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CVT Hopes MERLIN Is Magic: Can Outcomes Trial Reverse Ranexa’s Fortune?

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Large outcomes studies "will be the wave of the future for many products, not just cardiovascular products," CV Therapeutics CEO Louis Lange predicted during a Feb. 8 earnings call.

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CV Therapeutics’ Pre-"Approvable" Letter To FDA’s Temple

Excerpts from an Oct. 20, 2003 letter to Office of Drug Evaluation I Director Robert Temple. CV Therapeutics CEO Robert Lange and VP-Clinical R&D Andrew Wolff proposed a risk management program (ultimately not instituted upon approval) and downplayed QT concerns regarding Ranexa. FDA issued an "approvable" letter ten days later.

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Even in the grip of the pandemic, review times for priority drugs were also consistent with the last three years.

Breakthroughs, Orphans Hit High Notes As US FDA’s 2020 Novel Approvals Play A Familiar Tune

Influence of expedited review pathways and regulatory incentives is on display in 2020’s novel approvals, which have a composition reassuringly consistent with recent years.




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