Recent developments
Manufacturing capacity shifts
U.S. biomanufacturing expanded with Genentech’s Holly Springs facility investment to $2 billion. Johnson & Johnson outlined a $55 billion investment in U.S. manufacturing, research, and development, including new cell therapy and drug product sites. SPIE extended its maintenance contract with Merck at the Molsheim site to optimize utilities and energy performance.
CDMO and digitalization
AGC Biologics’ Waskyra gene therapy gained U.S. and EU authorization, reinforcing ex vivo cell and gene manufacturing. WuXi Biologics secured UK MHRA GMP certifications for ophthalmic biologic drug product and packaging. It also launched the PatroLab digital twin platform enabling real‑time monitoring, predictive control, and alignment with real‑time release testing.
Oncology pipeline activity
The FDA granted Breakthrough Therapy designation to sofetabart mipitecan, a FRα ADC for platinum‑resistant ovarian cancer. Merck opened the KANDLELIT-007 Phase 3 clinical trial of calderasib with subcutaneous KEYTRUDA QLEX. Genmab reported PFS gains in the EPCORE DLBCL-1 trial, while J&J’s MajesTEC-9 study showed survival improvements with teclistamab. Additional signals included EGFR/MET (OrigAMI‑1), dual HER2 blockade (Boehringer–Jazz), and individualized mRNA immunotherapy (KEYNOTE‑942).
Modalities and delivery
Aspect Biosystems and Novo Nordisk advanced cellular medicines for diabetes, integrating selected manufacturing assets. Boehringer Ingelheim initiated a Phase IIa clinical trial for BI 765423 (IL‑11 mAb) in IPF. Takeda licensed Halozyme’s ENHANZE drug delivery technology for use with vedolizumab to enable subcutaneous dosing. Lilly’s TOGETHER‑PsA Phase 3b trial supported incretin–biologic co‑treatment. Lilly agreed to acquire Ventyx Biosciences for NLRP3 programs.
Markets, AI, policy
Genmab reported worldwide net sales of DARZALEX of USD 14.351 billion, generating J&J royalties. Johnson & Johnson reached a voluntary agreement with the U.S. government to improve access and reduce costs. NVIDIA and Lilly formed an AI co-innovation lab, and Genmab launched a partnership with Anthropic. Merck completed the acquisition of Cidara Therapeutics. The EU Critical Chemicals Alliance convened to prioritize critical molecules and production sites.