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.

→ The blockbuster fledgling that Celgene $CELG and Acceleron $XLRN have been carefully hatching is headed to the FDA. The partners has filed a BLA for luspatercept, a potential treatment for anemia associated with myelodysplastic syndrome as well as beta thalassemia. The drug is among a group of late-stage products that Bristol-Myers Squibb highlighted in its case for acquiring Celgene, which it believes could collectively fetch $15 billion in annual revenue. An EMA submission is expected to follow later this year.

→ In the aftermath of a mid-stage flop that triggered a landslide on its stock, Aerpio Pharma is cutting deep into its small team and laying off 11 staffers — almost half of the entire company. The restructuring will cost $0.9 million, but will hopefully stem the bleeding as Aerpio marches on with AKB-9778, which is says still has potential in diabetic complications and as well as for open angle glaucoma.

ContraVir has called off a licensing pact with Chimerix, returning worldwide rights to CMX157, an oral pro-drug of tenofovir.

With contribution by John Carroll.

The best place to read Endpoints News? In your inbox.

Comprehensive daily news report for those who discover, develop, and market drugs. Join 47,300+ biopharma pros who read Endpoints News by email every day.

Free Subscription

Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
Director of Operations
Atlas Venture Cambridge, MA

Visit Endpoints Careers ->