US Food and Drug Administration (FDA) approvals in 3Q show no effect of the pandemic, with roughly the same number of approvals as in 3Q19. The agency granted three accelerated approvals for cancer indications, including two that target CD19 in unique ways (Gilead’s Tecartus, which has circulating malignant cells removed during manufacturing, and MorphoSys’s Monjuvi, which has modifications to the Fc portion). The first small-molecule exon-skipping drug, Roche’s Evrysdi, was approved. The saga of Biogen’s monoclonal aducanumab may finally come to a resolution in early 2021, when the FDA reviews data from its restarted continuation trial for Alzheimer’s disease. Both the European Medicines Agency (EMA) and FDA gave thumbs down to BioMarin’s hemophilia A drug valoctocogene roxaparvovec.

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Fonte: 1230 news Nature Biotechnology | VOL 38 | November 2020 | 1221–1233 | www.nature.com/naturebiotechnology