June 21 Company Quick Takes: FDA rejects Daiichi's AML candidate; plus Sanofi, Novartis and more

Complete response letter for Daiichi's quizartinib
Daiichi Sankyo Co. Ltd. (Tokyo:4568) said FDA issued a complete response letter for quizartinib, its candidate to treat relapsed/refractory FLT3-ITD-positive acute myelogenous leukemia (AML). In May, an FDA advisory committee voted 8-3 against approval of the oral small molecule FLT3 inhibitor, as marginal efficacy and missing data in a pivotal study's control arm concerned panelists. The letter came more than two months ahead of quizartinib's Aug. 25 PDUFA date (see "Quizartinib Hiccup at ODAC").

Sanofi looks to trim U.S. head count
After announcing plans Wednesday to cut 466 positions in France and Germany, Sanofi (Euronext:SAN; NASDAQ:SNY) said Friday it is also offering some of its U.S. employees a voluntary early exit program. The pharma declined to disclose how many employees have accepted the offer (see "Gene Therapy, Vaccines in Focus as Sanofi Maps out Priorities")...