Kura Oncology Inc. and Kyowa Kirin Co. Ltd.’s selective oral menin inhibitor, ziftomenib, met the primary endpoints in the phase II registrational Komet-001 trial in patients with relapsed/refractory NPM1-mutant acute myeloid leukemia (AML), and Kura expects to submit its NDA to the U.S. FDA in the second quarter of 2025.
Kura Oncology Inc. and Kyowa Kirin Co. Ltd.’s selective oral menin inhibitor, ziftomenib, met the primary endpoints in the phase II registrational Komet-001 trial in patients with relapsed/refractory NPM1-mutant acute myeloid leukemia (AML), and Kura expects to submit its NDA to the U.S. FDA in the second quarter of 2025.
Japan’s drug pricing scheme has gotten more complicated, and pharma companies should brace themselves for annual price cuts. Industry has been pushing back against the annual price reductions to no avail, Ray Fujii, managing director of LEK’s San Francisco office told BioWorld. Although 2025 is a mid-year revision in Japan, and not a formal price revision year, the system for considering drug prices has gotten more confusing with a new formula for determining price cuts.
Inflammatory diseases specialist AB2 Bio Ltd. has signed a potential $686 million U.S. commercialization deal for its interleukin-18 neutralizing drug tadekinig. The agreement with Japanese pharma company Nippon Shinyaku Co. Ltd. includes an initial payment of $6 million, with a further $30 million due later this year.
Japan’s drug pricing scheme has gotten more complicated, and pharma companies should brace themselves for annual price cuts. Industry has been pushing back against the annual price reductions to no avail, Ray Fujii, managing director of LEK’s San Francisco office told BioWorld. Although 2025 is a mid-year revision in Japan, and not a formal price revision year, the system for considering drug prices has gotten more confusing with a new formula for determining price cuts.
Inflammatory diseases specialist AB2 Bio Ltd. has signed a potential $686 million U.S. commercialization deal for its interleukin-18 neutralizing drug tadekinig. The agreement with Japanese pharma company Nippon Shinyaku Co. Ltd. includes an initial payment of $6 million, with a further $30 million due later this year.
Shionogi & Co. Ltd. won a $375 million project agreement from the Rapid Response Partnership Vehicle to develop its 3CL protease inhibitor, S-892216, as a long-acting injectable for COVID-19 pre-exposure prophylaxis. The project was awarded to New Jersey-based Shionogi Inc., a subsidiary of the Osaka, Japan-based pharmaceutical company. S-892216 is an investigational second-generation 3CL protease inhibitor in development as a long-acting injectable for prophylaxis treatment of SARS-CoV-2.
As more Asia biotechs turn to regenerative medicine to address disorders without a cure, Medipost Inc. is continuing global expansion with Cartistem, its allogeneic human umbilical cord blood-derived mesenchymal stem cell product that gained clearance in South Korea in 2012 to treat knee osteoarthritis.
Marking the second global approval after Japan, the U.S. FDA has approved Datroway (datopotamab deruxtecan), a trophoblast cell surface antigen 2-directed antibody-drug conjugate (ADC) from Daiichi Sankyo Co. Ltd. and Astrazeneca plc, for treating adults with hormone receptor-positive, HER2-negative unresectable or recurrent breast cancer after prior chemotherapy.
Shionogi & Co. Ltd. won a $375 million project agreement from the Rapid Response Partnership Vehicle to develop its 3CL protease inhibitor, S-892216, as a long-acting injectable for COVID-19 pre-exposure prophylaxis.
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