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...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
Seventeen new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended seventeen medicines for approval at its December 2024 meeting. This brings the total...
Europe – First treatment recommended for rare progressive lung conditions in children and adolescents
EMA has recommended extending the indication of Ofev (nintedanib) to include the treatment of progressive fibrosing interstitial lung diseases (ILDs) in children and adolescents from the age of...
Europe – ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms –...
ICH M13A Guideline is intended to provide recommendations on conducting bioequivalence (BE) studies during both development and post approval phases for orally administered immediate-release (IR) solid oral dosage forms...
Canada – Drug and medical device databases
This list of Health Canada's drug and medical device databases briefly describes the information available in each database. It does not provide an in...
UK – NICE endorses Neuraxpharm’s ublituximab for treating MS
Neuraxpharm Group has announced that the National Institute for Health and Care Excellence (NICE) has recommended ublituximab (BRIUMVI®) for the treatment of relapsing-remitting multiple...
