regulatory
confidence high
sentiment positive
materiality 0.65
Emergent BioSolutions receives FDA approval for raxibacumab manufacturing at Winnipeg site
Emergent BioSolutions Inc.
- FDA approved sBLA for Winnipeg as drug product manufacturing and testing site for raxibacumab.
- Raxibacumab is a monoclonal antibody for treatment and prophylaxis of inhalational anthrax.
- Approval supports multi-year turnaround strategy to consolidate manufacturing in Winnipeg and Lansing.
- Winnipeg facility has over 45 years experience in commercial therapeutics manufacturing.
- CEO Joe Papa says this regulatory action advances flexible, streamlined manufacturing network.