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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
    #982

    Novatis Mayzent : https://www.reuters.com/article/us-fda-mayzent/novartis-gets-u-s-approval-for-new-drug-to-treat-multiple-sclerosis-idUSKCN1R8019

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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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