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Mis-Reading the Minutes: Arena Approval Follows Sell-Off Based on Advisory Committee Summary

This article was originally published in RPM Report

Executive Summary

Arena received great news June 27: approval of the weight loss therapy Belviq with a very clean label and no special marketing restrictions. That was what Wall Street expected—except when investors read the summary of the advisory committee review of the drug published by FDA on June 22.

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The Inevitable Outcome: Diabetes Safety Model Expands to Weight Loss…and Beyond?

The cardiovascular outcomes standard used for diabetes drugs since 2008 is moving to weight loss. That is important in itself, but also for what it says about the lessons FDA has taken from the diabetes experience—and what it might mean about regulatory expectations for other chronic drug classes in the future.

Weighty Issues: GW Obesity Drug Outcomes Project Tests a Model for Patient Input in Drug Development

A stakeholder project on obesity treatment outcomes will complete its work this summer, setting the stage for FDA to rethink efficacy endpoints for weight loss drug development. The closed-door project is happening in parallel with public advisory committee discussions on pending applications and safety standards. One impact will be to shape more formal patient-centered drug development activities in years to come.

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