Administration for Strategic Preparedness and Response

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.

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.

Marinus Pharmaceuticals Provides Business Update and Reports Third Quarter 2023 Financial Results

Retrieved on: 
Tuesday, November 7, 2023
Professional Services, Health, FDA, Finance, Clinical Trials, Pharmaceutical, Biotechnology, Biomedical Advanced Research and Development Authority, Research, Security (finance), NMPA, Therapy, Medication, Ganaxolone, SG, Human services, G&A, Marinus, Administration for Strategic Preparedness and Response, National Medical Products Administration, GAAP, Center for Drug Evaluation and Research, BARDA, MAD, Lennox–Gastaut syndrome, Administration, R, Development, RAISE, CDE, Epilepsy, RSE, API, TSC, NDA, U.S. Department of Defense Strategy for Operating in Cyberspace, Office of Inspector General, U.S. Department of Health and Human Services, Investment, Patient, Status epilepticus, Pharmaceutical industry, Fine chemical, Cryptocurrency, CDD

Marinus Pharmaceuticals , Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today reported business highlights and financial results for the third quarter ended September 30, 2023.

Key Points: 
  • Marinus Pharmaceuticals , Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today reported business highlights and financial results for the third quarter ended September 30, 2023.
  • Dr. Braunstein continued, “We remain acutely focused on advancing our Phase 3 clinical trials in refractory status epilepticus and tuberous sclerosis complex.
  • Net product revenue consists of ZTALMY product sales, which was launched in the U.S. in the third quarter of 2022.
  • Selected Financial Data (in thousands, except share and per share amounts)

Draper Announces BARDA Award Supporting COVID and CBRN Countermeasure Development

Retrieved on: 
Tuesday, November 7, 2023
Biomedical Advanced Research and Development Authority, HHS, MCM, Chemical substance, Microsoft, Therapy, Vaccine, SARS-CoV-2, Government, Draper, Business development, Human services, Administration for Strategic Preparedness and Response, CBRN, Office of Inspector General, U.S. Department of Health and Human Services, Administration, ASPR, Multimedia, Development, Lung, COVID, MPS, COVID-19, Partnership, Nextgen, Radiation, Infection, U.S. Department of Defense Strategy for Operating in Cyberspace, CBRN defense, Wuhan Institute of Biological Products, Pharmaceutical industry, Medical imaging

CAMBRIDGE, Mass., Nov. 7, 2023 /PRNewswire-PRWeb/ -- Draper, a leader in national security and biodefense solutions and technologies, has received an award valued at $26 million from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS), to support the development of tools and technologies to protect people against global infectious disease threats, including COVID-19, and accelerate responses to biothreats in the future.

Key Points: 
  • BARDA awarded Draper $26 million to advance technologies such as Draper's PREDICT96 to support development of vaccines and therapies for COVID and emerging biothreats.
  • "Draper's collaboration with BARDA marks an important milestone in the development of the company's end-to-end MCM evaluation and screening platform," Roger Odegard, senior program manager, National Security/Biosecurity Programs at Draper.
  • Commenting on this partnership, Roger Odegard, senior program manager, National Security/Biosecurity Programs at Draper, said, "Draper's collaboration with BARDA marks an important milestone in the development of the company's end-to-end MCM evaluation and screening platform."
  • Funding for this award comes from BARDA's Chemical, Biological, Radiological and Nuclear (CBRN) Countermeasures and Project NextGen programs.

MeMed awarded US BARDA contract to demonstrate clinical utility of the FDA-cleared MeMed BV® test for distinguishing bacterial from viral infections

Retrieved on: 
Tuesday, October 24, 2023
MA, FDA, Global health, Biomedical Advanced Research and Development Authority, Human services, BARDA, Administration, Development, Meme, Administration for Strategic Preparedness and Response, Drive, Division, Office of Inspector General, U.S. Department of Health and Human Services, Randomized controlled trial, United States Department of Defense, Pharmaceutical industry, Medical device, Research

The contract will support the execution of a randomized controlled trial designed to build on existing clinical utility data demonstrating that MeMed BV can improve patient outcomes.

Key Points: 
  • The contract will support the execution of a randomized controlled trial designed to build on existing clinical utility data demonstrating that MeMed BV can improve patient outcomes.
  • The FDA-cleared MeMed BV test is a pioneering host response-based diagnostic tool.
  • Eran Eden, CEO of MeMed, said: "We are committed to generating the highest level of clinical utility evidence to establish the impact of MeMed BV on improving patient outcomes.
  • This contract follows U.S. Department of Defense funding that supported development of MeMed Key, a platform to rapidly measure MeMed BV that will be employed in the trial,” commented Tanya Gottlieb, VP Scientific Affairs at MeMed.

MeMed awarded US BARDA contract to demonstrate clinical utility of the FDA-cleared MeMed BV® test for distinguishing bacterial from viral infections

Retrieved on: 
Tuesday, October 24, 2023
MA, FDA, Global health, Biomedical Advanced Research and Development Authority, Human services, BARDA, Administration, Development, Meme, Administration for Strategic Preparedness and Response, Drive, Division, Office of Inspector General, U.S. Department of Health and Human Services, Randomized controlled trial, United States Department of Defense, Pharmaceutical industry, Medical device, Research

The contract will support the execution of a randomized controlled trial designed to build on existing clinical utility data demonstrating that MeMed BV can improve patient outcomes.

Key Points: 
  • The contract will support the execution of a randomized controlled trial designed to build on existing clinical utility data demonstrating that MeMed BV can improve patient outcomes.
  • The FDA-cleared MeMed BV test is a pioneering host response-based diagnostic tool.
  • Eran Eden, CEO of MeMed, said: "We are committed to generating the highest level of clinical utility evidence to establish the impact of MeMed BV on improving patient outcomes.
  • This contract follows U.S. Department of Defense funding that supported development of MeMed Key, a platform to rapidly measure MeMed BV that will be employed in the trial,” commented Tanya Gottlieb, VP Scientific Affairs at MeMed.

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.

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.

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.

BARDA Expands Partnership With Evidation to Validate and Improve Machine Learning Models for Early Detection of Influenza-like Illness Using Wearables

Retrieved on: 
Tuesday, October 17, 2023
Research, Pharmaceutical, Telemedicine, Virtual Medicine, Medical Devices, Technology, Infectious Diseases, Artificial Intelligence, Health Technology, Science, Biotechnology, Wearables, Mobile Technology, Health, COVID-19, Administration for Strategic Preparedness and Response, Disease, Development, Office of Inspector General, U.S. Department of Health and Human Services, PCR, Human services, Risk, Home, Biomedical Advanced Research and Development Authority, Administration, Sensor, Education, Urinary tract infection, Sleep, RSV, Respiratory syncytial virus, BARDA, Life, HHS, ILI, Heart Protection Study, Ill, Vaccine, Evidence-based policy

The Detect & Protect Studies will support the development of machine learning models to detect respiratory viral infections with data collected from consumer-grade wearable devices.

Key Points: 
  • The Detect & Protect Studies will support the development of machine learning models to detect respiratory viral infections with data collected from consumer-grade wearable devices.
  • This contract will also fund research to expand and better understand the potential impact of Evidation’s FluSmart program to encourage protective health behaviors.
  • This is the third BARDA award issued to Evidation to advance understanding and detection tools for respiratory infections.
  • In 2020, BARDA funded follow-on research to investigate if and how machine learning models and novel data from wearables could be used to detect symptoms of COVID-19 infection .