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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.
  • SolsenS Offline
    SolsenS Offline
    Solsen
    wrote on sidst redigeret af
    #138

    http://www.news-medical.net/news/20130829/FDA-approves-NDA-filing-for-ibrutinib-inhibitor-in-two-B-cell-malignancies.aspx 2,5 måned efter FDAs acceptance kom approval

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    • 1 Offline
      1 Offline
      120281
      wrote on sidst redigeret af
      #139

      Ja den samme fart så vi gerne til gsk/gen

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      • G Offline
        G Offline
        gentogen
        wrote on sidst redigeret af
        #140

        301 Moved Permanently

        favicon

        (clinicaltrials.gov)

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        • S Offline
          S Offline
          Sukkeralf
          wrote on sidst redigeret af
          #141

          og gerne også Janssen/Genmab med Daratumumab senere hen

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          • 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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