Zealand Pharma — Maj 2024
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Zealand Pharma announces positive CHMP opinion for dasiglucagon for treatment of severe hypoglycemia in diabetes from European Medicines Agency
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Copenhagen, Denmark, May 31, 2024 – Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078), a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending granting marketing authorization for dasiglucagon solution for injection in the treatment of severe hypoglycemia in adults, adolescents, and chil
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"We are very pleased that the European regulatory authorities have recommended approval of dasiglucagon as a rescue treatment for very low blood sugar in people with diabetes," said Adam Steensberg, Chief Executive Officer of Zealand Pharma. "This is an important step in achieving our ambition of bringing this product to many more patients around the world through our partnership with Novo Nordisk, a global leader in diabetes."
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The positive opinion from the CHMP will be referred to the European Commission (EC) for a final decision whether to grant marketing authorization in the European Union (EU). Zealand expects this decision within approximately three months. Dasiglucagon injection was approved by the U.S. FDA in March 2021 under the brand name Zegalogue
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Zealand Pharma: Ekspertpanel anbefaler nødpen udlicenseret til Novo godkendt i EU https://proinvestor.com/investornyt/1167142/zealand-pharma-ekspertpanel-anbefaler-nodpen-udlicenseret-til-novo-godkendt-i-eu
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