Anthrax

Aditxt Signs a Definitive Agreement to Acquire Appili Therapeutics Inc., Developer of a Biodefense Vaccine Funded by the U.S. Department of Defense (DoD)

Retrieved on: 
Tuesday, April 2, 2024

The U.S. FDA's approval of LIKMEZ highlighted Appili’s capacity to identify and develop significant opportunities within the infectious disease domain.

Key Points: 
  • The U.S. FDA's approval of LIKMEZ highlighted Appili’s capacity to identify and develop significant opportunities within the infectious disease domain.
  • Appili licensed the manufacturing and commercialization rights in the U.S. and other selected territories to Saptalis Pharmaceuticals, LLC (“Saptalis”).
  • Appili, in collaboration with Saptalis, continued the product's development, ultimately achieving FDA approval in the United States.
  • With FDA approval, future revenue is expected to be derived from milestone payments and royalties from Saptalis under the license agreement.

Paratek Pharmaceuticals Announces Positive Efficacy Data for NUZYRA® as Post-Exposure Prophylaxis of Inhalational Anthrax, Triggering Additional Procurement under BARDA Project BioShield Contract

Retrieved on: 
Tuesday, March 5, 2024

Anthrax (B. anthracis) is an infectious disease caused by gram-positive, rod-shaped, spore-forming bacteria that can lead to severe illness and death.

Key Points: 
  • Anthrax (B. anthracis) is an infectious disease caused by gram-positive, rod-shaped, spore-forming bacteria that can lead to severe illness and death.
  • Oral NUZYRA tablets associated with this procurement were manufactured in the United States as part of the company’s U.S. onshoring efforts.
  • “This procurement also represents a significant milestone in the company’s onshoring efforts as for the first time Paratek is providing BARDA with NUZYRA tablets produced on U.S. soil.
  • In December 2019, BARDA awarded Paratek a contract (75A50120C00001) that is now valued at up to approximately $304 million.

Emergent BioSolutions Awarded Procurement Contract Valued up to $235.8 Million to Supply BioThrax® (Anthrax Vaccine Adsorbed) to the U.S. Department of Defense

Retrieved on: 
Thursday, January 11, 2024

GAITHERSBURG, Md., Jan. 11, 2024 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced that it has secured an indefinite-delivery, indefinite-quantity (IDIQ) procurement contract with a maximum value up to $235.8 million to supply BioThrax® (Anthrax Vaccine Adsorbed) for use by all branches of the U.S. military as Pre-Exposure Prophylaxis (PrEP) for anthrax disease.

Key Points: 
  • GAITHERSBURG, Md., Jan. 11, 2024 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced that it has secured an indefinite-delivery, indefinite-quantity (IDIQ) procurement contract with a maximum value up to $235.8 million to supply BioThrax® (Anthrax Vaccine Adsorbed) for use by all branches of the U.S. military as Pre-Exposure Prophylaxis (PrEP) for anthrax disease.
  • The new contract with the U.S. Department of Defense (DoD) and led by the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, is comprised of a five-year base agreement ending on September 30, 2028, and an additional five-year option that would extend the contract to September 30, 2033.
  • “As a part of our mission to protect and enhance lives, Emergent is proud to continue supporting and preparing our nation’s service members who have a high risk of exposure to anthrax bacteria by supplying BioThrax vaccine,” said Paul Williams, senior vice president, products head at Emergent.
  • “This new contract award is a testament to the importance of Emergent’s medical countermeasures portfolio, and we look forward to delivering on our commitments to the U.S. DoD.”
    Under the initial five-year IDIQ contract, there is a guaranteed purchase minimum of $20.1 million, with future orders estimated to be at least $20 million for each following year for a total award value up to $235.8 million.

Emergent BioSolutions Receives $75 Million Contract Option from BARDA to Procure Doses of CYFENDUS™ (Anthrax Vaccine Adsorbed, Adjuvanted)

Retrieved on: 
Tuesday, November 28, 2023

Deliveries are expected to begin this calendar year and be complete by the end of the first quarter of 2024.

Key Points: 
  • Deliveries are expected to begin this calendar year and be complete by the end of the first quarter of 2024.
  • Anthrax is considered a high-priority national security threat and has the potential for major public health impact.
  • In April 2022, Emergent submitted the Biologics License Application to the FDA for review, leading to approval and licensure in July 2023.
  • This latest contract option supplements previous contract procurements and supports the U.S. biodefense preparedness efforts.

AHF: Anthrax Outbreak Exposes Global Health Inequities

Retrieved on: 
Friday, December 22, 2023

“The anthrax outbreak is another example of why we need equity, not charity on global health.

Key Points: 
  • “The anthrax outbreak is another example of why we need equity, not charity on global health.
  • As long as some places have all the resources to respond and others don't—we won't have truly functional pandemic preparedness.
  • “Lower-income countries will continue to suffer from preventable disease outbreaks until big pharma and rich countries prioritize lives over profits.
  • It can be prevented by vaccinating humans and livestock and is not contagious, except in rare cases of cutaneous anthrax.

908 Devices Announces MX908 Integration Capabilities

Retrieved on: 
Tuesday, November 14, 2023

The MX908, an essential tool to identify illicit materials at trace levels in multiple forms, including solids, liquids, vapors and aerosols, will be integrated into both companies’ products, at the request of customers, to expand their capabilities.

Key Points: 
  • The MX908, an essential tool to identify illicit materials at trace levels in multiple forms, including solids, liquids, vapors and aerosols, will be integrated into both companies’ products, at the request of customers, to expand their capabilities.
  • “At 908 Devices, we’re broadening the reach of our differentiated technology so that our customers can have increased access to trace detection capabilities,” said John Kenneweg, Vice President of Government, 908 Devices.
  • With the integration of the MX908, it is the only UGV that provides standoff identification of aerosolized chemical warfare and pharmaceutical based agents.
  • To learn more about the MX908 and 908 Devices, please visit: 908devices.com .

Major Gap in Public Safety From Contaminated Gloves Identified - “Don’t be cheap” Says Industry Veteran

Retrieved on: 
Monday, October 30, 2023

“Food gloves are not required to be clean and intact or be tested on arrival for chemical or microbial contaminants.

Key Points: 
  • “Food gloves are not required to be clean and intact or be tested on arrival for chemical or microbial contaminants.
  • “Currently, stockpiles of these low-quality gloves are being dumped into local markets with suspect expiry dates, no traceability, and no accountability,” says Ardagh.
  • Protective gloves are meant to protect, not infect
    Glove safety is critical in food processing and service to ensure gloves do not contaminate food.
  • Based in South Lake Tahoe, Eagle’s Delta Zero™ third-party testing program verifies Eagle gloves adhere to the highest level of consistent glove safety and performance.

The World's First "Recombinant Anthrax Vaccine": GC Biopharma applies for MFDS Approval

Retrieved on: 
Monday, November 6, 2023

YONGIN, South Korea, Nov. 5, 2023 /PRNewswire/ -- GC Biopharma announced 1 Nov. 2023 that it has applied for the marketing approval of "GC1109", an anthrax vaccine jointly developed by GC Biopharma and the Korea Disease Control and Prevention Agency (KDCA), to the Korean Ministry of Food and Drug Safety (MFDS).

Key Points: 
  • YONGIN, South Korea, Nov. 5, 2023 /PRNewswire/ -- GC Biopharma announced 1 Nov. 2023 that it has applied for the marketing approval of "GC1109", an anthrax vaccine jointly developed by GC Biopharma and the Korea Disease Control and Prevention Agency (KDCA), to the Korean Ministry of Food and Drug Safety (MFDS).
  • If approved, "GC1109" will be the world's first recombinant anthrax vaccine.
  • In order to prepare against potential bioterrorism and consequent national crisis, GC Biopharma, under the research project supported by KDCA, has been working on developing a recombinant vaccine for anthrax since 2002.
  • GC Biopharma stated, "We believe in the significance of our journey to localize the anthrax vaccine in terms of securing vaccine sovereignty, while promoting public health and national security.

Qnovia Enters Collaboration with University of Virginia to Advance Inhaled Drug Candidates for Treating Infectious Diseases

Retrieved on: 
Thursday, October 19, 2023

Qnovia, Inc., a pharma company developing inhaled therapeutics across a variety of indication areas, today announced it has entered into a drug development collaboration with the University of Virginia (UVA) to advance novel inhaled-drug candidates for treating bacterial infections in the lungs.

Key Points: 
  • Qnovia, Inc., a pharma company developing inhaled therapeutics across a variety of indication areas, today announced it has entered into a drug development collaboration with the University of Virginia (UVA) to advance novel inhaled-drug candidates for treating bacterial infections in the lungs.
  • “We are delighted to be working with the team at UVA to combine their exciting work on lead-series antimicrobial peptides with our inhaled drug delivery platform.
  • We believe our technology has the potential to provide meaningful therapeutic options for patients combating life-threatening infectious diseases,” said Brian Quigley, Qnovia’s Chief Executive Officer.
  • Additional high-priority indication areas for the inhaled delivery of UVA’s bactericidal peptides using Qnovia’s drug delivery platform will continue to be explored as part of the agreement.

BioFlyte Successfully Validates Aerosolized Fentanyl Detection Capabilities

Retrieved on: 
Thursday, September 28, 2023

“BioFlyte’s mission is to protect people and critical infrastructure, while also ensuring the continuity of operations in the face of evolving biological and chemical threats,” said Todd Sickles, CEO of BioFlyte.

Key Points: 
  • “BioFlyte’s mission is to protect people and critical infrastructure, while also ensuring the continuity of operations in the face of evolving biological and chemical threats,” said Todd Sickles, CEO of BioFlyte.
  • “Key decision makers in government and public safety are struggling to control the flow of fentanyl into the country.
  • Our ability to quickly and accurately detect life-threatening chemical threats like fentanyl, in addition to serious biological agents sets us apart from every other solution on the market.
  • In testing with Avarint, the BioTOF was exposed to both pure fentanyl and fentanyl mixed with common cutting agents such as xylazine and acetaminophen.