Top-line results from the firm’s pivotal trial of pivekimab sunirine in a rare cancer indication have been delayed for two more years as the firm shifts focus to a specific subpopulation.

Chaos wrought by the ongoing coronavirus pandemic. A heavy workload and continuing resource constraints at the European Medicines Agency. Nonetheless, a record number of novel drugs and vaccines were cleared for marketing in the EU last year.

Two years into her tenure as the head of Menarini, Elcin Barker Ergun has already inked two major cancer deals with the acquisition of Stemline and a key licensing pact with Radius Health. The future for the Italian group is bright, she explained to Scrip in an exclusive interview.

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.