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agency has formalized the "progressive" biomarker qualification process described in the paper and will be releasing a draft guidance detailing the formal steps of the process this July.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

Gene drives might run into biological resistance, the Economist reports.

Forensic experts exhumed painter Salvador Dalí's body to collect DNA for a paternity test, CBS News reports.

Yale Environment 360 writes that synthetic and conservation biologists aren't always on the same wavelength, but they are trying to reach an understanding.

In Science this week: full CRISPR locus integration complex structure, and more.