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Genmab — September 2020

Planlagt Fastgjort Låst Flyttet Genmab
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Denne tråd er blevet slettet. Kun brugere med emne behandlings privilegier kan se den.
  • E Offline
    E Offline
    E_L
    wrote on sidst redigeret af
    #161

    The sBLA is being reviewed under the FDA Real-Time Oncology Review (RTOR) program,

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      Sukkeralf
      wrote on sidst redigeret af
      #162

      wauu - nice 🙂

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      • S Offline
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        Sukkeralf
        wrote on sidst redigeret af
        #163

        Lets beat the record time for approval please 🙂

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        • E Offline
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          E_L
          wrote on sidst redigeret af
          #164

          😉

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          • E Offline
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            E_L
            wrote on sidst redigeret af
            #165

            ADC Therapeutics Announces Publication Highlighting the Potential of Camidanlumab Tesirine (Cami) as a Novel Immuno-oncology Approach for Solid Tumor Cancers
            Preclinical study published in the Journal for ImmunoTherapy of Cancer supports continued evaluation of CD25-targeted ADC in Phase 1b clinical trial in selected advanced solid tumors https://www.businesswire.com/news/home/20200910005550/en/ADC-Therapeutics-Announces-Publication-Highlighting-Potential-Camidanlumab

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            • E Offline
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              E_L
              wrote on sidst redigeret af
              #166

              The study evaluated the antitumor activity of a pyrrolobenzodiazepine (PBD) dimer-based, CD25-targeted ADC, either alone or in combination with a checkpoint inhibitor, in CD25-negative syngeneic colon cancer models that exhibit tumor infiltration of CD25-expressing regulatory T cells (Tregs).

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              • E Offline
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                E_L
                wrote on sidst redigeret af
                #167

                Data demonstrated that single low doses of the CD25-targeted ADC resulted in potent and durable antitumor activity against established CD25-negative solid tumors with infiltrating Tregs, both as a monotherapy and in combination with an anti-PD1 checkpoint inhibitor.

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                • K Offline
                  K Offline
                  kkjoel
                  wrote on sidst redigeret af
                  #168

                  Genmab Announces that Janssen has Submitted a Supplemental Biologics License Application to U.S. FDA for use of DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj) in Patients with Light-chain (AL) Amyloidosis.

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                  • K Offline
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                    kkjoel
                    wrote on sidst redigeret af
                    #169

                    https://ir.genmab.com/news-releases/news-release-details/genmab-announces-janssen-has-submitted-supplemental-biologics

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                    • K Offline
                      K Offline
                      kkjoel
                      wrote on sidst redigeret af
                      #170

                      Sådan! Mon ikke kursen vil udvise en stigende tendens resten af dagen...!? 😉

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                      • E Offline
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                        E_L
                        wrote on sidst redigeret af
                        #171

                        Jan dodged the question on increasing the participation in Cami-T last Q&A, but i expect with data out, they will have to make a decision soon?

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                        • P Offline
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                          Plimsoller
                          wrote on sidst redigeret af
                          #172

                          Det startede den med kl. 13:54 da E L postede nyheden første gang 😉

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                            kkjoel
                            wrote on sidst redigeret af
                            #173

                            Ups. Nyheden var kommet her allerede. Sorry.

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                              kkjoel
                              wrote on sidst redigeret af
                              #174

                              Dejligt, Plims!

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                                Plimsoller
                                wrote on sidst redigeret af
                                #175

                                Det var blot en joke 🙂

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                                • E Offline
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                                  E_L
                                  wrote on sidst redigeret af
                                  #176

                                  it is great news, and worthy of repeating a few times 😉

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                                  • K Offline
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                                    kkjoel
                                    wrote on sidst redigeret af
                                    #177

                                    Absolutely 🙂

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                                      kkjoel
                                      wrote on sidst redigeret af
                                      #178

                                      Og ja, nu må GEN da have en begrænset periode at melde tilbage til ADC. Oprindeligt havde de hvor lang tid efter data-release?

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                                      • K Offline
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                                        kkjoel
                                        wrote on sidst redigeret af
                                        #179

                                        Og vedr. AL) Amyloidosis: "The U.S. FDA will review the application under their Real-Time Oncology Review (RTOR) pilot program and Project Orbis."

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                                        • K Offline
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                                          kkjoel
                                          wrote on sidst redigeret af
                                          #180

                                          Meget positivt - giver jo kortere behandlingstid: "About the RTOR Pilot Program1 and Project Orbis2
                                          The aim of the RTOR pilot program is to explore a more efficient review process for supplemental New Drug Applications (sNDAs) and sBLAs to provide safe and effective treatments to patients as early as possible. Inclusion in the RTOR pilot program does not guarantee or increase the probability of approval of this sBLA."

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