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...
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...
UK – NICE recommends Immunocore’s Kimmtrak as first drug for aggressive eye cancer
Kimmtrak will now be available on the NHS in England to treat HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma, with more than 100...
Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 November 2024
Doxycycline: currently available evidence not supporting link with risk of suicidality
EMA’s safety committee (PRAC) has concluded that the currently available evidence is not sufficient...
