Europe – European Shortages Monitoring Platform fully operational for monitoring of shortages in the...
The European Shortages Monitoring Platform (ESMP) is now live with the full scope of functionalities. This will enable marketing authorisation holders (MAHs) and national competent authorities (NCAs) to...
Europe – New combination of medicines to treat parasitic worm infections
EMA’s human medicines committee (CHMP) has adopted a positive scientific opinion for Ivermectin/Albendazole for the treatment of infections caused by several types of worm...
Europe – European Pharmacopoeia Commission adopts first three general texts on mRNA vaccines
At its 180th session in November 2024, the European Pharmacopoeia Commission (EPC) adopted three new general texts relating to the production and quality control of...
UK – NICE recommends olaparib for BRCA-mutated breast cancer treatment
The National Institute for Health and Care Excellence (NICE) has given a positive recommendation for Lynparza (olaparib) for NHS use in England and Wales.
This...
UK – AstraZeneca’s Lynparza recommended by NICE to treat advanced breast cancer
The health technology assessment agency has recommended that the drug be used on the NHS in England and Wales to treat adults with HER2-negative,...
Europe – A common EU approach to data transparency in medicine regulation
EMA and HMA (Heads of Medicines Agencies) have published a comprehensive overhaul of their guidance on the identification of commercially confidential information (CCI) and...
Europe – Successful pilot paves the way for implementation of ePI
The report of a pilot exploring the creation and testing of ePIs (electronic product information) in real regulatory procedures was published today. The pilot...
Europe – First medicine to treat rare genetic disorder causing cysts and tumours
EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Welireg (belzutifan) in adults with certain von Hippel-Lindau (VHL) disease-associated tumours and...
UK – NICE recommends Santhera’s Duchenne muscular dystrophy drug Agamree
The drug has been recommended for use on the NHS in England, Wales and Northern Ireland to treat the rare muscle-wasting disorder in those...
Europe – First treatment for peripheral thyrotoxicosis in patients with Allan-Herndon-Dudley syndrome
EMA has recommended granting a marketing authorisation in the European Union (EU) for Emcitate (tiratricol), an oral treatment for peripheral thyrotoxicosis (inappropriately high levels of circulating...
