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Genmab — November 2013

Planlagt Fastgjort Låst Flyttet Genmab
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Denne tråd er blevet slettet. Kun brugere med emne behandlings privilegier kan se den.
  • 1 Offline
    1 Offline
    120281
    wrote on sidst redigeret af
    #145

    Dejligt for Pharmacyclics

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    • G Offline
      G Offline
      gentogen
      wrote on sidst redigeret af
      #146

      Det er altså lidt interessant at læse FDAs meddelelse

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      • G Offline
        G Offline
        gentogen
        wrote on sidst redigeret af
        #147

        the agency's accelerated approval program, which allows the FDA to approve a drug to treat a serious disease based on clinical data showing that the drug has an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients

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        • G Offline
          G Offline
          gentogen
          wrote on sidst redigeret af
          #148

          An improvement in survival or disease-related symptoms has not been established.

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          • G Offline
            G Offline
            gentogen
            wrote on sidst redigeret af
            #149

            Other clinically significant side effects include bleeding, infections, kidney problems and the development of other types of cancers.

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            • G Offline
              G Offline
              gentogen
              wrote on sidst redigeret af
              #150

              Uden at jeg på nohen måde er blot i nærheden af at være ekspert, så får man jo lidt en fonemmelse af, at disse hurtige godkendelser måske også er lidt for hurtige...

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              • SolsenS Offline
                SolsenS Offline
                Solsen
                wrote on sidst redigeret af
                #151

                Nej jeg undrede mig også over surrogate endpoints, som FDA i vid udstrækning går bort fra og så at stoffet ikke viste der ikke var signifikans på survival. En tynd omgang synes man for 130.000usd.

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                • G Offline
                  G Offline
                  gentogen
                  wrote on sidst redigeret af
                  #152

                  Er GSK bare for sløve eller hvad. Ofatumumab har jo vist ganske gode resultater i MCL

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                  • G Offline
                    G Offline
                    gentogen
                    wrote on sidst redigeret af
                    #153

                    Among the 19 patients evaluable for response, overall response rate was 94%, with CR in 17 patients, partial remission in one patient and progressive disease after the second cycle in one patient; 15 out of 15 patients evaluable for minimal residual disease in the BM showed molecular remission.

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                    • G Offline
                      G Offline
                      gentogen
                      wrote on sidst redigeret af
                      #154

                      Link Preview Image

                      favicon

                      (ash.confex.com)

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                      • G Offline
                        G Offline
                        gentogen
                        wrote on sidst redigeret af
                        #155

                        in most cases, R-CHOP immuno-chemotherapy, with its 34% complete remission (CR) rate, is still considered the standard of care.

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                        • SolsenS Offline
                          SolsenS Offline
                          Solsen
                          wrote on sidst redigeret af
                          #156

                          Du styrker hele tiden vores tiltro til Arzerra. Tak for din indsats Gentogen !

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                          • investor1989I Offline
                            investor1989I Offline
                            investor1989
                            wrote on sidst redigeret af
                            #157

                            Godt at Arzerra kun jagter R/R DLBLC label, for SPectrums nye stof Marqibo deler satme tæsk ud i frontline DLBLC. TJek lige de har 10 years follow up data: https://ash.confex.com/ash/2013/webprogram/Paper55944.html

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                            • SolsenS Offline
                              SolsenS Offline
                              Solsen
                              wrote on sidst redigeret af
                              #158

                              Jo men det er vel Rituxan at Arzerra jagter.

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                              • investor1989I Offline
                                investor1989I Offline
                                investor1989
                                wrote on sidst redigeret af
                                #159

                                ja nemlig. i CHOP behandling består O jo af Vincristine. Det SPPI vil er at udskifte Vincristine med deres Liposome formulation af Vincristine kaldet marqibo og derfor lave R-CHMP (Eller A-CHMP med arzerra) istedet for CHOP fordi de beviser at Marqibo er langt stærkere end normal vincristine

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                                • investor1989I Offline
                                  investor1989I Offline
                                  investor1989
                                  wrote on sidst redigeret af
                                  #160

                                  men jeg syntes alligevel det er vanvittige resultater at få ved at skifte fra normal vincristine til marqibo. Den liposome formulation giver godt nok gas.

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                                  • investor1989I Offline
                                    investor1989I Offline
                                    investor1989
                                    wrote on sidst redigeret af
                                    #161

                                    Iøvrigt tester SPPI jo også Zevalin i phase III i frontline DLBLC med Z-CHOP. Men igen, det er heller ikke konkurrent til Arzerra da de jo jagter Rituxan R/R DLBLC patienter

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                                    • SolsenS Offline
                                      SolsenS Offline
                                      Solsen
                                      wrote on sidst redigeret af
                                      #162

                                      Enig i at det er super resultater !

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                                      • investor1989I Offline
                                        investor1989I Offline
                                        investor1989
                                        wrote on sidst redigeret af
                                        #163

                                        Det er fedt at Jan glæder sig over at Genmab har 10 præsentationer til ASH som det højeste nogensinde 🙂 Prøv at søg på Ibrutinib. Der er 71 præsentationer alene på det produkt 😄

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                                        • SolsenS Offline
                                          SolsenS Offline
                                          Solsen
                                          wrote on sidst redigeret af
                                          #164

                                          http://clinicaltrials.gov/ct2/show/NCT01985126?term=Daratumumab&rank=1 det går ikke hurtigt nok !

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