Pink Sheet - News And Expert Analysis On Pharma Policy And Regulation since 1939

A new survey of French healthcare professionals reveals concerns that France is increasingly being excluded from major international clinical studies.

Although the legislation has little chance of passing, it offers some clues about the administration's goals for MFN agreements, which differ from the voluntary deals struck with large pharma companies.

Strengthening the European Medicines Agency’s capacity to analyze clinical and non‑clinical raw data, expanding real-world evidence infrastructure, and boosting AI literacy across the EU regulatory network all feature prominently in a new 2026–2028 workplan.

England’s health technology institute, NICE, said that Astellas’ non-hormonal drug for menopausal hot flushes, Veoza, should be funded for use via the National Health Service and that the drug addresses a “real and important” need for people who cannot take hormone replacement therapy.

The FDA's widely referenced scale-up and post-approval changes (SUPAC) guidelines could be modernized to acknowledge evolving science and conflicts with newer recommendations.

So far this year, four drug candidates have secured a place on the European Medicines Agency’s priority medicines scheme for promising treatments for unmet medical needs.