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[{"company":"Astellas Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Approves VESIcare LS\u2122 (solifenacin succinate) Oral Suspension for Pediatric Patients","therapeuticArea":"Urology","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"May 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Astellas Pharma"},{"company":"Kyorin Pharmaceutical","sponsor":"Eisai","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"KYORIN and Eisai Enter Into License Agreement Concerning the Development and Marketing of Vibegron","therapeuticArea":"Urology","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"March 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Kyorin Pharmaceutical"},{"company":"Astellas Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Astellas Garners New Indication & New Product Formulation Approvals From U.S. FDA for Children with Neurogenic Detrusor Overactivity (NDO)","therapeuticArea":"Urology","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"March 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Astellas Pharma"}]

Kyorin Pharmaceutical

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KYORIN and Eisai Enter Into License Agreement Concerning the Development and Marketing of Vibegron

Details:

Based on this agreement, Eisai will acquire exclusive development and marketing rights from Kyorin for the agent in the said four countries, and will be responsible for submitting a New Drug Application for the agent.

Lead Product(s): Vibegron

Therapeutic Area: Urology Product Name: Gemtesa

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Eisai

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement March 31, 2021

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Astellas Pharma

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Astellas Garners New Indication & New Product Formulation Approvals From U.S. FDA for Children with Neurogenic Detrusor Overactivity (NDO)

Details:

The U.S. Food and Drug Administration (FDA) approved Myrbetriq for the treatment of NDO in pediatric patients aged three years and older who weigh 35 kg or more, and Myrbetriq® Granules for the treatment of NDO in pediatric patients aged three years and older.

Lead Product(s): Mirabegron

Therapeutic Area: Urology Product Name: Myrbetriq

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 March 26, 2021

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Astellas Pharma

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FDA Approves VESIcare LS™ (solifenacin succinate) Oral Suspension for Pediatric Patients

Details:

VESIcare LS is an oral suspension dosage form that was specifically developed to facilitate dosing and administration in the pediatric population.

Lead Product(s): Solifenacin

Therapeutic Area: Urology Product Name: VESIcare LS

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 May 27, 2020

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