Sponsors of several new medicines are set to learn if their products are on track for pan-EU approval. One product on the list is Pfizer/Lilly’s osteoarthritis drug, tanezumab, which recently ran into trouble in the US.

Apellis plans to file pegcetacoplan for approval as the first drug to treat the advanced AMD condition geographic atrophy, despite the C3 inhibitor hitting its endpoint in only one of two pivotal trials.

Agnafit Bidco, comprised of Advent International and an affiliate of GIC Pte Ltd, will pay a premium for the rare disease specialist in an effort to capture value from Sobi’s planned growth.  

Close to 90% of the FDA’s 2021 first half novel approvals were cleared in the US before Europe, while the EU’s EMA acted first on only 15% of its first half marketing authorizations for new active substances. Exclusive Pink Sheet analysis explores use of expedited review schemes, special pathways and other comparative trends.