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[{"orgOrder":0,"company":"GSK","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"GSK's asthma biologic Nucala is one step closer to approval in key chronic rhinosinusitis population","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase III","country":"UNITED KINGDOM","productType":"Large molecule","productStatus":"Approved","date":"April 2020","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Phase III"},{"orgOrder":0,"company":"GSK","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Grants Priority Review of Nucala for Patients with Hypereosinophilic Syndrome","therapeuticArea":"Hematology","highestDevelopmentStatus":"Phase III","country":"UNITED KINGDOM","productType":"Large molecule","productStatus":"Approved","date":"May 2020","url1":"","url2":"","graph1":"Hematology","graph2":"Phase III"},{"orgOrder":0,"company":"GSK","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Approves Glaxosmithkline's Nucala as the First and Only Biologic Treatment for Hypereosinophilic Syndrome (HES)","therapeuticArea":"Hematology","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Large molecule","productStatus":"Approved","date":"September 2020","url1":"","url2":"","graph1":"Hematology","graph2":"Approved"},{"orgOrder":0,"company":"GSK","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"GlaxoSmithKline's Nucala Filings Accepted by European Medicines Agency for Three Additional Eosinophil-Driven Diseases","therapeuticArea":"Rare Diseases and Disorders","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Large molecule","productStatus":"Approved","date":"October 2020","url1":"","url2":"","graph1":"Rare Diseases and Disorders","graph2":"Approved"},{"orgOrder":0,"company":"GSK","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"GSK Receives CHMP Positive Opinions Recommending Approval of Nucala (mepolizumab) in Three Additional Eosinophil-Driven Diseases","therapeuticArea":"Hematology","highestDevelopmentStatus":"Phase III","country":"UNITED KINGDOM","productType":"Large molecule","productStatus":"Approved","date":"September 2021","url1":"","url2":"","graph1":"Hematology","graph2":"Phase III"},{"orgOrder":0,"company":"GSK","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"NUCALA (Mepolizumab) The First and Only Anti-Il-5 Add-On Treatment Approved in Canada that Targets Eosinophilic Inflammation in Adults with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Large molecule","productStatus":"Approved","date":"November 2021","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Approved"},{"orgOrder":0,"company":"GSK","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"European Commission Approves Nucala (Mepolizumab) in Three Additional Eosinophil-Driven Diseases","therapeuticArea":"Rare Diseases and Disorders","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Large molecule","productStatus":"Approved","date":"November 2021","url1":"","url2":"","graph1":"Rare Diseases and Disorders","graph2":"Approved"},{"orgOrder":0,"company":"Bio-Thera Solutions","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Bio-Thera Solutions Announces First Patient Dosed in Phase 1 Study for BAT2606, a Proposed Biosimilar of Nucala\u00ae (mepolizumab)","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase I","country":"CHINA","productType":"Large molecule","productStatus":"Biosimilar","date":"October 2022","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Phase I"},{"orgOrder":0,"company":"GSK","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"China National Medical Products Administration Accepts Regulatory Submission for Nucala (Mepolizumab) in Severe Eosinophilic Asthma","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Large molecule","productStatus":"Approved","date":"March 2023","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Approved"},{"orgOrder":0,"company":"GSK","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"GSK\u2019s Regulatory Submission Accepted for Review by Japanese Regulator for Use of Nucala (Mepolizumab) in Adults with Chronic Rhinosinusitis with Nasal Polyps","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase III","country":"UNITED KINGDOM","productType":"Large molecule","productStatus":"Approved","date":"September 2023","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Phase III"},{"orgOrder":0,"company":"GSK","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Nucala (mepolizumab) Approved in China for Use in Severe Asthma with An Eosinophilic Phenotype","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Large molecule","productStatus":"Approved","date":"January 2024","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Approved"}]

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            GSK

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            • Development Update

            Details:

            Nucala (mepolizumab) is the first targeted anti-Interleukin-5 (IL-5) biologic. It is approved as an add-on maintenance treatment for severe eosinophilic asthma.

            Lead Product(s): Mepolizumab

            Therapeutic Area: Pulmonary/Respiratory Diseases 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 January 10, 2024

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            GSK

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            • Development Update

            Details:

            Nucala (mepolizumab) is the first-in-class monoclonal antibody to target IL-5. It is believed to work by preventing IL-5 from binding to its receptor on the surface of eosinophils, reducing blood eosinophils and maintaining them within normal levels.

            Lead Product(s): Mepolizumab

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Nucala

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 01, 2023

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            GSK

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            • Development Update

            Details:

            Nucala (mepolizumab) is the first-in-class monoclonal antibody to target IL-5. It is believed to work by preventing IL-5 from binding to its receptor on the surface of eosinophils, reducing blood eosinophils and maintaining them within normal levels.

            Lead Product(s): Mepolizumab

            Therapeutic Area: Pulmonary/Respiratory Diseases 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 March 14, 2023

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            Details:

            BAT2606 a proposed biosimilar of Nucala® (mepolizumab) is an interleukin-5 (IL-5) antagonist mAB that is administered subcutaneously with a syringe or autoinjector for treatment of severe asthma, chronic rhinosinusitis with nasal, eosinophilic granulomatosis with polyangiitis.

            Lead Product(s): Mepolizumab

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: BAT2606

            Highest Development Status: Phase I Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 14, 2022

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            GSK

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            • Development Update

            Details:

            Nucala (mepolizumab) is the first-in-class monoclonal antibody targets IL-5 from binding to its receptor on the surface of eosinophils, reducing blood eosinophils and maintaining them within normal levels.

            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 November 17, 2021

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            GSK

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            • Development Update

            Details:

            NUCALA (mepolizumab) is a monoclonal antibody that works by blocking a specific protein called interleukin-5. This is the fourth approved indication for NUCALA for Canadian patients with eosinophilic driven diseases.

            Lead Product(s): Mepolizumab

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) 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 November 08, 2021

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            GSK

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            • Development Update

            Details:

            Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), for use in three eosinophil-driven diseases; hypereosinophilic syndrome (HES), eosinophilic granulomatosis with polyangiitis (EGPA) and chronic rhinosinusitis with nasal polyps (CRSwNP).

            Lead Product(s): Mepolizumab

            Therapeutic Area: Hematology Product Name: Nucala

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 17, 2021

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            GSK

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            • Development Update

            Details:

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

            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

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            • Development Update

            Details:

            Nucala was evaluated in a randomized, double-blind, multicenter, placebo-controlled trial in 108 patients with HES. In the study, patients were randomly assigned to receive Nucala or placebo by injection every four weeks.

            Lead Product(s): Mepolizumab

            Therapeutic Area: Hematology 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 September 25, 2020

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            GSK

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            • Development Update

            Details:

            If approval is obtained, it would make Nucala the first targeted biologic treatment for patients with this rare and life-threatening disease caused by eosinophilic inflammation.

            Lead Product(s): Mepolizumab

            Therapeutic Area: Hematology Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 27, 2020

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