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    [{"orgOrder":0,"company":"Eton Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Eton Pharmaceuticals Submits New Drug Application to the FDA for Orphan Drug Dehydrated Alcohol Injection (DS-100)","therapeuticArea":"Pharmacology\/Toxicology","highestDevelopmentStatus":"Undisclosed","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"July 2020","url1":"","url2":"","graph1":"Pharmacology\/Toxicology","graph2":"Undisclosed"},{"orgOrder":0,"company":"Citius Pharmaceuticals","sponsor":"H.C. Wainwright & Co.","pharmaFlowCategory":"D","amount":"$15.0 million","upfrontCash":"Undisclosed","newsHeadline":"Citius Pharmaceuticals Announces Closing of $15 Million Registered Direct Offering","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2023","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase III"},{"orgOrder":0,"company":"Biorasi","sponsor":"Citius Pharmaceuticals","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Citius Pharmaceuticals to Accelerate Phase 3 Mino-Lok Trial by Expanding Trial Sites Internationally","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase III"},{"orgOrder":0,"company":"Eton Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Eton Pharmaceuticals Announces FDA Acceptance of NDA Response for Dehydrated Alcohol Injection","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"January 2023","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Eton Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Eton Pharmaceuticals Receives Complete Response Letter (CRL) for Dehydrated Alcohol Injection","therapeuticArea":"Pharmacology\/Toxicology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2023","url1":"","url2":"","graph1":"Pharmacology\/Toxicology","graph2":"Phase III"},{"orgOrder":0,"company":"Citius Pharmaceuticals","sponsor":"The University of Texas MD Anderson Cancer Center","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Citius Pharmaceuticals Reaches 92 Event Milestone in Mino-Lok\u00ae Phase 3 Trial","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"August 2023","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase III"},{"orgOrder":0,"company":"Ablative Solutions","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ablative Solutions, Inc. Announces Primary Endpoint Met in the TARGET BP I Pivotal Trial of the Peregrine System\u2122 Kit for Patients with Uncontrolled Hypertension","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"December 2023","url1":"","url2":"","graph1":"Cardiology\/Vascular Diseases","graph2":"Phase III"},{"orgOrder":0,"company":"Citius Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Citius Pharmaceuticals Completes Enrollment in Pivotal Phase 3 Trial of its Mino-Lok\u00ae Therapeutic to Salvage Catheters","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"January 2024","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase III"}]

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              Citius Pharmaceuticals

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              Citius Pharmaceuticals Completes Enrollment in Pivotal Phase 3 Trial of its Mino-Lok® Therapeutic to Salvage Catheters

              Details:

              Mino-Lok (MLT) is a novel antibiotic lock therapy that combines minocycline with edetate disodium, which is investigated for the treatment of patients with catheter-related blood stream infections.

              Lead Product(s): Minocycline Hydrochloride,Edetate Calcium Disodium,Ethanol

              Therapeutic Area: Infections and Infectious Diseases Product Name: Mino-Lok

              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 January 02, 2024

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              Ablative Solutions

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              Ablative Solutions, Inc. Announces Primary Endpoint Met in the TARGET BP I Pivotal Trial of the Peregrine System™ Kit for Patients with Uncontrolled Hypertension

              Details:

              Peregrine system (ethanol) is a small molecule drug candidate, which is currently being evaluated for the treatment of patients with uncontrolled hypertension.

              Lead Product(s): Ethanol

              Therapeutic Area: Cardiology/Vascular Diseases Product Name: Peregrine System

              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 December 19, 2023

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              Citius Pharmaceuticals

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              Citius Pharmaceuticals Reaches 92 Event Milestone in Mino-Lok® Phase 3 Trial

              Details:

              Mino-Lok (MLT), a novel antibiotic lock therapy that combines minocycline with edetate disodium, which is investigated for the treatment of patients with catheter-related blood stream infections.

              Lead Product(s): Minocycline Hydrochloride,Edetate Calcium Disodium,Ethanol

              Therapeutic Area: Infections and Infectious Diseases Product Name: Mino-Lok

              Highest Development Status: Phase III Product Type: Small molecule

              Partner/Sponsor/Collaborator: The University of Texas MD Anderson Cancer Center

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable August 10, 2023

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              Eton Pharmaceuticals

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              Eton Pharmaceuticals Receives Complete Response Letter (CRL) for Dehydrated Alcohol Injection

              Details:

              FDA issued a Complete Response Letter (CRL) in response to its New Drug Application (NDA) for dehydrated alcohol injection for the treatment of methanol poisoning.

              Lead Product(s): Ethanol

              Therapeutic Area: Pharmacology/Toxicology Product Name: Undsclosed

              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 June 28, 2023

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              Citius Pharmaceuticals

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              Citius Pharmaceuticals Announces Closing of $15 Million Registered Direct Offering

              Details:

              The net proceeds will be used to fund the company's pre-clinical and clinical development of its product candidates, including Mino-Lok® (minocycline), an antibiotic lock solution used to treat patients with catheter-related bloodstream infections (CRBSIs) and CLABSIs.

              Lead Product(s): Minocycline Hydrochloride,Edetate Calcium Disodium,Ethanol

              Therapeutic Area: Infections and Infectious Diseases Product Name: Mino-Lok

              Highest Development Status: Phase III Product Type: Small molecule

              Partner/Sponsor/Collaborator: H.C. Wainwright & Co.

              Deal Size: $15.0 million Upfront Cash: Undisclosed

              Deal Type: Public Offering May 08, 2023

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              Eton Pharmaceuticals

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              Eton Pharmaceuticals Announces FDA Acceptance of NDA Response for Dehydrated Alcohol Injection

              Details:

              USFDA has accepted for review the company’s NDA response for dehydrated alcohol injection (a nerve blocking agent) for the proposed indication of methanol poisoning.

              Lead Product(s): Ethanol

              Therapeutic Area: Psychiatry/Psychology 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 January 11, 2023

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              Biorasi

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              Citius Pharmaceuticals to Accelerate Phase 3 Mino-Lok Trial by Expanding Trial Sites Internationally

              Details:

              Mino-Lok (minocycline) is an antibiotic lock solution used to treat patients with catheter-related bloodstream infections (CRBSIs) and central line associated bloodstream infections (CLABSIs).

              Lead Product(s): Minocycline Hydrochloride,EDTA acid,Ethanol

              Therapeutic Area: Infections and Infectious Diseases Product Name: Mino-Lok

              Highest Development Status: Phase III Product Type: Small molecule

              Partner/Sponsor/Collaborator: Citius Pharmaceuticals

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable May 06, 2022

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              Eton Pharmaceuticals

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              Eton Pharmaceuticals Submits New Drug Application to the FDA for Orphan Drug Dehydrated Alcohol Injection (DS-100)

              Details:

              Eton Pharmaceuticals has submitted a new drug application (NDA) for dehydrated alcohol injection, previously known as the company’s DS-100 product candidate, to the U.S. Food & Drug Administration (FDA) for the treatment of methanol poisoning.

              Lead Product(s): Ethanol

              Therapeutic Area: Pharmacology/Toxicology Product Name: DS-100

              Highest Development Status: Undisclosed Product Type: Small 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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              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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