Europe – EMA updates Q&A document on publication of clinical trial data
In December 2018 all Clinical Data Publication (CDP) activities were suspended due to the
implementation of the EMA’s business continuity plan (BCP). During the COVID-19...
UK – NICE recommends STADA and Calliditas’ Kinpeygo to treat rare kidney disease IgAN
Affecting approximately 14,000 people in England, IgAN occurs when IgA accumulates in the kidneys, causing inflammation and scarring, which can lead to kidney failure.
Patients...
Europe – First nasal adrenaline spray for emergency treatment against allergic reactions
EMA’s human medicines committee (CHMP) has recommended granting a marketing authorisation in the European Union for Eurneffy (epinephrine), the first medicine to be taken through the...
Switzerland – Swissmedic updates guidances on API, fast-track pathway, and more
Swissmedic has made updates to several of guidances related to active pharmaceutical ingredients (API), temporary authorization, products that receive fast-track authorization, and other documents...
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 – Commission proposes new measures for the better lifecycle management of medicine authorisations
The Commission has proposed to amend the variation legislation for medicines, to make the lifecycle management of medicines more efficient and better adapted to the...
Europe – Review of pholcodine medicines started
The European Medicines Agency (EMA) has started a review of medicines that contain pholcodine following concerns that their use may put people at risk...
Europe – PRAC starts review of topiramate use in pregnancy and women of childbearing...
EMA’s safety committee (PRAC) has started a review of topiramate and the risk of neurodevelopmental disorders in children whose mothers were taking topiramate during...
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 – CHMP recommends 12 new medicines, including first RSV treatment for infants
The European Medicine Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) last week endorsed 12 new medicines for authorization, including the first treatment to...
