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agency has formalized the "progressive" biomarker qualification process described in the paper and will be releasing a draft guidance detailing the formal steps of the process this July.

The Associated Press reports that the US government wasted $341,000 on travel by former Health and Human Services Secretary Tom Price.

Women who post YouTube science videos get more critical comments and more comments about their appearance than male video hosts, the New York Times reports.

The Wall Street Journal writes that participating in genetic research brings up the specter of past research ethics lapses for some African Americans.

In PLOS this week: sequences influencing yeast prion aggregation or degradation, dengue virus genetic variants affect transmission dynamics, and more.