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Genmab — Marts 2019

Planlagt Fastgjort Låst Flyttet Genmab
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  • B Offline
    B Offline
    bibob
    wrote on sidst redigeret af
    #998

    https://ir.genmab.com/news-releases/news-release-details/genmab-announces-european-regulatory-submission-daratumumab-3

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    • S Offline
      S Offline
      Sukkeralf
      wrote on sidst redigeret af
      #999

      jans answer: The COLUMBA study is the only non inferiority PHIII that would be needed to obtain a label for SC daratumumab...

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      • S Offline
        S Offline
        Sukkeralf
        wrote on sidst redigeret af
        #1000

        In order to obtain a broader label, we would also need to obtain safety data from the PLEIADES study which is evaluating 3 cohorts of patients DARA + RD, DARA + VMP and DARA + VRD. If this study reads out positively, we expect to obtain a broad label for SC DARA..

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        • S Offline
          S Offline
          Sukkeralf
          wrote on sidst redigeret af
          #1001

          To me thats sounds like they will file first on the Columba data............and then later a sBLA on combination data

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          • E Offline
            E Offline
            E_L
            wrote on sidst redigeret af
            #1002

            that is also my best geuss at the moment

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            • BulderB Offline
              BulderB Offline
              Bulder
              wrote on sidst redigeret af
              #1003

              Yes,and with a label limited to R/R MM and not frontline.

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              • S Offline
                S Offline
                Sukkeralf
                wrote on sidst redigeret af
                #1004

                yes and maybe maintenance

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                • D Offline
                  D Offline
                  Doc4
                  wrote on sidst redigeret af
                  #1005

                  @pensionisten 8:28....FYI Mayzent = Siponimod og er beskrevet her: https://scleroseforeningen.dk/nyheder/gilenya-20. Samme virkning da siponimod er en syntetisk udgave af Gilenya, som har væet på markedet i 7 år. Siponimod har en bedre bivirkningsprofil, da target kun er 2 ud af 5 forskellige SiP molekyler, hvor Gilenya targets 4/5, hvoraf et i hjertet. Held og lykke;)

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                  • D Offline
                    D Offline
                    Doc4
                    wrote on sidst redigeret af
                    #1006

                    Hmm...ser ud til links fungere bedst, som afslutning og uden andre karakterer efterfølgende, så her er link der fårhåbentlig fungerer https://scleroseforeningen.dk/nyheder/gilenya-20

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                    • V Offline
                      V Offline
                      Vester
                      wrote on sidst redigeret af
                      #1007

                      The Plaides study has been fully recruited for approx 5 months now.. One could hope that the label expansion happens fast, as they only need safety data, as Jan states..

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                      • A Offline
                        A Offline
                        AaBforever
                        wrote on sidst redigeret af
                        #1008

                        Nå..så skal den lige have en over nakken her sidst på dagen.

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                        • Legolas23L Offline
                          Legolas23L Offline
                          Legolas23
                          wrote on sidst redigeret af
                          #1009

                          Det er meget bredt og ikke specifikt genmab, som falder. Hovedet op og på med de lange briller

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                          • A Offline
                            A Offline
                            AaBforever
                            wrote on sidst redigeret af
                            #1010

                            Vestas stiger..:-)

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                            • Helge_LarsenPI-redaktørH Offline
                              Helge_LarsenPI-redaktørH Offline
                              Helge_LarsenPI-redaktør
                              wrote on sidst redigeret af
                              #1011

                              Just a moment...

                              favicon

                              (www.proinvestor.com)

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                              • BulderB Offline
                                BulderB Offline
                                Bulder
                                wrote on sidst redigeret af
                                #1012

                                FDA Puts Partial Hold on Venetoclax’s Multiple Myeloma Trials https://myelomaresearchnews.com/2019/03/27/fda-partially-stops-venetoclax-clinical-trials-in-multiple-myeloma/?utm_source=Myeloma+List&utm_campaign=5e5e2e74d5-RSS_WEEKLY_EMAIL_CAMPAIGN&utm_medium=email&utm_term=0_14fcd0022a-5e5e2e74d5-72491777

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                                • BulderB Offline
                                  BulderB Offline
                                  Bulder
                                  wrote on sidst redigeret af
                                  #1013

                                  Dara-Veneto suspenderet https://clinicaltrials.gov/ct2/show/NCT03701321?term=NCT03701321&rank=1

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                                  • nohopeN Offline
                                    nohopeN Offline
                                    nohope
                                    wrote on sidst redigeret af
                                    #1014

                                    Har kikket - men ikke fundet nogen begrundelse - noget jeg overser ?

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                                    • BulderB Offline
                                      BulderB Offline
                                      Bulder
                                      wrote on sidst redigeret af
                                      #1015

                                      17:42?

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                                      • nohopeN Offline
                                        nohopeN Offline
                                        nohope
                                        wrote on sidst redigeret af
                                        #1016

                                        17:43

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                                        • BulderB Offline
                                          BulderB Offline
                                          Bulder
                                          wrote on sidst redigeret af
                                          #1017

                                          begrundelsen kan du se 17:42

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