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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
    #142

    Her en lidt mere dansk vers.

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    • 1 Offline
      1 Offline
      120281
      wrote on sidst redigeret af
      #143

      Link Preview Image
      J&J får hurtig FDA-godkendelse

      FDA har godkendt et lægemiddel fra Johnson & Johnson til behandling af lymfekræft efter en ualmindelig kort evalueringsperiode på blot fire måneder. Det er blot anden gang, at et lægemiddel bliver godkendt under FDAs specielle Breakthrough-program.

      favicon

      (medwatch.dk)

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      • investor1989I Offline
        investor1989I Offline
        investor1989
        wrote on sidst redigeret af
        #144

        Ibrutinib sælges for 20$ pr. pille 🙂 det svarer til 130.000$ om året pr. patient i Mantle cell så vidt jeg kan se !!! 😄

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        • 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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