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EU Cites Serious Tavneos Trial Breaches After Pulling Amgen Authorization

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European regulators released their rationale for withdrawing Amgen’s rare-disease drug Tavneos, citing serious breaches of proper clinical trial guidelines in the pivotal study. Unblinded efficacy data became visible after database lock, certain patients were re-adjudicated, and the primary result changed to significant—without regulator notification. The EMA found the overall study unreliable and the submitted results misleading, and the FDA is also scrutinizing Tavneos.

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