Latest

VG801 gene therapy improved vision through 12 months in a Stargardt disease trial as VeonGen aligned with FDA on its pivotal phase 3 design.

UCB will use Cradle’s AI-driven protein design platform in selected discovery projects, from hit generation through preclinical readiness, expanding its digital antibody engineering program.

Boehringer Ingelheim licenses six preclinical ADC and T-cell engager programs from Sino Biopharmaceutical in a deal worth up to $7 billion, Spyre Therapeutics drops anti-TL1A antibody SPY072 in rheumatic diseases after phase 2 misses and turns to hidradenitis suppurativa, and Biora Therapeutics gets ethics approval for a first-in-human trial of its BioJet oral adalimumab capsule.

Matt Trupo, Richard Jaenisch, and Brian Drapeau explore how AI advances biological insights, drug-target discovery, and supply chains.

As access to low Earth orbit expands, space-based research is opening possibilities in drug discovery, formulation, and manufacturing. In Part 1, the authors look at how microgravity changes biology and chemistry in ways that can’t be reproduced on Earth and where it fits from target discovery to life cycle management.

Aldevron and IDT added PE Ultra prime editor mRNA and 6 ABE8e base editor mRNAs to help researchers edit DNA without double-strand breaks.

The half-life-extended antibody failed its primary endpoints in two Phase 2 SKYWAY sub-studies, so Spyre is dropping it in rheumatic diseases and moving it into a combination trial in hidradenitis suppurativa.

Biora will test oral adalimumab via its BioJet capsule vs injection in healthy volunteers, with dosing from December 2026 and data in early 2027.

Boehringer Ingelheim will pay Sino Biopharmaceutical $358 million upfront and near-term for options on six biologic oncology programs, deepening a partnership that began in 2024.

Shilpa CDMO's $50 million plan adds 10 kL of SPPS reactor capacity in Raichur, India, with its first commercial peptide line opening in December 2026.

Today’s BioPharm Brief covers FDA’s final potency assurance guidance for cell and gene therapies, Lonza’s deal to acquire Merck KGaA’s US CDMO business, and Phase 2a data for Tiziana’s intranasal anti-CD3 antibody foralumab in progressive multiple sclerosis.

At AAPS PharmSci 360 2026, University of Iowa PhD candidate Siddhanth Hejmady explains how adding a payload or radiolabel to trastuzumab changes its behavior in bulk solution and at interfaces, and why developability teams should pair DLS with QCM-D.

Final FDA guidance replaces 2011 potency testing advice, asking CGT makers to build potency assurance from IND filing through postmarket monitoring.