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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":"Small molecule","graph2":"Shionogi"},{"orgOrder":0,"company":"Sosei Heptares","sponsor":"Novartis Pharmaceuticals Corporation","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sosei Heptares Notes Phase IIIb ARGON Study With Enerzair\u00ae Breezhaler\u00ae (QVM149) Meets Primary Endpoint in Patients With Uncontrolled Asthma","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"June 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Sosei Heptares"},{"orgOrder":0,"company":"Sosei Heptares","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sosei Heptares Notes that Enerzair\u00ae Breezhaler\u00ae has Been Recommended for Approval in the E.U for treating Uncontrolled Asthma","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"May 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Sosei Heptares"}]

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            Once-daily Enerzair® Breezhaler® (QVM149; IND/GLY/MF) met primary endpoint, demonstrating non-inferiority to a free combination of twice-daily Sal/Flu plus once-daily Tio in improving quality of life in people with uncontrolled asthma.

            Lead Product(s): Indacaterol Acetate,Glycopyrronium Bromide,Mometasone Furoate

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Enerzair Breezhaler

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 05, 2020

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            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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            If the EC follows this recommendation and approves Enerzair® Breezhaler®, it will become the first LABA/long-acting muscarinic antagonist (LAMA)/ICS fixed-dose combination for uncontrolled asthma patients.

            Lead Product(s): Indacaterol Acetate,Glycopyrronium Bromide,Mometasone Furoate

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Enerzair Breezhaler

            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 01, 2020

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