BARDA

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.

Government Agencies Emphasize the Importance of Decentralized Methodologies for Future of Clinical Research

Retrieved on: 
Wednesday, November 8, 2023
SCRS, FDA, DCT, Biomedical Advanced Research and Development Authority, Office of the National Coordinator for Health Information Technology, National Institutes of Health, Face, European Medicines Agency, Organization, BARDA, Entrepreneurship, Research, Development, DTRA, DCTS, Clinical trial, Decentralized Trials & Research Alliance, EMA, Annual general meeting, NIH, Government agency, ONC, Chairperson, Map, Government, SAN, Pharmaceutical industry, Medical device

SAN DIEGO, Nov. 08, 2023 (GLOBE NEWSWIRE) -- The Decentralized Trials & Research Alliance (DTRA), a global alliance focused on the adoption of decentralized trials, today concluded its 2023 Annual Meeting, including members from biopharmaceutical companies, government agencies, research sites, healthcare organizations, patient groups, and service and technology companies.

Key Points: 
  • SAN DIEGO, Nov. 08, 2023 (GLOBE NEWSWIRE) -- The Decentralized Trials & Research Alliance (DTRA), a global alliance focused on the adoption of decentralized trials, today concluded its 2023 Annual Meeting, including members from biopharmaceutical companies, government agencies, research sites, healthcare organizations, patient groups, and service and technology companies.
  • The DTRA community learned of their strategic intentions regarding decentralized clinical trial (DCT) adoption, drivers to achieve scale with these methods, and the importance of DCT to our research ecosystem.
  • DTRA has harnessed this industry-leading expertise into creating new resources, sharing key learnings, and establishing best practices for research teams to use in implementing DCTs.
  • “Each of our Initiative outputs is available at www.dtra.org and the resources are available to all.”

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)

OPKO Health Reports Third Quarter 2023 Business Highlights and Financial Results

Retrieved on: 
Monday, November 6, 2023
Modex, Appetite, Biomedical Advanced Research and Development Authority, Colon, United Kingdom, Operating cost, Epstein–Barr virus, PIN, International, SARS-CoV-2, Obesity, COVID-19 testing, SHPT, Weight loss, Growth hormone therapy, HIV, Absorption, Health, Merck, Intellectual property, BARDA, Short bowel syndrome, Poster, Oxyntomodulin, Chronic kidney disease, Development, Society, Pfizer, MSTAR, COVID-19, Glucagon, GeneDx, OXM, Public, OPKO Health, CKD, Kidney, Therapy, Patient, Nutrient, Vaccine, Pharmaceutical industry, Video game, EU

OPKO Health presented late-breaking clinical data on RAYALDEE extended-release calcifediol in a poster presentation at the American Society of Nephrology Kidney Week.

Key Points: 
  • OPKO Health presented late-breaking clinical data on RAYALDEE extended-release calcifediol in a poster presentation at the American Society of Nephrology Kidney Week.
  • Operating loss was $25.4 million in the third quarter of 2023 compared with $28.3 million in the third quarter of 2022.
  • Operating loss for the third quarter of 2023 was $64.4 million compared with an operating loss of $87.8 million for the 2022 quarter.
  • OPKO’s senior management will provide a business update, discuss third quarter financial results, provide financial guidance and answer questions during a conference call and audio webcast today beginning at 4:30 p.m. Eastern time.

Stevanato Group Reports Third Quarter 2023 Financial Results

Retrieved on: 
Tuesday, October 31, 2023
Science, Biotechnology, Research, Pharmaceutical, Health, Engineering, Health Technology, Manufacturing, Ageing, Biomedical Advanced Research and Development Authority, NYSE, PIN, Public expenditure, EBITDA, Marex (British company), BARDA, Development, Segment, Growth, Biopharmaceutical, EPS, Medicine, Webcast, Messenger, Depreciation, DCS, Investment, COVID-19, Pharmaceutical industry, Video game, Fine chemical, Fertilizer

Stevanato Group S.p.A. (NYSE: STVN), a leading global provider of drug containment, drug delivery, and diagnostic solutions to the pharmaceutical, biotechnology, and life sciences industries, today announced its financial results for the third quarter of 2023.

Key Points: 
  • Stevanato Group S.p.A. (NYSE: STVN), a leading global provider of drug containment, drug delivery, and diagnostic solutions to the pharmaceutical, biotechnology, and life sciences industries, today announced its financial results for the third quarter of 2023.
  • Adjusted EBITDA margin increased 70 basis points to 27.5% in the third quarter of 2023, compared with the third quarter of 2022.
  • This led to gross profit margin of 32.7% and operating profit margin of 21.2% for the third quarter of 2023.
  • The Company will host a conference call and webcast at 8:30 a.m. (ET) on Tuesday, October 31, 2023 to discuss financial results.

EverGlade Consulting Funding Alert: Advanced Research Projects Agency (ARPA-H) Solicits Proposals for Resilient Extended Automatic Cell Therapies (REACT) Program

Retrieved on: 
Wednesday, November 1, 2023
Sentinel, Advanced Research Projects Agency for Health, MAI, TAS, ARPA, Therapy, Biomarker, DARPA, Federation, BARDA, ASPR, Multimedia, Management consulting, DTRA, Public sector, ARPA-H, REACT, 2021 Giro d'Italia, Stage 1 to Stage 11, TA, NIH, Self-management, Patient, Technical area, Risk management, Pharmaceutical industry

CHARLESTON, S.C., Nov. 1, 2023 /PRNewswire/ -- The Advanced Research Projects Agency for-Health (ARPA-H) is actively seeking innovative proposals through the Resilient Extended Automatic Cell Therapies (REACT) program, employing a Master Announcement Instruction (MAI) strategy for proposal submissions. This strategy enables proposers to tailor their submissions according to the scale of their planned projects, categorized into small (BIT/BYTE), medium (KILO/MEGA), and large (GIG/TERA) scales. The REACT program specifically targets the large-scale GIG Module category, aiming to revolutionize therapeutic development and affordability, and enhance patient self-management. The program addresses the issue of ineffective therapeutics, often resulting not from medical unsoundness, but from patient barriers such as limited access and high costs, leading to compromised treatment adherence and poor health outcomes.

Key Points: 
  • By Laura Powell, Managing Consultant and Eric Jia-Sobota, Founder
    CHARLESTON, S.C., Nov. 1, 2023 /PRNewswire/ -- The Advanced Research Projects Agency for-Health (ARPA-H) is actively seeking innovative proposals through the Resilient Extended Automatic Cell Therapies (REACT) program, employing a Master Announcement Instruction (MAI) strategy for proposal submissions.
  • The REACT program specifically targets the large-scale GIG Module category, aiming to revolutionize therapeutic development and affordability, and enhance patient self-management.
  • Living Pharmacy track proposals must address TAs 1-4, and Living Sentinel track proposals must address TAs 1-3 and 5.
  • For additional information about EverGlade Consulting, visit: https://www.EverGlade.com
    View original content to download multimedia: https://www.prnewswire.com/news-releases/everglade-consulting-funding-al...

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.