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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agency has formalized the "progressive" biomarker qualification process described in the paper and will be releasing a draft guidance detailing the formal steps of the process this July.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 US has sent its formal notice of withdrawal from the World Health Organization, according to the Wall Street Journal.

Science reports that a draft spending bill would increase the US National Institutes of Health budget by 13 percent.

The Harvard Crimson reports that Harvard and MIT are suing the Department of Homeland Security and ICE over the new international student visa policy.

In Nucleic Acids Research this week: algorithm to determine molecular sequence types and other microbial features, computational method to uncover R-loop structures, and more.