MDx/CDx Focus: FDA Accepts Pfizer's Bosutinib NDA; Kalydeco Approval; AssureRx Credit Line; and more | GenomeWeb

FDA Grants Standard Review for Pfizer's NDA for Bosutinib in Ph-Positive CML

The US Food and Drug Administration has accepted Pfizer's new drug application for bosutinib, an investigational drug for previously treated Philadelphia chromosome-positive chronic myeloid leukemia patients.

Pfizer said this week that the agency will conduct a standard review of the NDA, which places it on a 10-month review cycle from the date of its receipt.

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Replication studies that don't quite reflect the original findings underscore the need to better share data, the Wall Street Journal reports.

About two-thirds of proposals to work with select agents are denied — though most proposals that come in don't meet the definition of a restricted experiment, according to an analysis by the Centers for Disease Control and Prevention.

Researchers examine plant and human DNA found on the Shroud of Turin.

In PNAS this week: Plasmodium knowlesi population structure, 'pre-adaptations' in algal ancestors of land plants, and more.

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