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    [{"orgOrder":0,"company":"Idorsia Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Idorsia Announces Positive Results of the Two Japanese Registration Studies with Clazosentan","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"SWITZERLAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2020","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"Idorsia Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Idorsia Submits NDA for Clazosentan to Japanese PMDA","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"SWITZERLAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2021","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"Idorsia Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Idorsia Receives Japanese PMDA Approval of PIVLAZ (clazosentan sodium) 150 mg","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Small molecule","productStatus":"Approved","date":"January 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Idorsia Pharmaceuticals","sponsor":"Sosei Heptares","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Sosei Heptares Acquires Idorsia\u2019s Pharmaceuticals Business in Japan and APAC (ex-China), Accelerating its Transformation into a Fully Integrated Biopharmaceutical Company","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Small molecule","productStatus":"Approved","date":"July 2023","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Sosei Group Corporation","sponsor":"HANDOK","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Nxera Pharma Announces Exclusive Supply and Distribution Agreement with Handok for PIVLAZ\u2122 in South Korea","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"April 2024","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Idorsia Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Idorsia Announces the Results Of REACT a Phase 3 Study of Clazosentan in Patients Following Aneurysmal Subarachnoid Hemorrhage","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"SWITZERLAND","productType":"Small molecule","productStatus":"Approved","date":"February 2023","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"Sosei Group Corporation","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sosei Group Announces Marketing Approval for PIVLAZ\u2122 (clazosentan sodium) 150 mg in South Korea","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"December 2023","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"}]

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              Sosei Group Corporation

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              Nxera Pharma Announces Exclusive Supply and Distribution Agreement with Handok for PIVLAZ™ in South Korea

              Details:

              Handok is exclusively responsible for the promotion, marketing, sales and distribution of Pivlaz (clazosentan sodium), the first drug approved in South Korea for the prevention of Cerebral Vasospasm in patients with Aneurysmal Subarachnoid Hemorrhage, in South Korea.

              Lead Product(s): Clazosentan Sodium

              Therapeutic Area: Neurology Product Name: Pivlaz

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: HANDOK

              Deal Size: Undisclosed Upfront Cash: Undisclosed

              Deal Type: Agreement April 14, 2024

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              Sosei Group Corporation

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              Sosei Group Announces Marketing Approval for PIVLAZ™ (clazosentan sodium) 150 mg in South Korea

              Details:

              South Korea approved PIVLAZ™ (clazosentan sodium), an ETAR antagonist, for the prevention of cerebral vasospasm, vasospasm-related cerebral infarction, and cerebral ischemic symptoms after aneurysmal subarachnoid hemorrhage (aSAH) securing.

              Lead Product(s): Clazosentan Sodium

              Therapeutic Area: Neurology Product Name: Pivlaz

              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 December 07, 2023

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              Idorsia Pharmaceuticals

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              Sosei Heptares Acquires Idorsia’s Pharmaceuticals Business in Japan and APAC (ex-China), Accelerating its Transformation into a Fully Integrated Biopharmaceutical Company

              Details:

              Through the acquisition, Sosei also gains assignment of Pivlaz (clazosentan), for the treatment of cerebral vasospasm, and license rights to daridorexant in the Asia Pacific (ex-China) region.

              Lead Product(s): Clazosentan Sodium

              Therapeutic Area: Neurology Product Name: Pivlaz

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Sosei Heptares

              Deal Size: Undisclosed Upfront Cash: Undisclosed

              Deal Type: Acquisition July 20, 2023

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              Idorsia Pharmaceuticals

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              Idorsia Announces the Results Of REACT a Phase 3 Study of Clazosentan in Patients Following Aneurysmal Subarachnoid Hemorrhage

              Details:

              ACT-108475 (clazosentan) is a fast-acting, endothelin A (ETA) receptor antagonist, that Idorsia has developed as a continuous intravenous infusion for the prevention of clinical deterioration due to delayed cerebral ischemia (DCI) in patients following aSAH.

              Lead Product(s): Clazosentan Sodium

              Therapeutic Area: Neurology Product Name: ACT-108475

              Highest Development Status: Phase III Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable February 06, 2023

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              Idorsia Pharmaceuticals

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              Idorsia Receives Japanese PMDA Approval of PIVLAZ (clazosentan sodium) 150 mg

              Details:

              PIVLAZ (clazosentan sodium), a selective endothelin A receptor antagonist received Japanese PMDA approval on the basis of statistically significant result from the Japanese Phase 3 program for the prevention of cerebral vasospasm after subarachnoid hemorrhage treatment.

              Lead Product(s): Clazosentan Sodium

              Therapeutic Area: Neurology Product Name: Pivlaz

              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 January 20, 2022

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              Idorsia Pharmaceuticals

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              Idorsia Submits NDA for Clazosentan to Japanese PMDA

              Details:

              A Phase 2 study in Japanese and Korean patients showed that 10 mg/hr of clazosentan administered by continuous intravenous infusion significantly reduced vasospasm and vasospasm-related morbidity and mortality events.

              Lead Product(s): Clazosentan Sodium

              Therapeutic Area: Neurology Product Name: ACT-108475

              Highest Development Status: Phase III Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable March 01, 2021

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              Idorsia Pharmaceuticals

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              Idorsia Announces Positive Results of the Two Japanese Registration Studies with Clazosentan

              Details:

              Both studies demonstrated that clazosentan reduced the occurrence of cerebral vasospasm-related morbidity and all-cause mortality within 6 weeks post-aSAH with statistical significance (p<0.01 for both studies).

              Lead Product(s): Clazosentan Sodium

              Therapeutic Area: Neurology Product Name: ACT-108475

              Highest Development Status: Phase III Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable November 23, 2020

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              Biopharma Group offers CDMO services with expertise in contract R&D for dried products & liquid formulations.
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