UK – Efanesoctocog alfa approved to prevent and treat bleeding in children and adults...
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 14 February 2025, approved efanesoctocog alfa (brand name Altuvoct) to be used to treat...
UK – Nemolizumab approved to treat prurigo nodularis and atopic dermatitis (eczema) for patients...
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 17 February 2025, approved the medicine nemolizumab (brand name Nemluvio) for the treatment of...
UK – Access, new active substance and biosimilar work sharing initiatives
The New Active Substance Work Sharing Initiative (NASWSI) has successfully approved several medicines through this international collaboration and continues to foster cooperation and strong...
UK – Decision tree for navigating nanotechnology-based products for medical application
The decision tree above is to help support researchers and developers to understand how different guidelines from the International Council for Harmonisation of Technical...
Switzerland – Update of the position paper of Swissmedic and swissethics on decentralised clinical...
This position paper reflects the current state of thinking of swissethics and Swissmedic on
decentralised clinical trials (DCTs) with medicinal products in Switzerland interpreting their
respective...
Europe – Guideline on assessment and reporting of mechanistic models used in the context...
Mechanistic models, i.e. mathematical or computer models that integrate biopharmaceutical, physico mechanical, (patho)physiological and pharmacological processes, along with population characteristics, are frequently and increasingly...
Europe – Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal...
The guideline provides guidance on the structure and data requirements for a clinical trial application for investigational ATMPs and a perspective towards Marketing Authorisation...
UK – MHRA drafts mRNA cancer immunotherapy guidance
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is seeking input on its draft guidance for developing individualized messenger ribonucleic acid (mRNA) cancer...
Europe – Clinical Trials Regulation becomes fully applicable
From today, all clinical trials in the European Union (EU), including ongoing trials that were approved under the previous legal framework, the Clinical Trials Directive (CTD), are governed...
UK – NICE approves Vertex’s Casgevy one-time gene therapy for sickle cell disease
NICE’s final draft guidance states that the one-time treatment will be made available on the NHS in England under a managed access scheme for...
