Cambridge, Massachusetts-based Praxis Precision Medicines raised about $110 million in a Series C financing, led by Eventide Asset Management,
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 Alert
Acromegaly, 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), TherapeuticsWrapping 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.
The U.S. Food and Drug Administration accepted Aquestive Therapeutics’ New Drug Application for Libervant (diazepam) Buccal Film for seizure clusters.
Zogenix Reports Positive Results from Phase III Trial of Rare Childhood Epilepsy Study
Children, 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&DEmeryville, California-based Zogenix announced positive topline data from the company’s Phase III trial of Fintepla (fenfluramine) in Lennox-Gastaut Syndrome.
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.
The U.S. Food and Drug Administration approved Neurelis Inc.’s Valtoco (diazepam nasal spray) as an acute treatment of intermittent, stereotypic episodes of frequent seizure activity that are distinct from a patient’s usual seizure pattern in people with epilepsy 6 years of age and older.
Swiss biotech group Idorsia lifted the lid off a 2019 deal for the company’s investigational epilepsy medicine, revealing the pact that is potentially worth more than $400 million is with U.S.-based Neurocrine Biosciences.
As part of the deal, Neurocrine Biosciences gains an exclusive license to XEN901, a clinical-stage selective Nav1.6 sodium channel inhibitor with potential in SCN8A developmental and epileptic encephalopathy (SCN8A-DEE) and other forms of epilepsy.