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    [{"orgOrder":0,"company":"AstraZeneca","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Approves First Therapy for Children with Debilitating and Disfiguring Rare Disease","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"April 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"AstraZeneca","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Selumetinib Granted Orphan Drug Designation in Japan for Neurofibromatosis Type 1","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"June 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"AstraZeneca","sponsor":"Merck & Co","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Selumetinib Gets EU Recommendation as the First Medicine for Children with Neurofibromatosis Type 1 and Plexiform Neurofibromas","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"April 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"AstraZeneca","sponsor":"Merck & Co","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Koselugo Approved in Japan for Paediatric Patients With Plexiform Neurofibromas in Neurofibromatosis Type 1","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"September 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"AstraZeneca","sponsor":"Merck & Co","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Koselugo Approved in China for Paediatric Patients with Neurofibromatosis Type 1 and Plexiform Neurofibromas","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"May 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"}]

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              AstraZeneca

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              Koselugo Approved in China for Paediatric Patients with Neurofibromatosis Type 1 and Plexiform Neurofibromas

              Details:

              Koselugo (selumetinib) blocks MEK1 and MEK2, which are involved in stimulating cells to grow. It is the first and only approved therapy by China’s NMPA for the treatment of symptomatic, inoperable PNs in paediatric patients with NF1 aged three years and above.

              Lead Product(s): Selumetinib

              Therapeutic Area: Oncology Product Name: Koselugo

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Merck & Co

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable May 08, 2023

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              AstraZeneca

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              Koselugo Approved in Japan for Paediatric Patients With Plexiform Neurofibromas in Neurofibromatosis Type 1

              Details:

              Koselugo (selumetinib) has been approved in Japan for treatment of paediatric patients three years of age and older with plexiform neurofibromas in neurofibromatosis type 1 with clinical symptoms cannot be completely removed by surgery without risk of substantial morbidity.

              Lead Product(s): Selumetinib

              Therapeutic Area: Oncology Product Name: Koselugo

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Merck & Co

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable September 27, 2022

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              AstraZeneca

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              Selumetinib Gets EU Recommendation as the First Medicine for Children with Neurofibromatosis Type 1 and Plexiform Neurofibromas

              Details:

              Recommendation based on the results from the National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP)-sponsored SPRINT Stratum 1 Phase II trial, which showed selumetinib reduced tumour volume in children.

              Lead Product(s): Selumetinib

              Therapeutic Area: Oncology Product Name: Koselugo

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Merck & Co

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable April 26, 2021

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              AstraZeneca

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              Selumetinib Granted Orphan Drug Designation in Japan for Neurofibromatosis Type 1

              Details:

              In the SPRINT trial, selumetinib was shown to reduce the size of these tumours in children. Phase I/II SPRINT Stratum 1 trial showed an overall response rate of 66% in paediatric patients with NF1 PN when treated with selumetinib as a twice-daily oral monotherapy.

              Lead Product(s): Selumetinib

              Therapeutic Area: Oncology Product Name: Koselugo

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable June 30, 2020

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              AstraZeneca

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              FDA Approves First Therapy for Children with Debilitating and Disfiguring Rare Disease

              Details:

              The approval was based on positive results from the National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP)-sponsored Phase II SPRINT Stratum 1 trial.

              Lead Product(s): Selumetinib

              Therapeutic Area: Oncology Product Name: Undisclosed

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable April 13, 2020

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