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Takeda Would See Added Costs Under U.S. FDA Plan

This article was originally published in PharmAsia News

Executive Summary

A plan under review by the U.S. FDA could have an impact on Japan's Takeda Pharmaceutical and its diabetes drugs worth $2.9 billion in sales. The U.S. agency is considering raising standards that would require existing and new diabetes drugs to have a positive impact on cardiovascular disease and the life span of the patient. That could mean an end to the use of surrogate endpoints currently relied on by drug makers to measure benchmarks. If the FDA moves in that direction, Takeda, GlaxoSmithKline and other makers of diabetes drugs could be required to conduct additional studies to show the improvements. (Click here for more - a subscription may be required
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