Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The US Food and Drug Administration (FDA) has granted fast track designation to Emergent BioSolutions' experimental anthrax vaccine NuThrax (Anthrax Vaccine Adsorbed with CPG 7909 Adjuvant).
Subscribe to our email newsletter
Currently, the company is evaluating the safety, tolerability and immunogenicity of NuThrax also known as AV7909, which is in a Phase 1b trial.
According to the company, the Phase 1b trial has been organized with the support of National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health (NIH), and the Office of the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services (HHS).
Emergent president and chief operating officer Daniel Abdun-Nabi said expedited regulatory review could mean more frequent communications with FDA, priority review of biologics license applications (BLA) for their vaccine, and a rolling BLA submission, which allows FDA to review sections of the BLA in advance of receiving the complete submission.