Genmab — Maj 2015
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nej starter om 10 min: http://edge.media-server.com/m/p/7c9tc824
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Registreringsansøgninger baseret på fase 2-data på relativt få patienter og inden gennemførelsen af de store fase 3-studier er usædvanlige, men en mulighed for Daratumumab, der har fået status af såkaldt breakthrough therapy til behandling af myelomatose eller knoglemarvskræft.
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Men dejligt at de også siger de vil sende registreringsansøgning. Så skulle den være sikker når både genmab og J&J siger det
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Late-stage products expected to drive growth in the next several years, following regulatory approvals, include daratumumab for multiple myeloma; sirukumab for rheumatoid arthritis; guselkumab for psoriasis; JNJ-927 (ARN-509) for pre-metastatic prostate cancer; imetelstat for myelofibrosis; JNJ-493 (FGFRi kinase inhibitor) for urothelial cancer; esketamine for treatment-resistant depression; AL-8176 for respiratory syncytial virus (RSV); fulranumab for osteoarthritic pain; JNJ-872 (VX-787) for i
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influenza A; JNJ-922 (Orexin-2 antagonist) for primary insomnia; and AL-335 for hepatitis C.4 In addition, daratumumab and esketamine have both received Breakthrough Therapy Designations from the U.S. Food and Drug Administration (FDA). Janssen is also announcing today that it plans to submit a Biologic Licensing Application to the FDA and a Marketing Authorization Application to the EMA this year for daratumumab in double refractory multiple myeloma. The submission will be based on Phase 2 dat
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