The FDA approves asundexian, the first factor XIa inhibitor, cutting stroke risk 26% and setting a regulatory benchmark for factor XI drug developers.
|Articles|February 1, 2003
Pharmaceutical Technology Europe
- Pharmaceutical Technology Europe-02-01-2003
- Volume 15
- Issue 2
It's my Constitution, Doctor
Author(s)Albedo
Brussels report
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As the deadline approaches for the Euroepan Union to adopt s dozen new member states, the pharmaceutical industry has expressed its concern that an expanded EU would no longer be able to effectively legislate health care policy. A revised proposal from the EC concerning medicine rules has been prepared, but final agreement on all points still seems a long way off.
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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.
The FDA grants accelerated approval to subcutaneous amivantamab for head and neck cancer, extending the IV-to-subcutaneous shift in biologics formulation.
USP data show fewer US drug shortages but longer ones, averaging 5+ years. Drug shortages are an incentive problem, not a manufacturing mystery.
The pharmaceutical supply chain is a complex system with high stakes. USP provides insights on how it is helping industry navigate global disruptions and procurement issues.
Mitigating nitrosamine risk requires assessing each product individually and chasing zero nitrite in pharmaceutical excipients is often impractical and costly.
In October, FDA reorganized rare disease development around a fit-for-purpose framework and a new pathway for individualized gene editing. Regulators in Europe and the UK set out long-term plans for clinical trials, AI, and moving away from animal testing.
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