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Sanofi and Lilly boosted by Novo's shock Tresiba FDA knockback

This article was originally published in Scrip

Executive Summary

Sanofi and Lilly have been dealt an unexpectedly positive hand by the surprise decision of the US FDA not to approve Novo Nordisk's novel ultra long-acting once-daily basal insulin product Tresiba (insulin degludec) or the combination treatment Ryzodeg (insulin degludec plus insulin aspart). It now looks like Tresiba's approval in the US may have been set back by three or more years.

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