News

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 launch window isn't just getting shorter, it’s moving earlier. Here’s how emerging biopharma companies can prepare for commercialization before approval arrives.

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.

Cytiva’s Pierre-Alain Ruffieux discusses standardization, regionalization, talent gaps, and regulatory pathways shaping advanced biomanufacturing’s future ahead of BIO 2026.

Early clinical data highlight advances in bispecific antibodies and immune modulation, with new findings in Type 2 inflammatory diseases, alopecia areata, and platinum-resistant ovarian cancer.

Bambusa Therapeutics reported positive preliminary phase 1 multiple ascending dose data for BBT002, a bispecific antibody targeting IL-4Rα and IL-5. The investigational therapy demonstrated sustained biomarker suppression, a favorable safety profile, and a half-life supporting extended dosing intervals.

The company reported that all three participants in the 3 µg/kg dose cohort achieved a ≥25% SALT score reduction following single-dose subcutaneous administration, with dose escalation ongoing toward a recommended phase 2 dose.

Interim phase 1 data show CTIM-76 achieved a 29% confirmed overall response rate in heavily pretreated patients with platinum-resistant ovarian cancer, while demonstrating a favorable safety profile and low rates of cytokine release syndrome.

Johnson & Johnson reported that the MonumenTAL-3 trial showed 24-month progression-free survival up to 81.3% and overall survival up to 89.2% with the GPRC5D bispecific combination versus standard of care.

New clinical data highlight advances in endocrine, metabolic, and rare disease drug development, with positive updates from MBX Biosciences, Gan & Lee Pharmaceuticals, and Novartis.

Novartis announced that delpacibart braxlosiran met primary and key secondary biomarker endpoints in the Phase 1/2 FORTITUDE study for facioscapulohumeral muscular dystrophy. The investigational antibody oligonucleotide conjugate is being evaluated as a potential disease-modifying therapy for a condition that currently has no approved treatments.

New one-year data from MBX Biosciences show sustained efficacy, improved kidney and bone markers, and continued calcium control with once-weekly canvuparatide in chronic hypoparathyroidism, supporting advancement into phase 3 development.

Gan & Lee has reported positive topline trial results for insulin ludefen in type 2 diabetes and the GLP-1 bofanglutide in obesity.

New developments in CAR-T cell therapy, antibody-drug conjugates, and biosimilars highlight continued innovation across oncology and immunology.

Andrea Zobel and Marco Hogenboom of Cencora World Courier discuss how advances in radiopharmaceutical manufacturing, cancer biology, and specialty logistics are enabling the expansion of targeted radiopharmaceutical therapies into larger patient populations and broader oncology indications.

Phase 3 cancer vaccines and rare disease programs are positioning mRNA therapeutics beyond COVID-19, expanding precision treatment opportunities across oncology and genetic disorders.

New data presented at EHA 2026 showed promising efficacy and manageable safety for Imviva Biotech's investigational allogeneic CAR-T therapy CTD402 in pediatric and adult patients with relapsed or refractory T-cell acute lymphoblastic leukemia and lymphoblastic lymphoma.

Immunome has dosed the first patient in a Phase 1 clinical trial evaluating IM-1617, a potential first-in-class antibody-drug conjugate incorporating the company's proprietary HC74 topoisomerase I inhibitor payload. The study will assess safety and preliminary anti-tumor activity in patients with advanced solid tumors.

FDA has approved Organon's tocilizumab-bavi (Tofidence) for CAR T-cell–induced CRS and hospitalized COVID-19 in adults and children aged 2 years or older.