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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":"Large molecule","graph2":"GSK"},{"orgOrder":0,"company":"AstraZeneca","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"AstraZeneca's Fasenra Met Both Co-Primary Endpoints of Reduced Nasal Polyp Size and Blockage in the Ostro Phase III Trial","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase III","country":"UNITED KINGDOM","productType":"Large molecule","productStatus":"Approved","date":"September 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"AstraZeneca"},{"orgOrder":0,"company":"AstraZeneca","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Update on US Regulatory Review of Fasenra in Chronic Rhinosinusitis with Nasal Polyps","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase III","country":"UNITED KINGDOM","productType":"Large molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"AstraZeneca"},{"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":"Large molecule","graph2":"GSK"}]

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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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            Details:

            The sBLA submitted to FDA by AstraZeneca included data from OSTRO Phase III trial for Fasenra (benralizumab), an mAB that binds directly to IL-5 receptor alpha on eosinophils met both co-primary endpoints with a safety profile consistent with known profile of medicine.

            Lead Product(s): Benralizumab,Mometasone Furoate

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

            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 March 14, 2022

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            Details:

            Fasenra showed a statistically significant improvement in the endoscopic total nasal polyp score and the nasal blockage score compared to placebo, in patients with severe bilateral nasal polyposis who were still symptomatic despite continued treatment with standard of care.

            Lead Product(s): Benralizumab,Mometasone Furoate

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

            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 10, 2020

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            GSK

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            • Development Update

            Details:

            This is the first time an anti-IL5 biologic has reported positive phase 3 data in CRSwNP, and adds to the range of eosinophil-driven diseases in which Nucala has efficacious data.

            Lead Product(s): Mepolizumab

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) 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 April 03, 2020

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