UK – NICE recommends Pfizer’s Paxlovid on NHS
Pfizer has announced today that the National Institute for Health and Care Excellence (NICE) has issued an appraisal consultation document which recommends Paxlovid.
Also known...
Europe – Commission proposes new measures for the better lifecycle management of medicine authorisations
The Commission has proposed to amend the variation legislation for medicines, to make the lifecycle management of medicines more efficient and better adapted to the...
Europe – New Quality Innovation Expert Group (QIG) supports medicine innovation
EMA has established a Quality Innovation Expert Group (QIG) to support innovative approaches for the development, manufacture, and quality control of medicines for the benefit of...
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),...
UK – NICE issues two recommendations for UCB’s inflammatory disease drug
Bimzelx, which is already authorised in the UK to treat certain patients with plaque psoriasis, is now the first treatment available for PsA and...
UK – Children and teenagers with an aggressive form of brain cancer set to...
A new targeted drug combination treatment, described as a ‘step-change in care’ for children and young people with an aggressive form of brain cancer,...
Europe – Precautionary measures to address potential risk of neurodevelopmental disorders in children born...
On 24 January 2024, the CMDh1 endorsed precautionary measures recommended by EMA’s safety committee (PRAC) for the treatment of male patients with valproate medicines. These measures...
Europe – Parliament adopts its position on EU pharmaceutical reform
The legislative package, covering medicinal products for human use, consists of a new directive (adopted with 495 votes in favour, 57 against and 45...
Europe – European Commission proposes framework for joint clinical assessments
The European Commission has proposed a framework for joint clinical assessments (JCA) as part of its effort to implement the EU health technology assessment...
Europe – EMA takes further steps to address critical shortages of medicines in the...
Today, EMA published details of the newly created solidarity mechanism developed by the EMA Medicines Shortages Steering Group (MSSG). This voluntary mechanism allows Member States to...
