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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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[6] [7] The fundamental mechanism involves binding to GLP-1 receptors located throughout the body, particularly in pancreatic beta cells, the gastrointestinal tract, and the central nervous system

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Cola C, Almeida M, Li D, Romeo F, Mehta JL

Diselenide- and disulfide-mediated synthesis of isocoumarins