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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
    #159

    Janssen Submits Application Seeking U.S. FDA Approval of DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj) for the Treatment of Patients with Light Chain (AL) Amyloidosis

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    • E Offline
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      E_L
      wrote on sidst redigeret af
      #160

      https://www.prnewswire.com/news-releases/janssen-submits-application-seeking-us-fda-approval-of-darzalex-faspro-daratumumab-and-hyaluronidase-fihj-for-the-treatment-of-patients-with-light-chain-al-amyloidosis-301126998.html

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      • E Offline
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        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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        • S Offline
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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
                E Offline
                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
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                          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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                              • K Offline
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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
                                        K Offline
                                        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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