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    [{"orgOrder":0,"company":"Vanda Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Vanda Pharmaceuticals Inks Agreement with FDA on Resubmission of the Application for HETLIOZ to Treat Patients with Smith-Magenis Syndrome","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2020","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"},{"orgOrder":0,"company":"Vanda Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Accepts and Grants Priority Review of Vanda's Applications for HETLIOZ\u00ae (tasimelteon) in the Treatment of Smith-Magenis Syndrome","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"August 2020","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"},{"orgOrder":0,"company":"Vanda Pharmaceuticals","sponsor":"MSN Laboratories","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Vanda Pharmaceuticals Settles HETLIOZ\u00ae Patent Litigation with MSN","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"January 2022","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Approved"},{"orgOrder":0,"company":"Vanda Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Vanda Pharmaceuticals Announces Presentations at SLEEP 2022","therapeuticArea":"Sleep","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Sleep","graph2":"Approved"},{"orgOrder":0,"company":"Vanda Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Vanda Pharmaceuticals Announces Notice Of Opportunity For An Fda Hearing On The Snda For Hetlioz\u00ae In Jet Lag Disorder","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2022","url1":"","url2":"","graph1":"Sleep","graph2":"Phase III"},{"orgOrder":0,"company":"Vanda Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Vanda Pharmaceuticals Responds to Ruling in HETLIOZ\u00ae ANDA Litigation","therapeuticArea":"Sleep","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"December 2022","url1":"","url2":"","graph1":"Sleep","graph2":"Approved"},{"orgOrder":0,"company":"Vanda Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Vanda Pharmaceuticals Announces FDA Update for Supplemental NDA for HETLIOZ\u00ae in the Treatment of Insomnia","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"February 2024","url1":"","url2":"","graph1":"Sleep","graph2":"Phase III"}]

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              Vanda Pharmaceuticals

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              Vanda Pharmaceuticals Announces FDA Update for Supplemental NDA for HETLIOZ® in the Treatment of Insomnia

              Details:

              Hetlioz (tasimelteon) is a melatonin receptor agonist. It is being evaluated in Phase 3 clinical trials for the treatment of insomnia characterized by difficulties with sleep initiation.

              Lead Product(s): Tasimelteon

              Therapeutic Area: Sleep Product Name: Hetlioz

              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 05, 2024

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              Vanda Pharmaceuticals

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              Vanda Pharmaceuticals Responds to Ruling in HETLIOZ® ANDA Litigation

              Details:

              HETLIOZ® (tasimelteon), is a melatonin receptor agonist that is FDA approved for both Non-24-Hour Sleep-Wake Disorder (a serious, chronic circadian rhythm disorder) and nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in patients 16 years of age and older.

              Lead Product(s): Tasimelteon

              Therapeutic Area: Sleep Product Name: Hetlioz

              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 13, 2022

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              Vanda Pharmaceuticals

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              Vanda Pharmaceuticals Announces Notice Of Opportunity For An Fda Hearing On The Snda For Hetlioz® In Jet Lag Disorder

              Details:

              HETLIOZ® (Tasimelteon), is a melatonin receptor agonist and the first and only medication that's been proven to treat people with Non-24 and nighttime sleep disturbances in SMS.

              Lead Product(s): Tasimelteon

              Therapeutic Area: Sleep Product Name: Hetlioz

              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 September 07, 2022

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              Vanda Pharmaceuticals

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              Vanda Pharmaceuticals Announces Presentations at SLEEP 2022

              Details:

              HETLIOZ® (Tasimelteon) is a melatonin receptor agonist that is FDA approved for both Non-24-Hour Sleep-Wake Disorder (a serious, chronic circadian rhythm disorder) and nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in patients 16 years of age and older.

              Lead Product(s): Tasimelteon

              Therapeutic Area: Sleep Product Name: Hetlioz

              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 31, 2022

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              Vanda Pharmaceuticals

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              Vanda Pharmaceuticals Settles HETLIOZ® Patent Litigation with MSN

              Details:

              Under the License Agreement, Vanda granted MSN and Impax a non-exclusive license to manufacture and commercialize MSN's version of HETLIOZ® in the U.S. effective March 13, 2035, unless prior to that date Vanda obtains pediatric exclusivity for HETLIOZ.

              Lead Product(s): Tasimelteon

              Therapeutic Area: Genetic Disease Product Name: Hetlioz

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: MSN Laboratories

              Deal Size: Undisclosed Upfront Cash: Undisclosed

              Deal Type: Licensing Agreement January 14, 2022

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              Vanda Pharmaceuticals

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              FDA Accepts and Grants Priority Review of Vanda's Applications for HETLIOZ® (tasimelteon) in the Treatment of Smith-Magenis Syndrome

              Details:

              The applications include a Supplemental New Drug Application (sNDA) for HETLIOZ® capsules and a New Drug Application (NDA) for the liquid formulation of HETLIOZ® for the treatment of adults and children, respectively, with Smith-Magenis Syndrome (SMS).

              Lead Product(s): Tasimelteon

              Therapeutic Area: Genetic Disease Product Name: Hetlioz

              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 August 03, 2020

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              Vanda Pharmaceuticals

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              Vanda Pharmaceuticals Inks Agreement with FDA on Resubmission of the Application for HETLIOZ to Treat Patients with Smith-Magenis Syndrome

              Details:

              Following the completion of a Type A Meeting with the U.S. FDA on May 8, 2020, it has reached agreement with the FDA to resubmit its application for HETLIOZ® (tasimelteon) for the treatment of Smith-Magenis Syndrome (SMS).

              Lead Product(s): Tasimelteon

              Therapeutic Area: Genetic Disease Product Name: Undisclosed

              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 May 13, 2020

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