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UCB/Amgen misses fracture punt after FDA moves goalposts

This article was originally published in Scrip

Executive Summary

UCB and Amgen's 50-50 collaboration on the novel sclerostin antibody romosozumab (CDP7851/AMG785) will not proceed into Phase III trials in fracture healing. The decision is based on two factors: firstly, the FDA has moved the goalposts for clinical studies in fracture healing, and secondly, in a Phase II trial investigating its use in accelerating tibial fracture healing, the drug was "not reaching its endpoint to our full satisfaction", according to a UCB spokesperson.



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