The Trump administration’s broad slash to university research budgets raises pertinent questions over impacts to the biopharma ecosystem, specifically how a changed trajectory of early research programs will affect tomorrow’s treatments and cures. Who is going to bridge research from idea to company if grants from the U.S. NIH are no longer an option?
The U.S. FDA approval of Johnson & Johnson’s Imaavy (nipocalimab-aahu) for myasthenia gravis brings the monoclonal antibody into a treatment space that teems with competition, both approved and in-development candidates. The human Fc receptor inhibitor was approved to treat generalized myasthenia gravis in patients who are 12 years and older. Patients must be anti-acetylcholine receptor [AChR] or anti-muscle-specific kinase [MuSK] antibody positive. Anti-AChR and anti-MuSK antibody-positive individuals make up more than 90% of all antibody-positive gMG patients.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Abeona, Astrazeneca, Bioinvent, Cosmo, CSL, Incyclix, Shorla, Stealth Bio, Telix, Travere.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alpha Anomeric, Alpharose, Charles River Laboratories, Granata, Innosign, Medigene, Oviva, Revelation, Scipher, Vaxart.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Agenus, Ankyra, Astrazeneca, Bayer, Cingulate, Coherus, Idorsia, Incyte, Novadip, Palatin , Puma, Relmada.
South Korea’s Ministry of Food and Drug Safety approved 18 biosimilar products in 2024, making it a record year for domestic biosimilar approvals since the agency’s first nod of Celltrion Inc.’s Remsima, a reference product of Remicade (infliximab), in 2012.
Shanghai-based D3 Bio (Wuxi) Co. Ltd. showed positive results for its lead candidate, next-generation KRAS G12C inhibitor, D3S-001, also known as elisrasib, in patients with KRAS G12C mutation cancers, including patients previously treated with first-generation KRAS G12C inhibitors. Presented at the American Association for Cancer Research (AACR 2025) meeting on April 29, the data were simultaneously published in Nature Medicine.
If the April 30 hearing on biomedical research before the U.S. Senate Appropriations Committee is any indication, the Trump administration could face a big challenge if it tries to cut more than 40% of the NIH’s budget in fiscal 2026 as proposed and slap a 15% cap on indirect costs.
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