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Genmab — November 2013

Planlagt Fastgjort Låst Flyttet Genmab
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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

          http://clinicaltrials.gov/ct2/show/NCT01527149?term=ofatumumab&cond=mantle+cell&rank=1

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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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