Building Velocity into Fill/Finish Timelines: Your Guide to Quality and Regulatory Success in the CDMO Space

Partnering with a CDMO with collective insights and capabilities to support the development and manufacture of an innovative biotherapeutic program is an essential first step to providing better care to patients.

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October 22nd, 2026

Turn Supply Chain Data Into Decisions Before Shortages Reach Patients, Says RELEX’s Rohit Tripathi

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.

October 22nd, 2026

The BioPharm Brief: Kidney Approval, Retinal Cell Therapy, and a Breast Cancer Trial Shift

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.

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October 22nd, 2026

Zylidac Bio to Scale Prolific's Optogenetic Cell Line Platform to GMP

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.

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October 22nd, 2026

Alcon Pays $550 Million for Neurotech and Its MacTel Cell Therapy

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

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October 22nd, 2026

BioNTech, BMS to Pair Pumitamig With Trodelvy in Phase 3 First-Line TNBC Trial

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.

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October 22nd, 2026

FDA Grants Accelerated Approval to Ultomiris as First C5 Inhibitor for IgA Nephropathy

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.

October 21st, 2026

The BioPharm Brief: Insulin Supply Security, a Bispecific Head-to-Head, and Long-Acting HIV Antibodies

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.

October 21st, 2026

Reshoring Should Be Judged by Risk Removed, Not Factories Moved, Says RELEX’s Rohit Tripathi

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.

Building Velocity into Fill/Finish Timelines: Your Guide to Quality and Regulatory Success in the CDMO Space

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