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...
USA – Drug, device makers scramble for tariff exemptions, warn of supply disruptions
Drug and device manufacturers are raising concerns about President Donald Trump’s tariffs on imports from China, Mexico, and Canada, warning that they could worsen...
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The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is seeking input on its draft guidance for developing individualized messenger ribonucleic acid (mRNA) cancer...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NICE’s final draft guidance states that the one-time treatment will be made available on the NHS in England under a managed access scheme for...
USA – FDA approves new Alzheimer’s treatment regimen
The US Food and Drug Administration (FDA) has approved Eisai and Biogen’s Supplemental Biologics License Application for once every four weeks intravenous (IV) maintenance...
Europe – European Shortages Monitoring Platform fully operational for monitoring of shortages in the...
The European Shortages Monitoring Platform (ESMP) is now live with the full scope of functionalities. This will enable marketing authorisation holders (MAHs) and national competent authorities (NCAs) to...
Europe – New combination of medicines to treat parasitic worm infections
EMA’s human medicines committee (CHMP) has adopted a positive scientific opinion for Ivermectin/Albendazole for the treatment of infections caused by several types of worm...
International – Health agencies recommend best practices for using surrogate endpoints
A consortium of health technology assessment (HTA) agencies has released a white paper that aims to help pharmaceutical manufacturers provide better data on using...
USA – CDER announces new guidance agenda for 2025
The US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has released a new guidance agenda detailing the new and revised guidance...
