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    [{"orgOrder":0,"company":"PPD","sponsor":"First Wave BioPharma","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"AzurRx BioPharma Engages PPD to Manage Clinical Trial for Niclosamide as Treatment for COVID-19 Gastrointestinal Infections","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"February 2021","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"PPD","sponsor":"US Army","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"PPD Awarded US Army Study to Help Develop Post-Traumatic Stress Disorder Drugs","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Undisclosed","country":"U.S.A","productType":"Undisclosed","productStatus":"Undisclosed","date":"February 2021","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Undisclosed"},{"orgOrder":0,"company":"PPD","sponsor":"First Wave BioPharma","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"AzurRx BioPharma Engages PPD to Manage Clinical Trial for Niclosamide as Treatment Colitis","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2021","url1":"","url2":"","graph1":"Gastroenterology","graph2":"IND Enabling"},{"orgOrder":0,"company":"PPD","sponsor":"Zogenix","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Zogenix Submits Supplemental New Drug Application for FINTEPLA\u00ae (Fenfluramine) for the Treatment of Seizures Associated with Lennox-Gastaut Syndrome","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2021","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"PPD","sponsor":"Theratechnologies","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Theratechnologies Provides Update on the Dose Escalation Portion of Fast Track Designated TH1902 First-in-Human Study in Advanced Resistant Malignancies","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Peptide","productStatus":"New Molecular Entity","date":"July 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"}]

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              Theratechnologies Provides Update on the Dose Escalation Portion of Fast Track Designated TH1902 First-in-Human Study in Advanced Resistant Malignancies

              Details:

              TH1902 (Docetaxel-TH19P01 Conjugate) is Theratechnologies’ proprietary peptide drug conjugate (“PDC”) linked, a well-established and well-characterized cytotoxic agent.

              Lead Product(s): Docetaxel-TH19P01 Conjugate

              Therapeutic Area: Oncology Product Name: TH1902

              Highest Development Status: Phase I Product Type: Peptide

              Recipient: Theratechnologies

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable July 14, 2022

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              Zogenix Submits Supplemental New Drug Application for FINTEPLA® (Fenfluramine) for the Treatment of Seizures Associated with Lennox-Gastaut Syndrome

              Details:

              sNDA is supported by Phase 3 Study 1601 for FINTEPLA® (fenfluramine) for treatment of seizures associated with Lennox-Gastaut Syndrome to FDA. FINTEPLA is approved by the FDA and European Commission for treatment of seizures associated with Dravet syndrome.

              Lead Product(s): Fenfluramine

              Therapeutic Area: Neurology Product Name: Fintepla

              Highest Development Status: Approved Product Type: Small molecule

              Recipient: Zogenix

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable September 28, 2021

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              AzurRx BioPharma Engages PPD to Manage Clinical Trial for Niclosamide as Treatment Colitis

              Details:

              PPD will manage the Phase 1b/2a clinical trial using both oral immediate-release tablet and topical rectal enema foam formulations of micronized oral niclosamide, also known as FW-420.

              Lead Product(s): Niclosamide

              Therapeutic Area: Gastroenterology Product Name: FW-420

              Highest Development Status: IND Enabling Product Type: Small molecule

              Partner/Sponsor/Collaborator: First Wave BioPharma

              Deal Size: Undisclosed Upfront Cash: Undisclosed

              Deal Type: Collaboration April 13, 2021

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              PPD Awarded US Army Study to Help Develop Post-Traumatic Stress Disorder Drugs

              Details:

              PPD will work with U.S. Army Medical Materiel Development Activity’s Warfighter Brain Health Project Management Office to test the efficacy and safety of at least two pharmacotherapeutic drugs for the treatment of PTSD in U.S. military active duty personnel and veterans.

              Lead Product(s): Undisclosed

              Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

              Highest Development Status: Undisclosed Product Type: Undisclosed

              Partner/Sponsor/Collaborator: US Army

              Deal Size: Undisclosed Upfront Cash: Undisclosed

              Deal Type: Collaboration February 18, 2021

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              AzurRx BioPharma Engages PPD to Manage Clinical Trial for Niclosamide as Treatment for COVID-19 Gastrointestinal Infections

              Details:

              Under the terms of the agreement, PPD will manage the Phase 2 clinical trial for an immediate-release capsule formulation of micronized oral niclosamide, also known as FW-1022.

              Lead Product(s): Niclosamide

              Therapeutic Area: Infections and Infectious Diseases Product Name: FW-1022

              Highest Development Status: Phase II Product Type: Small molecule

              Partner/Sponsor/Collaborator: First Wave BioPharma

              Deal Size: Undisclosed Upfront Cash: Undisclosed

              Deal Type: Agreement February 09, 2021

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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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