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Takeda will use Boltz biomolecular AI models to support structure prediction, affinity estimation, and molecular design in preclinical research.

Japan's Ministry of Health, Labour and Welfare has approved the subcutaneous formulation of isatuximab (Sarclisa) across multiple myeloma treatment lines, making it the second country after the European Union to greenlight the administration route change backed by Phase 3 IRAKLIA trial data — with a US decision now expected by July 23, 2026.

The FDA's Vaccines and Related Biological Products Advisory Committee voted unanimously on June 18, 2026 that the benefits of mFLUSIVA (mRNA-1010) outweigh its risks for adults 50 and older, positioning Moderna for a potential approval by August 5 that would make the vaccine the first mRNA-based seasonal influenza product licensed in the US.

Today's BioPharm Brief covers an FDA filing acceptance for Roche's Lunsumio and Polivy combination in lymphoma, a pediatric expansion for Merck's CAPVAXIVE vaccine, and a key advisory committee meeting for Moderna's mRNA-based flu vaccine.

Basel’s innovation campus is expanding with new research institutes, laboratories, and collaborative infrastructure for life sciences growth.

During an interview with BioPharm International, Cencora experts Andrea Zobel, senior manager of dangerous goods, and Marco Hogenboom, senior director of specialty logistics, highlighted the unique regulatory, logistical, and educational challenges associated with delivering radiopharmaceutical therapies to patients worldwide.

The FDA has accepted Roche's supplemental BLA for a chemotherapy-free combination of mosunetuzumab (Lunsumio VELO) and polatuzumab vedotin (Polivy) in adults with relapsed or refractory large B-cell lymphoma, based on Phase 3 SUNMO trial data showing a 59% reduction in the risk of disease progression or death compared to standard salvage chemotherapy.

The supplemental approval is based on immunogenicity data from the STRIDE-13 phase 3 trial and, according to Merck, makes the vaccine the only one of its type specifically indicated for this at-risk pediatric population in the United States.

Moderna's mFLUSIVA (mRNA-1010) faces an FDA advisory committee vote on June 18 — a pivotal step for the first mRNA-based seasonal influenza vaccine to seek US licensure, following a turbulent regulatory path that began with an unprecedented refusal-to-file decision earlier this year.

The company reported that phase I data show approximately 40% of patients remained cancer-free at 10 years, while 2 phase 2 trials are ongoing.

LG AI Research and D&D Pharmatech have launched a collaboration aimed at developing next-generation oral peptide therapeutics by combining artificial intelligence-driven molecular design with peptide formulation and development expertise.

Jazz Pharmaceuticals and AbCellera have entered a research collaboration to discover and develop next-generation multispecific T-cell engaging antibodies for gastrointestinal cancers and other solid tumors, with the agreement potentially valued at up to $792 million per program.

Collapsing entry prices and a thickening field of competitors have recast process intensification for biosimilars as a question of commercial survival through speed and agility.