The European Medicines Agency’s CHMP was set to adopt opinions on SK Bioscience’s COVID-19 vaccine and Mycovia/Gedeon’s Vivjoa for vulvovaginal candidiasis during its September meeting, but both marketing authorization filings were voluntarily withdrawn.

Formycon has become the latest firm to announce a new CEO, after similar moves at Orion and Strides. Meanwhile, Gedeon Richter has made management changes and a new director has joined Coherus.

Hikma has made the next move to build up its nascent US biosimilars business by striking a deal with Gedeon Richter for its denosumab candidate.

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.