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.
San Francisco-based Xyphos Biosciences Inc. is pooling technology platforms with Boston’s Kelonia Therapeutics Inc. in a novel immuno-oncology (I-O) drug discovery deal that could fetch more than $800 million. Xyphos and Kelonia will collaborate to develop a maximum of two in vivo CAR T-cell therapy programs, utilizing both Kelonia’s in vivo gene placement system called iGPS and Xyphos’ Accel technology platform.
Ono Pharmaceutical Co. Ltd. inked deals with Shattuck Labs Inc. and Numab Therapeutics AG aimed at bolstering its pipeline in oncology and autoimmune and inflammatory diseases. Ono struck a drug discovery collaboration and option agreement with Shattuck Labs to generate bifunctional fusion proteins for pathways involved in autoimmune and inflammatory diseases. It also signed a global research, development and commercialization deal with Numab for its NM-49, a multispecific antibody designed to activate tumor-associated macrophage phagocytosis for treating cancers.
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.
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.
Palo Alto, Calif.-based Bridgebio Pharma Inc. will hand over development and sales of its rare bone growth disorder therapy, infigratinib, in Japan to Kyowa Kirin Co. Ltd. under its latest exclusive licensing deal.
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.
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.
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.
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