USA – FDA details policy on facility reclassification requests under GDUFA III
The US Food and Drug Administration (FDA) recently issued a manual of policies and procedures (MAPP) on the procedures it will follow in following...
UK – AbbVie’s Rinvoq recommended by NICE for Crohn’s disease
The authorisation, which makes Rinvoq the first oral Janus Kinase (JAK) inhibitor available for this indication in England and Wales, specifically applies to patients...
Europe – DARWIN EU® welcomes first data partners
EMA has selected the first set of data partners to collaborate with DARWIN EU®, the Data Analysis and Real-World Interrogation Network. The data available to these...
France – Cannabis médical : point d’étape sur la dernière année de l’expérimentation et...
La fin de l'expérimentation et la mise à disposition pour 2025 des médicaments à base de cannabis se préparent. Ces médicaments devront avoir obtenu...
Europe – New medicine to protect babies and infants from respiratory syncytial virus (RSV)...
EMA has recommended a marketing authorisation in the European Union (EU) for Beyfortus (nirsevimab) for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease...
Europe – Synchron Research Service: suspension of medicines over flawed studies
EMA’s human medicines committee (CHMP) has recommended the suspension of the marketing authorisations of several generic medicines tested by Synchron Research Services, a contract research organisation (CRO) located...
Europe – Regulatory information – adjusted fees for pharmacovigilance applications from 3 October 2022
Pharmacovigilance fees payable to the European Medicines Agency by applicants and marketing authorisation holders increase by 5.6% as of 3 October 2022, to reflect the inflation rate...
Suisse – Swissmedic updates guidance on temporary medicine authorization to harmonize deadlines
The Swiss Agency for Therapeutic Products (Swissmedic) has updated its guidance on the temporary authorization of human medicinal products.
In the document, Swissmedic outlines the...
UK – NICE recommends Novartis’ Piqray in combination with Faslodex for advanced breast cancer...
The recommendation follows the ‘consistent, significant improvements’ in median progression-free survival and overall response rates when using Piqray in combination with Faslodex.
Breast cancer is...
International – ICH adopts Q13 guideline on continuous manufacturing
The International Council for Harmonisation (ICH) has adopted its guideline on continuous manufacturing (CM), in a nod to embracing more modern modes of manufacturing....
