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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 ...

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: ApprovedProduct 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 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: ApprovedProduct 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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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 IIIProduct 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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