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Oritavancin Phase III Results Support FDA’s New Endpoint, Sponsor Says

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA’s new early endpoint for efficacy in ABSSSI had been criticized at the time it was released. But reporting positive results for a second Phase III study of oritavancin, The Medicines Co. CEO says the agency’s ABSSSI endpoints are “appropriate” for industry.

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