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.
Panelists on the PharmTech AI Pulse Check weigh a December AI playbook, EMA/MHRA moves, PCCP accountability gaps, and MCP-ready regulatory guidance.
The FDA approves asundexian, the first factor XIa inhibitor, cutting stroke risk 26% and setting a regulatory benchmark for factor XI drug developers.
Unnatural Products for up to $1.15B, bringing oral macrocyclic peptides and new formulation challenges to its antibody ...
No operator touches a CAR-T batch before demonstrating proficiency. Generative AI users should meet the same standard, and a ...
Janssen, PhD, of DFE Pharma, won the CPHI Pharma Award for Future Leader. In this interview with PharmTech, she provides ...
Janssen, PhD, product development manager and global technical lead at DFE Pharma, explains excipient variability and ...
Coverage from AAPS PharmSci 360 and CPHI Milan featured discussion about impurities, devices, and supply resilience. This ...
Boehringer, AbbVie, ASKA, and Evommune license ADC, IBD, thyroid eye disease, and degrader assets, raising tech transfer ...
The agreement between CDER and OII with allow for coordinated marketing application assessments and inspections.
CDMOs announced expansions, exhibitors showcased automated equipment, and supply chain strategy discussions were a focus at ...
Ron Filler, Drug Development Consultants, explains how USP's 1074 revision brings human-relevant safety science to ...