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Genmab — September 2020

Planlagt Fastgjort Låst Flyttet Genmab
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  • E Offline
    E Offline
    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)...

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    (www.prnewswire.com)

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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
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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
                      K Offline
                      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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                            • 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
                                    E Offline
                                    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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                                      • K Offline
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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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