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  4. Bavarian Nordic — Marts 2021

Bavarian Nordic — Marts 2021

Planlagt Fastgjort Låst Flyttet Bavarian Nordic
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  • exitnuE Offline
    exitnuE Offline
    exitnu
    wrote on sidst redigeret af
    #496

    Jeg har denne fra mit feed: (men er i tvivl)

    Approval Date: 03/22/2021; Drug Name: Zegalogue, Nda #214231; Active Ingredients: DASIGLUCAGON; Company: Zealand Pharma As; Submission Status: Approval; Submission Classification: Type 1 - New Molecular Entity; Application Number: 214231

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    • J Offline
      J Offline
      Jakob440
      wrote on sidst redigeret af
      #497

      Link Preview Image
      ZEAL: Zealand Sp ADR Latest Stock Price, Analysis, News and Trading Ideas

      Get real-time Zealand Sp ADR (ZEAL) stock price, news, financials, community insights, and trading ideas. Join 10 million+ investors and traders tracking markets in real-time on Stocktwits.

      favicon

      Stocktwits (stocktwits.com)

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      • exitnuE Offline
        exitnuE Offline
        exitnu
        wrote on sidst redigeret af
        #498

        Zealand Pharma surges on news of FDA approval for dasiglucagon

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        • exitnuE Offline
          exitnuE Offline
          exitnu
          wrote on sidst redigeret af
          #499

          Zealand Pharma (NASDAQ:ZEAL) rose in late trading hours to end the day with a ~12.9% gain on the news that its glucagon analog dasiglucagon, with the brand name Zegalogue, won FDA approval, according to a posting on the federal agency’s website.The company hasn’t officially released a statement yet.

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          • exitnuE Offline
            exitnuE Offline
            exitnu
            wrote on sidst redigeret af
            #500

            The PDUFA was March 27 for the company’s marketing application for dasiglucagon for congenital hyperinsulinism.Zealand Pharma dropped sharply in December on the announcement of topline data from the first Phase 3 trial evaluating dasiglucagon as a treatment of Congenital Hyperinsulinism (“CHI”).

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            0
            • exitnuE Offline
              exitnuE Offline
              exitnu
              wrote on sidst redigeret af
              #501

              Zealand Pharma surges on news of FDA approval for dasiglucagon

              Access to this page has been denied

              px-captcha

              favicon

              (seekingalpha.com)

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              • D Offline
                D Offline
                DevOp
                wrote on sidst redigeret af
                #502

                Og her sad man og ventede på godkendelse af HypoPal® rescue pen - så er der da basis for lidt mere i løbet af ugen 😄

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                • J Offline
                  J Offline
                  Jakob440
                  wrote on sidst redigeret af
                  #503

                  Indlægssedlen lyder også fin. Har lige kort kigget den igennem.

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                  • exitnuE Offline
                    exitnuE Offline
                    exitnu
                    wrote on sidst redigeret af
                    #504

                    ZEGALOGUE (dasiglucagon) injection, for subcutaneous use. Initial U.S. Approval: 2021:

                    https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214231s000lbl.pdf

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                    • M Offline
                      M Offline
                      Munchi
                      wrote on sidst redigeret af
                      #505

                      er dette ikke hypopalpennen ? hvis nej hvad er det så ?

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                      • D Offline
                        D Offline
                        DevOp
                        wrote on sidst redigeret af
                        #506

                        Exitnu, det ser jo ud som dasi til Rescue pen mod "severe hypoglycemia" - de nævner bare ikke pennen, men de har tilsyneladende også fået godkendelse til dasi mod
                        "congenital hyperinsulinism"

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                        0
                        • J Offline
                          J Offline
                          Jakob440
                          wrote on sidst redigeret af
                          #507

                          Godkendelsen er for Dasiglucagon hypopal pennen

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                          0
                          • J Offline
                            J Offline
                            Jakob440
                            wrote on sidst redigeret af
                            #508

                            Pensionisten, det der link er forældet så det skal du bare glemme. Det var såmænd bare en bekræftelse tilbage fra maj 2020, at FDA har modtaget ansøgningen.

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                            • exitnuE Offline
                              exitnuE Offline
                              exitnu
                              wrote on sidst redigeret af
                              #509

                              "autoinjector and prefilled syringe are for subcutaneous
                              injection only"

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                              0
                              • J Offline
                                J Offline
                                Jakob440
                                wrote on sidst redigeret af
                                #510

                                DevOp, det er udelukkende en godkendelse af hypopal pennen.

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                                • D Offline
                                  D Offline
                                  DevOp
                                  wrote on sidst redigeret af
                                  #511

                                  Ja, men betyder det så ikke, at "congenital hyperinsulinism" stadig mangler og endda også har PDUFA date d.27. marts?

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                                  • D Offline
                                    D Offline
                                    DevOp
                                    wrote on sidst redigeret af
                                    #512

                                    havde da umiddelbart forstået det som to forskellige indikationer...

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                                    0
                                    • J Offline
                                      J Offline
                                      Jakob440
                                      wrote on sidst redigeret af
                                      #513

                                      DevOp, der er ikke blevet ansøgt om godkendelse for CHI congenitial hyperinsulism i nu. De mangler det sidste fase 3 forsøg som bliver udmeldt formentlig i Q3.

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                                      • D Offline
                                        D Offline
                                        DevOp
                                        wrote on sidst redigeret af
                                        #514

                                        ok, har ikke fulgt med ift CHI - men så har de måske byttet rundt på seeking alpha linket - der nævner de netop "congenital hyperinsulinism" med PDUFA date d.27.marts

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                                        • D Offline
                                          D Offline
                                          DevOp
                                          wrote on sidst redigeret af
                                          #515

                                          Der skulle vel så have stået "severe hypoglycemia" i stedet.

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