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Kollaps
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  4. Genmab — Juni 2022

Genmab — Juni 2022

Planlagt Fastgjort Låst Flyttet Genmab
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  • B Offline
    B Offline
    bibob
    wrote on sidst redigeret af
    #1267

    Just a moment...

    favicon

    (firstwordpharma.com)

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    0
    • BulderB Offline
      BulderB Offline
      Bulder
      wrote on sidst redigeret af
      #1268

      Lidt pudsigt at man annoncerer, at man har til hensigt at indsende ansøgning. Plejer man ikke at vente til ansøgningen sendes?

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      0
      • BulderB Offline
        BulderB Offline
        Bulder
        wrote on sidst redigeret af
        #1269

        Måske for at komme før Roche?

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        0
        • D Offline
          D Offline
          deleted-user
          wrote on sidst redigeret af
          #1270

          Man vurderer, at markedet skal informeres om væsentlige forhold

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          0
          • D Offline
            D Offline
            deleted-user
            wrote on sidst redigeret af
            #1271

            Da man ansøgte Tisotumab Vedotin kom selskabsmeddelelsen først da FDA havde accepteret ansøgningen.

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            0
            • SolsenS Offline
              SolsenS Offline
              Solsen
              wrote on sidst redigeret af
              #1272

              Det sidste vi hørte til epco var, at de ville tale med myndighederne om det videre
              forløb.

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              0
              • SolsenS Offline
                SolsenS Offline
                Solsen
                wrote on sidst redigeret af
                #1273

                Nu bekræfter de at de gav ok til ansøgning. Dejlig nyhed !

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                0
                • Helge_LarsenPI-redaktørH Offline
                  Helge_LarsenPI-redaktørH Offline
                  Helge_LarsenPI-redaktør
                  wrote on sidst redigeret af
                  #1274

                  Fedt. 🙂

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                  0
                  • Helge_LarsenPI-redaktørH Offline
                    Helge_LarsenPI-redaktørH Offline
                    Helge_LarsenPI-redaktør
                    wrote on sidst redigeret af
                    #1275

                    Genmab to Submit Biologics License Application to U.S. Food and Drug Administration for Epcoritamab (DuoBody®-CD3xCD20) for the https://www.proinvestor.com/investornyt/844797/genmab-to-submit-biologics-license-application-to-us-food-and-drug-administration-for-epcoritamab-duobody-cd3xcd20-for-the

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                    0
                    • S Offline
                      S Offline
                      Sukkeralf
                      wrote on sidst redigeret af
                      #1276

                      Normalt indsendes BLA’en vel 3 måneder efter topline data, når det går hurtigt. Så dejligt de henter mere tid.

                      1 Reply Last reply
                      0
                      • E Offline
                        E Offline
                        E_L
                        wrote on sidst redigeret af
                        #1277

                        FDA warns about possible increased risk of death and serious side effects with cancer drug Copiktra (duvelisib) https://www.healio.com/news/hematology-oncology/20220630/fda-warns-about-potential-elevated-risk-for-death-with-blood-cancer-therapy-durvelisib
                        https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-about-possible-increased-risk-death-and-serious-side-effects-cancer-drug-copiktra#:~:text=The U.S. Food and Drug,found in the lymph nodes.

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                        0
                        • S Offline
                          S Offline
                          Stroka
                          wrote on sidst redigeret af
                          #1278

                          Super nyhed. Der er medvind på cykelstien for Genmab allerede fra starten af sommertouren. 🙂

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