The EMA’s Head of Advanced Therapies Dr Ana Hidalgo-Simon outlines Europe’s evolving regulatory framework for regenerative medicines, how it differs from those in the USA and Asia, ethical and pricing challenges, and why global regulatory harmonization and collaboration is crucial.
For advanced therapies, market approval is not the end of the journey, and we really want to reach the final destination, which is having patients benefit from these therapies. Access is fundamental
Janssen’s Cyril Titeux highlights the commonalities and challenges within his 31-country portfolio, his hopes and expectations for the evolution of market access in the region, and some of the key…
Niklas Hedberg outlines the role of EUnetHTA as both a network and project built up of national HTAs in Europe, the potential for a continent-wide mandate on health technology assessment,…
Professor Nicolaus Kröger, president of the European Society for Blood and Marrow Transplantation (EBMT) introduces the multi-stakeholder GoCART Coalition and the impact that it stands to have on the cell…
Writing in the December edition of DIA’s Global Forum magazine, Thomas Kühler updates his August piece on the progress towards a unified HTA system in Europe and the objectives of the recently…
Europe lags behind the US in terms of biotech success stories, but one company bucking that trend is Denmark-headquartered Genmab, with a market cap of over USD 25 billion. Dual-listed…
A rundown of five things to know about the healthcare and life sciences industry in Catalonia. Nestled in Northeastern Spain and bordering France, Catalonia’s capital and largest city is Barcelona.…
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