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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.
  • S Offline
    S Offline
    Sukkeralf
    wrote on sidst redigeret af
    #135

    Access denied | www.fiercebiotech.com used Cloudflare to restrict access | www.fiercebiotech.com | Cloudflare

    favicon

    (www.fiercebiotech.com)

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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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