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Foundation Medicine, Inc.

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Latest From Foundation Medicine, Inc.

The Real World Is Not Enough: Comparability Is Common Obstacle For RWE In US FDA Decisions

Unsuccessful attempts to use real-world evidence for approvals highlight the need to demonstrate relationship between real-world data and clinical trial patients. The Pink Sheet examines what went wrong for Bluebird/Bristol’s Abecma, Ultragenyx’s Dojolvi, and Karyopharm’s Xpovio.

Real-World Evidence Review Pathway

Keeping Track: US FDA Clears New Uses For Incyte’s Pemazyre, AbbVie’s Imbruvica; Minerva Seeks First Negative Symptoms Claim In Schizophrenia

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

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FoundationOne Nabs US FDA Approval As Companion Diagnostic For Rare Cancers

The approval is the 25th indication for the diagnostic, but the first for any companion diagnostic to Roche’s Rozlytrek. 

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AstraZeneca Partners With AmoyDx On Companion Diagnostics For Lynparza

Deal Snapshot: Teaming again with the Shanghai biotech, AstraZeneca will seek assays that can be incorporated into companion diagnostics for Lynparza in prostate and breast cancer.

Deals Personalized Medicine
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