FDA expedites Merck's experimental Ebola vaccine

The Food and Drug Administration granted Kenilworth, N.J.-based Merck's experimental Ebola virus vaccine with a Breakthrough Therapy Designation.

The FDA's Breakthrough Therapy Designation is intended to expedite the development and review of drugs that show early signs of potential clinical benefit in serious diseases to provide patients with access to new therapies as soon as possible.

The vaccine, known as V920, was developed by scientists from the Public Health Agency of Canada's National Microbiology Laboratory. The vaccine was originally licensed to Ames, Iowa-based NewLink Genetics before Merck acquired the licensing rights in 2014 — at the peak of the Ebola outbreak in western Africa.

Merck is in charge of the research, development, manufacturing and regulatory efforts for V920.

The company is currently performing additional research to evaluate the vaccine.

More articles on supply chain:

Olympus told US execs no warning needed on scopes, despite previous superbug outbreaks
FDA turns to banned factory to prevent cancer drug shortages
New prostate cancer therapy earns FDA approval

© Copyright ASC COMMUNICATIONS 2019. Interested in LINKING to or REPRINTING this content? View our policies by clicking here.

 

Top 40 Articles from the Past 6 Months