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.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acelyrin, Aerovate, Alumis, Hikma, Jade, Jorna, Ollin, Ono, Novugen, Velavigo.
Ongoing restructurings in the biopharma sector show common themes of cost-cutting, clinical failures and shifting strategic priorities. Companies are increasingly focusing on high-value pipeline assets, closing or consolidating non-core operations and making difficult workforce reductions to preserve capital. While these adjustments may lead to short-term setbacks, they are crucial for ensuring long-term sustainability.
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