Last week, we reported on the FDA’s accelerating enforcement activity — including 30 warning letters issued to telehealth companies in a single day and a broader surge in manufacturing-related citations. The response from the PharmaSource community was significant. A recurring
When selecting a new contract manufacturer for a biomanufacturing project, Manufacturing/Production personnel hold the greatest average influence at 18%, according to ISR’s Bioprocessing Market Outlook 2025–2030. Executive Management and R&D follow closely, each accounting for 15% of decision-making influence. Department
“A high-level Pfizer manager went on record and said: if they had to choose between lowering prices in the US or not launching in France — they would not launch in France.” Christoffer Frendesen, EU correspondent for Dagens Pharma and
FDA sends 30 warning letters to telehealth firms for misleading compounded GLP-1 claims — the second major enforcement wave in six months On March 3, the FDA issued warning letters to 30 telehealth companies for making false or misleading promotional
“The biology of aging guides our science — but regulatory conversations are about patient benefit and clinical outcomes. Framing is critical.” Eric Leire is CEO of GenFlow Biosciences, a Belgian biotech developing gene therapy-based interventions targeting age-associated diseases via the
This guest editorial is by Kishore Hotha, PhD, MBA, President, Dr. Hotha’s Life Sciences LLC Chemistry can fail in drug development. Unexpected impurity profiles, scale-up variability, conjugation instability, containment exceedances—these are real and consequential. Anyone who has led a CMC
Guest Editorial by Dainius Guzauskas CMC Professional, former Project Leader at Rentschler Biopharma, former Senior CMC – Regulatory Manager at InflaRx Recent Complete Response Letters (CRLs) from the FDA have sparked fierce debate across industry forums, with many calling for CMC
The European Biotech Act is a proposed EU regulation aimed at transforming the Union into a globally competitive biotechnology and biomanufacturing hub, particularly in health-related biotech, by modernizing rules, boosting investment, streamlining regulation, and strengthening innovation ecosystems. It is part
This article is brought to you in partnership with Lannett CDMO The pharmaceutical industry has a tech transfer problem. Industry executives consistently cite timeline delays, cost overruns, and quality compromises as major pain points in tech transfer that could have
A coalition of 15 Democratic-led states filed a federal lawsuit Tuesday against the U.S. Department of Health and Human Services and Health Secretary Robert F. Kennedy Jr., seeking to reverse the CDC’s January 2026 decision to eliminate universal immunization recommendations
