Medipal Holdings Corp. and JCR Pharmaceuticals Co. Ltd. have announced the completion of the clinical trial notification review by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for a phase I/II study of JR-446 for the treatment of mucopolysaccharidosis type IIIB (MPS IIIB; Sanfilippo syndrome type B).
Japan’s Pharmaceutical and Medical Devices Agency (PMDA) has jumped on board the e-consent train for clinical trials, publishing a guidance for the use of electronic means for obtaining a study participant’s informed consent.
Kissei Pharmaceutical Co. Ltd. has withdrawn its NDA in Japan for rovatirelin (KPS-0373) for the treatment of spinocerebellar degeneration. Kissei, of Osaka, Japan, said it temporarily withdrew the application for marketing approval and would discuss the possibility of conducting additional clinical trials with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), because the PMDA expressed concern about the approval based on the current clinical trial data.
