Officially, there have been four new chemical entities have been approved since our last issue.
Officially, there have been four new chemical entities have been approved since our last issue: Symbiomix Therapeutics’ Solosec, for bacterial vaginosis; Bayer’s Aliqopa for relapsed follicular lymphoma; Chemo Group’s benznidazole for Chagas disease in children; and The Medicine Company’s Vabomere for complicated urinary tract infections. Oddly, the agency is not currently counting Kymriah, aka CTL-019, Novartis’ groundbreaking CAR-T therapy for acute lymphoblastic leukemia that was approved August 30. (Perhaps they are still deciding how to classify it?).
In any case, this is clearly a significant step forward. But also significant is the approval of a biosimilar to Roche’s Avastin. Amgen has a healthy pipeline of biosimilars to augment its proprietary drug development, and this is a critical player for them. -KT
