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Details:
Taiwan approved sNDA for Xofluza (baloxavir marboxil) for the treatment and postexposure prophylaxis for influenza virus infection for paediatrics aged 5 to <12 years.
Lead Product(s): Baloxavir Marboxil
Therapeutic Area: Infections and Infectious Diseases Product Name: Xofluza
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 16, 2024
Details:
Xofluza (baloxavir marboxil), a first-in-class, single-dose oral medicine with an innovative mechanism of action that has demonstrated efficacy in a wide range of influenza viruses.
Lead Product(s): Baloxavir Marboxil
Therapeutic Area: Infections and Infectious Diseases Product Name: Xofluza
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 12, 2023
Details:
Xofluza® (baloxavir marboxil) is first-in-class, single-dose oral medicine with an innovative proposed MOA that has demonstrated efficacy in influenza viruses, including in vitro activity against oseltamivir-resistant strains and avian strains in non-clinical studies.
Lead Product(s): Baloxavir Marboxil
Therapeutic Area: Infections and Infectious Diseases Product Name: Xofluza
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 11, 2022
Details:
Xofluza is the first single-dose influenza medicine approved for post-exposure prophylaxis. The sNDA allows Xofluza® (baloxavir marboxil) to be used as a treatment to prevent influenza in people 12 years of age and older following contact with someone with influenza.
Lead Product(s): Baloxavir Marboxil
Therapeutic Area: Infections and Infectious Diseases Product Name: Xofluza
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Shionogi
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 23, 2020
Details:
The filings are based on positive results from two Phase III studies, miniSTONE-2 and BLOCKSTONE, which were both recently presented as late breakers at the 2019 OPTIONS X congress in Singapore.
Lead Product(s): Baloxavir Marboxil
Therapeutic Area: Infections and Infectious 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 March 27, 2020
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