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    [{"orgOrder":0,"company":"F2G Limited","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"F2G's Olorofim Receives Both FDA Orphan Drug Designation for Coccidioidomycosis and FDA QIDP Designation for Multiple Fungal Infections","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"F2G Limited","sponsor":"Cowen Healthcare Investments","pharmaFlowCategory":"D","amount":"$60.8 million","upfrontCash":"Undisclosed","newsHeadline":"F2G Raises $61M for Late-Phase Antifungal R&D","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"F2G Limited","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"F2G Receives Second US FDA Breakthrough Therapy Designation for Olorofim","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"F2G Limited","sponsor":"Shionogi","pharmaFlowCategory":"D","amount":"$480.0 million","upfrontCash":"$100.0 million","newsHeadline":"Shionogi & Co., Ltd. and F2G Ltd., Enter Strategic Collaboration to Develop and Commercialize the New Antifungal Agent Olorofim in Europe and Asia","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase III","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2022","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase III"},{"orgOrder":0,"company":"F2G Limited","sponsor":"Forbion","pharmaFlowCategory":"D","amount":"$70.0 million","upfrontCash":"Undisclosed","newsHeadline":"F2G Announces $70 Million Financing to Advance Development and Commercialization of New Antifungal Agent Olorofim","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase III","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2022","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase III"},{"orgOrder":0,"company":"F2G Limited","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"F2G Announces Data from Phase 2b Study at ID Week 2022 Showing Positive Therapeutic Response in Patients with Invasive Fungal Infections Treated with Olorofim","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2022","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"F2G Limited","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"F2G Announces FDA Filing Acceptance of New Drug Application for Olorofim for the Treatment of Invasive Fungal Infections","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2022","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"F2G Limited","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"F2G Receives Complete Response Letter from FDA for New Drug Application for Olorofim for the Treatment of Invasive Fungal Infections; Plans Resubmission With Additional Data and Analyses","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase III","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2023","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase III"}]

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              F2G Limited

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              F2G Receives Complete Response Letter from FDA for New Drug Application for Olorofim for the Treatment of Invasive Fungal Infections; Plans Resubmission With Additional Dat...

              Details:

              F901318 (olorofim) is F2G’s leading candidate from the orotomide class and is currently being investigated in a Phase 2b open-label study in patients who have limited treatment options for difficult-to-treat invasive, rare fungal mold infections.

              Lead Product(s): Olorofim

              Therapeutic Area: Infections and Infectious Diseases Product Name: F901318

              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 19, 2023

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              F2G Announces FDA Filing Acceptance of New Drug Application for Olorofim for the Treatment of Invasive Fungal Infections

              Details:

              Olorofim (formerly, F901318) is F2G’s leading candidate from the orotomide class and is currently being investigated in a Phase 2b open-label study in patients who have limited treatment options for difficult-to-treat invasive, rare fungal mold infections.

              Lead Product(s): Olorofim

              Therapeutic Area: Infections and Infectious Diseases Product Name: Olorofim

              Highest Development Status: Phase II Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable December 19, 2022

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              F2G Limited

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              F2G Announces Data from Phase 2b Study at ID Week 2022 Showing Positive Therapeutic Response in Patients with Invasive Fungal Infections Treated with Olorofim

              Details:

              Olorofim (formerly, F901318) is F2G’s leading candidate from the orotomide class for treatment options for difficult-to-treat invasive, rare fungal mold infections such as azole-resistant aspergillosis, scedosporiosis, lomentosporiosis, and other rare mold infections.

              Lead Product(s): Olorofim

              Therapeutic Area: Infections and Infectious Diseases Product Name: Olorofim

              Highest Development Status: Phase II Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable October 21, 2022

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              F2G Limited

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              F2G Announces $70 Million Financing to Advance Development and Commercialization of New Antifungal Agent Olorofim

              Details:

              The proceeds from the financing with Shionogi & Co., Ltd., will enable F2G to advance late-stage development and commercialization in the US of F901318 (olorofim), a novel oral antifungal therapy to treat invasive aspergillosis and other rare mold infections.

              Lead Product(s): Olorofim

              Therapeutic Area: Infections and Infectious Diseases Product Name: F901318

              Highest Development Status: Phase III Product Type: Small molecule

              Partner/Sponsor/Collaborator: Forbion

              Deal Size: $70.0 million Upfront Cash: Undisclosed

              Deal Type: Financing August 04, 2022

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              Shionogi & Co., Ltd. and F2G Ltd., Enter Strategic Collaboration to Develop and Commercialize the New Antifungal Agent Olorofim in Europe and Asia

              Details:

              Under the terms of the agreement, Shionogi will conduct the clinical trials of Olorofim, a novel oral antifungal therapy developed by F2G to treat invasive aspergillosis and other rare mold infections, and commercialization of olorofim for IA in Europe and Asia.

              Lead Product(s): Olorofim

              Therapeutic Area: Infections and Infectious Diseases Product Name: Olorofim

              Highest Development Status: Phase III Product Type: Small molecule

              Partner/Sponsor/Collaborator: Shionogi

              Deal Size: $480.0 million Upfront Cash: $100.0 million

              Deal Type: Collaboration May 16, 2022

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              F2G Receives Second US FDA Breakthrough Therapy Designation for Olorofim

              Details:

              Olorofim has been well tolerated across more than 30 years of cumulative patient dosing days with a median therapy duration of 12 weeks, in an ongoing open-label single-arm Phase 2b study in patients with proven invasive fungal disease.

              Lead Product(s): Olorofim

              Therapeutic Area: Infections and Infectious Diseases Product Name: F901318

              Highest Development Status: Phase II Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable October 22, 2020

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              F2G Raises $61M for Late-Phase Antifungal R&D

              Details:

              Proceeds from the financing will be used to fund F2G's late-stage clinical programs for their novel antifungal agent olorofim and organisational scale-up in preparation for commercialisation.

              Lead Product(s): Olorofim

              Therapeutic Area: Infections and Infectious Diseases Product Name: F901318

              Highest Development Status: Phase II Product Type: Small molecule

              Partner/Sponsor/Collaborator: Cowen Healthcare Investments

              Deal Size: $60.8 million Upfront Cash: Undisclosed

              Deal Type: Financing August 12, 2020

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              F2G Limited

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              F2G's Olorofim Receives Both FDA Orphan Drug Designation for Coccidioidomycosis and FDA QIDP Designation for Multiple Fungal Infections

              Details:

              Following the granting of Breakthrough Therapy designation in November, the U.S. FDA has also granted Qualified Infectious Disease Product (QIDP) designation to its lead first-in-class candidate, olorofim (formerly F901318).

              Lead Product(s): Olorofim

              Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

              Highest Development Status: Phase II Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable June 10, 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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