Europe – New gene therapy treatment for haemophilia B
EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Durveqtix (fidanacogene elaparvovec) to treat severe and moderately severe haemophilia B in...
USA – FDA plans to release AI drug development guidance this year
The US Food and Drug Administration (FDA) plans to release a draft guidance this year on the use of artificial intelligence/machine learning (AI/ML) to...
Europe – Commission approves up to €1 billion of State aid by six Member...
The European Commission has approved, under EU State aid rules, the first Important Project of Common European Interest (‘IPCEI') to support research, innovation and...
Europe – Commission facilitates faster access to medicines with clear rules for joint clinical...
Today, the European Commission adopted new rules for the joint clinical assessments of medicines at Union level, contributing to faster access to medicines for...
USA – FDA issues platform technology designation draft guidance
The US Food and Drug Administration (FDA) has published a much-awaited draft guidance detailing how it plans to implement its new platform technology designation...
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...
