Europe – Comirnaty: EMA recommends approval of adapted COVID-19 vaccine targeting Omicron XBB.1.5
EMA’s human medicines committee (CHMP) has recommended authorising an adapted Comirnaty vaccine targeting the Omicron XBB.1.5 subvariant.
The vaccine – known as Comirnaty Omicron XBB.1.5...
UK – NHS world first rollout of cancer jab that cuts treatment time by...
Following the green light from the Medicines and Healthcare products Regulatory Agency (MHRA), the NHS in England will be the first health system in...
UK – Nitrosamines impurities in medicines
The Medicines and Healthcare products Regulatory Agency (MHRA) has assessed the risk of nitrosamine formation or presence during the manufacture of human medicines and...
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UK – NICE publishes draft guidance not recommending CSL’s haemophilia B gene therapy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...
