European Medicines Agency


EMA pilot to provide regulatory support to selected ATMP developers

By Rachel Arthur

The European Medicines Agency (EMA) will provide up to five selected advanced therapy medicinal products (ATMPs) with enhanced regulatory support - and in the process hopes to learn how to improve the regulatory processes for other ATMP drugs in the future.


Europe launches initiative to transform clinical trials

By Rachel Arthur

Regulatory bodies in the European Union have launched an initiative to develop the region as a focal point for clinical research and to better integrate clinical research in the European health system.


EU nears decision on Novavax COVID-19 vaccine

By Rachel Arthur

The European Medicines Agency (EMA) could issue an opinion on Novavax’ Conditional Marketing Authorization for its COVID-19 vaccine ‘within weeks’.

Hospira launch biosimilar mAb in the EU

Hospira launches first mAb biosimilar in major EU markets

By Zachary Brennan

Hospira, recently acquired by Pfizer, announced Monday the launch of the first biosimilar monoclonal antibody (mAb), Inflectra (infliximab), in major European markets, following the patent expiry of J&J’s Remicade. 

(Picture credit: Joe Flintham/flickr)

J&J and EGA differ on safety impact of same INNs for biosimilars

By Fiona Barry

Johnson & Johnson (J&J) has called on the US FDA to prevent biosimilars being given the same non-proprietary names as their original biologics, while the European Generics Association maintains the practice is “proven to be safe” and “supported...