UK – Bristol Myers Squibb’s acute myeloid leukaemia oral maintenance therapy recommended by NICE
The recommendation is specifically for use in patients who have achieved complete remission or complete remission with incomplete blood count recovery following induction therapy...
Europe – EU adopts 10-part workplan to guide the acceleration of clinical trials
The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have adopted ten priorities as part of a...
Europe – New measures to minimise risk of meningioma with medicines containing nomegestrol or...
EMA’s human medicines committee (CHMP) has endorsed the recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC), which concluded that the benefits of medicines containing nomegestrol or...
Europe – Review of pholcodine medicines started
The European Medicines Agency (EMA) has started a review of medicines that contain pholcodine following concerns that their use may put people at risk...
Europe – PRAC starts review of topiramate use in pregnancy and women of childbearing...
EMA’s safety committee (PRAC) has started a review of topiramate and the risk of neurodevelopmental disorders in children whose mothers were taking topiramate during...
Europe – First adapted COVID-19 booster vaccines recommended for approval in the EU
EMA’s human medicines committee (CHMP) has recommended authorising two vaccines adapted to provide broader protection against COVID-19. Comirnaty Original/Omicron BA.1 and Spikevax bivalent Original/Omicron...
Europe – EU issues long-awaited GMP Annex 1 revision
The EU’s eagerly anticipated revision of its good manufacturing practice (GMP) Annex 1 for sterile drug products was released on Thursday after 14 years...
Europe – Patient registries: EMA officials highlight opportunities in orphan drug development
Officials from the European Medicines Agency (EMA) tout the benefits of patient registries to support regulatory decision making for orphan medicinal products in a...
Europe – EMA accepts application for leukaemia drug from Otsuka and Astex
The application is supported by positive results from the phase 3 ASCERTAIN clinical trial which demonstrated an exposure equivalence of an oral fixed-dose of...
Europe – EMA reviewing data on sabizabulin for COVID-19
EMA’s Emergency Task Force (ETF) has started a review of data on the use of sabizabulin for treating COVID-19.
The review will look at all available...
