On Jan. 21, economist Jay Bhattacharya spoke publicly for the first time since becoming the current NIH director, addressing the NIH Council of Councils in an open session. The goal of Bhattacharya’s remarks seemed to be to reassure troubled staffers. His reassurances, however, were given in the face of another blow to NIH research.
Ascentage Pharma Group Corp. Ltd. said two of its novel candidates have been included in the 2025 Chinese Society of Clinical Oncology Guidelines, including its in-house developed Bcl-2 selective inhibitor, lisaftoclax (APG-2575), which is under review in China and could be the first domestically approved Bcl-2 inhibitor and the second global approval.
Synthetic lethality specialist Tessellate Bio NV has closed its first deal, agreeing to a €500 million-plus (US$570 million) research and license agreement with Boehringer Ingelheim GmbH, to develop small molecules targeting tumors that depend on alternative lengthening of telomeres (ALT) for their growth.
If U.S. sectoral tariffs on biopharmaceuticals become a reality and most country-by-country tariffs on other medical products resume, manufacturers may have to rethink their use of U.S. free trade zones to turn foreign-sourced active pharmaceutical ingredients and other components into finished products for the U.S. market.
Veraxa Biotech AG is merging with special purpose acquisition company (SPAC) Voyager Acquisition Corp. to become a publicly traded company that will develop treatments for solid tumors.
China’s National Medical Products Administration (NMPA) has accepted Innocare Pharma Ltd.’s NDA for its second-generation pan-tropomyosin receptor kinase inhibitor, zurletrectinib (ICP-723), for treating adults and adolescents with advanced solid tumors harboring neurotrophic tyrosine receptor kinase gene fusions.
China’s National Medical Products Administration has given the thumbs up to Akeso Pharmaceuticals Inc.’s ebdarokimab for treating moderate to severe plaque psoriasis in adults. An interleukin (IL)-12/IL-23 dual-targeted monoclonal antibody, ebdarokimab (also known as AK-101) is the company's first class 1 new drug approved for autoimmune diseases.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akeso, BMS, GSK, NS Pharma, Regeneron, Sanofi, Tempest, Valneva, Viatris and Zai Lab.
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