Japan’s decision gives quizartinib its first approval globally in specific first-line AML indication, in relatively small but high-need patient population.

Dunn is retiring after an 18-year career that included involvement in some high-profile and controversial drug approval decisions, not the least of which is Biogen’s Alzheimer’s treatment Aduhelm; deputy director Teresa Buracchio takes over the neurology office on an acting basis.

With cash preservation in mind, Rubius will dissolve, while EQRx, Impel, Cybin and Graphite cut jobs. Meanwhile, Jounce is restructuring and it plans to merge with Redx, yet the dually troubled firms MEI Pharma and Infinity will combine, while VBL will disappear in a reverse merger with Notable Labs. 

A long-anticipated pruning back of the ev vivo gene therapy pipeline for sickle cell disease has arrived with Novartis, Graphite Bio and Sangamo each dropping projects, but some challengers are looking ahead to a future of in vivo approaches to the condition.