Otsuka Pharmaceutical Co. Ltd.’s AVP-786 missed the primary endpoint for a third time in a phase III trial for agitation associated with dementia due to Alzheimer’s disease (AD). Two previous phase III trials also failed to show statistical significance for AVP-786.
The U.S. FDA has accepted for review Daiichi Sankyo Co. Ltd.’s and Astrazeneca plc’s BLA for datopotamab deruxtecan (dato-dxd) to treat adults with locally advanced or metastatic nonsquamous non-small-cell lung cancer who have received prior systemic therapy.
Takeda Pharmaceutical Co. Ltd. and Protagonist Therapeutics Inc. have inked a global development and commercialization deal worth up to $1.7 billion for Protagonist’s rusfertide for treatment of polycythemia vera (PV), a rare and chronic blood disorder affecting bone marrow.
Armed with strong phase III safety data in Japanese patients, Palo Alto, Calif.-based Bridgebio Pharma Inc. is planning to file for Japan approval of its investigational drug acoramidis for a rare heart disorder.
Vision Care Group CEO Masayo Takahashi led the world's first clinical study of a retinal cell transplant derived from induced pluripotent stem cells (iPS cells) in 2014 when she led the Laboratory for Retinal Regeneration at Japan’s Riken Center for Biosystems Dynamics Research. In 2019, she founded Vision Care and subsequently founded two subsidiary companies dedicated to developing cell and gene therapies.
Shanghai-based Ji Xing Pharmaceuticals has signed a number of licensing deals over the last week for China rights to cardiovascular drugs to advance its pipeline and its global ambitions, partnering most recently with Tokyo-based TMS Co. Ltd. after the Chinese company acquired global rights for TMS-007 (also known as BIIB-131) from Biogen Inc.
The U.S. FDA issued Astellas Pharma Inc. a complete response letter for its BLA for zolbetuximab, citing unresolved deficiencies following its pre-license inspection of a third-party manufacturing facility for claudin 18.2-targeting drug, which was recently listed in the 2024 edition of Clarivate’s Drugs to Watch.
If the COVID-19 pandemic shocked countries to build self-reliance in biomedical ecosystems, the re-opening of borders in 2023 kickstarted international collaborations to grow major biohubs in Asia. Countries in the Asia Pacific region – including Singapore, China, Japan, Korea and Australia – increasingly drew overseas investors and collaborators, helping each country grow national biotech capabilities and expertise.
In a global first, Japan's Ministry of Health, Labor and Welfare has approved CSL Ltd.’s and Arcturus Therapeutics Inc.’s self-amplifying messenger RNA (sa-mRNA) vaccine (ARCT-154) for COVID-19 in adults. The approval marks the first milestone for a November 2022 licensing deal under which CSL subsidiary CSL Seqirus in-licensed Arcturus’ late-stage sa-mRNA vaccine platform technology.
The U.S. FDA’s Office of Prescription Drug Promotion is calling out Otsuka Pharmaceutical Co. Ltd. for making “false or misleading claims and representations about the efficacy of Rexulti” in a television advertisement.