U.S. FDA commissioner Marty Makary appeared at the May 22 Senate Appropriations Committee with the news the White House proposed an FDA budget for fiscal 2026 of $6.8 billion including user fees. This is a cut of 11.5% that will not likely go over well on Capitol Hill as the FY 2026 budget process unwinds.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abli, Belite, Cel-Sci, Genentech, Innocare, Johnson & Johnson, Moderna.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acelyrin, Alumis, Evofem, Genfit, Ipsen, Multispan, Optinose, Paratek, Pfizer, Pharma 1, SK Bioscience, Synfini.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Accro, Avalyn, EMD Serono, Endeavor, Pepromene, Puretech, Sarepta, Soleno.
Samsung Biologics Co. Ltd. plans to establish a new holding company and to spin off its biosimilar division, Samsung Bioepis Co. Ltd., by October. The corporate restructuring will draw clear lines between Samsung Biologics’ CDMO operations and Samsung Bioepis’ biosimilar business.
Annji Pharmaceutical Co. Ltd.’s rosolutamide (AJ-201, JM-17) achieved positive results in a phase I/II trial in adults with spinal and bulbar muscular atrophy, also known as Kennedy’s disease.
Infectious disease stocks stumbled in the early months of 2025, with the BioWorld Infectious Disease Index (BIDI) plunging 17.83% by the end of April, well behind the broader markets. By comparison, the Nasdaq Biotechnology Index slipped just 1.16%, and the Dow Jones Industrial Average declined 4.41%. In 2024, the BIDI ended the year down 6.28%, after hitting a low of -25.12% in late April.
The recent 8-1 adcom vote against the U.S. applicability of Genentech Inc.’s Starglo trial is being seen as a warning signal expanding beyond the confirmatory trial for Columvi (glofitamab) as a treatment for relapsed/refractory diffuse large B-cell lymphoma.
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