More than half of the complete response letters issued for applications holding breakthrough status have been issued since 2020, reflecting difficult – and often rancorous – efficacy debates.

As its acquisition by AstraZeneca moves toward closure, Alexion plans to file the Soliris follow-on for generalized myasthenia gravis in the US, EU and Japan. But potential competition awaits in the C5 inhibitor and FcRn antagonist classes.

Plus deals involving Y-Biologics/Pierre Fabre, Contera/Abzu, Chugai/Alebund, Catalyst/DyDo, Spergogenix/Abbiska, Nippon Gene/ERS Genomics, Simcere/Vivoryon, Dr. Reddy’s/Journey Medical and Innovent/Synaffix.

Anaveon of Switzerland plans to take the clinical road less travelled with its novel interleukin-2 agonist, ANV419, its CEO told Scrip as the firm launched a Phase I/II study for its lead asset.