Newron Pharmaceuticals

Newron Pharmaceuticals S.p.A. is a biopharmaceutical company

Newron Pharmaceuticals S.p.A. is a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the Central Nervous System (CNS) and pain. Marketing authorization in the EU for Xadago (safinamide) was granted by the EU Commission in February 2015, following the recommendation by the Committee for Medicinal Products for Human Use (CHMP) to approve the compound in the EU on Dec. 19, 2014. The New Drug Application (NDA) to the U.S. FDA, as informed in early March, has been accepted for filing, after being re-submitted by Newron on Dec. 26, 2014. In March 2014, Zambon Group, a partner of Newron, submitted a MAA to Swissmedic. Zambon has the rights to commercialize safinamide globally, excluding Japan and other key Asian territories where Meiji Seika has the rights to develop and commercialize the compound.