The numbers may be down, but Europeans will in future be able to gain access to a number of highly innovative medicines, including several products for hard-to-treat cancers, a gene therapy for severe and moderately severe hemophilia B, and two vaccines against disease caused by respiratory syncytial virus.

The European Medicines Agency has recommended against the pan-EU marketing approval of two new medicines, while three others received positive opinions on marketing authorization.

A visual perspective on key regulatory topics in 2023, from clinical trial diversity to product approval trends and Medicare drug price negotiation.

Starting off with MSD as an anchor partner, Aurobindo plans to eventually spar with the likes of WuXi and Lonza while building scale for its biologics CDMO business. Meanwhile, EMA approval for a greenfield project in China and an US FDA nod for Ryzneuta, licensed from Yifan’s Evive Biotech, signal a boost.