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agency has formalized the "progressive" biomarker qualification process described in the paper and will be releasing a draft guidance detailing the formal steps of the process this July.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

CNN reports that researchers have tied a new variant to opioid addiction risk.

Organoids derived from patients' tumors may help determine what chemotherapy treatment patients would benefit from, according to New Scientist.

An initiative from GenomeAsia 100K hopes to increase the number of South Asians in genetic research, according to NBC News.

In Science this week: genomic analysis of ancient and modern horses indicates population turnover, and more.