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    [{"orgOrder":0,"company":"Merck & Co","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Accepts Review Supplemental New Drug Application for RECARBRIO","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"February 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase III"},{"orgOrder":0,"company":"Merck & Co","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Results of Phase 3 Trial Evaluating the Efficacy and Safety of Merck\u2019s RECARBRIO Vs Piperacillin and Tazobactam in HABP\/VABP ","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase III"},{"orgOrder":0,"company":"Merck & Co","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Approves Antibiotic to Treat Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Entasis Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Entasis Therapeutics, a Wholly Owned Subsidiary of Innoviva, Presents Efficacy and Safety Data from Landmark Phase 3 ATTACK Trial at IDWEEK 2022","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2022","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase III"},{"orgOrder":0,"company":"Innoviva","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Innoviva Announces FDA Acceptance and Priority Review of New Drug Application for Sulbactam-Durlobactam (SUL-DUR)","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"November 2022","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase III"}]

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              Innoviva

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              Innoviva Announces FDA Acceptance and Priority Review of New Drug Application for Sulbactam-Durlobactam (SUL-DUR)

              Details:

              SUL-DUR is an IV, investigational drug that is a combination of sulbactam, an IV β-lactam antibiotic, and durlobactam, a rationally designed broad-spectrum IV BLI, being developed for the treatment of infections caused by ABC, including carbapenem-resistant strains.

              Lead Product(s): Sulbactam,Durlobactam,Imipenem

              Therapeutic Area: Infections and Infectious Diseases Product Name: SUL-DUR

              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 November 30, 2022

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              Entasis Therapeutics

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              Entasis Therapeutics, a Wholly Owned Subsidiary of Innoviva, Presents Efficacy and Safety Data from Landmark Phase 3 ATTACK Trial at IDWEEK 2022

              Details:

              Sulbactam-Durlobactam (SUL-DUR) is an IV, investigational drug that is combination of sulbactam, an IV β-lactam antibiotic, and durlobactam, novel broad-spectrum IV BLI, developed for treatment of infections caused by ABC complex, including carbapenem-resistant strains.

              Lead Product(s): Sulbactam,Durlobactam,Imipenem

              Therapeutic Area: Infections and Infectious Diseases Product Name: ETX2514sul

              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 19, 2022

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              Merck & Co

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              FDA Approves Antibiotic to Treat Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia

              Details:

              FDA has approved sNDA for RECARBRIO (imipenem, cilastatin, and relebactam) for the treatment of patients 18 years of age and older with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP).

              Lead Product(s): Imipenem,Cilastatin,Relebactam

              Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

              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 June 05, 2020

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              Merck & Co

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              Results of Phase 3 Trial Evaluating the Efficacy and Safety of Merck’s RECARBRIO Vs Piperacillin and Tazobactam in HABP/VABP

              Details:

              The results demonstrated noninferiority of RECARBRIO compared to piperacillin and tazobactam (PIP/TAZ), in the primary and key secondary endpoints of the study.

              Lead Product(s): Imipenem,Cilastatin,Relebactam

              Therapeutic Area: Infections and Infectious 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 May 06, 2020

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              Merck & Co

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              FDA Accepts Review Supplemental New Drug Application for RECARBRIO

              Details:

              The submission is based on the results of the pivotal Phase 3 RESTORE-IMI 2 trial in adult patients with HABP/VABP.

              Lead Product(s): Imipenem

              Therapeutic Area: Infections and Infectious 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 February 03, 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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