Keeping Track: J&J Esketamine, Sanofi Caplacizumab Lead Off September Submissions; US FDA Says No To Nucala

The US FDA seeks advice on the clinical meaningfulness of the endpoints of J&J’s AQUILA trial in smoldering multiple myeloma, highlighting the pitfalls of being the first candidate for the precancerous condition.

Patients from Asia saw a differential treatment effect versus non-Asian regions in the Phase III multiregional study, with an adverse survival trend seen in the latter group, the FDA said about the lymphoma drug.

Brensocatib, Insmed's investigational treatment for non-cystic fibrosis bronchiectasis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.