BioPharm International May 2017 Outsourcing Resources ebook

ProBio grants AbTis exclusive global rights to a discovery-stage oncology antibody for development as a site-specific antibody-drug conjugate.

ImvivaBio’s off-the-shelf CD19/BCMA CAR-T cell therapy CTA313 kept 88% of evaluable patients with refractory lupus in DORIS remission at Month 12, according to longer-term phase 1 data presented at ACR Convergence 2026.

Beam’s base-edited cell therapy met its primary endpoint in the BEACON trial, and a U.S. biologics license application is planned as early as year-end.

Full phase 3 OASIZ-301 results show both dosing regimens of Amgen’s CD40L antagonist fusion protein dazodalibep reduced systemic disease activity in Sjögren’s disease at Week 48. The every-four-weeks dose also improved patient-reported dryness.

AstraZeneca acquired preclinical biotech Omniose, adding a bioconjugation platform for conjugate vaccines against serious bacterial infections.

FDA grants RMAT and Fast Track designations to AbelZeta’s CD20/CD19 bispecific CAR-T prizlon-cel in relapsed or refractory large B-cell lymphoma, Larimar Therapeutics completes a BLA seeking accelerated approval of nomlabofusp for Friedreich’s ataxia, and Merck’s GLP-1/glucagon receptor agonist efinopegdutide meets its primary endpoint in a phase 2b MASH trial.

This FAQ explains how aseptic processing, contamination control, and validation protect patients amid sterile injectable failures.

Merck's GLP-1/glucagon co-agonist raised MASH resolution versus placebo at 52 weeks, but fibrosis and dose-response questions remain.