Download our White Paper and learn about quality attributes, critical process parameters, and key performance indicators at the bioreactor. Our White Paper provides a comprehensive, but accessible, overview of requirements and recommendations related to the FDA's Process Analytical Technology (PAT) initiative for the biopharmaceutical industry.
Nano24 ’s inhaled exosome therapy reduces mortality in a phase 2b ARDS trial, the FDA grants fast track designation to Nuravax’s preventive Alzheimer vaccine, and Bionyra’s long-acting anti-TL1A antibody shows a half-life that could support dosing every 3 to 6 months.
METiS TechBio will apply its AI-driven AiLNP ionizable lipid platform to discover LNPs designed to deliver therapeutics beyond the liver, under a collaboration with Eli Lilly worth up to $1.1 billion in milestones.
The American Association of Pharmaceutical Scientists appointed former president Patrick J. Sinko as chief science officer to lead its scientific strategy, programming, and peer-reviewed journals.
The FDA grants accelerated approval to dostarlimab for rectal cancer, Lilly reports one-year remission data for pediatric ulcerative colitis, and Johnson & Johnson shares longer-term fistula remission results for Tremfya.
Accelerated approval for dostarlimab-gxly (Jemperli) pairs a single-arm phase 2 dataset with an FDA-authorized biomarker test and confirmatory requirements.
