Infections and Infectious Diseases | Phase III Developments | JAPAN

Fujifilm

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Fujifilm Shares Fall After Report Avigan Not Showing Clear Efficacy in Some Coronavirus Trials

Lead Product(s): Favipiravir

Therapeutic Area: Infections and Infectious Diseases

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 20, 2020

Details:

The data reported to Japan’s health ministry by hospitals treating people showing mild or no symptoms raises doubts about whether the drug can be approved by the end of this month as sought by Japan’s government.

Fujifilm

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Japan Expects to Launch Clinical Trials Of Covid-19 Vaccine in July

Lead Product(s): Favipiravir

Therapeutic Area: Infections and Infectious Diseases

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 12, 2020

Details:

Government of Japan intends to approve Fujifilm’s anti-flu drug Avigan by the end of this May 2020 for the treatment of patients suffering from Covid-19 infection.

CMIC Holdings

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CMIC Group Supports Clinical Trials and Manufacturing of Influenza Antiviral Drug “Avigan® Tablet”

Lead Product(s): Favipiravir

Therapeutic Area: Infections and Infectious Diseases

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: FUJIFILM Toyama Chemical

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement April 23, 2020

Details:

CMIC is providing monitoring services as a CRO for Avigan® for phase III clinical trial in Japan led by FUJIFILM Toyama Chemical and will support for manufacturing the product as a CDMO.

Chugai Pharmaceutical

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Chugai Starts Ph III Trial of Actemra for COVID-19 Pneumonia

Lead Product(s): Tocilizumab

Therapeutic Area: Infections and Infectious Diseases

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 10, 2020

Details:

Chugai Starts Phase III Clinical Trial of Actemra for COVID-19 Pneumonia in Japan.

Fujifilm

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Fujifilm Announces the Start of a Phase II Clinical Trial of its Influenza Antiviral Drug "Avigan® Tablet" for COVID-19

Lead Product(s): Favipiravir

Therapeutic Area: Infections and Infectious Diseases

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 April 09, 2020

Details:

The clinical trial in the U.S. will enroll approximately 50 patients with COVID-19, in collaboration with Brigham and Women’s Hospital, and other hospitals.

Takeda Pharmaceutical

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The Lancet publishes papers from studies of Takeda’s dengue vaccine candidate

Lead Product(s): TAK-003

Therapeutic Area: Infections and Infectious Diseases

Highest Development Status: Phase III Product Type: Vaccine

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 17, 2020

Details:

Results published in first paper from 18-month analysis of ongoing pivotal Phase 3 trial were generally consistent with overall efficacy and safety data reported in previous 12-month analysis.

Astellas Pharma

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U.S. FDA Approves Supplemental New Drug Application (sNDA) for Expanded Indication of MYCAMINE® (micafungin for injection) for the Treatmen...

Lead Product(s): Micafungin

Therapeutic Area: Infections and Infectious Diseases

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 January 08, 2020

Details:

With the approval, MYCAMINE is the first antifungal drug approved in the United States specifically for the treatment of invasive candidiasis for this patient population.

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Fujifilm

Fujifilm Shares Fall After Report Avigan Not Showing Clear Efficacy in Some Coronavirus Trials

Fujifilm

Japan Expects to Launch Clinical Trials Of Covid-19 Vaccine in July

CMIC Holdings

CMIC Group Supports Clinical Trials and Manufacturing of Influenza Antiviral Drug “Avigan® Tablet”

Chugai Pharmaceutical

Chugai Starts Ph III Trial of Actemra for COVID-19 Pneumonia

Fujifilm

Fujifilm Announces the Start of a Phase II Clinical Trial of its Influenza Antiviral Drug "Avigan® Tablet" for COVID-19

Takeda Pharmaceutical

The Lancet publishes papers from studies of Takeda’s dengue vaccine candidate

Astellas Pharma

U.S. FDA Approves Supplemental New Drug Application (sNDA) for Expanded Indication of MYCAMINE® (micafungin for injection) for the Treatmen...