United States Department of Health and Human Services

Melinta Therapeutics and Venatorx Pharmaceuticals Announce Licensing Agreement to Commercialize Cefepime-Taniborbactam in the U.S.

Retrieved on: 
Thursday, November 9, 2023
Research, Infectious Diseases, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Other Science, Science, Wellcome Trust, Government, FDA, Biomedical Advanced Research and Development Authority, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Meropenem, PDUFA, Food, Cutis laxa, United States Department of Health and Human Services, Pyelonephritis, Melinta Therapeutics, End-user license agreement, Prescription Drug User Fee Act, Human services, Regulation of tobacco by the U.S. Food and Drug Administration, Urinary tract infection, R, Administration, QIDP, CDC, Pseudomonas aeruginosa, Regulation, Medicine, Partnership, Infection, AP, ESBL, NDA, License, Therapy, Patient, Bangladesh Technical Education Board, Pharmaceutical industry

The partnership follows Venatorx’s submission of a New Drug Application (NDA) for cefepime-taniborbactam for the treatment of cUTI including pyelonephritis, in adults.

Key Points: 
  • The partnership follows Venatorx’s submission of a New Drug Application (NDA) for cefepime-taniborbactam for the treatment of cUTI including pyelonephritis, in adults.
  • Venatorx has been assigned a Prescription Drug User Fee Act (PDUFA) target action date for February 22, 2024.
  • The U.S. Food and Drug Administration (FDA) granted cefepime-taniborbactam Qualified Infectious Disease Product (QIDP) and Fast Track designations for both the cUTI and HABP/VABP indications.
  • Venatorx has granted GARDP exclusive rights to distribute and sub-distribute cefepime-taniborbactam, once it is approved for clinical use, in low- and lower middle-income countries.

Gritstone bio Reports Third Quarter 2023 Financial Results and Provides Corporate Updates

Retrieved on: 
Wednesday, November 8, 2023
PCV, SLATE, CORAL, FDA, Biomedical Advanced Research and Development Authority, Research, IND, Gritstone bio, NCI, Food, Health, Infection, Vaccine, Human services, National Institutes of Health Clinical Center, Administration for Strategic Preparedness and Response, HIV, Gates, BARDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, United States Department of Health and Human Services, Administration, Development, Gilead, NAB, Clinical trial, COVID-19, National Cancer Institute, Messenger, Collaboration, Immunotherapy, Safety, Office of Inspector General, U.S. Department of Health and Human Services, Cancer, CEPI, Chemistry, Patient, Pharmaceutical industry, Gritstone, LNP

EMERYVILLE, Calif., Nov. 08, 2023 (GLOBE NEWSWIRE) -- Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, today reported financial results for the third quarter ended September 30, 2023 and provided recent corporate and clinical updates.

Key Points: 
  • In oncology, preliminary findings from the randomized Phase 2/3 study of our personalized cancer vaccine, GRANITE, in MSS-CRC are rapidly approaching.
  • The scientific bedrock of GRANITE extends to SLATE, where our collaboration with Steven A. Rosenberg and the NCI is now advancing.
  • Gritstone met its enrollment target of 100 patients randomized in August 2023.
  • An IND to run a Phase 1 study was cleared by the U.S. Food and Drug Administration (FDA) in October 2023.

National Braille Press Hosts "A Million Laughs for Literacy: Braille All Stars" Gala at Fenway Park

Retrieved on: 
Wednesday, November 8, 2023
Science, National Braille Association, Blind, Literacy, Sport, Comic Relief USA, The Late Show, Columbia Threadneedle Investments, McGann, National Federation of the Blind, Cabinet (government), Fenway Sports Management, Learning, ADA, Madison Square Garden, Braille, United States Department of Health and Human Services, Beep baseball, Fenway Park, Lisamaria Meirowsky, Toronto Parks, Forestry and Recreation Division, NBP, Publishing, Entertainment, Health

BOSTON, Nov. 8, 2023 /PRNewswire-PRWeb/ -- National Braille Press (NBP) will host the annual "Million Laughs for Literacy: Braille All Stars" gala on Friday, November 17, 2023, at 6pm, at The 521 Overlook at Fenway Park in Boston. Comedian Pat McGann is the special entertainment and the Braille All-Stars will be featured during the speaking program talking about how braille has impacted their lives.

Key Points: 
  • The annual "Million Laughs for Literacy: Braille All Stars" gala will be held on 11/17/2023 at Fenway Park in Boston.
  • BOSTON, Nov. 8, 2023 /PRNewswire-PRWeb/ -- National Braille Press (NBP) will host the annual "Million Laughs for Literacy: Braille All Stars" gala on Friday, November 17, 2023, at 6pm, at The 521 Overlook at Fenway Park in Boston.
  • "Braille literacy will be front and center at our annual gala as we will hear from our Braille All-Stars and Future All-Stars who have been using braille all their lives," said Brian Mac Donald, President, National Braille Press.
  • Tickets to "A Million Laughs for Literacy: Braille All-Stars" Gala can be purchased here or donate here .

Battelle Part of Team Selected to Support New Technologies to Prepare for Future COVID-19 Outbreaks

Retrieved on: 
Wednesday, November 8, 2023
Engineering, Public Policy, Government, Chemicals, Plastics, Defense, Technology, Manufacturing, COVID-19, Pharmaceutical, Medical Devices, Infectious Diseases, Health Technology, Genetics, Science, Biotechnology, White House, Federal Government, Health, Other Technology, Other Science, Other Manufacturing, Research, Other Defense, Contracts, Biomedical Advanced Research and Development Authority, HHS, Autumn, Therapy, SARS-CoV-2, Battelle, Human services, Administration for Strategic Preparedness and Response, Project, BARDA, United States Department of Health and Human Services, Administration, ASPR, Development, Lung, MPS, Antibody, Nextgen, Messenger, IDIQ, Office of Inspector General, U.S. Department of Health and Human Services, Vaccine, Medical device

These technologies have the potential to enable shorter development timelines for monoclonal antibodies through mRNA, increased efficiency in virus testing, and alternate routes for vaccine administration.

Key Points: 
  • These technologies have the potential to enable shorter development timelines for monoclonal antibodies through mRNA, increased efficiency in virus testing, and alternate routes for vaccine administration.
  • Battelle researchers will develop a human lung microphysiological system (MPS) platform to enable in vitro modeling of SARS-CoV-2 infection and testing of therapeutics.
  • This complex in vitro model is expected to recapitulate relevant human lung biology, including viral pathogenesis and response to medical countermeasures.
  • The MPS model is expected to be established and ready for therapeutic screening in the Fall of 2025.

The NYSPCC Receives $1.65 Million in Grants for Programs that Advance Agency's Mission to Prevent Child Abuse

Retrieved on: 
Tuesday, November 7, 2023
Knowledge, Supreme court, Woman, Domestic violence, New York Society for the Prevention of Cruelty to Children, Child, Gold, HHS, International Food Protection Training Institute, Survivor, NYSPCC, Health, Heart, OVW, Violence Against Women Act, Human services, Organization, Violence, Research, Trauma, Caregiver, Curriculum, Protective factor, Physical abuse, Violence against women, School, Nanjing Land and Visit Program, Office on Violence Against Women, NIH, Safety, Depression, Office of Inspector General, U.S. Department of Health and Human Services, United States Department of Health and Human Services, Anxiety, Randomized controlled trial, Bangladesh Technical Education Board, Parent, Nursing, New York University

NEW YORK, Nov. 7, 2023 /PRNewswire/ -- The New York Society for the Prevention of Cruelty to Children (NYSPCC), the world's first child protection agency, has received $1.65 million across three grants to help fund critical programs and services that further the agency's mission to respond to the complex needs of abused and neglected children.

Key Points: 
  • The grants come from the United States Department of Health and Human Services (HHS), the Office on Violence Against Women (OVW) and the National Institutes of Health (NIH).
  • For nearly 150 years, the NYSPCC has worked to protect children and those involved in their care by providing best-practice counseling, legal and educational services.
  • "To have been awarded such significant grants from key federal programs speaks volumes about the critical work the New York Society for the Prevention of Cruelty to Children does on behalf of children's safety.
  • Safe Touches is an evidence-based child sexual abuse prevention program designed for children in kindergarten through third grade.

Charlie Baker Joins UnitedHealth Group’s Board of Directors

Retrieved on: 
Friday, November 3, 2023
General Health, Health, Health Technology, Managed Care, Health Insurance, Harvard Pilgrim Health Care, NYSE, Government, Human services, UnitedHealth Group, Administration, National Collegiate Athletic Association, UNH, United States Department of Health and Human Services, Arkansas Department of Finance and Administration, Patient, Management

UnitedHealth Group (NYSE: UNH) announced Charlie Baker, the former governor of Massachusetts and a prominent former health care executive, has been appointed to its Board of Directors, effective immediately.

Key Points: 
  • UnitedHealth Group (NYSE: UNH) announced Charlie Baker, the former governor of Massachusetts and a prominent former health care executive, has been appointed to its Board of Directors, effective immediately.
  • “Charlie Baker’s leadership and deep health care experience will serve UnitedHealth Group well in its efforts to make the health system work better for everyone,” said UnitedHealth Group Board Chairman Stephen J. Hemsley.
  • “Charlie is an outstanding addition to our board given his proven track record in government and in leading businesses in the health sector, including care delivery and benefits.”
    “UnitedHealth Group has unique capabilities to improve health care outcomes, lower costs and make the experience better for both patients and providers,” Baker said.
  • “I am honored to join such a distinguished board and excited to help accelerate the company’s work.”
    Baker is the current president of the National Collegiate Athletic Association.

Real Adoptive Parents and Teens Choose Each Other in New Heartwarming PSAs

Retrieved on: 
Thursday, October 26, 2023
HHS, United States Children's Bureau, Second-parent adoption, Television, Advertising, Council, Private sector, Youth, Gold Lion, U.S. Department of Defense Strategy for Operating in Cyberspace, Sustainable Development Goal 5, Parent, Mental health, PR, ACYF, Child, Love, Human, Organization, Intuition, Office of Inspector General, U.S. Department of Health and Human Services, Marketing, Lead, Provocation, United States House Select Committee on Children, Youth, and Families, Safety, Sport, Radio, Reward, Research, Smokey Bear, ACF, Hearing, Family, United States Department of Health and Human Services, Administration, Commissioner, PSAS, Administration for Children and Families, Disability, Ad Council, Edelman, Sustainable Development Goals, Sales, Toy, Residential care

WASHINGTON, Oct. 26, 2023 /PRNewswire/ -- The U.S. Department of Health and Human Services (HHS), Administration for Children and Families (ACF), AdoptUSKids, and the Ad Council today launched moving new public service advertisements (PSAs) that encourage prospective parents to adopt teens from foster care. Created by Edelman, the PSAs build on the campaign's "You Can't Imagine the Reward" message and feature real adoptive families sharing their adoption from foster care stories and how rewarding the journey has been for both parents and teens.

Key Points: 
  • A common misconception about teen adoption is that the decision to adopt is driven solely by adoptive parents, but in reality, teens also have an active role in that choice.
  • New PSAs, " Parents Adopted ," developed pro bono by Edelman celebrate how teens and adoptive parents actively choose each other and showcase adoptive parents talking about how they too were "adopted" by their teens.
  • Together, adoptive parents and teens talk openly about choosing to be each other's family and how they've built and fostered a life of deep and mutual rewards.
  • By inviting prospective parents to hear from these six dynamic and relatable families, the new PSAs help viewers see themselves as potential adoptive parents.

Sabin Vaccine Institute Begins Phase 2 Clinical Trial for Marburg Vaccine in Uganda

Retrieved on: 
Thursday, October 19, 2023
Biomedical Advanced Research and Development Authority, Guinea, Makerere University Walter Reed Project, Sabin Vaccine Institute, Vaccine, Family, Human services, Kenya Medical Research Institute, Administration for Strategic Preparedness and Response, Viral hemorrhagic fever, Organization, BARDA, United States Department of Health and Human Services, Research, Volunteering, Administration, Development, Epidemic, Disease, Clinical trial, Blood, Safety, Office of Inspector General, U.S. Department of Health and Human Services, Polio, Marburg virus disease, Medical device, Pharmaceutical industry

WASHINGTON, Oct. 19, 2023 (GLOBE NEWSWIRE) -- The Sabin Vaccine Institute has launched a Phase 2 clinical trial for its vaccine candidate against the lethal Marburg virus. Healthy volunteers received the single-dose vaccine at Makerere University Walter Reed Project (MUWRP) in Kampala, Uganda today.

Key Points: 
  • WASHINGTON, Oct. 19, 2023 (GLOBE NEWSWIRE) -- The Sabin Vaccine Institute has launched a Phase 2 clinical trial for its vaccine candidate against the lethal Marburg virus.
  • “Makerere University Walter Reed Project (MUWRP) is delighted to partner with the Sabin Vaccine Institute to launch the clinical testing for a preventive Marburg vaccine,” says Dr. Mwesigwa.
  • In addition to the current trial in Uganda and Kenya, Sabin plans to conduct a similar Phase 2 clinical trial for Marburg in the U.S.
  • Sabin has also initiated plans for a Phase 2 Sudan ebolavirus vaccine clinical trial in Uganda and Kenya.

LANES Named Qualified Health Information Organization by California Health and Human Services

Retrieved on: 
Tuesday, October 24, 2023
DSA, AutoCAD, California Health and Human Services Agency, Enhanced service, Organization, Health, Population health, United States Department of Health and Human Services, Hospital, HIO, Public, Nursing

LOS ANGELES, Oct. 24, 2023 /PRNewswire/ -- Los Angeles Network of Enhanced Services (LANES), the first and only regional health information organization (HIO) for the greater Los Angeles area, today announced California Health and Human Services (CalHHS) has named it a Qualified Health Information Organization (QHIO). This qualification signifies that by joining LANES, healthcare organizations meet the requirements of the state's Data Exchange Framework (DxF). The DxF defines health data sharing standards for most of the state's healthcare organizations and is designed to help every resident in the state benefit from seamlessly coordinated care and services, regardless of where they live or receive care.

Key Points: 
  • LOS ANGELES, Oct. 24, 2023 /PRNewswire/ -- Los Angeles Network of Enhanced Services (LANES) , the first and only regional health information organization (HIO) for the greater Los Angeles area, today announced California Health and Human Services (CalHHS) has named it a Qualified Health Information Organization (QHIO).
  • This qualification signifies that by joining LANES, healthcare organizations meet the requirements of the state's Data Exchange Framework (DxF) .
  • "By joining LANES, healthcare organizations are connected to a vast and always-growing network of providers, resulting in streamlined care delivery and improved population health."
  • LANES' services are used by leading hospitals, health systems, health plans, behavioral health services, and providers.

Velico Medical launches Blood Center Education Program with South Texas Blood & Tissue

Retrieved on: 
Friday, October 20, 2023
Plasma, Joint Medical Service (Germany), Biomedical Advanced Research and Development Authority, Temperature, History, Human services, United States Department of Health and Human Services, Administration, Administration for Strategic Preparedness and Response, Spray drying, BioBridge Global, STB, Pharmaceutical industry, Centro Velico Caprera

BOSTON, Oct. 20, 2023 /PRNewswire/ -- Velico Medical is proud to announce the launch of its Blood Center Education Program (BCEP) at South Texas Blood & Tissue (STB&T), a subsidiary of San Antonio non-profit BioBridge Global.

Key Points: 
  • BOSTON, Oct. 20, 2023 /PRNewswire/ -- Velico Medical is proud to announce the launch of its Blood Center Education Program (BCEP) at South Texas Blood & Tissue (STB&T), a subsidiary of San Antonio non-profit BioBridge Global.
  • "This collaboration is the first of its kind in the nation and reflects the shared vision of Velico and STB&T of advancing life-saving blood products through the development process," says Richard Meehan, President and CEO of Velico.
  • Velico's BCEP is designed to generate deep customer feedback on the commissioning and operational aspects of the FrontlineODP™ system for spray drying plasma.
  • "South Texas Blood & Tissue is pleased to collaborate with Velico as a BCEP partner.