Training session on ‘Emergency Preparedness through Platform Trials in the European Union-European Economic Area’ on September 5th and 6th, 2024, in Brussels

CT CURE, the European Union’s joint action, will conduct the training session titled ‘Emergency Preparedness through Platform Trials in the European Union - European Economic Area’ on September 5th and 6th in Brussels. The training is designed specifically for assessors of clinical trial applications from Medical Research Ethics Committees and National Competent Authorities.

PRAC May 2024 – 17-hydroxyprogesterone caproate medicines to be suspended from the EU market

During its May 2024 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has recommended the suspension of the marketing authorisations for medicines containing 17-hydroxyprogesterone caproate (17-OHPC) in the European Union (EU). 

CT CURE extends expedited review of multinational clinical trial applications on COVID-19 therapeutics

CT CURE, coordinated by the FAMHP, is the European Union’s (EU) joint action seeking ways to expedite assessment and decisions on multinational clinical trial applications related to COVID-19 therapeutics and has entered its final year. The project involves 15 EU Member States and now extends its scope to therapies that bridge the gap between therapeutic and preventive treatments in order to include as many clinical trials as possible and make the European Union a more attractive region for large, multi-country trials using master protocols.

PRAC April 2024 – PRAC finds no link between suicidal thoughts and thoughts of self-harm and GLP-1 receptor agonists and new safety information for HCPs on new Rybelsus tablets

During its April 2024 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has concluded that there is no available evidence supporting a link between GLP-1 receptor agonists and suicidal thoughts and thoughts of self-harm and advice to CHMP on new Rybelsus tablets.

Cibinqo

Active substance abrocitinib
Holder Pfizer NV/SA
Status Running
Indication the treatment of adolescents (12-17 years old) with severe atopic dermatitis or who have participated to the Abrocitinib Expanded access JADE REAL – B7451064 with EudraCT reference 2020-003610-12. 
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