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    [{"orgOrder":0,"company":"Monopar Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Monopar Announces Issuance of New Patents Broadening Protections For Phase 2b\/3 Clinical-Stage Lead Product Candidate Validive\u00ae","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"November 2020","url1":"","url2":"","graph1":"Gastroenterology","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Sabal Therapeutics","sponsor":"Athena Bioscience","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Sabal Therapeutics Announces Sales and Marketing Agreement to Promote Athena Bioscience Cardiovascular Product Portfolio","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"February 2022","url1":"","url2":"","graph1":"Cardiology\/Vascular Diseases","graph2":"Approved"},{"orgOrder":0,"company":"BetterLife Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Monopar to Present Results from Analysis of Oropharyngeal Cancer Patients in Completed Phase 2 Validive\u00ae Trial at MASCC\/ISOO","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II\/ Phase III","country":"CANADA","productType":"Small molecule","productStatus":"Approved","date":"June 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Monopar Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Monopar Reaches Target Number of Clinical Sites in Phase 2b Portion of 2b\/3 Validive\u00ae VOICE Trial","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"August 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Monopar Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Monopar Expands Phase 2b\/3 VOICE Clinical Trial to Europe","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Athena Bioscience","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Athena Bioscience Announces Launch of Nexiclon\u2122 XR, the Only Once-Daily Clonidine Extended-Release Tablets for Treatment of Hypertension","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Cardiology\/Vascular Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Monopar Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Monopar Announces Completion of Phase 2b Enrollment and Commencement of Phase 3 Enrollment in its VOICE Trial for Severe Oral Mucositis","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2022","url1":"","url2":"","graph1":"Gastroenterology","graph2":"Phase III"},{"orgOrder":0,"company":"Monopar Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Monopar Announces Timeline of Upcoming Data Events for Validive, Camsirubicin, and MNPR-202","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2022","url1":"","url2":"","graph1":"Gastroenterology","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Monopar Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Monopar Announces Result of Interim Analysis of Phase 2b\/3 VOICE Trial Evaluating Validive for Severe Oral Mucositis","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2023","url1":"","url2":"","graph1":"Immunology","graph2":"Phase III"},{"orgOrder":0,"company":"BioSenic","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"BioSenic Reacquires Global IP Rights and Provides Update On JTA-004 Development","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase III","country":"BELGIUM","productType":"Small molecule","productStatus":"Approved","date":"May 2023","url1":"","url2":"","graph1":"Musculoskeletal","graph2":"Phase III"}]

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              BioSenic

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              BioSenic Reacquires Global IP Rights and Provides Update On JTA-004 Development

              Details:

              JTA-004 consists of a unique mix of plasma proteins, hyaluronic acid, a natural component of knee synovial fluid and a fast-acting analgesic. It was designed to provide added lubrication and protection to the arthritic joint cartilage and to alleviate osteoarthritis pain.

              Lead Product(s): Clonidine,Hyaluronic Acid

              Therapeutic Area: Musculoskeletal Product Name: JTA-004

              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 17, 2023

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              Monopar Therapeutics

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              Monopar Announces Result of Interim Analysis of Phase 2b/3 VOICE Trial Evaluating Validive for Severe Oral Mucositis

              Details:

              Validive® (clonidine hydrochloride) is a novel mucobuccal tablet formulation, indiacted for oropharyngeal cancer. It agonizes the alpha-2 adrenergic receptor on macrophages, decreasing the release of the destructive cytokines that are produced in response to radiotherapy.

              Lead Product(s): Clonidine

              Therapeutic Area: Immunology Product Name: Validive

              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 27, 2023

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              Monopar Therapeutics

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              Monopar Announces Timeline of Upcoming Data Events for Validive, Camsirubicin, and MNPR-202

              Details:

              Validive® (clonidine hydrochloride) is a novel mucobuccal tablet (MBT) formulation of clonidine. The mucobuccal tablet provides for prolonged local delivery of clonidine to the regions of oral mucosal radiation damage in oropharyngeal cancer (OPC) patients.

              Lead Product(s): Clonidine

              Therapeutic Area: Gastroenterology Product Name: Validive

              Highest Development Status: Phase II/ Phase III Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable October 27, 2022

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              Monopar Therapeutics

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              Monopar Announces Completion of Phase 2b Enrollment and Commencement of Phase 3 Enrollment in its VOICE Trial for Severe Oral Mucositis

              Details:

              Validive® (clonidine HCl MBT) is a novel mucobuccal tablet (MBT) formulation of clonidine. A completed double-blind, randomized, placebo-controlled Phase 2 clinical trial showed reduced incidence and duration of SOM and improvement of oral mucositis-related symptoms.

              Lead Product(s): Clonidine

              Therapeutic Area: Gastroenterology Product Name: Validive

              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 October 05, 2022

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              Athena Bioscience

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              Athena Bioscience Announces Launch of Nexiclon™ XR, the Only Once-Daily Clonidine Extended-Release Tablets for Treatment of Hypertension

              Details:

              The launch of Nexiclon XR, the only once-daily clonidine extended-release tablets is based on Tris's LiquiXR drug delivery technology, which has led to the development of multiple first-in-category products indicated for treatment of hypertension.

              Lead Product(s): Clonidine

              Therapeutic Area: Cardiology/Vascular Diseases Product Name: Nexiclon

              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 03, 2022

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              Sabal Therapeutics

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              Sabal Therapeutics Announces Sales and Marketing Agreement to Promote Athena Bioscience Cardiovascular Product Portfolio

              Details:

              This partnership aligns perfectly with Sabal’s mission to support commercial launch for two products, Nexiclon™ XR and Fibricor®, by helping them deliver their products to physicians and patients who need them.

              Lead Product(s): Clonidine

              Therapeutic Area: Cardiology/Vascular Diseases Product Name: Nexiclon XR

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Athena Bioscience

              Deal Size: Undisclosed Upfront Cash: Undisclosed

              Deal Type: Agreement February 22, 2022

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              Monopar Therapeutics

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              Monopar Expands Phase 2b/3 VOICE Clinical Trial to Europe

              Details:

              The trial, which began earlier this year in the US, is evaluating Validive® (clonidine HCl MBT) to prevent the onset of severe oral mucositis (SOM) in oropharyngeal cancer (OPC) patients treated with chemoradiotherapy.

              Lead Product(s): Clonidine

              Therapeutic Area: Oncology Product Name: Validive

              Highest Development Status: Phase II/ Phase III Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable September 13, 2021

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              Monopar Therapeutics

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              Monopar Reaches Target Number of Clinical Sites in Phase 2b Portion of 2b/3 Validive® VOICE Trial

              Details:

              The VOICE study evaluates Validive® for the prevention of severe oral mucositis (SOM) in oropharyngeal cancer patients. SOM results from the chemoradiation used to treat oropharyngeal cancer (OPC).

              Lead Product(s): Clonidine

              Therapeutic Area: Oncology Product Name: Validive

              Highest Development Status: Phase II/ Phase III Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable August 05, 2021

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              BetterLife Pharma

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              Monopar to Present Results from Analysis of Oropharyngeal Cancer Patients in Completed Phase 2 Validive® Trial at MASCC/ISOO

              Details:

              This analysis provided the rationale for the design of Monopar’s Phase 2b/3 VOICE trial, which is open and accruing oropharyngeal cancer patients in the US.

              Lead Product(s): Clonidine

              Therapeutic Area: Oncology Product Name: Validive

              Highest Development Status: Phase II/ Phase III Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable June 24, 2021

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              Monopar Therapeutics

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              Monopar Announces Issuance of New Patents Broadening Protections For Phase 2b/3 Clinical-Stage Lead Product Candidate Validive®

              Details:

              Patent provide claims covering “Clonidine and/or clonidine derivatives for use in the prevention and/or treatment of adverse side effects of chemotherapy”.

              Lead Product(s): Clonidine

              Therapeutic Area: Gastroenterology Product Name: Validive

              Highest Development Status: Phase II/ Phase III Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable November 09, 2020

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              Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.
              ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
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