Revolutionizing Biologics Regulation

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.