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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.

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.

Nate Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about the regulatory and manufacturing hurdles facing rare disease drug developers.

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.

Zylidac will test whether optogenetic cell lines that hit 21 g/L in small-scale CHO runs can deliver higher-yield complex biologics at GMP scale.

Revakinagene taroretcel (Encelto), the only FDA-approved MacTel therapy, slowed photoreceptor loss by up to 54.8% vs sham in phase 3 trials.

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.