Process Considerations During API Development

FDA approved pimicotinib for TGCT based on a 56% response rate; its Project Orbis review signals tighter global launch planning for manufacturers.

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

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.

Almac Clinical Services’ clinical supply strategy won the 2026 CPHI Award for Supply Chain Excellence. Nishma Patel, supply chain solutions manager, explains how her team managed the study’s strict −80 °C handling requirement, quality release, and site readiness, and how the Almac Adapt approach can apply beyond this program.

The FDA grants accelerated approval to subcutaneous amivantamab for head and neck cancer, extending the IV-to-subcutaneous shift in biologics formulation.