Protocols

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.

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

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