Suanfarma Suanfarma

X
[{"orgOrder":0,"company":"Ultragenyx Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ultragenyx and Kyowa Kirin Announce Submission of Supplemental Biologics License Application to U.S. FDA for Crysvita\u00ae (burosumab) for Tumor-Induced Osteomalacia (TIO)","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"January 2020","url1":"","url2":"","graph1":"Musculoskeletal","graph2":"Phase II"},{"orgOrder":0,"company":"Kyowa Kirin","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Kyowa Kirin Receives Positive CHMP Opinion for the Expanded Use of CRYSVITA\u00ae (burosumab) to Include Older Adolescents and Adults for the Treatment of X-Linked Hypophosphataemia (XLH)","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Large molecule","productStatus":"Approved","date":"July 2020","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Approved"},{"orgOrder":0,"company":"Kyowa Kirin","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Kyowa Kirin Announces EC Approval of CRYSVITA\u00ae for the Treatment of X-Linked Hypophosphataemia (XLH) in Older Adolescents and Adults","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Large molecule","productStatus":"Approved","date":"October 2020","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Approved"},{"orgOrder":0,"company":"Kyowa Kirin","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Kyowa Kirin Receives Positive CHMP Opinion for the Self-Administration of CRYSVITA to Treat X-Linked Hypophosphataemia","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Large molecule","productStatus":"Approved","date":"May 2021","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Approved"},{"orgOrder":0,"company":"Ultragenyx Pharmaceutical","sponsor":"Kyowa Kirin","pharmaFlowCategory":"D","amount":"$500.0 million","upfrontCash":"Undisclosed","newsHeadline":"Ultragenyx Announces Sale of a Portion of Future North American Royalties on Crysvita (burosumab) for $500 Million to OMERS Capital Markets","therapeuticArea":"Rare Diseases and Disorders","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"July 2022","url1":"","url2":"","graph1":"Rare Diseases and Disorders","graph2":"Approved"},{"orgOrder":0,"company":"Kyowa Kirin","sponsor":"Ultragenyx Pharmaceutical","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ultragenyx Announces Crysvita\u00ae (burosumab) and UX143 (setrusumab) Data Presentations at Upcoming American Society for Bone and Mineral Research (ASBMR) 2021 Annual Meeting","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Large molecule","productStatus":"Approved","date":"September 2021","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Approved"},{"orgOrder":0,"company":"Kyowa Kirin","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Kyowa Kirin Receives Positive CHMP Opinion for Use of CRYSVITA\u00ae (burosumab) for the Treatment of Tumour-Induced Osteomalacia (TIO)","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Large molecule","productStatus":"Approved","date":"June 2022","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Approved"},{"orgOrder":0,"company":"Kyowa Kirin","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Kyowa Kirin Receives European Commission Approval for Use of CRYSVITA\u00ae (burosumab) for the Treatment of Tumour-Induced Osteomalacia (TIO)","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Large molecule","productStatus":"Approved","date":"August 2022","url1":"","url2":"","graph1":"Musculoskeletal","graph2":"Approved"}]

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            Details:

            CRYSVITA (burosumab) is a recombinant fully human monoclonal antibody that binds to and inhibits the activity of FGF23.2 CRYSVITA blocks the action of FGF23, which is produced in excess in TIO, restoring phosphate homeostasis.

            Lead Product(s): Burosumab

            Therapeutic Area: Musculoskeletal Product Name: Crysvita

            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 August 19, 2022

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            Crysvita (burosumab) is a recombinant fully human monoclonal IgG1 antibody, discovered by Kyowa Kirin, against the phosphaturic hormone FGF23. Crysvita is designed to bind to and thereby inhibit the biological activity of FGF23.

            Lead Product(s): Burosumab

            Therapeutic Area: Rare Diseases and Disorders Product Name: Crysvita

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Kyowa Kirin

            Deal Size: $500.0 million Upfront Cash: Undisclosed

            Deal Type: Divestment July 14, 2022

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            CRYSVITA (burosumab) was created and developed by Kyowa Kirin and is a recombinant fully human monoclonal antibody that binds to and inhibits the activity of FGF23.2 CRYSVITA blocks the action of FGF23, restoring phosphate homeostasis.

            Lead Product(s): Burosumab

            Therapeutic Area: Genetic Disease Product Name: Crysvita

            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 27, 2022

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            Crysvita® (burosumab-twza) is a fibroblast growth factor 23 (FGF23)-blocking antibody indicated for the treatment of X-linked hypophosphatemia and FGF23-related hypophosphatemia.

            Lead Product(s): Burosumab

            Therapeutic Area: Genetic Disease Product Name: Crysvita

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Ultragenyx Pharmaceutical

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 27, 2021

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            The Committee indicated that, if a patient is receiving a stable dose of Crysvita (burosumab), their treating physician can then recommend that administration be performed by the patient or their carer following training.

            Lead Product(s): Burosumab

            Therapeutic Area: Genetic Disease Product Name: Crysvita

            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 May 10, 2021

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            Details:

            CRYSVITA, created by Kyowa Kirin, is a recombinant fully human monoclonal IgG1 antibody against the FGF23. More people in Europe are now eligible for treatment with CRYSVITA, the only therapy that targets the underlying pathophysiology of XLH.

            Lead Product(s): Burosumab

            Therapeutic Area: Genetic Disease Product Name: Crysvita

            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 05, 2020

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            The European Commission has already granted a conditional marketing authorisation for CRYSVITA for the treatment of XLH with radiographic evidence of bone disease in children one year of age and older and adolescents with growing skeletons.

            Lead Product(s): Burosumab

            Therapeutic Area: Genetic Disease Product Name: Crysvita

            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 July 27, 2020

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            Details:

            The sBLA package includes data from two single-arm Phase 2 studies including 14 adult patients conducted by Ultragenyx in the U.S. and 13 adult patients conducted by Kyowa Kirin in Japan.

            Lead Product(s): Burosumab

            Therapeutic Area: Musculoskeletal Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 14, 2020

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