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  4. Bavarian Nordic — Marts 2021

Bavarian Nordic — Marts 2021

Planlagt Fastgjort Låst Flyttet Bavarian Nordic
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Denne tråd er blevet slettet. Kun brugere med emne behandlings privilegier kan se den.
  • J Offline
    J Offline
    Jakob440
    wrote on sidst redigeret af
    #489

    Det er gammel artikel exitnu

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    • exitnuE Offline
      exitnuE Offline
      exitnu
      wrote on sidst redigeret af
      #490

      Er det bare det nye trademark som der er info om?

      1 Reply Last reply
      0
      • exitnuE Offline
        exitnuE Offline
        exitnu
        wrote on sidst redigeret af
        #491

        Ja gammel artikel sorry.

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        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

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          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.

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              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

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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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                      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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                          • 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 😄

                              1 Reply Last reply
                              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.

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