PERTH, Australia – The FDA granted Melbourne-based Neuren Pharmaceuticals Ltd. and San Diego, California-based Acadia Pharmaceuticals Inc. a rare pediatric disease designation for trofinetide for treatment of Rett syndrome, a rare neurodevelopmental congenital central nervous system disorder.
Four new U.S. drug approvals, one accelerated for need, have handed a string of year-end victories to five drugmakers, marking an unusually active start to a week full of global holiday celebrations. Daiichi Sankyo Co. Ltd., Astrazeneca plc, Eisai Inc., Intra-Cellular Therapies Inc. and Allergan plc all secured new approvals from the agency.
BEIJING – Chinese drug regulators granted conditional approval to Shanghai Green Valley (Group) Co. Ltd.'s marine-derived oligosaccharide, GV-971, to treat Alzheimer's disease (AD), but required further trials to prove the drug's efficacy after marketing.
A subtype of schizophrenia is related to abnormally high brain levels of hydrogen sulfide (H2S), which has important implications for the development of new treatments, according to a study by researchers at the RIKEN Center for Brain Science (CBS) in Japan.
Days after going public, Viela Bio Inc. nailed down a deal with Mitsubishi Tanabe Pharma Corp. to develop and commercialize Viela’s humanized anti-CD19 monoclonal antibody, inebilizumab, in nine Asia regions for the rare disease called neuromyelitis optica spectrum disorder (NMOSD), as well as other potential future indications.
HONG KONG – South Korean pharmaceutical company Chong Kun Dang Holdings recently invested KRW5 billion (US$4.1 million) in Biorchestra Co. Ltd., a Korean startup based in Daejeon that aims to develop Alzheimer’s dementia treatment based on microRNA.