Friday, January 27, 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 Industry News

FDA Modifies Hold on Tekmira Ebola Drug

by Global Biodefense Staff
August 8, 2014
Ebola Virion

Tekmira Pharmaceuticals Corporation yesterday announced that the U.S. Food & Drug Administration (FDA) has verbally confirmed they have modified the full clinical hold placed on the TKM-Ebola Investigational New Drug Application (IND) to a partial clinical hold.

This action enables the potential use of TKM-Ebola in individuals infected with Ebola virus.

“We are pleased that the FDA has considered the risk-reward of TKM-Ebola for infected patients. We have been closely watching the Ebola virus outbreak and its consequences, and we are willing to assist with any responsible use of TKM-Ebola. The foresight shown by the FDA removes one potential roadblock to doing so,” said Dr. Mark Murray, CEO and President, Tekmira Pharmaceuticals. “This current outbreak underscores the critical need for effective therapeutic agents to treat the Ebola virus. We recognize the heightened urgency of this situation, and are carefully evaluating options for use of our investigational drug within accepted clinical and regulatory protocols.”

TKM-Ebola is being developed by Tekmira Pharmaceuticals under a $140 million contract with the U.S. Department of Defense’s Medical Countermeasure Systems BioDefense Therapeutics (MCS-BDTX) Joint Product Management Office.

The company remains on clinical hold as it relates to the multi-ascending dose portion of the Phase I clinical study in healthy volunteers with TKM-Ebola. “We are focused on an expedient resolution of this so that we can advance our TKM-Ebola to evaluate the multiple ascending dose regimen,” said Dr. Mark Murray, CEO and President, Tekmira Pharmaceuticals.

In March 2014, Tekmira was granted a Fast Track designation from the U.S. Food and Drug Administration for the development of TKM-Ebola.

Tags: EbolaEmerging Threats

Related Posts

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
NISTCHO: New Living Reference Material for Producing Monoclonal Antibodies
Medical Countermeasures

NISTCHO: New Living Reference Material for Producing Monoclonal Antibodies

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