Here is our regular summary of content of relevance to neurology from the Human Medicines Highlights – April 2026
Key EMA News Updates:
- New tools under PRIME to accelerate medicine development
The EMA has introduced enhancements to its PRIME scheme following a pilot phase, enabling more continuous and streamlined scientific dialogue with developers to speed up the development of promising medicines. Click here for more details: New PRIME tools to accelerate development of medicines in the EU | European Medicines Agency (EMA) - Launch of Vaccine Essentials communication tool
A new initiative aims to improve vaccine literacy by addressing information gaps and concerns identified by healthcare professionals. The first edition focuses on meningococcal B vaccines. Click here for more details: Vaccine Essentials: Supporting vaccine literacy | European Medicines Agency (EMA) - Draft guidance on clinical trials during public health emergencies
The EMA has published draft guidance outlining how clinical trials should be conducted in public health emergencies, with consultation open until 30 April 2026. Click here for more details: New guidance on the conduct of clinical trials during public health emergencies in the EU | European Medicines Agency (EMA) - EU recommendations for seasonal influenza vaccines (2026/2027)Review started for Tavneos (avacopan)
The EMA has issued recommendations on the composition of seasonal influenza vaccines for the upcoming 2026/2027 flu season. Click here for more details: Click here for more details: EU recommendations for 2026/2027 seasonal flu vaccine composition | European Medicines Agency (EMA) - Consultation on virtual control groups to reduce animal use
The EMA has opened a consultation on a draft qualification opinion for a novel preclinical testing method using virtual control groups, aimed at reducing the number of animals used in medicines development. Click here for more details: EMA consults on virtual control groups to help reduce animal use in medicines development | European Medicines Agency (EMA) - Highlights from EMA Management Board – March 2026 meeting
The EMA Board adopted the EMA’s 2025 annual report and reviewed key updates, including progress on the electronic product information (ePI) implementation roadmap. Click here for more details: EMA Management Board: highlights of March 2026 meeting | European Medicines Agency (EMA) - Inside EMA podcast Episode 5 – obesity and GLP-1 therapies
The latest episode explores obesity and weight management in the context of emerging GLP-1 treatments, featuring perspectives from EMA staff and expert guests. Click here for more details: Podcast: Inside EMA | European Medicines Agency (EMA)
Medicines
- Blarcamesine Anavex (blarcamesine) – Withdrawal of application – Anavex Germany GmbH withdrew its EU marketing authorisation application for Blarcamesine (Anavex) to treat Alzheimer’s disease on 25 March 2026. The EMA had recommended refusal in December 2025, and the company ended its re-examination before completion. Click here for more details: Blarcamesine Anavex | European Medicines Agency (EMA)
