PSTC

Led by the Critical Path Institute and Roche's Ventana Medical Systems, the project aims to fill a gap in the current biomarker pipeline, and will hopefully speed the progression of proposed biomarkers through the FDA's qualification pipeline, said a C-Path official.

The decision is the first ever biomarker qualification decision by Japan's PMDA and means that the biomarkers are now qualified at the same level by all of the regulatory agencies comprising the ICH, including FDA and EMEA.

An FDA official said that the agency has formalized the "progressive" biomarker qualification process described in the paper and will be releasing a draft guidance detailing the formal steps of the process this July.

A new study finds that a placental protein linked with preeclampsia can be targeted by RNA silencing, according to the New Scientist.

A settlement is expected in a Duke University lawsuit hinging on using falsified data to win grants, Retraction Watch and Science report.

In PNAS this week: approach for analyzing the expression of endogenous retroviruses, circular RNAs that influence host-virus interactions, and more.

A phylogenetic analysis finds that the rare hemimastigotes form their own supra-kingdom, CBC reports.