Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Baloxavir Marboxil
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Positive Phase III Results Show Xofluza Reduces Influenza Virus Transmission
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.
Product Name : Xofluza
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 19, 2024
Lead Product(s) : Baloxavir Marboxil
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Baloxavir Marboxil
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Positive Phase III Results Show Xofluza Reduces Influenza Virus Transmission
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.
Product Name : Xofluza
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 19, 2024
Lead Product(s) : Baloxavir Marboxil
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Baloxavir Marboxil
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Taiwan Approves Japan-Based Shionogi's Influenza Drug for Paediatric Use
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.
Product Name : Xofluza
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 16, 2024
Lead Product(s) : Baloxavir Marboxil
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Baloxavir Marboxil
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Xofluza
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
December 01, 2023
Lead Product(s) : Baloxavir Marboxil
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Baloxavir Marboxil
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Genentech Announces FDA Approval of Xofluza to Treat Influenza in Children Aged Five and Older
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-cl...
Product Name : Xofluza
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 08, 2022
Lead Product(s) : Baloxavir Marboxil
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Baloxavir Marboxil
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Approved FDF
Sponsor : Shionogi
Deal Size : Inapplicable
Deal Type : Inapplicable
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 w...
Product Name : Xofluza
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 23, 2020
Lead Product(s) : Baloxavir Marboxil
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Sponsor : Shionogi
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Baloxavir Marboxil
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
FDA Accepts Genentech’s New Drug Application for Xofluza for the Treatment of Influenza in Children
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.
Product Name : Xofluza
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 27, 2020
Lead Product(s) : Baloxavir Marboxil
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable