Blogs
Accelerated approval and accelerated withdrawal – will the new clinical trial guidance bring US closer to Europe?
Written by: Srishti Gupta, PhD; Senior Consultant Contact: [email protected] In March 2023, the Food and Drug Administration (FDA) published, a first of its kind, draft
Orphan Drug market, how is Italy doing? The latest OSSFOR Booklet paints a favourable picture for the Italian landscape.
By Marco Sancandi, PhD; Analyst On the 31st of January 2023, the 6th joint report from the Orphan Drugs Observatory and the Italian Society of
New UK Regulation to Spark Major Changes in the CAR-T Landscape
By Fisentzos Stylianou, PhD; Senior Analyst The UK will be the first country to introduce a regulatory framework for innovative medicines manufactured at the point
Official countdown for the implementation of the Joint European Health Technology Assessment (EUnetHTA) begins!
Written by Priyanka Kiritharan, Analyst Contact: [email protected] Taking effect from January 2025, all advanced therapeutic medicines (ATMPs) and oncology drugs will be mandated to undergo
Is the G-BA becoming more lenient towards surrogate endpoints?
By Fisentzos Stylianou, PhD; Senior Analyst Contact: [email protected] “I can say on behalf of the G-BA that it is possible that we will recognise some
Is the Innovative Medicines Fund a risk too great for small pharmaceutical companies?
By Fisentzos Stylianou, PhD Contact: [email protected] NICE’s launches a real-world evidence framework Closing knowledge gaps and advancing patient access to innovations are major aims of the
HAS Changes its Criteria for Pharmacoeconomic Evaluation
By Priyanka Kiritharan, Analyst Email: [email protected] Last month, France’s HTA body; Haute Autorite De Sante (HAS) changed its criteria that triggers the cost-effectiveness evaluation of products
Is AIFA on the verge of significant reforms?
By Andrea Bernardini, Senior Analyst Email: [email protected] Nicola Magrini, the General Director of the Italian Medicines Agency’s (AIFA) has just suggested that significant changes are on
DARWIN EU and the evolution of real-world data regulation in Europe
By Fisentzos Stylianou, PhD Contact: [email protected] One of the main healthcare challenges raised by the European Medicines Agency’s (EMA) network strategy to 2025 is the
