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Genmab — September 2020

Planlagt Fastgjort Låst Flyttet Genmab
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    Sukkeralf
    wrote on sidst redigeret af
    #158

    The trial did not meet the threshold for statistical significance and the primary endpoint of PFS was not met.

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      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_L
        wrote on sidst redigeret af
        #160

        Link Preview Image
        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

        /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a supplemental Biologics License Application (sBLA)...

        favicon

        (www.prnewswire.com)

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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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            Sukkeralf
            wrote on sidst redigeret af
            #162

            wauu - nice 🙂

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              Sukkeralf
              wrote on sidst redigeret af
              #163

              Lets beat the record time for approval please 🙂

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                E_L
                wrote on sidst redigeret af
                #164

                😉

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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_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_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
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                        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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                          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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                            kkjoel
                            wrote on sidst redigeret af
                            #170

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

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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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                                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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                                          kkjoel
                                          wrote on sidst redigeret af
                                          #177

                                          Absolutely 🙂

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