UK – NICE recommends Amryt’s Filsuvez for rare skin disorder
Around 670 people in England with epidermolysis bullosa will benefit from the treatment
The National Institute for Health and Care Excellence (NICE) has recommended Amryt...
UK – NICE gives green light for MSD’s Keytruda
The decision is the first verdict based on data from a wider immunotherapy ‘basket’ study
MSD has revealed that the National Institute for Health and...
Europe – EMA review of data on paternal exposure to valproate
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) is reviewing data on the potential risk of neurodevelopmental disorders (NDDs) in children conceived by fathers taking valproate medicines.
The review...
Europe – Revocation of authorisation for sickle cell disease medicine Adakveo
On 26 May 2023, EMA’s human medicines committee (CHMP) recommended revoking the marketing authorisation for Adakveo (crizanlizumab), a medicine for preventing painful crises (called vaso-occlusive crises)...
Europe – EMA updates Q&A document on publication of clinical trial data
In December 2018 all Clinical Data Publication (CDP) activities were suspended due to the
implementation of the EMA’s business continuity plan (BCP). During the COVID-19...
UK – NICE publishes draft guidance not recommending CSL’s haemophilia B gene therapy
The company has been seeking approval for use of the therapy in adults with severe or moderately severe haemophilia B without a history of...
Europe – Paving the way towards coordinated clinical trials in public health emergencies in...
EMA has published a report from a workshop that collected insights and suggestions for possible EU-level actions to improve the way clinical trials are set...
Europe – Review: real-world data studies
Sustainable framework to support scientific evaluations in the EU
By complementing existing evidence, use of real-world data (RWD) and real-world evidence (RWE) can speed up...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
14 new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended 14 medicines for approval at its July 2023 meeting.
The CHMP recommended granting a marketing authorisation for Abrysvo (bivalent, recombinant),...
Europe – First RSV vaccine to protect infants up to 6 months of age...
EMA has recommended granting a marketing authorisation in the European Union (EU) for Abrysvo, a vaccine to protect against disease caused by the respiratory syncytial virus (RSV)....
