EMA introduced its New Fee Regulation in January 2025, but what impact will the new fees and charges have on medicine developers? On 1 Jan. 2025, the European Medicines Agency (EMA) introduced a new ...

Kent Malmros is senior director of training at Veeva Systems. He has spent the majority of his career delivering technology-enabled training solutions to life-sciences companies and has held ...

PharmTech spoke with Dr. Hui-Yin (Harry) Li, president and CEO of Wilmington PharmaTech, about steps that should be taken to build a productive relationship between sponsor and contract organizations.

OSTP's July 2026 report to Trump diagnoses U.S. science slowdown and pushes deregulation, new funding models, reshoring, and AI-driven "Genesis Mission." Much of the report is broad science policy: ...

Campbell Bunce, chief scientific officer at Abzena, provides an update on the momentum in antibody-oligonucleotide conjugates development and the operational pressures shaping CDMO/CRO strategy for ...

AI tools have arrived, but organizational readiness, data governance, and regulatory gaps now limit real-world impact. Six months after industry experts laid out their predictions for 2026, many of ...

Pressure-rated retention agitation can preserve batch uniformity through storage/unloading, mitigating settling and phase separation under elevated temperature and pressure common to reactive ...

Modernizing infrastructures, record drug approvals, and harmonization were all positive regulatory advancements in July 2026. This month in pharmaceutical regulations, in the United States, the FDA ...

Atul Mohindra is vice president of R&D for Lonza Integrated Biologics where he brings more than 20 years of experience in cell biology, bioprocessing, media development, and process scale up ...

Nitrosamines arise via nitrosating agents (nitrites, NO2/NOx, nitrous acids/oxides) reacting with secondary/tertiary amines or some amides, yielding high-risk N-nitroso compounds. Regulatory actions ...

Leading manufacturers now deploy validated agentic AI that detects OOS events, retrieves batch records, correlates prior deviations, and drafts RCA packages, yielding ≥50% faster investigations.

Across development, manufacturing, quality, and outsourcing, the pharma industry is being asked to scale complexity without sacrificing control. Pharmaceutical manufacturing is entering a phase ...