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              Biogen

              • Development Update

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              UNITED STATES United States

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              AAPS 2020 PHARMSCI 360

              Participation Not Confirmed

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              Biogen to Initiate Phase 4 Respond Study Evaluating Benefit of Spinraza in Patients Treated with Zolgensma

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              Lead Product(s): Nusinersen

              Therapeutic Area: Genetic Disease Product Name: Spinraza

              Highest Development Status: Phase IV Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable July 21, 2020

              Details:

              The RESPOND study will seek to understand if the proven efficacy of SPINRAZA and its continuous production of SMN protein may also benefit patients previously treated with gene therapy.

              Vertex Pharmaceuticals

              • Development Update

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              UNITED STATES United States

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              AAPS 2020 PHARMSCI 360

              Participation Not Confirmed

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              Vertex Pharmaceuticals Reports Positive Phase 3 Study Results for TRIKAFTA® in People Ages 12 and Older With Cystic Fibrosis

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              Lead Product(s): Ivacaftor,Tezacaftor,Elexacaftor

              Therapeutic Area: Genetic Disease Product Name: Trikafta

              Highest Development Status: Phase IV Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable July 20, 2020

              Details:

              The results of this study demonstrate that the triple combination provides significant additional benefit compared to existing CFTR modulator therapy for F/G and F/RF patients and supports the benefit of the medicine for patients with at least one F508del mutation.

              NHS England

              • Deals

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              AAPS 2020 PHARMSCI 360

              Participation Not Confirmed

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              Vertex Announces Expansion of Reimbursement Agreement With NHS England

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              Lead Product(s): Ivacaftor,Tezacaftor,Elexacaftor

              Therapeutic Area: Genetic Disease Product Name: Kaftrio

              Highest Development Status: Phase IV Product Type: Small molecule

              Partner/Sponsor/Collaborator: Vertex Pharmaceuticals

              Deal Size: Undisclosed Upfront Cash: Undisclosed

              Deal Type: Agreement June 30, 2020

              Details:

              As part of the agreement with NHS England, Vertex has committed to submit ORKAMBI®, SYMKEVI® and KAFTRIO® to the National Institute for Health and Care Excellence (NICE) within an agreed upon timetable, allowing for a period of real-world data collection on the medicines.

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