EMEA

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agency has formalized the "progressive" biomarker qualification process described in the paper and will be releasing a draft guidance detailing the formal steps of the process this July.

When Vectibix received approval from the US Food and Drug Administration in 2006, "Amgen already knew the response rate was low," according to an Amgen official. The company began collecting patient tissue samples from mid-2005 to early 2007, knowing it would "need those samples for a biomarker analysis."

The UK's Human Fertility and Embryology Authority calls for consumer genetic testing companies to warn customers that testing could uncover family secrets, according to the Guardian.

The New York Times reports that United Nations delegates have been discussing how to govern the genetic resources of the deep sea.

Researchers have transplanted edited cells into mice that appear to combat cocaine addiction, New Scientist reports.

In PNAS this week: analysis of proteolytic enzymes secreted by circulating tumor cells, phylogenetic study of Fv1 evolution, and more.