Europe – EMA Procedural Advice on Recommendations on unforeseen variations according to Article 5...
Article 3 paragraph 1 of Commission Regulation (EC) No 1234/2008 (Variation Regulation) refers to Annex II where a classification of minor variations, type IA...
Europe – The evolution of biologicals in the European Pharmacopoeia
Biological medicinal products – or biologicals – are a class of pharmaceutical products derived or refined from biological sources including micro-organisms, animal tissue and...
Europe – Joint strategy sets direction of EMA and EU medicines regulatory agencies to...
EMA and the Heads of Medicines Agencies (HMA) have published their joint EU medicines agencies’ network strategy to 2028 (EMANS), following its recent adoption by the HMA...
UK – NICE recommends Pharming’s Joenja as first treatment for ultra-rare immune disease APDS
The small molecule phosphoinositide 3-kinase delta inhibitor, which is now the first ever APDS treatment to be licensed for use in the NHS in...
USA – FDA approves first treatment for adults with complement 3 glomerulopathy, a rare...
The U.S. Food and Drug Administration has approved Fabhalta (iptacopan) for the treatment of adults with complement 3 glomerulopathy (C3G) to reduce proteinuria.
Fabhalta is...
Europe – Finding clinical trials with the ACT EU Trial Map
In January 2024, the ACT EU Clinical Trials Analytics Workshop introduced a key deliverable: the integration of a map of clinical trials in the EU, with the CTIS...
USA – FDA makes flu vaccine recommendations after canceled VRBPAC, closed-door meeting
After canceling a routine meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to review the composition of the 2025-2026 influenza vaccine,...
UK – NICE recommends Gideon Richter’s Ryeqo as first daily pill for endometriosis
NICE has recommended in final draft guidance that the relugolix combination therapy be used on the NHS in England to treat the symptoms of...
UK – Merck KGaA’s Mavenclad tablets recommended by NICE for wider MS use
The health technology assessment agency has recommended in final draft guidance that the short-course oral therapy be used on the NHS as a first-line...
France – Chez Sanofi, la vente de l’Aspégic fait craindre « un effet domino...
Le printemps n’est pas encore là, mais, déjà, Sanofi se lance dans un nouveau grand ménage dans ses médicaments et produits de santé grand...
