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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agency has formalized the "progressive" biomarker qualification process described in the paper and will be releasing a draft guidance detailing the formal steps of the process this July.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 US Food and Drug Administration is to announce stricter standards for emergency authorizations of SARS-CoV-2 vaccines, reports the Washington Post.

The Associated Press reports Johnson & Johnson is starting a late-stage clinical trial of its candidate SARS-CoV-2 vaccine.

Bloomberg reports the budget of Operation Warp Speed is actually $18 billion, higher than the number typically cited.

In Genome Research this week: genomic analysis reveals role of super-spreaders in SARS-CoV-2, epigenetic drivers of cancer, and more.