Europe – EMA encourages companies to submit type I variations for 2023 in November...
EMA is advising marketing authorisation holders to submit type IA and type IAIN variations for 2023 no later than Thursday, 30 November 2023. This will enable EMA to...
Europe – AbbVie’s Rinvoq granted NICE recommendation as ulcerative colitis treatment
The recommendation is specifically for adults with the immune-mediated inflammatory bowel disease, for whom conventional or biologic treatments cannot be tolerated, or for those...
Europe – EMA Management Board: highlights of June 2023 meeting
The European Commission informed the Board about its legal proposals to revise the pharmaceutical legislation, published on 26 April, which aim to make the...
Europe – Two new advice pilots to improve clinical trials in Europe
The Accelerating Clinical Trials in the EU (ACT EU) initiative is today launching two advice pilots aimed at improving the quality of applications for clinical trials, the...
Europe – New vaccine to protect people in the EU and worldwide against dengue
EMA’s human medicines committee (CHMP) has adopted a positive opinion for Dengue Tetravalent Vaccine (live, attenuated) Takeda, used to prevent disease caused by dengue...
Europe – EMA update on shortages of antibiotics in the EU
EMA's Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) met on Thursday to discuss the progress made and to agree on the next...
UK – NICE issues two recommendations for UCB’s inflammatory disease drug
Bimzelx, which is already authorised in the UK to treat certain patients with plaque psoriasis, is now the first treatment available for PsA and...
UK – Amvuttra recommended by NICE for amyloidosis
Alnylam has welcomed a draft decision from the National Institute for Health and Care Excellence (NICE) recommending the use of Amvuttra on the NHS...
UK – MHRA authorises world-first gene therapy for two inherited blood disorders
Vertex Pharmaceuticals and CRISPR Therapeutics’ Casgevy (exagamglogene autotemcel) is now the first licensed treatment that uses the gene-editing tool CRISPR, for which its inventors...
Europe – European Health Union: EU steps up the fight against antimicrobial resistance
The Commission welcomes today's adoption by the Council of the European Union of the Commission's proposal to strengthen EU action against antimicrobial resistance (AMR).
Announced together with...
