Office of Inspector General, U.S. Department of Health and Human Services

Gritstone bio Announces Presentations from Phase 1 Studies Evaluating Next-Generation Vaccine Candidate for COVID-19 at IDWeek 2023

Retrieved on: 
Wednesday, October 4, 2023
Vaccine, Nextgen, Biomedical Advanced Research and Development Authority, Therapy, Office of Inspector General, U.S. Department of Health and Human Services, HHS, National Institute of Allergy and Infectious Diseases, Gritstone bio, COVID-19, Infection, Messenger, Development, Infectious Disease Clinics of North America, NIAID, CORAL, BARDA, Gritstone, Pharmaceutical industry

EMERYVILLE, Calif., Oct. 04, 2023 (GLOBE NEWSWIRE) -- Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, today announced results from all three (3) Phase 1 studies evaluating its self-amplifying mRNA (samRNA) vaccine candidates against COVID-19 (part of the company’s CORAL program) are to be presented at IDWeek 2023, occurring October 11-15, 2023, in Boston, MA.

Key Points: 
  • EMERYVILLE, Calif., Oct. 04, 2023 (GLOBE NEWSWIRE) -- Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, today announced results from all three (3) Phase 1 studies evaluating its self-amplifying mRNA (samRNA) vaccine candidates against COVID-19 (part of the company’s CORAL program) are to be presented at IDWeek 2023, occurring October 11-15, 2023, in Boston, MA.
  • Last week, Gritstone bio announced a contract with the Biomedical Advanced Research and Development Authority (BARDA) to advance the program into a 10,000 patient, randomized Phase 2b comparative study against COVID-19.
  • Gritstone last presented data from the CORAL-BOOST and CORAL-CEPI studies in April 2023 ( press release ).
  • At IDWeek, Gritstone will present further follow up from both of those studies.

HDT Bio Receives $1 Million Award from BLUE KNIGHT™ Resident QuickFire Challenge in Support of Project NextGen

Retrieved on: 
Wednesday, October 4, 2023
Infection, ASPR, BLUE, Biomedical Advanced Research and Development Authority, Nasal cavity, Office of Inspector General, U.S. Department of Health and Human Services, HHS, SARS-CoV-2, Cancer, Anglo-Scandinavian, RNA, Epidemic, Development, Administration, Administration for Strategic Preparedness and Response, BARDA, Disease, Vaccine

Award will fund the development of HDT-201, HDT Bio's thermo-stable and broad-spectrum intranasal RIG-I Agonist RNA SARS-CoV-2 antiviral candidate

Key Points: 
  • Award will fund the development of HDT-201, HDT Bio's thermo-stable and broad-spectrum intranasal RIG-I Agonist RNA SARS-CoV-2 antiviral candidate
    SEATTLE, Oct. 4, 2023 /PRNewswire/ -- HDT Bio Corp., a clinical-stage private company developing advanced RNA products to treat and prevent infectious diseases and cancer, today announced that it has received a $1 million award from the BLUE KNIGHT™ Resident QuickFire Challenge.
  • BLUE KNIGHT is a joint initiative between the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS), and Johnson & Johnson Innovation – JLABS (JLABS).
  • The award will be used to support further development of HDT-201, HDT Bio's thermo-stable and broad-spectrum intranasal small RIG-I Agonist RNA antiviral candidate to prevent infection and transmission of SARS-CoV-2.
  • "We are honored to be recognized as an awardee of the BLUE KNIGHT™ Resident QuickFire Challenge and welcome the opportunity to collaborate together with BARDA to increase preparedness against new and ongoing epidemics.

Advanced Technology International to manage BARDA's Rapid Response Partnership Vehicle OTA

Retrieved on: 
Wednesday, October 4, 2023
Acceleration, ATI, Biomedical Advanced Research and Development Authority, Consortium, Office of Inspector General, U.S. Department of Health and Human Services, Human services, Public, OTA, Infection, Organization, Administration, Development, Administration for Strategic Preparedness and Response, ANSER, Federation, BARDA, Pharmaceutical industry

SUMMERVILLE, S.C., Oct. 4, 2023 /PRNewswire/ -- Advanced Technology International (ATI) has been awarded an Other Transaction Agreement (OTA) by the Biomedical Advanced Research and Development Authority ( BARDA ), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, to serve as the consortium manager for the Rapid Response Partnership Vehicle (RRPV).

Key Points: 
  • SUMMERVILLE, S.C., Oct. 4, 2023 /PRNewswire/ -- Advanced Technology International (ATI) has been awarded an Other Transaction Agreement (OTA) by the Biomedical Advanced Research and Development Authority ( BARDA ), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, to serve as the consortium manager for the Rapid Response Partnership Vehicle (RRPV).
  • The RRPV will help fortify national health security by developing medical countermeasures prior to and during a pandemic or public health emergency.
  • The RRPV will focus on the acceleration of products and technology development, regulatory approval, commercialization, and sustainment to address pandemic influenza, emerging infectious diseases, and other biological threats.
  • Members will focus on advancing health security, enhancing preparedness, and enabling a rapid response to the next pandemic or health emergency.

Cannabix’s MSBS Marijuana Breathalyzer Technology Advances Quantification of THC in Breath

Retrieved on: 
Tuesday, October 3, 2023
Drug, Human, Hemp Industries Association v. Drug Enforcement Administration, CSE, U.S. Department of Defense Strategy for Operating in Cyberspace, Workflow, Office of Inspector General, U.S. Department of Health and Human Services, LOQ, Area under the curve (pharmacokinetics), ICH, Research, MSBS, LOD, LSA, Consultant, Government, MS, Thermo, Gold, Area, LCMS, Collection, Mass, Level, AUC, OTC, Cannabis, BCU, THC, Smoking, Oil, Fine chemical, Quantification

Over recent months, the Company has developed the capability to quantify delta-9 THC in breath samples using Cannabix’s proprietary technology.

Key Points: 
  • Over recent months, the Company has developed the capability to quantify delta-9 THC in breath samples using Cannabix’s proprietary technology.
  • Cannabix scientists are using deuterated delta-9 THC (THC-D3) as an internal standard to generate a calibration curve for THC quantification in breath samples (ng/cartridge).
  • The quantification of delta-9 THC in breath presents an opportunity to help establish a legal limit for THC in breath, a limit which has not yet been achieved.
  • Furthermore, the method and technology used to quantify delta-9 THC in breath samples are in the preliminary testing phase and will require additional validation.

U.S. Department of Veterans Affairs Awards Acentra Health $52.3M Financial Services Center Contract for Claims Adjudication, Provider Access, Data Analytics and Visualization

Retrieved on: 
Tuesday, October 3, 2023
VHA, Partnership, Office of Inspector General, U.S. Department of Health and Human Services, Air Force Financial Services Center, Veterans Health Administration, U.S. Department of Veterans Affairs, Office of Inspector General, Organization, Trust, CNSI, OGA, FSC, Veteran

MCLEAN, Va., Oct. 03, 2023 (GLOBE NEWSWIRE) -- The U.S. Department of Veterans Affairs (VA) has awarded Acentra Health (formerly CNSI) a three-year, $52.3 million contract to support claims adjudication, provider access, data analytics, and visualization for its Financial Services Center (FSC).

Key Points: 
  • MCLEAN, Va., Oct. 03, 2023 (GLOBE NEWSWIRE) -- The U.S. Department of Veterans Affairs (VA) has awarded Acentra Health (formerly CNSI) a three-year, $52.3 million contract to support claims adjudication, provider access, data analytics, and visualization for its Financial Services Center (FSC).
  • The contract builds on Acentra Health’s existing body of technology-enabled services and solutions work for the FSC, dating back to 2017.
  • The new rules helped reduce manual claims review by department staff, resulting in a 98% reduction of the FSC’s claims backlog.
  • Under the terms of the contract, Acentra Health will continue providing its platforms and services to FSC and its stakeholders, which include the Veterans Health Administration (VHA) and Other Governmental Agencies (OGA).”

NV5 Awarded $10 Million Geospatial Forest Resource Management Contract

Retrieved on: 
Tuesday, October 3, 2023
PE, Office of Inspector General, U.S. Department of Health and Human Services, NV5, Data collection, USGS, United States Geological Survey, Natural Resources, Forestry, United States Forest Service, Geographic data and information, Surveying

HOLLYWOOD, Fla., Oct. 03, 2023 (GLOBE NEWSWIRE) -- NV5 Global, Inc. (the “Company” or “NV5”) (Nasdaq: NVEE), a provider of technology, conformity assessment, and consulting solutions, today announced that it has been selected by United States Geological Survey (USGS) for a $10 million contract to perform geospatial lidar data collection and processing of 28,359 square miles in Oregon and Washington state as part of the USGS 3D Elevation Program (3DEP).

Key Points: 
  • HOLLYWOOD, Fla., Oct. 03, 2023 (GLOBE NEWSWIRE) -- NV5 Global, Inc. (the “Company” or “NV5”) (Nasdaq: NVEE), a provider of technology, conformity assessment, and consulting solutions, today announced that it has been selected by United States Geological Survey (USGS) for a $10 million contract to perform geospatial lidar data collection and processing of 28,359 square miles in Oregon and Washington state as part of the USGS 3D Elevation Program (3DEP).
  • The project will support forest resource management and is jointly funded by USGS and the U.S. Forest Service Geospatial Technology and Applications Center of the U.S. Department of Agriculture.
  • The two-year project includes leaf-on lidar data collection in the fall and spring and is expected to be completed in September 2025.
  • “The application of geospatial data in the management of natural resources continues to grow, and we are pleased to support forestry management efforts of the USGS and U.S. Forest Service,” said Dickerson Wright, PE, Chairman and CEO of NV5.

Vir Biotechnology Awarded BARDA Funding to Support Development of Antibody Platform Technologies for Global Infectious Disease Threats

Retrieved on: 
Tuesday, October 3, 2023
OT, United States Department of Health and Human Services, ASPR, Office of Inspector General, U.S. Department of Health and Human Services, Nextgen, Biomedical Advanced Research and Development Authority, Therapy, CBRN, HHS, Human services, OTA, COVID-19, Infection, Administration for Strategic Preparedness and Response, Hope, MBA, Research, Government, Wind, Administration, Development, Division, SAN, BARDA, Radiation, Vaccine, Hook effect

SAN FRANCISCO, Oct. 03, 2023 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ (HHS) Administration for Strategic Preparedness and Response (ASPR), has awarded Vir approximately $50 million in new funding to advance the development of novel monoclonal antibody (mAb) candidates and delivery solutions to widen the applicability of mAbs in COVID-19 and in pandemic preparedness and response.

Key Points: 
  • “We are grateful to the U.S. government for its continued support of our innovative technological approaches in mAb research and development as we seek to optimize mAb delivery.
  • Such delivery could widen the breadth of administration options and shorten development and manufacturing timelines.
  • The new investment falls under Vir’s existing Other Transaction Authority (OTA), a multi-year contract BARDA awarded Vir in 2022 .
  • This OTA allows for a potential total investment of up to $1 billion to support Vir’s development of future pandemic influenza mAbs as well as the potential development of up to 10 emerging infectious disease or CBRN medical countermeasure candidates.

Unitek 2023 Conference: Building Momentum Through Caring Partnerships

Retrieved on: 
Tuesday, October 3, 2023
Momentum, Workforce, Learning, ATI, U.S. Department of Defense Strategy for Operating in Cyberspace, Education, Health, Nursing, Harvard University, Human services, Teaching, Office of Inspector General, U.S. Department of Health and Human Services, Wolters Kluwer, Multimedia, Brookline College, Organization, Provost, Workforce development, Physics, Provo College, Conference, Eagle Gate College, Management

NEWPORT BEACH, Calif., Oct. 3, 2023 /PRNewswire-PRWeb/ -- On September 15, 2023, Unitek hosted their eighth annual conference. Dr. Eric Mazur, the Balkanski Professor of Physics and Applied Physics and Area Chair of Applied Physics at Harvard University, served as the welcome keynote speaker. This event also featured Angela Ramirez, the Deputy Chief of Staff at the U.S. Department of Health and Human Services, as the closing keynote speaker. The virtual event focused on the theme of "Expanding Equity: Building Momentum Through Caring Partnerships." Guest speakers from academia, practice institutions, and national nursing and healthcare advocacy organizations explored megatrends in teaching, learning, and healthcare delivery shaped by responses to the most expensive and widespread public health crises of our time.

Key Points: 
  • NEWPORT BEACH, Calif., Oct. 3, 2023 /PRNewswire-PRWeb/ -- On September 15, 2023, Unitek hosted their eighth annual conference.
  • The virtual event focused on the theme of "Expanding Equity: Building Momentum Through Caring Partnerships."
  • "This conference focused on building equity and fostering caring partnerships across the healthcare and education industries.
  • Unitek Learning is the parent company of several distinguished learning institutions: Unitek College, Unitek EMT, Unitek Training Healthcare, Eagle Gate College, Provo College, and Brookline College.

FTC Staff Submit Comment Supporting Proposed Amendments to Regulations Implementing the Mental Health Parity and Addiction Equity Act

Retrieved on: 
Monday, October 2, 2023
Consumer protection, Insurance, U.S. Department of the Treasury, Office of Inspector General, Suds, Office of Inspector General, U.S. Department of Health and Human Services, Marketing, Human services, Commission, United States Department of Health and Human Services, Tic disorder, Blog, Federal Trade Commission, Bell Trade Act, Treasury, United States Department of Labor, FTC, Comment, SUD, Consumer, News, Social media, Dietary supplement

Staff in the Federal Trade Commission’s Bureau of Consumer Protection have submitted a comment to the U.S. Department of the Treasury, U.S. Department of Labor, and U.S. Department of Health and Human Services supporting proposed amendments to regulations implementing the Mental Health Parity and Addiction Equity Act.

Key Points: 
  • Staff in the Federal Trade Commission’s Bureau of Consumer Protection have submitted a comment to the U.S. Department of the Treasury, U.S. Department of Labor, and U.S. Department of Health and Human Services supporting proposed amendments to regulations implementing the Mental Health Parity and Addiction Equity Act.
  • The comment further details how the FTC has used additional enforcement tools included in the 2018 Opioid Addiction Recovery Fraud Prevention Act (OARFPA) to combat SUD treatment scams.
  • The comment noted that the proposed amendments strike the right balance between leaving intact previous enforcement systems while promoting better insurance coverage for SUD treatment.
  • Follow the FTC on social media, read consumer alerts and the business blog, and sign up to get the latest FTC news and alerts.

FTC Staff Submit Comment Supporting Proposed Amendments to Regulations Implementing the Mental Health Parity and Addiction Equity Act

Retrieved on: 
Monday, October 2, 2023
Consumer protection, Insurance, U.S. Department of the Treasury, Office of Inspector General, Suds, Office of Inspector General, U.S. Department of Health and Human Services, Marketing, Human services, Commission, United States Department of Health and Human Services, Tic disorder, Blog, Federal Trade Commission, Bell Trade Act, Treasury, United States Department of Labor, FTC, Comment, SUD, Consumer, News, Social media, Dietary supplement

Staff in the Federal Trade Commission’s Bureau of Consumer Protection have submitted a comment to the U.S. Department of the Treasury, U.S. Department of Labor, and U.S. Department of Health and Human Services supporting proposed amendments to regulations implementing the Mental Health Parity and Addiction Equity Act.

Key Points: 
  • Staff in the Federal Trade Commission’s Bureau of Consumer Protection have submitted a comment to the U.S. Department of the Treasury, U.S. Department of Labor, and U.S. Department of Health and Human Services supporting proposed amendments to regulations implementing the Mental Health Parity and Addiction Equity Act.
  • The comment further details how the FTC has used additional enforcement tools included in the 2018 Opioid Addiction Recovery Fraud Prevention Act (OARFPA) to combat SUD treatment scams.
  • The comment noted that the proposed amendments strike the right balance between leaving intact previous enforcement systems while promoting better insurance coverage for SUD treatment.
  • Follow the FTC on social media, read consumer alerts and the business blog, and sign up to get the latest FTC news and alerts.