Dec 23 (Reuters) - Zealand Pharma said on Saturday that the U.S. Food and Drug Administration (FDA) had declined to approve its drug for preventing and treating low blood sugar in children with a genetic disorder after finding deficiencies at a third-party manufacturing facility.
Copenhagen, Denmark, August 30, 2023 – 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 US FDA has granted priority review designation for dasiglucagon for the prevention and treatment of hypoglycemia in pediatric patients 7 days of age and older with CHI for up to 3 weeks of dosing.
Press release“ No. 8 / 2023 Zealand Pharma submits New Drug Application to US FDA for dasiglucagon in congenital hyperinsulinism Copenhagen, Denmark, June 30, 2023“ Zealand Pharma A/S...
Press release No. 7 / 2023 Zealand Pharma Submits Marketing Authorization Application for Dasiglucagon for Treatment of Severe Hypoglycemia in Diabetes to the European Medicines Agency ...
Copenhagen, DK and Boston MA, U.S. September 19, 2022 – Zealand Pharma A/S (CVR-no. 20045078,) a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced that clinical results from the two-part Phase 3 trial of dasiglucagon for the treatment of congenital hyperinsulinism (CHI) in newborns and infants up to 12 months of age were presented at the 60th annual European Society for Paediatric Endocrinology (ESPE) meeting, held in Rome, September 15-17, 2022. Topline results from Part 1 of the trial were previously announced in May 2022 (Company Announcement No. 22 / 2022).
Copenhagen, DK and Boston MA, U.S. September 19, 2022 – Zealand Pharma A/S (CVR-no. 20045078,) a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced that clinical results from the two-part Phase 3 trial of dasiglucagon for the treatment of congenital hyperinsulinism (CHI) in newborns and infants up to 12 months of age were presented at the 60th annual European Society for Paediatric Endocrinology (ESPE) meeting, held in Rome, September 15-17, 2022. Topline results from Part 1 of the trial were previously announced in May 2022 (Company Announcement No. 22 / 2022).
Copenhagen, DK and Boston, MA, U.S. September 7, 2022 – 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 it has entered into a global license and development agreement with Novo Nordisk A/S to commercialize ZEGALOGUE® (dasiglucagon) for injection.
Copenhagen, DK and Boston, MA, U.S. September 7, 2022 – 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 it has entered into a global license and development agreement with Novo Nordisk A/S to commercialize ZEGALOGUE® (dasiglucagon) for injection.
On Thursday, Zealand Pharma has announced positive topline results from a phase III trial of dasiglucagon, a treatment for congenital hyperinsulinism (CHI), the firm reports in a press release.
Company announcement – No. 9 / 2022 Zealand Pharma: Significant Advancement of Clinical Pipeline and Building Commercial Momentum. Key Data for Glepaglutide and Dasiglucagon Programs Expected in...