EMA
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.
The European Medicines Agency wants to discourage drug companies from submitting marketing applications with very interim data cuts and then expecting they can supplement their application with more data later on by requesting for extended clock-stops.
US FDA
The pharmaceutical industry has been quiet on Trump's early federal government overhauls that could harm the drug business, still betting he will help produce better results than Biden.
Stakeholders are waiting for the dust to settle to better understand who was laid off as part of the Trump Administration's cuts at the FDA, the reductions' impact on applications currently under review and broader drug development efforts.
Jim Jones, the head of the FDA's food programs, resigned due to widespread layoffs at the agency imposed by the Trump administration’s Department of Government Efficiency.
Experts worry new restrictions on remote work, plans to eliminate certain employees’ job protections and workforce cuts will make the FDA a less attractive employer and hurt pharma’s efforts to get innovative medicines to patients.