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Novo’s Insulin Degludec Faces Advisory Cmte. Scrutiny On Hypoglycemic Benefit, CV Safety

This article was originally published in The Pink Sheet Daily

Executive Summary

In briefing documents for the Nov. 8 panel review, FDA suggests the clinical trial data do not support Novo Nordisk’s assertion of a hypoglycemia advantage with its new long-acting insulin. Agency also raises concerns about a meta-analysis suggesting an increased cardiovascular risk.

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