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  4. Genmab — Maj 2025

Genmab — Maj 2025

Planlagt Fastgjort Låst Flyttet Genmab
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Denne tråd er blevet slettet. Kun brugere med emne behandlings privilegier kan se den.
  • L Offline
    L Offline
    lahn1
    wrote on sidst redigeret af
    #208

    ODAC 6-2 i favør for Darzalex i SMM

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    • Helge_LarsenPI-redaktørH Offline
      Helge_LarsenPI-redaktørH Offline
      Helge_LarsenPI-redaktør
      wrote on sidst redigeret af
      #209

      Godmorgen 🙂

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      • P Offline
        P Offline
        ProinvestorNEWS
        wrote on sidst redigeret af
        #210

        FDA cancer panel gives thumbs up to J&J's Darzalex, votes nay on Roche's Columvi https://firstwordpharma.com/story/5964785

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        • L Offline
          L Offline
          LP90
          wrote on sidst redigeret af
          #211

          Godmorgen 🙂

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          • T Offline
            T Offline
            transalp
            wrote on sidst redigeret af
            #212

            Go morgen.. 🙂

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            • B Offline
              B Offline
              bibob
              wrote on sidst redigeret af
              #213

              God morgen. 🙂

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              • E Offline
                E Offline
                E_L
                wrote on sidst redigeret af
                #214

                Dr Falchi on the Safety of Fixed-Duration Epcoritamab Plus Lenalidomide/Rituximab in R/R Follicular Lymphoma https://www.onclive.com/view/dr-falchi-on-the-safety-of-fixed-duration-epcoritamab-plus-lenalidomide-rituximab-in-r-r-follicular-lymphoma

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                • E Offline
                  E Offline
                  E_L
                  wrote on sidst redigeret af
                  #215

                  JNJ press release - U.S. FDA Oncologic Drugs Advisory Committee votes in favor of the benefit-risk profile of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for high-risk smoldering multiple myeloma - https://www.jnj.com/media-center/press-releases/u-s-fda-oncologic-drugs-advisory-committee-votes-in-favor-of-the-benefit-risk-profile-of-darzalex-faspro-daratumumab-and-hyaluronidase-fihj-for-high-risk-smoldering-multiple-myeloma

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                  • N Offline
                    N Offline
                    NiklasZ
                    wrote on sidst redigeret af
                    #216

                    Så er aktien brudt ud af den nedadgående trend kanal igen. Lad os se om det kan holde denne gang.

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                    • SolsenS Offline
                      SolsenS Offline
                      Solsen
                      wrote on sidst redigeret af
                      #217

                      Ret interessant melding på Columvi. Stoffet virker tilsyneladende ikke så godt på non-asiatiske pts.

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                      • P Offline
                        P Offline
                        Plimsoller
                        wrote on sidst redigeret af
                        #218

                        Enig Solsen, og som E L skrev, så vil et nyt fase 3 studie med flere US pts tage år.

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                        • E Offline
                          E Offline
                          E_L
                          wrote on sidst redigeret af
                          #219

                          I guess the moral of the story is if you lost money in the first quarter in biotech, you have plenty of good company. https://x.com/MBbiotech/status/1925123717287346356

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                          • G Offline
                            G Offline
                            gentogen
                            wrote on sidst redigeret af
                            #220

                            Egentlig ret utroligt, at de ikke havde styr på deres geografiske fordeling af patienter, men ifølge oprindelige link fra EL, så havde kun få af de i princippet medvirkende amerikanske klinikker i praksis deltaget

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                            • E Offline
                              E Offline
                              E_L
                              wrote on sidst redigeret af
                              #221

                              yes, i am surprised too, for such a large firm, and surely they will have been in touch with the FDA during the trial.. here is a bit more:

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                              • E Offline
                                E Offline
                                E_L
                                wrote on sidst redigeret af
                                #222

                                Asia stymies Columvi's expansion
                                21 May 2025

                                Starglo isn't applicable to a US population, an adcom rules. https://www.oncologypipeline.com/apexonco/node/1334

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                                • L Offline
                                  L Offline
                                  lahn1
                                  wrote on sidst redigeret af
                                  #223

                                  Har ikke set nærmere på patient grp men kunne Columvi's rekrutterings issues være pga af den samtidige rekruttering i EPCORE DLBCL

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                                  • L Offline
                                    L Offline
                                    lahn1
                                    wrote on sidst redigeret af
                                    #224

                                    De har kun brugt 2 år på STARGLO, og kunne vel nok have fået 3-4 år af FDA til at færdiggøre forsøget. Så den mest oplagte grund er at konkurrence fra ande behandlings regimer bl.a. EPCORE 1+2+4. Er det forkert set at dette er et bragging point for Genmab ?

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                                    • E Offline
                                      E Offline
                                      E_L
                                      wrote on sidst redigeret af
                                      #225

                                      good thought

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                                      • E Offline
                                        E Offline
                                        E_L
                                        wrote on sidst redigeret af
                                        #226

                                        by the way, ODAC also voted 5 to 4 against the risk/benefit profile of UGN-102 for bladder cancer ; the company UroGen Pharma -48%....

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                                        • SolsenS Offline
                                          SolsenS Offline
                                          Solsen
                                          wrote on sidst redigeret af
                                          #227

                                          Som jeg læser er det en diskutabel virkning og bivirkningsprofil i non-asiatiske pts mere end en fejl i rekruttering.

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