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    [{"orgOrder":0,"company":"Shionogi","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Accepts Shionogi\u2019s sNDA with Priority Review for FETROJA\u00ae for Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"June 2020","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Phase III"},{"orgOrder":0,"company":"TB Alliance","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"TB Alliance Announces European Commission Authorisation of New Treatment for Highly Drug-Resistant Tuberculosis","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"August 2020","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Shionogi","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Shionogi Announces FDA Approval of Fetroja\u00ae for Hospital-Acquired Bacterial Pneumonia AND Ventilator-Associated Bacterial Pneumonia","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"September 2020","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Approved"},{"orgOrder":0,"company":"TB Alliance","sponsor":"Lupin Ltd","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"TB Alliance and Lupin Announce Commercial Partnership for New Therapy for Highly Drug-Resistant TB","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2021","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"TB Alliance","sponsor":"Australian Government","pharmaFlowCategory":"D","amount":"$11.0 million","upfrontCash":"Undisclosed","newsHeadline":"Australian Government Grants TB Alliance an Award to Help Bolster Clinical Research and Improve Access to New Treatments for Drug-Resistant TB","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2024","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"TB Alliance","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"TB Alliance Launches Five-Country Phase 2 Clinical Trial Evaluating Next-Generation TB Drug","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2023","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II"}]

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              TB Alliance

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              Australian Government Grants TB Alliance an Award to Help Bolster Clinical Research and Improve Access to New Treatments for Drug-Resistant TB

              Details:

              The funding will contribute toward the completion of the NC-009 Pan-Phase 2 clinical trial evaluating the safety and efficacy of a combination of a new experimental compound, TBAJ-876, with pretomanid and linezolid, for both drug-sensitive and drug-resistant tuberculosis.

              Lead Product(s): TBAJ-876,Pretomanid,Linezolid

              Therapeutic Area: Infections and Infectious Diseases Product Name: TBAJ-876

              Highest Development Status: Phase II Product Type: Small molecule

              Partner/Sponsor/Collaborator: Australian Government

              Deal Size: $11.0 million Upfront Cash: Undisclosed

              Deal Type: Funding March 24, 2024

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              TB Alliance

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              TB Alliance Launches Five-Country Phase 2 Clinical Trial Evaluating Next-Generation TB Drug

              Details:

              TBAJ-876 is a diarylquinoline antibiotic that targets a key enzyme of TB bacteria involved in energy production, it is being evaluated in combination with pretomanid and linezolid, for the treatment for both drug-sensitive and drug-resistant TB.

              Lead Product(s): TBAJ-876,Pretomanid,Linezolid

              Therapeutic Area: Infections and Infectious Diseases Product Name: TBAJ-876

              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 November 16, 2023

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              TB Alliance

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              TB Alliance and Lupin Announce Commercial Partnership for New Therapy for Highly Drug-Resistant TB

              Details:

              Lupin intends to commercialize the anti-tuberculosis (TB) medicine, Pretomanid, in approximately 140 countries and territories, including many of the highest TB burden countries around the world.

              Lead Product(s): Pretomanid,Bedaquiline,Linezolid

              Therapeutic Area: Infections and Infectious Diseases Product Name: PA-824

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Lupin Ltd

              Deal Size: Undisclosed Upfront Cash: Undisclosed

              Deal Type: Partnership September 06, 2021

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              Shionogi

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              Shionogi Announces FDA Approval of Fetroja® for Hospital-Acquired Bacterial Pneumonia AND Ventilator-Associated Bacterial Pneumonia

              Details:

              U.S.FDA has approved a supplemental New Drug Application for FETROJA® (cefiderocol) for the treatment of patients 18 years of age or older with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP).

              Lead Product(s): Cefiderocol,Linezolid

              Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Fetroja

              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 September 28, 2020

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              TB Alliance

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              TB Alliance Announces European Commission Authorisation of New Treatment for Highly Drug-Resistant Tuberculosis

              Details:

              The new drug was authorised as part of a three-drug, six month, all-oral regimen for the treatment of adults with extensively drug-resistant TB (XDR-TB) or multidrug-resistant TB (MDR-TB) who are treatment-intolerant or non-responsive.

              Lead Product(s): Pretomanid,Bedaquiline,Linezolid

              Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: PA-824

              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 August 03, 2020

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              Shionogi

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              FDA Accepts Shionogi’s sNDA with Priority Review for FETROJA® for Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia

              Details:

              FDA has accepted the company’s supplemental New Drug Application (sNDA) for FETROJA® (cefiderocol) and granted Priority Review designation with a Prescription Drug User Fee Act (PDUFA) date of September 27, 2020.

              Lead Product(s): Cefiderocol,Linezolid

              Therapeutic Area: Pulmonary/Respiratory Diseases 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 June 01, 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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