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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":"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":"Shionogi","sponsor":"Clinton Health Access Initiative","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Shionogi, GARDP and CHAI Announce Landmark License and Collaboration Agreements to Treat Bacterial Infections by Expanding Access to Cefiderocol in 135 Countries","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"June 2022","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"}]

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              Shionogi

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              Shionogi, GARDP and CHAI Announce Landmark License and Collaboration Agreements to Treat Bacterial Infections by Expanding Access to Cefiderocol in 135 Countries

              Details:

              The collaboration agreement includes provisions to work with ministries of health and other experts to strengthen hospital-based stewardship programmes that ensure appropriate use. These provisions are especially important to avoid fuelling resistance to Fetroja (cefiderocol).

              Lead Product(s): Cefiderocol

              Therapeutic Area: Infections and Infectious Diseases Product Name: Fetroja

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Clinton Health Access Initiative

              Deal Size: Undisclosed Upfront Cash: Undisclosed

              Deal Type: Collaboration June 15, 2022

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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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              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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