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Genmab — November 2013

Planlagt Fastgjort Låst Flyttet Genmab
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  • SolsenS Offline
    SolsenS Offline
    Solsen
    wrote on sidst redigeret af
    #136

    Mantle cell er ikke konkurrent til Arzerra. Hvornår
    søgte de FDA.

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    • 1 Offline
      1 Offline
      120281
      wrote on sidst redigeret af
      #137

      J&J har ben i hver lejr. Godt set af dem. Men også smidt en del penge efter de to aftaler. Kunne Genmab ikke snart indhente pharmacyclics kurs 🙂

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      • 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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