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              Janssen Pharmaceutical

              • Development Update

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              UNITED STATES United States

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              CPhI Japan 2021

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              Janssen's Darzalex Faspro® Becomes the First FDA-Approved Treatment for Patients with Newly Diagnosed Light Chain Amyloidosis

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              Lead Product(s): Daratumumab,Hyaluronidase-fihj,Bortezomib

              Therapeutic Area: Rare Diseases and Disorders Product Name: Darzalex Faspro

              Highest Development Status: Approved Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable January 15, 2021

              Details:

              Accelerated approval of DARZALEX FASPRO-based combination regimen supported by the Phase 3 ANDROMEDA study demonstrating a significantly higher hematologic complete response rate in this rare and serious blood cell disorder.

              GlaxoSmithKline

              • Development Update

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              UNITED KINGDOM United Kingdom

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              CPhI Japan 2021

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              GlaxoSmithKline's Nucala Filings Accepted by European Medicines Agency for Three Additional Eosinophil-Driven Diseases

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              Lead Product(s): Mepolizumab

              Therapeutic Area: Rare Diseases and Disorders Product Name: Nucala

              Highest Development Status: Approved Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable October 29, 2020

              Details:

              Submissions based on positive data from pivotal studies in hypereosinophilic syndrome, chronic rhinosinusitis with nasal polyps and eosinophilic granulomatosis with polyangiitis.

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