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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
    #491

    Ja gammel artikel sorry.

    1 Reply Last reply
    0
    • J Offline
      J Offline
      Jakob440
      wrote on sidst redigeret af
      #492

      Jeg har fundet indlægssedlen https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214231s000lbl.pdf

      1 Reply Last reply
      0
      • J Offline
        J Offline
        Jakob440
        wrote on sidst redigeret af
        #493

        Indlægsgodkendelsen er tilhørende dasiglucagon hypopal.

        1 Reply Last reply
        0
        • J Offline
          J Offline
          Jakob440
          wrote on sidst redigeret af
          #494

          Så må godkendelsen officelt blive meldt ud snart.

          1 Reply Last reply
          0
          • J Offline
            J Offline
            Jakob440
            wrote on sidst redigeret af
            #495

            Nu er det officielt

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            0
            • 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

              1 Reply Last reply
              0
              • 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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                0
                • exitnuE Offline
                  exitnuE Offline
                  exitnu
                  wrote on sidst redigeret af
                  #498

                  Zealand Pharma surges on news of FDA approval for dasiglucagon

                  1 Reply Last reply
                  0
                  • 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

                        https://seekingalpha.com/news/3674971-zealand-pharma-surges-on-news-of-fda-approval-for-dasiglucagon

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                        0
                        • 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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                          0
                          • J Offline
                            J Offline
                            Jakob440
                            wrote on sidst redigeret af
                            #503

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

                            1 Reply Last reply
                            0
                            • 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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                              0
                              • M Offline
                                M Offline
                                Munchi
                                wrote on sidst redigeret af
                                #505

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

                                1 Reply Last reply
                                0
                                • 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"

                                  1 Reply Last reply
                                  0
                                  • J Offline
                                    J Offline
                                    Jakob440
                                    wrote on sidst redigeret af
                                    #507

                                    Godkendelsen er for Dasiglucagon hypopal pennen

                                    1 Reply Last reply
                                    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.

                                      1 Reply Last reply
                                      0
                                      • exitnuE Offline
                                        exitnuE Offline
                                        exitnu
                                        wrote on sidst redigeret af
                                        #509

                                        "autoinjector and prefilled syringe are for subcutaneous
                                        injection only"

                                        1 Reply Last reply
                                        0
                                        • J Offline
                                          J Offline
                                          Jakob440
                                          wrote on sidst redigeret af
                                          #510

                                          DevOp, det er udelukkende en godkendelse af hypopal pennen.

                                          1 Reply Last reply
                                          0

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