Clearing Regulatory Hurdles

From AI validation to microstructure imaging, AAPS PharmSci 360 speakers pushed toward faster drug development backed by stronger evidence. Here are PharmTech's biggest takeaways.

The FDA approves asundexian, the first factor XIa inhibitor, cutting stroke risk 26% and setting a regulatory benchmark for factor XI drug developers.

Panelists on the PharmTech AI Pulse Check weigh a December AI playbook, EMA/MHRA moves, PCCP accountability gaps, and MCP-ready regulatory guidance.

France’s 2030 Health Initiative is driving growth in biotechnology, health innovation, biomanufacturing, and digital health.

CPHI Award winner, Pauline van der Wijst-Janssen, PhD, product development manager and global technical lead at DFE Pharma, explains excipient variability and excipients’ role in continuous manufacturing.

Pauline van der Wijst-Janssen, PhD, of DFE Pharma, won the CPHI Pharma Award for Future Leader. In this interview with PharmTech, she provides advice for scientists looking to advance to leadership roles.

Coverage from AAPS PharmSci 360 and CPHI Milan featured discussion about impurities, devices, and supply resilience. This week also included topics such as AI accountability, oral peptides, and new licensing deals.

No operator touches a CAR-T batch before demonstrating proficiency. Generative AI users should meet the same standard, and a higher one, because an AI error does not stay inside one batch.