Sanofi appears to have failed to convince the European Medicines Agency that its just-filed marketing authorization application for isatuximab should be granted accelerated assessment. AB Science's request regarding its planned MAA for masitinib has been rejected and Alnylam is declining to disclose the fate of its request relating to givosiran. See our latest updates in the tracker below.

Isatuximab could be the next building block in Sanofi's ambitions to rebuild in oncology. The CD38-targeting antibody extended PFS in relapsed/refractory multiple myeloma in combination with Celgene's Pomalyst and dexamethasone.

While the Dutch government negotiates an acceptable price for Leadiant Biosciences’ orphan drug CDCA, a university hospital has resumed supplying pharmacy compounded versions of the drug after addressing initial problems with the sourcing of raw materials.