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Latest Top (4) News


HHS partners to develop new treatment for seizures caused by nerve agents

A new treatment for seizures that cannot be stopped with current medicines will be developed under an agreement between the U.S. Department of Health and Human Services (HHS)’ Office of the Assistant Secretary for Preparedness and Response (ASPR) and Proniras Corporation of Seattle, Washington. Uncontrollable seizures are a devastating result of exposure to nerve agents and can be deadly or lead to permanent brain damage.

“Nerve agents are the most toxic and rapidly acting of the known chemical warfare agents,” explained Rick Bright, Ph.D., director of the Biomedical Advanced Research and Development Authority (BARDA), a component of ASPR. “Although the Strategic National Stockpile includes anti-seizure medications, those medications may not be completely effective in stopping all seizures. To save more lives and improve long-term health for survivors, a second-line anti-seizure medication is needed.”

Under the 9-month, approximately $3 million agreement announced today, Proniras will develop Tezampanel as a treatment for seizures that have not been stopped by benzodiazepines, a class of drugs that includes the stockpiled medication diazepam (better known as valium). The contract can be extended up to a total of approximately $89.5 million over five years.

In clinical trials Tezampanel, which works by a different mechanism than diazepam, was shown to be safe. Recent studies also have shown Tezampanel to be an effective seizure treatment in rats with soman nerve agent poisoning, even when the drug was given after a significant delay. Soman is an extremely toxic man-made chemical warfare agent, originally developed as an insecticide in Germany in 1944.

Under the BARDA contract, Proniras will conduct studies to evaluate whether Tezampanel also stops seizures in rats even after benzodiazepine treatment has failed to do so. These studies may lead Proniras to apply for FDA approval of Tezampanel to treat seizures that do not respond to benzodiazepines, including seizures resulting from nerve agent exposure. Proniras also will explore other potential commercial uses for the drug.

Development of this new drug is part of ASPR’s efforts to develop medical products, procedures, and capabilities to protect health and save lives in terrorist attacks, including those using nerve agents. Nerve agents were used in an attack in the Tokyo subway in 1995 and in the Syrian civil war.

BARDA’s preparedness efforts include development of eight novel and repurposed therapeutics and PRISM, the first evidence-based decontamination procedures for use after exposure to any of four classes of chemical agents.

BARDA continues to seek proposals for the development of effective products to treat injuries caused by chemical agents, including new products and new indications for products already in clinical use. The products must be easy to use in a mass casualty situation and safe and effective for all segments of the population. Proposals are accepted through the Broad Agency Announcement BARDA- BAA-18-100-SOL-00003 at the Federal Business Opportunities website, www.fbo.gov.

The project announced today is part of BARDA’s integrated portfolio for the advanced research and development, innovation, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergency threats. These threats include chemical, biological, radiological, and nuclear agents, pandemic influenza, and emerging infectious diseases.

HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. Within HHS, ASPR’s mission is to save lives and protect Americans from 21st century health security threats. ASPR leads the nation’s medical and public health preparedness for, response to, and recovery from disasters and public health emergencies.

To learn more about ASPR, visit www.phe.gov. For more information about partnering with BARDA, visit www.medicalcountermeasures.gov.



Friday, April 27, 2018 - 09:00


Trump Administration Releases Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs

Today, the Trump Administration released “American Patients First,” the President’s blueprint to lower drug prices and reduce out-of-pocket costs.  Below is the blueprint’s introductory message from HHS Secretary Alex Azar:

The United States is first in the world in biopharmaceutical investment and innovation. Combining our free market system and generous public investment made America home to the first chemotherapy treatments for cancer, the first effective treatments for HIV, the first cure for Hepatitis C, and now, the first therapies that turn our own immune systems against cancer.

But too often, this system has not put American patients first. We have access to the greatest medicines in the world, but access is meaningless without affordability.

When it comes to the cost of prescription drugs, our healthcare system faces four major challenges: high list prices for drugs; seniors and government programs overpaying for drugs due to lack of the latest negotiation tools; out-of-pocket costs for consumers; and foreign governments free-riding off of American investment in innovation.

These problems have often been discussed, but gone unaddressed. Under President Trump, that has now changed. This blueprint is a historic plan for bringing down the high price of drugs and reducing out-of-pocket costs for the American consumer.

The time to act is now: Not only are costs spiraling out of control, but the scientific landscape is changing as well. Securing the next generation of cures for the next generation of American patients will require radical reforms to how our system works. Our blueprint will bring immediate relief to American patients while also delivering long-term reforms.

The men and women of the Department of Health and Human Services (HHS) are looking at every facet of HHS’s programs, authorities, and spending. Working with our partners in the private sector, we will turn this vison into action, and thereby improve the health and well-being of every American.

To view the American Patients First Blueprint visit: https://www.hhs.gov/drugpricing



Friday, May 11, 2018 - 16:00


ICYMI: Secretary Azar's Remarks on the Trump Administration's Drug Pricing Blueprint

Today, Secretary Azar delivered remarks on President Trump's blueprint to bring down the high price of prescription drugs and put American patients first, here are a few excerpts from his speech as prepared for delivery:

"You heard President Trump make it clear on Friday how important tougher negotiation is. That is exactly what our plan brings to Medicare, in an effective and targeted fashion. We are delivering on President Trump's promise to do smart bidding and tough negotiation in Medicare: We are going to bring negotiation to where it doesn't exist, in Part B, and making negotiation more effective than it is today, in Part D."

"You can imagine what happens when you're developing a drug: It's much more appealing for the drug to go into Part B, where the government just pays the bill you send them, than Part D. ... In short order, we will be issuing a request for proposal to make new use of an alternative system for buying Part B drugs, a Competitive Acquisition Program. We believe there are more private sector entities equipped to negotiate these better deals in Part B, and we want to let them do it. More broadly, the President has called for me to merge Medicare Part B into Part D, where negotiation has been so successful."

"For too long, there's been a lot of talk on drug prices, and no action. Drug companies have insisted we can have new cures or affordable prices, but not both. I've been a drug company executive—I know the tired talking points: the idea that if one penny disappears from pharma profit margins, American innovation will grind to a halt. I'm not interested in hearing those talking points anymore, and neither is the President."

To reach the full remarks as prepared for delivery, please visit: https://www.hhs.gov/about/leadership/secretary/speeches/2018-speeches/remarks-on-drug-pricing-blueprint.html



Monday, May 14, 2018 - 14:00


Secure API Server Showdown Winner Announced

The Department of Health and Human Service’s Office of the National Coordinator for Health Information Technology (ONC) today announced the Stage 2 winner of the “Secure API Server Showdown” Challenge. Application programming interfaces (APIs) are technology that allow one software program to access the services provided by another software program. The 21st Century Cures Act calls for the development of APIs that do not require “special effort” for developers to access and exchange health information.

The challenge sought to engage the health IT industry to identify Fast Healthcare Interoperability Resources (FHIR®) servers that reinforce the value of following technical security best practices on an industry-wide scale. These best practices ensure the most widely-accepted and effective measures are taken resulting in a high quality, secure FHIR server, further helping to protect the health information it contains. The winner of the challenge is 1upHealth.

In Stage 1 of the challenge, Asymmetrik built a secure, Health Level 7 (HL7®) FHIR server using current industry technical standards, best practices, and recently issued healthcare-specific technical requirements for security. This included using the Substitutable Medical Apps, Reusable Technology (SMART) App Authorization Guide.

To win stage 2, participants were tasked with finding weaknesses in the FHIR server developed by Asymmetrik. 1upHealth identified ways to strengthen the open source FHIR server, improving the overall security of the server and supporting the sensitive patient data being stored or transmitted.

As a result of this challenge, a unique open source FHIR implementation using JavaScript, Node.js and MongoDB is now available for industry developers to build upon. This implementation meets the security technical requirements as specified in the Argonaut Data Query Implementation Guide Version 1.0.0. The source code is available for public use on GitHub.



Thursday, May 17, 2018 - 09:30