FDA Generic Peptides Guidance Sets New Expectations
Revised FDA draft guidance for generic peptide products updates expectations for ANDAs, impurities, structure, immune response, and biological activity.
GLP-1 Obesity Evidence Is Changing Clinical Development
GLP-1 obesity clinical evidence is reshaping drug development as efficacy, safety, cardiovascular outcomes, and treatment durability become critical.
Bioprocessing Is Becoming a Smarter Manufacturing System
Bioprocessing is becoming more connected, automated, and data-driven. Here is what smarter process control means for biopharma manufacturing.
CRO Data Quality: Why Sponsor Datasets Slow MIDD
CRO data quality decides how fast MIDD models reach regulators. See what a pharmacometric CRO survey reveals about sponsor data, costs, and AI-led fixes.
Could Biological Ageing Be the Next Big Shift in Drug Discovery?
“The pharma industry is beginning to look at biological age as a surrogate endpoint to improve clinical trials."
Synthetic Genetic Codes Move Closer to Programmable Biology
Synthetic genetic codes are moving closer to programmable biology as automated cell-free systems enable faster testing of new protein chemistries in R&D.