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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.

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.

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.

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.

At PharmSci 360, Insilica CEO Thomas Luechtefeld will present on auditable agentic AI systems and how they are expanding computational toxicology beyond single predictive models.

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.

Dr Julie Gerberding and Dr David Berry will headline the October 25-28 New Orleans meeting, which adds a USP standards workshop and AI, organoid tracks.

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.