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    [{"orgOrder":0,"company":"Biogen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Biogen to Initiate Phase 4 Respond Study Evaluating Benefit of Spinraza in Patients Treated with Zolgensma","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase IV","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"July 2020","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase IV"},{"orgOrder":0,"company":"Biogen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Biogen Announces First Patient Treated in Respond Study Evaluating Benefit of Spinraza\u00ae in Patients Treated with Zolgensma\u00ae","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase IV","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"January 2021","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase IV"},{"orgOrder":0,"company":"Biogen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Biogen Advances Research in Spinal Muscular Atrophy with New Data at AAN 2021 Exploring Opportunities to Improve Outcomes for Patients","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"April 2021","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Approved"},{"orgOrder":0,"company":"Biogen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Biogen Plans to Start Phase 3b Study Evaluating Potential Benefit of a Higher Dose of Nusinersen in Patients Previously Treated with Evrysdi","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"September 2021","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Approved"},{"orgOrder":0,"company":"Alcyone Therapeutics","sponsor":"Biogen","pharmaFlowCategory":"D","amount":"$51.0 million","upfrontCash":"$10.0 million","newsHeadline":"Biogen and Alcyone Therapeutics Announce License and Collaboration Agreement to Evaluate a Novel Device to Improve Patient Experience and Access to Neurological ASO Therapies","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"January 2023","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Approved"},{"orgOrder":0,"company":"Ionis Pharmaceuticals","sponsor":"Royalty Pharma","pharmaFlowCategory":"D","amount":"$1,125.0 million","upfrontCash":"$500.0 million","newsHeadline":"Ionis and Royalty Pharma Enter Into Royalty Agreement for Up to $1.1 Billion to Further Advance Ionis' Genetic Medicines and Commercial Readiness","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"January 2023","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Approved"},{"orgOrder":0,"company":"Biogen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Biogen Announces New Updates Across its SMA Research Program at 2022 MDA Conference","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Approved"},{"orgOrder":0,"company":"Biogen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New Data Presented at Cure SMA Reveal Residual Unmet Needs in Young SMA Patients Treated With Gene Therapy and Suggest Further Potential of Using SPINRAZA (nusinersen)","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"June 2022","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Approved"},{"orgOrder":0,"company":"Alcyone Therapeutics","sponsor":"Biogen","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alcyone Therapeutics Receives FDA IDE Approval to Initiate Clinical Study of the ThecaFlex DRxTM System for Administration of SPINRAZA (nusinersen)","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"June 2023","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Approved"},{"orgOrder":0,"company":"Biogen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New Biomarker Data Add Further Evidence Supporting the Potential Benefit of SPINRAZA\u00ae (nusinersen) in Infants and Toddlers with Unmet Clinical Needs After Gene Therapy","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase IV","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"March 2024","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase IV"}]

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              Biogen

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              New Biomarker Data Add Further Evidence Supporting the Potential Benefit of SPINRAZA® (nusinersen) in Infants and Toddlers with Unmet Clinical Needs After Gene Therapy

              Details:

              Spinraza (nusinersen) is a survival motor neuron-2 (SMN2)-directed antisense oligonucleotide indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients.

              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 March 06, 2024

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              Alcyone Therapeutics

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              Alcyone Therapeutics Receives FDA IDE Approval to Initiate Clinical Study of the ThecaFlex DRxTM System for Administration of SPINRAZA (nusinersen)

              Details:

              SPINRAZA (nusinersen) is an antisense oligonucleotide (ASO) that targets the root cause of SMA by continuously increasing the amount of full-length survival motor neuron (SMN) protein produced in the body.

              Lead Product(s): Nusinersen

              Therapeutic Area: Genetic Disease Product Name: Spinraza

              Highest Development Status: Approved Product Type: Large molecule

              Partner/Sponsor/Collaborator: Biogen

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable June 27, 2023

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              Ionis Pharmaceuticals

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              Ionis and Royalty Pharma Enter Into Royalty Agreement for Up to $1.1 Billion to Further Advance Ionis' Genetic Medicines and Commercial Readiness

              Details:

              Spinraza (nusinersen) is a survival motor neuron-2 (SMN2)-directed antisense oligonucleotide indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients.

              Lead Product(s): Nusinersen

              Therapeutic Area: Genetic Disease Product Name: Spinraza

              Highest Development Status: Approved Product Type: Large molecule

              Partner/Sponsor/Collaborator: Royalty Pharma

              Deal Size: $1,125.0 million Upfront Cash: $500.0 million

              Deal Type: Agreement January 09, 2023

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              Alcyone Therapeutics

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              Biogen and Alcyone Therapeutics Announce License and Collaboration Agreement to Evaluate a Novel Device to Improve Patient Experience and Access to Neurological ASO Therapi...

              Details:

              SPINRAZA (nusinersen) is an antisense oligonucleotide (ASO) that targets the root cause of SMA by continuously increasing the amount of full-length survival motor neuron (SMN) protein produced in the body.

              Lead Product(s): Nusinersen

              Therapeutic Area: Genetic Disease Product Name: Spinraza

              Highest Development Status: Approved Product Type: Large molecule

              Partner/Sponsor/Collaborator: Biogen

              Deal Size: $51.0 million Upfront Cash: $10.0 million

              Deal Type: Collaboration January 04, 2023

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              Biogen

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              New Data Presented at Cure SMA Reveal Residual Unmet Needs in Young SMA Patients Treated With Gene Therapy and Suggest Further Potential of Using SPINRAZA (nusinersen)

              Details:

              RESPOND study is actively enrolling, with baseline characteristics reporting infants and toddlers have residual unmet medical needs in multiple areas after gene therapy; SPINRAZA (nusinersen) treatment following gene therapy was well-tolerated.

              Lead Product(s): Nusinersen

              Therapeutic Area: Genetic Disease Product Name: Spinraza

              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 June 15, 2022

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              Biogen

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              Biogen Announces New Updates Across its SMA Research Program at 2022 MDA Conference

              Details:

              The results from NURTURE, a study in infants treated in presymptomatic stage of SMA, demonstrate that early and sustained treatment with SPINRAZA for up to 5.7 years, helped participants to maintain and make progressive gains in motor function.

              Lead Product(s): Nusinersen

              Therapeutic Area: Genetic Disease Product Name: Spinraza

              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 March 14, 2022

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              Biogen

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              Biogen Plans to Start Phase 3b Study Evaluating Potential Benefit of a Higher Dose of Nusinersen in Patients Previously Treated with Evrysdi

              Details:

              The ASCEND study aims to evaluate whether treatment with a higher dose of nusinersen has the potential to improve clinical outcomes in spinal muscular atrophy (SMA) patients.

              Lead Product(s): Nusinersen

              Therapeutic Area: Genetic Disease Product Name: Spinraza

              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 September 15, 2021

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              Biogen

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              Biogen Advances Research in Spinal Muscular Atrophy with New Data at AAN 2021 Exploring Opportunities to Improve Outcomes for Patients

              Details:

              Initial findings from the DEVOTE study suggest no new safety concerns and support continued development of a higher dose of SPINRAZA® (nusinersen).

              Lead Product(s): Nusinersen

              Therapeutic Area: Genetic Disease Product Name: Spinraza

              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 April 19, 2021

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              Biogen

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              Biogen Announces First Patient Treated in Respond Study Evaluating Benefit of Spinraza® in Patients Treated with Zolgensma®

              Details:

              The RESPOND study aims to evaluate if Spinraza can benefit SMA patients who have experienced a ‘suboptimal’ response to Zolgensma (onasemnogene abeparvovec). It will be conducted at around 20 sites globally, with researchers aiming to enrol up to 60 children with SMA.

              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 January 08, 2021

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              Biogen

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

              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.

              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

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              Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.
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