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...
USA – FDA Approves First Treatment for Patients with Liver Scarring Due to Fatty...
Today, the U.S. Food and Drug Administration approved Rezdiffra (resmetirom) for the treatment of adults with noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced...
USA – FDA approves first interchangeable biosimilars to Prolia and Xgeva to treat certain...
FDA approved Jubbonti (denosumab-bbdz) injection as an interchangeable biosimilar to U.S.-licensed Prolia (denosumab), and Wyost (denosumab-bbdz) injection as an interchangeable biosimilar to U.S.-licensed Xgeva...
Europe – Procedural advice for orphan medicinal product designation
The legislation on orphan medicinal products, Regulation (EC) No 141/2000 of the European Parliament and of the Council, was adopted on 16 December 1999...
France – Forfait innovation : une 1ère technologie de santé inscrite au remboursement par...
Mis en place en 2009 et piloté par le ministère chargé de la santé, le forfait innovation est un dispositif dérogatoire et temporaire de...
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...
UK – UK’s MHRA approves first drug under international recognition procedure
The UK Medicines and Healthcare products Regulatory Agency (MHRA) recently approved Amgen’s bone cancer drug Xgeva (denosumab), the first drug submitted through the international...
International – ICH E2D(R1) Guideline on post-approval safety data: definitions and standards for management...
It is important to establish an internationally standardised procedure to ensure the quality of post approval safety information and to harmonise, where feasible, the...
USA – Cell therapy equipment: regulatory guidelines and feedback opportunities
Cell therapy manufacturing requires specialized equipment to prioritize cell health, yield, and performance. A range of suppliers offer tailored equipment, but evolving regulatory guidance...
USA – FDA updates early Alzheimer’s drug development guidance to add support for biomarkers,...
The US Food and Drug Administration (FDA) has released a second revision of its draft guidance for developing drugs intended to treat early Alzheimer’s...
