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Latest From Viatris Inc.

Deciphering Molnupiravir’s India Trial Discontinuation In Moderate COVID-19

Two Indian firms want to terminate specific Phase III trials for molnupiravir, the Merck/ Ridgeback Biotherapeutics’ antiviral in the spotlight as a treatment for mild-to-moderate COVID-19. Should much be read into these plans or is it merely an “administrative closure” that is being sought?

Research & Development Coronavirus COVID-19

US FDA Unlikely To Issue Broad Biosimilar Guidance Saying Comparative Clinical Studies Unnecessary

OTBB head Sarah Yim says FDA internal thinking is not aligned on the idea and that a lot of convincing was necessary to drop the clinical study requirement for insulin biosimilars.

Biosimilars Drug Approval Standards

A Break-Even Year For US FDA Advisory Committees?

Meetings have continued to be sparse through 2021, but there will end up being nearly as many panels on withdrawing approved uses as on approving new ones.

Advisory Committees Approvals

US FDA Unlikely To Issue Broad Biosimilar Guidance Saying Comparative Clinical Studies Unnecessary

OTBB head Sarah Yim says FDA internal thinking is not aligned on the idea and that a lot of convincing was necessary to drop the clinical study requirement for insulin biosimilars.

Biosimilars Drug Approval Standards
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Company Information

  • Industry
  • Pharmaceuticals
    • Generic Drugs
    • Drug Delivery
      • Transdermal
  • Other Names / Subsidiaries
    • Acton Pharmaceuticals, Inc.
    • Agila, Bioniche Pharma Holdings Limited
    • Alaven Pharmaceutical, LLC
    • Antula Healthcare AB
    • Bertek
    • Dow B. Hickham
    • Dow Hickam Pharmaceuticals, Inc.
    • Generics (UK) Ltd.
    • Jai Pharma
    • Madaus Pharma
    • Meda AB
    • Meda Pharmaceuticals Inc.
    • Mylan Inc.
    • Mylan Laboratories Limited (formerly Matrix Laboratories Limited)
    • Mylan Specialty (formerly Dey Pharma L.P.)
    • Rottapharm Madaus
    • Mylan Technologies, Inc.
    • UDL Laboratories
    • Viatris Inc.
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