Bay­er re­ports cy­ber at­tack point­ed to Chi­nese hack­ers; FDA pro­longs re­view of Dai­ichi Sanky­o's AML drug

→ Bay­er has stopped a cy­ber at­tack in its tracks, the com­pa­ny said, seem­ing­ly with­out hav­ing any da­ta stolen or com­pro­mis­ing third-par­ty per­son­al da­ta. The Ger­man drug­mak­er sus­pects that the in­fec­tious soft­ware — which it first de­tect­ed ear­ly last year and mon­i­tored un­til last month — was tied to a group of hack­ers in Chi­na, a spokesper­son told Reuters.

→ The FDA de­mand­ed some new da­ta on Dai­ichi Sankyo’s FLT 3 in­hibitor quizar­tinib, and now they’ll be tak­ing a few ex­tra months to take a close look as they re­view the Japan­ese com­pa­ny’s NDA. The new PDU­FA date is Au­gust 25 as the agency push­es through a 3-month ex­ten­sion on the re­view dead­line.

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