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agency has formalized the "progressive" biomarker qualification process described in the paper and will be releasing a draft guidance detailing the formal steps of the process this July.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

University of Idaho researchers model the scientific discovery process to examine the link between reproducibility and scientific truth.

A bill passed by a US House of Representatives appropriations subcommittee would give scientific agencies including the National Science Foundation boosts in funding.

Relocating USDA agencies outside of Washington, DC, may make them less effective, critics of the move tell NPR.

In PLOS this week: genes that help Borrelia burgdorferi survive in ticks, CiliaCarta collection of about 1,000 suspected cilia genes, and more.