"Where Fillmore County News Comes First"
Thursday, July 28th, 2016
Volume ∞ Issue ∞
- 1:55:04, Jul 27th 2016 - SV85 - @left luvr "Where are you getting this stuff?" Where I told you before----" ... [Read More]
- 12:58:29, Jul 27th 2016 - Kim Wentworth - @lolz- meant to type Carol Mosby in my last post. ... [Read More]
- 10:35:15, Jul 27th 2016 - Kim Wentworth - @lolz- Mr. Trump never uttered the "all" when talking about any ethn ... [Read More]
- 8:39:21, Jul 27th 2016 - Middle Man - Trump leaves a lot to be desired, hopefully if elected he surrounds hims ... [Read More]
- 7:13:53, Jul 27th 2016 - Aunt Barb - I am so proud of you, Michael, working to make this world a more peaceful ... [Read More]
- 12:36:54, Jul 27th 2016 - left luvr - @sv85 Where are you getting this stuff? One server for classified info a ... [Read More]
- 6:36:59, Jul 26th 2016 - What the ???? - @sv85 Where is this fact vs opinion stuff come from? Left luvr is mak ... [Read More]
- 2:34:51, Jul 26th 2016 - LOLZ - I think someone needs a dictionary or possibly his ears cleaned. 1) Misogyn ... [Read More]
- 1:46:43, Jul 26th 2016 - SV85 - @left luvr "I don't like Hillary because she is incompetent, that is a fact, ... [Read More]
- 9:27:19, Jul 26th 2016 - Kim Wentworth - @lolz- you could not show one example of a bigot, racist, or misogyni ... [Read More]
Mon, May 16th, 2011
Posted in State of Minnesota
Posted in State of Minnesota
The Biomedical Advanced Research and Development Authority (BARDA) today announced a five-year, $433 million contract for late-stage development of an antiviral drug to treat individuals infected with smallpox. The contract with SIGA Technologies Inc., of New York City also includes procurement of 1.7 million treatment courses of the drug, ST-246, within five years.
Today's contract is the first for smallpox antiviral drug development to be supported through Project BioShield, managed by BARDA within the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response.
The contract supports the final stages of ST-246 drug development needed to apply for U.S. Food and Drug Administration approval, including the development of techniques for scale-up manufacturing, a Phase III safety study which tests the drug in a large number of healthy human volunteers to be sure there are no adverse reactions to the drug, and studies in animals to demonstrate product efficacy.
Under the contract, the company also will develop a pediatric oral formulation of the drug, in compliance with requirements of the Pandemic and All-Hazards Preparedness Act of 2006.
Project BioShield, as amended by the Pandemic and All-Hazards Preparedness Act, provides additional and more flexible authorities and funding to support and expedite the development and acquisition of medical countermeasures against chemical, biological, radiological, and nuclear threats.
The work that will take place under this contract will build upon the initial drug research and development supported by the National Institute of Allergy and Infectious Diseases and the U.S. Department of Defense. This initial work, with support from the Centers for Disease Control and Prevention, and with World Health Organization assent, demonstrated effectiveness against the live variola virus, which causes smallpox. ST-246 is the first antiviral drug to transition from such support to BARDA for to continued development onward to ward acquisition and regulatory approval licensure under the Project BioShield Act of 2004.
"Today's contract represents an important milestone in the path from discovery to approval of a medical countermeasure against a potentially deadly bioterrorism threat," said Dr. Robin Robinson, deputy assistant secretary for preparedness and response and BARDA director. "Adding antiviral drugs to the health care provider's toolbox is an important part of being prepared for bioterrorism. Antiviral drugs can save lives so we look forward to the final stages of development and future acquisition of this product."
Routine smallpox vaccination ended in the United States in the early 1970s, so people born after routine vaccination ended are not immune to the disease. If the virus were used in a bioterrorism attack, HHS estimates that up to 1.7 million people or more could need treatment.
Although the Strategic National Stockpile (SNS) includes smallpox vaccine, vaccines only protect against disease if a person is vaccinated before or very soon after being exposed to the virus. Historically, approximately one-third of people who become ill with smallpox died from the virus. ST-246 is being developed to treat people who already have smallpox symptoms.
The U.S. strategy includes having two smallpox antiviral drugs for protecting the public against intentional or unintentional release of the smallpox virus. The development of these drugs supports not only U.S. national health security, but also global public health security, since any confirmed case of smallpox in the world would become a cause for international concern.
Today's contract is part of BARDA's comprehensive integrated portfolio approach to the advanced research and development, stockpile acquisition, innovation, and manufacturing infrastructure for medical countermeasures. BARDA supports development and acquisition of the necessary vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products such as ventilators for public health and medical emergencies including chemical, biological, radiological and nuclear treats, pandemic influenza, and emerging infectious diseases.
The SNS, operated by the CDC, has large quantities of medicine and medical supplies to protect the American public if there is a public health emergency, such as a terrorist attack or flu outbreak, severe enough to cause local supplies to run out. Once federal and local authorities agreed that the SNS supplies were needed medicines could be delivered to any state in the U.S. within 12 hours. Each state has plans to receive and distribute SNS medicine and medical supplies to local communities as quickly as possible.
For more information about BARDA and ASPR preparedness efforts for public health and medical emergencies, including Project BioShield contracts, visit www.phe.gov. More information about the Strategic National Stockpile is available at http://www.cdc.gov/phpr/stockpile.htm.