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Low-Dose Xarelto Effective In ACS Patients

This article was originally published in The Pink Sheet Daily

Executive Summary

Bayer and J&J tout positive results from a Phase III study of Xarelto in a new patient population, while Eliquis hits a setback.

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Xarelto Approval For Stroke Prevention Sets Up Marketing Battle With Pradaxa

J&J Saves Xarelto; But Faces tough Label

J&J’s defense of its pending stroke prevention indication in atrial fibrillation for Xarelto at the September 8 FDA Cardio-Renal Advisory Committee is likely to go down in FDA lore as an example of a successful argument that saved an application, but not the product. The presentation may also be notable into the future for two slides on benefit/risk which address one of FDA’s new interests: patient preferred outcomes.

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