EMA
An enhanced role for patients in the European Medicines Agency was a key proposal within the EU pharmaceutical legislation overhaul – but patient groups warn this provision could be scrapped or weakened due to ongoing negotiations.
The European Medicines Agency has published new policies on handling conflicts of interests for its scientific committee members, experts and management board members.
The European Medicines Agency has recommended several new products for pan-EU approval, including CSL Behring’s drug for hereditary angioedema and BridgeBio’s treatment for transthyretin amyloidosis in cardiomyopathy patients.
While annual fees for marketing authorization applications and annual payments to the European Medicines Agency are set to increase from 2025, micro-sized companies and SMEs that make orphan drugs will still benefit from full reductions.
US FDA
Calley Means defended reductions in force at the Health and Human Services Department that shocked and outraged federal workers and stakeholders.
Some employees were not impressed with FDA Commissioner Martin Makary's first speech to the agency staff, saying he did not seem to understand the agency's mission.
The loss of policy analyst, legal, project manager and social scientist positions has experts wondering if the Trump Administration is eyeing a broader effort to limit DTC advertising. The OPDP layoffs are expected to result in delayed reviews of promotional pieces.
One CDRH employee said the cuts already are having a major effect on morale.