Thursday, January 26, 2023
News on Pathogens and Preparedness
Global Biodefense
  • Featured
  • COVID-19
  • Funding
  • Directory
  • Jobs
  • Events
  • Subscribe
No Result
View All Result
  • Featured
  • COVID-19
  • Funding
  • Directory
  • Jobs
  • Events
  • Subscribe
No Result
View All Result
Global Biodefense
No Result
View All Result
Home Featured News

Health Canada Approves NDS for Botulinum Neurotoxin Countermeasure

by Global Biodefense Staff
January 2, 2017
Botulinum Neurotoxin Protein Structure

Botulinum Neurotoxin Protein Structure. Credit: Shutterstock

Health Canada has approved the Emergent BioSolutions Inc. New Drug Submission (NDS) for its botulism antitoxin, BAT® [Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) – (Equine)].

BAT is indicated for the treatment of symptomatic botulism following documented or suspected exposure to botulinum neurotoxin serotypes A, B, C, D, E, F, or G in adults and pediatric patients. BAT was approved under the Extraordinary Use New Drug (EUND) Regulations, which provide a regulatory pathway for products for which collecting clinical information for its intended use in humans is logistically or ethically not possible.

Emergent BioSolutions announced the milestone in a Dec. 12 statement.

“Emergent is pleased that Health Canada has approved this critical countermeasure against botulinum toxin, which has been identified by the U.S. Centers for Disease Control and Prevention and Public Health Agency of Canada as one of the more likely biological threat agents,” said Adam Havey, executive vice president and president, biodefense division at Emergent BioSolutions.

Previous to the Health Canada announcement, Emergent has an existing ten-year contract, implemented in 2012, to supply BAT to the Canadian Department of National Defense, Public Health Agency of Canada and individual provincial health authorities.

“As a leading global provider of medical countermeasures that address CBRNE threats and emerging infectious diseases, Emergent is committed to helping allied governments fulfill their preparedness needs,” noted Havey. “We expect to expand upon our longstanding relationship with the Canadian government and develop similar relations outside of North America as a key strategic objective for the organization.”

In the United States, Emergent has been supplying BAT to the Strategic National Stockpile as part of a $450 million contract with the Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services. BAT, which was licensed by the U.S. Food and Drug Administration in 2013, is the only botulism antitoxin available in the U.S. for treating naturally occurring, non-infant botulism, and for administering to patients under emergency conditions.

Tags: AntitoxinsASPRBotulinum NeurotoxinHHS

Related Posts

Influenza Proteins Tilt and Wave in ‘Breath-like’ Motions
Pathogens

Influenza Proteins Tilt and Wave in ‘Breath-like’ Motions

January 25, 2023
DARPA Selects Teams to Develop Vaccine Durability Prediction Model
Medical Countermeasures

DARPA Selects Teams to Develop Vaccine Durability Prediction Model

January 13, 2023
small glass vials on an assembly line await filling of vaccine solution
Industry News

Sabin Vaccine Institute to Advance Ebola Sudan and Marburg Vaccines with New BARDA Funding

January 12, 2023
How Are Bivalent COVID Vaccines Stacking Up Against Omicron?
Infectious Diseases

How Are Bivalent COVID Vaccines Stacking Up Against Omicron?

January 12, 2023
Load More

Latest News

Partner Therapeutics’ Novel Approach to Stratify Sepsis Patients Gains Backing From BARDA

Biopreparedness Research Virtual Environment (BRaVE) Initiative Backed by $105M DOE Funding

January 25, 2023
Influenza Proteins Tilt and Wave in ‘Breath-like’ Motions

Influenza Proteins Tilt and Wave in ‘Breath-like’ Motions

January 25, 2023
Biodefense Headlines – 24 January 2023

Biodefense Headlines – 24 January 2023

January 24, 2023
Biodefense Headlines – 17 January 2023

Biodefense Headlines – 17 January 2023

January 17, 2023

Subscribe

  • About
  • Contact
  • Privacy
  • Subscribe

© 2022 Stemar Media Group LLC

No Result
View All Result
  • Featured
  • COVID-19
  • Funding
  • Directory
  • Jobs
  • Events
  • Subscribe

© 2022 Stemar Media Group LLC