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Adalvo Acquires Enzene’s Romiplostim Biosimilar Program for ITP

Thermo Fisher Pairs In Silico Modeling With an Expanded ASD Toolbox at AAPS PharmSci 360

Platform Formulations Shift Risk Downstream, Pfizer’s Dr Stephanie Johnson Says

The BioPharm Brief: Two Phase 3 ADC Wins and a TCR Bispecific in PRAME-High Tumors

Immatics’ PRAME-Targeted TCR Bispecific IMA402 Shows 32% Response Rate in PRAME-High Tumors

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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.

Risvutatug rezetecan extended median progression-free survival to 5.5 months vs 1.4 months with chemotherapy in pretreated osteosarcoma.

Izalontamab brengitecan extended median progression-free survival to 11.1 months vs 5.7 months with chemotherapy after EGFR TKI failure.

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.

This year's PharmSci 360 will close with a plenary on fixing drug development economics given by Averin's Dr Berry.

Dr Karunakar Sukuru of Catalent explains how lipid-based softgels address physiological barriers to oral peptide delivery as approvals increase.

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.

A patient with relapsing MS died of septic pneumonia 44 days after zola-cel CAR T infusion, as all 60 dose level 2 patients stayed off DMTs.

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 is making antibody manufacturing more efficient and replacing costly raw materials to cut monoclonal antibody costs to about $10 per gram.

The Skyrizi approval pairs an interleukin-23 antibody with an on-body injector for 720 mg subcutaneous induction in adults, per phase 3 AFFIRM data.

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.

FNIH CEO Dr Julie Gerberding will open the October 25-28 meeting with a talk on using AI, adaptive trials, and alternative methods in drug development.

Insilica's Dr Thomas Luechtefeld argues process traceability, not benchmark accuracy alone, determines whether AI toxicology decisions can be trusted.

Phase 1 HCXT-2001, an oral macrocyclic IL-23R peptide, could be paired with emvistegrast as a daily oral IBD treatment, according to Gilead.























