGS), New Drug Application (NDA), Orphan Drug Designation, Orphan Drug Designation, Priority Review, R&D
Emeryville, California-based Zogenix announced positive topline data from the company’s Phase III trial of Fintepla (fenfluramine) in Lennox-Gastaut Syndrome.
Zogenix plans to resubmit a New Drug Application for Fintepla (fenfluramine) to treat seizures associated with Dravet syndrome.
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.