Updated phase 2 IOV-LUN-202 data show Iovance’s TIL cell therapy lifileucel produced a 24.6% response rate in previously treated non-squamous metastatic NSCLC, rising to 52.0% in KRAS and HER2 wild-type patients, as the company launches a biomarker-enriched registrational cohort.
In the 80-week phase 3 TRANSCEND-T2D-2 trial in adults with type 2 diabetes, Eli Lilly’s GIP/GLP-1/glucagon triple agonist retatrutide lowered A1C by 2.2% and body weight by up to 20.9%, compared with 1.8% and 9.4% with Ozempic 2 mg.
Genmab’s petosemtamab plus pembrolizumab cuts the risk of death by 50% in phase 3 head and neck cancer, AbbVie submits a BLA for etentamig in relapsed or refractory multiple myeloma, and Benitec reports interim data for BB-301 gene therapy in OPMD-related dysphagia.
The EGFR×LGR5 bispecific antibody met both primary endpoints, overall survival and objective response rate, at the first interim analysis of LiGeR-HN1 in first-line PD-L1-positive recurrent or metastatic head and neck cancer.
Long-term phase 2 data presented at ESMO 2026 show 3SBio’s tivunatamig plus chemotherapy extended progression-free survival vs tislelizumab plus chemotherapy in squamous and non-squamous NSCLC.
At AAPS PharmSci 360, Thermo Fisher Scientific scientists described how predictive modeling guides technology selection for poorly soluble drugs, and outlined plans to bring solvent-free KinetiSol technology to commercial scale in 2027.
BMS and SystImmune’s bispecific ADC iza-bren nearly doubles progression-free survival in EGFR-mutated lung cancer, GSK and Hansoh’s B7-H3 ADC Ris-Rez extends progression-free survival in relapsed osteosarcoma, and Immatics’ TCR bispecific IMA402 posts a 32% response rate in PRAME-high tumors.
Phase 1b data at ESMO 2026 show the TCR-based T-cell engager produced durable responses in PRAME-high melanoma, with 91% of patients alive at one year in the recommended dose range.
In two small phase 1b trials, the half-life-extended bispecific antibody improved skin disease and reduced airway inflammation. Aclaris will move next into a Phase 2b trial in eosinophilic esophagitis.
Merck and Kelun’s sac-TMT extends overall survival in pretreated endometrial cancer, Bristol Myers Squibb reports interim data and a patient death in its phase 1 CAR-T trial in multiple sclerosis, and BioNTech and DualityBio’s HER2 ADC meets its phase 3 goal but with limited expected benefit.
Full Phase 3 TroFuse-005 data presented at ESMO 2026 show the TROP2-directed ADC sacituzumab tirumotecan cut the risk of death by 32% vs chemotherapy, and an FDA decision is expected by June 2027.
BioNTech and DualityBio's HER2-directed ADC modestly improved progression-free survival over chemotherapy in DYNASTY-Breast02, but higher interstitial lung disease rates and an established competitor limit its potential in this setting.
Anurag Rathore, PhD, professor of chemical engineering at IIT Delhi, explains how his team cuts monoclonal antibody costs without cutting purification steps, and why the $10-per-gram target could make antibodies viable for infectious disease and global access.
Anurag Rathore, PhD, professor of chemical engineering at IIT Delhi, explains how his team is making antibody manufacturing more efficient and replacing costly raw materials to cut monoclonal antibody costs to about $10 per gram.
Gilead agrees to acquire PepStar’s oral IL-23R peptide program for $1.275 billion, Zymeworks licenses its DLL3-targeted trispecific T-cell engager ZW209 to Roche, and the US Treasury proposes adding biotechnology to its outbound investment restrictions.
Roche gains exclusive global rights to ZW209, a DLL3×CD3×CD28 trispecific T-cell engager designed for CD28 co-stimulation. A phase 1 study in small cell lung cancer and other neuroendocrine tumors is underway.
A Treasury proposed rule would restrict certain US investments in biotechnology in China and other countries of concern, raising questions about how cross-border licensing and joint venture deals will be treated.
Rohit Tripathi, vice president of industry strategy, consumer packaged goods, and manufacturing at RELEX Solutions, explains where cold-chain planning still breaks down and why biopharma supply chain leaders should use AI to act on data sooner, with humans making the final call.
The FDA grants accelerated approval to Ultomiris for IgA nephropathy, Alcon acquires Neurotech and its MacTel cell therapy for $550 million, and BioNTech and Bristol Myers Squibb add Trodelvy to a phase 3 trial in triple-negative breast cancer.
BioNTech and Bristol Myers Squibb will replace chemotherapy with Gilead’s TROP2-directed ADC sacituzumab govitecan in the Phase 3 ROSETTA Breast-01 trial of PD-L1×VEGF-A bispecific pumitamig in PD-L1-low or -negative TNBC.
Alexion’s ravulizumab won accelerated approval to reduce proteinuria in adults with IgA nephropathy after the Phase 3 I CAN trial showed a 43.4% placebo-adjusted reduction at Week 34.
Sanofi breaks ground on an EU-backed insulin API plant in Frankfurt, Summit and ECOG-ACRIN launch a phase 2/3 trial of ivonescimab in first-line biliary tract cancer, and TaiMed’s anti-CD4 antibody TMB-365 lowers HIV viral load in phase 1.
Rohit Tripathi, vice president of industry strategy, consumer packaged goods, and manufacturing at RELEX Solutions, explains what is driving biopharma reshoring, how USMCA uncertainty complicates sourcing for biologics, and where cold-chain visibility still breaks down.
Phase 1 data presented at IDWeek 2026 show TaiMed Biologics’ host-directed antibody TMB-365 lowered HIV-1 RNA without resistance, as the company advances an antibody-only maintenance regimen with TMB-380.
Geneos Therapeutics has initiated a 90-patient randomized phase 2 trial comparing its personalized neoantigen DNA vaccine GNOS-PV02 with active surveillance in patients with high-risk hepatocellular carcinoma after surgery.
Nano24’s inhaled exosome therapy reduces mortality in a phase 2b ARDS trial, the FDA grants fast track designation to Nuravax’s preventive Alzheimer vaccine, and Bionyra’s long-acting anti-TL1A antibody shows a half-life that could support dosing every 3 to 6 months.
Emily Heffernan, director of new process technologies at Arcadis, explains what it takes to design a facility that can produce both lentiviral vectors and mRNA-LNPs, and how in vivo platforms change QC release testing.
METiS TechBio will apply its AI-driven AiLNP ionizable lipid platform to discover LNPs designed to deliver therapeutics beyond the liver, under a collaboration with Eli Lilly worth up to $1.1 billion in milestones.
Interim phase 1 data presented at UEG Week 2026 showed Bionyra Pharma’s Fc-engineered anti-TL1A antibody BYN-002 suppressed soluble TL1A with a half-life supporting potential every-3-to-6-month maintenance dosing in IBD.
The American Association of Pharmaceutical Scientists appointed former president Patrick J. Sinko as chief science officer to lead its scientific strategy, programming, and peer-reviewed journals.
