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agency has formalized the "progressive" biomarker qualification process described in the paper and will be releasing a draft guidance detailing the formal steps of the process this July.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

In PNAS this week: diatom genetic diversity, microfluidic droplet method for single-cell screening, and more.

Scientific publishers are looking into whether artificial intelligence can help the peer-review process, Wired reports.

Researchers are using gene editing to develop more robust livestock and crops, AFP reports.

Researchers rally near the American Association for the Advancement of Science annual meeting in Boston.