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For Lilly’s Donanemab, US FDA Commissioner Is Already Thinking About Post-Market Questions

Executive Summary

From positive topline data to Robert Califf weighing in on the right patient population to treat with the Alzheimer’s candidate in less than a day, the drug rejected by the agency for accelerated approval earlier this year looks to make a quick comeback.

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US FDA Drugs Center Launches Clinical Trial Innovation Hub With Demonstration Projects

CDER’s Center for Clinical Trial Innovation (C3TI) will support innovative clinical trial approaches designed to improve the quality and efficiency of drug development and regulatory decision-making. The initiative includes demonstration projects on Bayesian analyses, selective safety data collection and point-of-care trials.

Lilly’s Donanemab Delay: Labeling, Real-World Operationalization May Be Reason For Adcomm

Close watchers of Lilly’s Alzheimer’s drug believe FDA’s last-minute advisory committee request is to deal with how to translate a complicated trial design into label recommendations, not because the agency is thinking of rejecting the drug, which had been seen as a shoo-in for approval.

A Lesson In Confidence Amid Development Hurdles: How Lilly Has Talked About Donanemab

The Alzheimer’s disease candidate’s positive milestones, and even its review delays, continue to produce confident statements in its future from the sponsor.

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