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Genmab — Marts 2019

Planlagt Fastgjort Låst Flyttet Genmab
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  • BulderB Offline
    BulderB Offline
    Bulder
    wrote on sidst redigeret af
    #983

    Link Preview Image
    Novartis receives FDA approval for Mayzent® (siponimod), the first oral drug to treat secondary progressive MS with active disease

    favicon

    Novartis (www.novartis.com)

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    • B Offline
      B Offline
      bibob
      wrote on sidst redigeret af
      #984

      Også Celgene i MS. Der er kamp om det. https://m.firstwordpharma.com/hot-heels-eu-application-celgene-files-us-clearance-ozanimod-relapsing-multiple-sclerosis

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      • P Offline
        P Offline
        Parasitism
        wrote on sidst redigeret af
        #985

        God morgen 🙂

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        • E Offline
          E Offline
          E_L
          wrote on sidst redigeret af
          #986

          from recent Conference, Tisotumab vedotin
          https://www.mdedge.com/hematology-oncology/article/197472/gynecologic-cancer/tisotumab-vedotin-shows-promise-recurrent

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          • P Offline
            P Offline
            polle1
            wrote on sidst redigeret af
            #987

            Godmorgen og god dag

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            • B Offline
              B Offline
              bibob
              wrote on sidst redigeret af
              #988

              @pensionisten. Jeg håber at din kone må få nye og bedre behandlingsmuligheder. Der kommer heldigvis nye og forhåbentlig bedre medicin på markedet. Held og lykke. 🙂

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              • J Offline
                J Offline
                JKY_VH
                wrote on sidst redigeret af
                #989

                Også H&L herfra og god morgen:-)

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                • BulderB Offline
                  BulderB Offline
                  Bulder
                  wrote on sidst redigeret af
                  #990

                  8:28: det var så lidt. og held og lykke

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                  • E Offline
                    E Offline
                    E_L
                    wrote on sidst redigeret af
                    #991

                    and europe
                    https://www.globenewswire.com/news-release/2019/03/27/1773690/0/en/Genmab-Announces-European-Regulatory-Submission-for-Daratumumab-in-Combination-with-Bortezomib-Thalidomide-and-Dexamethasone-in-Frontline-Multiple-Myeloma.html?culture=fr-ca

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                    • E Offline
                      E Offline
                      E_L
                      wrote on sidst redigeret af
                      #992

                      they are on a roll!

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                      • S Offline
                        S Offline
                        Sukkeralf
                        wrote on sidst redigeret af
                        #993

                        Nu nærmer ASCO sig snart - ikke at det bliver den vigtigste konference for Genmab, men om ikke andet kommer der vel opdateringer på diverse dara-studier. Abstract deadlines:

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                        • S Offline
                          S Offline
                          Sukkeralf
                          wrote on sidst redigeret af
                          #994

                          ASCO Meetings

                          ASCO Meetings Program Guide

                          favicon

                          (meetings.asco.org)

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                          • S Offline
                            S Offline
                            Sukkeralf
                            wrote on sidst redigeret af
                            #995

                            Nice E L - did we get 100% sure on filing for sc dosing. Was the Columba data enough or.......?

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                            • E Offline
                              E Offline
                              E_L
                              wrote on sidst redigeret af
                              #996

                              that's the million dollar question @Sukkeralf … well more like billion dollar question in this case lol

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                              • S Offline
                                S Offline
                                Sukkeralf
                                wrote on sidst redigeret af
                                #997

                                Bulders question: Can data from the Columba study be the basis for approval in all treatment lines in MM, or do we have to await the sc combo study MMY2040?

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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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