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Mary Claire Haver

The Denmark-based company announced Wednesday it had received a Complete Response Letter for dasiglucagon, which it was proposing for the ultra-rare genetic disease congenital hyperinsulinism, due to the timing of a third-party manufacturing facility reinspection. In an initial visit, the FDA had flagged deficiencies in a third-party contract manufacturer, which the company claims had been resolved by the time of a reinspection in August/September 2024

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Summary The cloning of the glucagon gene, identification of GLP-1(7-37) as an intestinal hormone satisfying the criteria of an incretin and its development into a drug is a milestone in medicine