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Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. TB Alliance has launched a new pan-phase 2 clinical trial to evaluate the safety and efficacy of replacing bedaquiline with a new experimental compound, TBAJ-876, in the organization’s three-drug BPaL regimen. The new regimen, composed of novel compounds with minimal pre-existing resistance, could provide a method to treat all patients with active tuberculosis (TB), including drug-sensitive and drug-resistant TB, with a universal treatment that is shorter, simpler, and more people-friendly than current regimens. Results from the preclinical and phase 2 studies showed that TBAJ-876, compared to bedaquiline, eliminated TB bacteria faster and was potentially safer. The study aims to enroll 300 participants with drug-sensitive TB at 21 trial sites in Georgia, the Philippines, South Africa, Tanzania, and Uganda.  Last week, the Bill & Melinda Gates Foundation announced a $23.6 million grant to US-based life science company Micron Biomedical to fund the first-ever mass production of needle-free vaccine technology. The technology, which uses dissolvable microneedles attached to the skin via a patch-like device, has the potential to boost the uptake of a variety of injectables, particularly in low-income countries, because it is simpler to transport and easier to administer. Specifically, the funding will support the development of a manufacturing facility that can make around 10 million doses annually for large clinical trials and hopefully wider use, subject to approval from regulatory authorities.A phase 3 clinical trial in South Africa found that a widely available oral antibiotic, levofloxacin, was safe and substantially reduced the risk of children and adults developing multidrug-resistant tuberculosis (MDR-TB). The trial is the first high-quality study to look at a preventive treatment for MDR-TB in children—there are currently no preventive MDR-TB treatments for adults or children. The researchers hope the new results will lead to updated guidelines from the World Health Organization that will lead to the rapid scale-up of levofloxacin because the drug is already widely available and relatively affordable, with child-friendly formulations already available through procurement agencies.  

Today, the Supporting Innovative Global Health Technologies (SIGHT) Act, a bill spearheaded and endorsed by GHTC, was introduced in the US House of Representatives. Below is a press release from the bill's sponsors, which quotes the executive director of GHTC.WASHINGTON, DC – Congressman Brian Fitzpatrick (PA-01), Congresswoman María Elvira Salazar (FL-27), and Congresswoman Chrissy Houlahan (PA-06) introduced the Supporting Innovative Global Health Technologies (SIGHT) Act of 2023. The bipartisan bill to empower the United States Agency for International Development (USAID) to boost its research and development capabilities for health care technologies in low and middle income countries abroad."The United States must remain a leader in health technology innovation at home and abroad," said Congressman Fitzpatrick. "Our bipartisan bill aims to address global health issues and provide further research and development in order to help save millions of lives on the world stage.”“We need stronger American investments to tackle the global health challenges of the 21st century,” said Congresswoman Salazar. “The SIGHT Act establishes a program dedicated to research at USAID, allowing us to better focus our energy on transformative tools that can save lives and drive down costs. I’m proud to co-lead this bipartisan bill to improve healthcare outcomes for the most vulnerable.”"COVID-19 laid bare that we must ensure populations at home and abroad have the resources to innovate rapidly, and that global health directly impacts economic stability and prosperity. As health emergencies continue to affect communities worldwide, it's important that we invest in organizations with a track record of successfully advancing global health. One great example is USAID," said Congresswoman Houlahan. "I am proud to introduce this bipartisan piece of legislation to support USAID, enabling them to advance cross-cutting research and development and respond quickly to emerging public health threats."“We applaud Reps. Fitzpatrick, Houlahan, and Salazar for recognizing both the need and the opportunity to elevate USAID’s role in global health R&D,” said Jamie Bay Nishi, executive director of the Global Health Technologies Coalition (GHTC), which represents 45 nonprofit organizations, academic institutions and aligned business committed to advancing innovations that save lives worldwide. “R&D partnerships led by USAID have been instrumental in saving millions of lives around the world—while also stimulating investments that create jobs here in the United States. It’s good to see Congressional leaders committed to intensifying the agency’s impact by encouraging USAID to go beyond a disease-specific approach and embrace a disease-agnostic approach—to pursue R&D partnerships that address the biggest priorities in global health, whatever and wherever they may be.”The SIGHT Act is also endorsed by:1. 3rd Stone Design2. Advancing Synergy3. American Academy of Pediatrics4. American Society of Tropical Medicine and Hygiene5. AVAC6. BEMPU Health7. BIO Ventures for Global Health8. Bugworks9. Catalysts for Change10.  Center for Global Health Innovation11.  CEPI U.S.12.  Coalition for Health Research and Development13.  CORE Group14.  Deutsche Stiftung Weltbevoelkerung15.  FIND16.  FREO2 Foundation17.  Global Health Council18.  Global Health Strategies19.  Global Health Technologies Coalition20.  Global Impact21.  Hemex Health22.  IAVI23.  Innovative Vector Control Consortium24.  International Union Against Tuberculosis and Lung Diseases25.  International Vaccine Institute26.  Makerere University School of Public Health27.  Management Sciences for Health28.  Mbarara University of Science and Technology29.  Medical IMPACT30.  Medicines for Malaria Venture31.  MRIGlobal32.  Pandemic Action Network33.  Panorama34.  PATH35.  Pathfinder International36.  Policy Cures Research37.  Population Council38.  Population Services International39.  Rice University Institute for Global Health Technologies Coalition40.  Sabin Vaccine Institute41.  Sightsavers42.  Sinapi Biomedical43.  Society for Children Orphaned by AIDS Inc.44.  South Africa Health Technologies Advocacy Coalition45.  Speak Up Africa46.  The BroadReach Group47.  The Task Force for Global Health48.  Treatment Action Group49.  Unlock Aid Coalition50.  White Ribbon AllianceRead the text of the bill here.

Page 1 of 4 Re: The Urgent Need to Reauthorize PAHPA Dear Leaders Schumer and McConnell, Speaker Johnson, and Leader Jeffries, On behalf of the undersigned organizations, we write to express our strong desire to see the Pandemic and All-Hazards Preparedness Act (PAHPA) reauthorized before the end of the calendar year in the same bipartisan fashion it has been supported since the original authorization 17 years ago. As you know, PAHPA underpins Department of Health and Human Services (HHS) agencies, programs, and funding authorizations for addressing national health security threats. PAHPA created the HHS Assistant Secretary for Preparedness and Response (now the Administration for Strategic Preparedness and Response) and the Biomedical Advanced Research and Development Authority (BARDA) and provides important congressional oversight and direction to federal programs related to early warning, prevention, preparedness, and response. This overall framework expired on September 30, 2023, requiring stopgap, temporary extensions in the continuing resolution, which expires on November 17. We encourage Congress to include a comprehensive five-year PAHPA reauthorization in the next moving legislative vehicle. The last three PAHPA bills all shared major recurring themes: they all adjusted to the changing threat landscape, focused on challenges identified since the prior bill, and considerably strengthened our nation’s health security with each reauthorization. Our nation’s changing health security threat landscape and the federal government’s responsibility to protect the American people demand that we work together now to find a strong bipartisan path forward to reauthorize this critical legislation. Whether the next health security threat is naturally occurring, the result of an accident, or intentionally caused, our country must be in a better position to prevent, prepare for, and respond to such incidents. Failing to reauthorize PAHPA would have serious effects on our country’s economic wellbeing, national security, and health security given the rapidly changing threat landscape. November 14, 2023 The Honorable Charles Schumer Majority Leader US Senate S-221 Capitol Building Washington, DC 20510 The Honorable Mike Johnson Speaker of the House US House of Representatives H-232 Capitol Building Washington, DC 20515 The Honorable Mitch McConnell Minority Leader US Senate S-230 Capitol Building Washington, DC 20510 The Honorable Hakeem Jeffries Minority Leader US House of Representatives H-204 Capitol Building Washington, DC 20515 Page 2 of 4 We are hopeful that PAHPA will remain a strong bipartisan legislative framework, as it has always been. We stand ready to assist you in whatever ways we can to help get this important law reauthorized this year. Sincerely (in alphabetical order), 1Day Sooner Acadian Ambulance Service, Inc. Adaptive Phage Therapeutics Aequor Inc. American Ambulance Association America’s Essential Hospitals American College of Emergency Physicians American College of Surgeons American Hospital Association American Lung Association American Pharmacies American Public Health Association American Society for Microbiology Arizona Bioindustry Association, Inc. (AZBio) Association for Professionals in Infection Control and Epidemiology Association of Maternal & Child Health Programs Association of State and Territorial Health Officials Asthma and Allergy Foundation of America AstraZeneca Pharmaceuticals ATCC (American Type Culture Collection) Atea Pharmaceuticals, Inc. Bavarian Nordic Big Cities Health Coalition BioCT BioForward Wisconsin BioKansas BioNJ Biotechnology Innovation Organization (BIO) Bugworks Cencora Colorado BioScience Association Council of State and Territorial Epidemiologists Council of State Bioscience Associations (CSBA) CSL Seqirus Emergency Department Practice Management Association Emergent BioSolutions Federation of American Scientists FluGen Inc. Georgia Bio Gerontological Society of America Ginkgo Bioworks Global Health Investment Corporation Global Health Technologies Coalition Gryphon Scientific GSK Health Industry Distributors Association (HIDA) Healthcare Distribution Alliance Page 3 of 4 Healthcare Leadership Council Healthcare Ready Helix HIMSS (Healthcare Information and Management Systems Society) HIV Medicine Association IAVI (International AIDS Vaccine Initiative) Illinois Biotechnology Innovation Organization Infectious Diseases Society of America INOVIO Pharmaceuticals Institute for Progress Johns Hopkins Center for Health Security Life Sciences PA Locus Biosciences Mallinckrodt Marked By Covid MassBio McKesson Medical Alley Medical Countermeasures Coalition Missouri Biotechnology Association (MOBIO) National Association of County and City Health Officials National Immigration Law Center New Mexico Biotechnoiogy & Biomedical Association (NMBio) New Orleans BioInnovation Center NewYorkBIO NightHawk Biosciences Novavax Ochsner Health Ohio Life Sciences Association Oklahoma Bioscience Association PDS Biotechnology PharmaJet Inc. Premier Inc. Public Health Accreditation Board Research!America SAB Biotherapeutics, Inc. Sanofi SecureBio Shionogi Inc. SIGA Technologies, Inc. Society for Public Health Education Soligenix, Inc. Technologies for Pandemic Defense Texas Healthcare & Bioscience Institute Tonix Pharmaceuticals Trinity Health TrippBio, Inc. Trust for America’s Health United States Pharmacopeia (USP) University of Hawaii University of Maryland School of Medicine Valneva USA Vaxxas Inc Virginia Biotechnology Association Page 4 of 4 Chair Cathy McMorris Rodgers Energy & Commerce Committee US House of Representatives Ranking Member Frank Pallone Energy & Commerce Committee US House of Representatives cc: Chair Bernie Sanders Health, Education, Labor & Pensions Committee US Senate Ranking Member Bill Cassidy Health, Education, Labor & Pensions Committee US Senate