International – ICH adopts M12 guideline on drug interaction studies, releases draft M14 guidance...
The International Council for Harmonisation (ICH) has adopted its M12 guidance, which promotes a harmonized approach in conducting and interpreting enzyme- or transporter-mediated in vitro and...
UK – Researchers combine herpes virus with cancer vaccine to treat brain cancer in...
Researchers in the US and UK are exploring a new type of cancer treatment as part of a £1.1m funded project by combining a...
France – L’ANSM inscrit de nouveaux cannabinoïdes sur la liste des stupéfiants
Nous avons pris la décision de classer de nouveaux cannabinoïdes sur la liste des stupéfiants en raison des risques et de la possible dépendance...
USA – Glioblastome : un essai vaccinal prometteur
C’est une lueur d’espoir pour traiter le glioblastome, la tumeur cérébrale la plus agressive. Une équipe de l’université de Floride a en effet annoncé...
Europe – EMA revises Q&A guidance on drug-device combination products
The European Medicines Agency and the Co-ordination Group for Mutual Recognition and Decentralized Procedures (CMDh) have issued a revised guidance that clarifies the information...
Europe – EMA confirms recommendation for non-renewal of authorisation of Duchenne muscular dystrophy medicine...
Update as of 21 May 2024
The European Commission has asked the CHMP to review its January opinion on the renewal of the marketing authorisation for Translarna. The CHMP will now consider the...
USA – Stakeholders provide feedback on FDA draft guidance on drug development for early...
Guidance for developing drugs to treat early Alzheimer’s disease should focus on factors such as cognitive changes and brain atrophy, according to comments submitted...
Europe – Hydroxyprogesterone caproate medicines to be suspended from the EU market
EMA’s safety committee, PRAC, has recommended the suspension of the marketing authorisations for medicines containing 17-hydroxyprogesterone caproate (17-OHPC) in the European Union (EU). A review by the PRAC concluded...
Europe – EU report examines barriers to combined studies of drugs, IVDs, and devices
A lack of alignment between the Clinical Trials Regulation (CTR) the In Vitro Diagnostic Medical Device Regulation (IVDR), and the Medical Device Regulations (MDR)...
USA – FDA unveils draft guidance on REMS logic models
The US Food and Drug Administration (FDA) has released a draft guidance outlining the agency’s risk evaluation and mitigation strategy (REMS) logic model.
FDA described...
