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...
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...
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...
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)...
UK – New cabotegravir formulations approved to help prevent HIV-1 infection in adults and...
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (3 May 2024) approved two new formulations of the medicine cabotegravir (Apretude 30 mg...
Europe – Guidance : Anonymisation of personal data and assessment of commercially confidential information...
This document gives general guidance to applicants/marketing authorisation holders (MAHs) on the retention/removal of personal data (PD) and identification of commercially confidential information (CCI)...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
Eight new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its April 2024 meeting.
The CHMP recommended granting a marketing authorisation for Altuvoct* (efanesoctocog alfa), for...
