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agency has formalized the "progressive" biomarker qualification process described in the paper and will be releasing a draft guidance detailing the formal steps of the process this July.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

Chinese state news agency Xinhua reports that a preliminary investigation has found He Jiankui performed his gene-editing work illegally.

John Mendelsohn, a former president of the University of Texas MD Anderson Cancer Center, has died, the New York Times reports.

Identical twins receive different estimates of ancestry from the same direct-to-consumer genetic testing firms, CBC reports.

In PNAS this week: chromosomal features of maize, adaptations in the vinous-throated parrotbill, and more.