BARDA

NIH Awards Prenosis With Two Grants Totaling $4.8 million to Enable Precision Medicine for Sepsis

Retrieved on: 
Wednesday, July 12, 2023
Infection, Partnership, Society, Housing, Biomedical Advanced Research and Development Authority, Sepsis, Society of Critical Care Medicine, EMR, SBIR, TED (conference), National Institute of General Medical Sciences, Research, Electronic health record, Biomarker, American Thoracic Society, Development, Death, Hospital, Collection, Patient, Data, Machine learning, Algorithm, Medicine, Artificial intelligence, Biosafety, Biology, Mortality, American Association for Clinical Chemistry, WHO, NIGMS, BARDA, Medtech, NIH, MDDI, National Institutes of Health Clinical Center, Critical Care Medicine (journal), Pharmaceutical industry, Medical imaging, Nursing

CHICAGO, July 12, 2023 /PRNewswire/ -- Prenosis, Inc., an artificial intelligence company enabling precision medicine in acute care, announced today that it has been awarded two Phase 2 SBIR grants totaling $4.8M in funding by the National Institute of General Medical Sciences (NIGMS), a division of the National Institute of Health (NIH). The grants will study the use of Prenosis's Immunix™ Artificial Intelligence platform for acute immune states. Prenosis has built a collection of artificial intelligence algorithms, broad clinical data, deep biological data, and biobanked samples of patients suspected of sepsis, in addition to detailed information about their treatment regime. The goal is to better understand how patients' health states rapidly evolve in acute care environments.

Key Points: 
  • Prenosis has built a collection of artificial intelligence algorithms, broad clinical data, deep biological data, and biobanked samples of patients suspected of sepsis, in addition to detailed information about their treatment regime.
  • The goal is to better understand how patients' health states rapidly evolve in acute care environments.
  • The outcomes of these studies could usher in a new era of predictive diagnostics, clinical decision support tools, improved clinical trials, and precision medicine drugs for sepsis.
  • Prenosis generates deep biological profiles of each patient by measuring critical sepsis biomarkers in its Biological Safety Level 2 lab in Chicago.

Paratek Pharmaceuticals Announces Modification of BARDA Contract to Advance the Development of NUZYRA® (omadacycline) for Post-Exposure Prophylaxis (PEP) and Treatment of Pulmonary Anthrax

Retrieved on: 
Monday, July 10, 2023
Post-exposure prophylaxis, ASPR, PEP, Biomedical Advanced Research and Development Authority, U.S. Department of Defense Strategy for Operating in Cyberspace, Human services, Public, Office of Inspector General, U.S. Department of Health and Human Services, Government, Administration, Development, Anthrax, Shanda, Administration for Strategic Preparedness and Response, Bioterrorism, Rabbit, FDA, BARDA, Vaccine

BOSTON, July 10, 2023 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases and other public health threats for civilian, government and military use, today announced a modification to its Project BioShield contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services. The modification provides new development milestones associated with the achievement of specific anthrax development milestones for the next BARDA procurement of NUZYRA® (omadacycline).

Key Points: 
  • The modification provides new development milestones associated with the achievement of specific anthrax development milestones for the next BARDA procurement of NUZYRA® (omadacycline).
  • BARDA and Paratek have agreed the next procurement of NUZYRA anthrax treatment courses will be split into two equal procurements based on the achievement of specific development milestones toward both treatment and post-exposure prophylaxis (PEP) indications of pulmonary anthrax.
  • The trigger for the final procurement of NUZYRA continues to be Paratek’s receipt of sNDA approval from the FDA for the treatment of inhalation anthrax.
  • The company will provide further specificity on these timelines as the anthrax development program progresses.

EQS-News: Just – Evotec Biologics awarded second contract from U.S. Department of Defense under accelerated antibodies program

Retrieved on: 
Wednesday, July 5, 2023
Linda, Immortalised cell line, ASPR, Office of Inspector General, U.S. Department of Health and Human Services, Plague, Medicine, Biomedical Advanced Research and Development Authority, Joint Program Executive Office Chemical and Biological Defense, U.S. Department of Defense Strategy for Operating in Cyberspace, Just, HHS, United States Department of Defense, OTA, AND, JUST, De novo, Orthopoxvirus, Administration, DOD, Development, MCDC, Administration for Strategic Preparedness and Response, Mab, ISIN, Frankfurt Stock Exchange, BARDA, Radiation, EVO, MDAX, Vaccine, Fine chemical, Pharmaceutical industry, Defense, Hook effect, Chemical substance

Just – Evotec Biologics awarded second contract from U.S. Department of Defense under accelerated antibodies program

Key Points: 
  • Just – Evotec Biologics awarded second contract from U.S. Department of Defense under accelerated antibodies program
    The issuer is solely responsible for the content of this announcement.
  • Under the contract, Just – Evotec Biologics will develop drug product prototype(s) from discovery through the execution of Phase I first-in human (“FIH”) clinical trials.
  • Dr Linda Zuckerman, Executive Vice President Global Head Biotherapeutics at Just – Evotec Biologics commented: “It is an honor to expand our collaboration with the DOD’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (“JPEO-CBRND”) with this second target program effort to support the DOD’s Accelerated Antibodies Program.
  • A first contract under the Accelerated Antibodies Program for the development of mAbs against plague was awarded to Just – Evotec Biologics in September of 2022.

ATCC Announces New Award from BARDA to Further Support its Medical Countermeasures Clinical Studies Network

Retrieved on: 
Tuesday, June 27, 2023
Other Health, Research, Pharmaceutical, Oncology, Infectious Diseases, Clinical Trials, Science, Biotechnology, Stem Cells, FDA, Other Science, Health, United States Department of Health and Human Services, ASPR, Biomedical Advanced Research and Development Authority, Office of Inspector General, U.S. Department of Health and Human Services, Senior, HHS, Doctor of Philosophy, CSN, Human services, Public, Trial of the century, Administration for Strategic Preparedness and Response, Government, Administration, Development, Biological specimen, Collection, BARDA, Air tasking order, Safety, Medical device, Pharmaceutical industry, ATCC

As part of this award, ATCC, a member of BARDA’s Clinical Studies Network (CSN), operates the CSN’s Biological Specimen and Investigational Product (BSIP) storage facility and provides centralized services, storage and distribution of its clinical samples and investigational products across BARDA-supported studies.

Key Points: 
  • As part of this award, ATCC, a member of BARDA’s Clinical Studies Network (CSN), operates the CSN’s Biological Specimen and Investigational Product (BSIP) storage facility and provides centralized services, storage and distribution of its clinical samples and investigational products across BARDA-supported studies.
  • “Since 2020, ATCC has been a partner in BARDA’s Clinical Study Network using demonstrated best practices for the safe and secure management of biological specimens,” said Raymond H. Cypess, D.V.M., Ph.D., chairman and CEO of ATCC.
  • “This award is another example of our ongoing support for medical countermeasures development to protect public health and safety.”
    This task order is specific to storing biosafety level 3 (BSL-3) select agents and non-select agent materials for BARDA under the Biological Specimen and Investigational Product (BSIP) program.
  • “We look forward to continuing to build our relationship with BARDA through this task order,” said Joseph Leonelli, Ph.D., Senior Vice President, and General Manager of ATCC Federal Solutions.

Shionogi Further Extends Infectious Disease Innovation Platform with Planned Acquisition of Qpex Biopharma, Inc.

Retrieved on: 
Monday, June 26, 2023
Research, Infectious Diseases, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Science, Biomedical Advanced Research and Development Authority, Doctor of Pharmacy, U.S. Department of Defense Strategy for Operating in Cyberspace, Head, OTA, Infection, Office of Inspector General, U.S. Department of Health and Human Services, Administration for Strategic Preparedness and Response, Global health, Chemistry, Administration, Development, Antimalarial medication, Acquisition, Patient, Acceleration, Bacteria, BARDA, Pharmaceutical industry, Sales, Shionogi

Following the completion of the acquisition, which is subject to customary closing conditions, Qpex will become a wholly owned subsidiary of Shionogi Inc.

Key Points: 
  • Following the completion of the acquisition, which is subject to customary closing conditions, Qpex will become a wholly owned subsidiary of Shionogi Inc.
    “We are pleased to welcome Qpex into the Shionogi family.
  • Qpex discovered xeruborbactam,1 an investigational extended spectrum β-lactamase inhibitor, which is being advanced clinically in both IV and oral2 combinations for infections caused by drug-resistant Gram-negative bacteria.
  • The Qpex acquisition further demonstrates Shionogi’s commitment to novel antimicrobial drug research and development and has the potential to accelerate critically needed innovation in infectious disease.
  • Qpex is a resistance-focused infectious disease company on a mission to make both dramatic and sustainable improvements in patient care across both inpatient and outpatient settings.

Innovation Pharmaceuticals Provides Update on U.S. Patent Applications Covering Use of Brilacidin in Inflammatory Bowel Diseases, Coronaviruses and Fungal Diseases

Retrieved on: 
Wednesday, June 21, 2023
Patent, Biomedical Advanced Research and Development Authority, Gastrointestinal tract, ALI, COVID-19, Infant respiratory distress syndrome, Nature Communications, OTCQB, HDP, Development, Patient, Ulcerative colitis, Biomarker, Acute respiratory distress syndrome, Host, BARDA, Pharmaceutical industry

Brilacidin is a Host Defense Protein-mimetic drug candidate with broad-spectrum immunomodulatory and antimicrobial properties.

Key Points: 
  • Brilacidin is a Host Defense Protein-mimetic drug candidate with broad-spectrum immunomodulatory and antimicrobial properties.
  • The Company out-licensed Brilacidin in UP/UPS to Alfasigma S.p.A. Brilacidin has also been evaluated in Phase 2 testing in moderate-to-severe hospitalized cases of COVID-19 (by intravenous delivery), with beneficial treatment effects observed in patient subgroups.
  • A separate patent application has been submitted to the USPTO for use of Brilacidin in fungal diseases.
  • Additional in vivo testing in efficacy models against two hard-to-treat fungal pathogens is scheduled for 3Q2023.

Vaxxas Opens World-Class Manufacturing Facility To Produce Proprietary Needle-Free Vaccine Patch For Late-Stage Clinical Trials and First Commercial Products

Retrieved on: 
Sunday, June 18, 2023
Biotechnology, Medical Devices, Infectious Diseases, Health, Pharmaceutical, Vaccine, Local government, Biomedical Advanced Research and Development Authority, Good manufacturing practice, Vaccination, European Medicines Agency, COVID-19, The Honourable, Research, Temperature, Queensland State Netball Centre, Bill & Melinda Gates Foundation, Government, Science, Department of State Development, Infrastructure, Local Government and Planning, Development, CGMP, Queensland Government, Palaszczuk, University, Economic development, Bill, Growth, University of Queensland, BARDA, Paralympic Games, Pharmaceutical industry, Renewable energy

The custom-built 5,500 square meter (60,000 square feet) Vaxxas Biomedical Facility will serve as the company’s global headquarters and support the scale-up of its operations to produce HD-MAP vaccines for future late-stage clinical trials and first commercial products.

Key Points: 
  • The custom-built 5,500 square meter (60,000 square feet) Vaxxas Biomedical Facility will serve as the company’s global headquarters and support the scale-up of its operations to produce HD-MAP vaccines for future late-stage clinical trials and first commercial products.
  • The Queensland Government provided funding and operational support to Vaxxas in developing the facility.
  • Vaxxas has received additional funding from the Australian Government through its Modern Manufacturing Initiative to support the installation of specialized manufacturing and production infrastructure.
  • The site will significantly increase our manufacturing capacity, creating new local, skilled jobs, while enabling Vaxxas to progress through late-stage clinical trials that will bring our first commercial vaccine products to the market,” said Mr. Hoey.

Spectral MD Holdings, Ltd (“Spectral MD” or the “Company”) Announces Publication of Peer Reviewed Proof-of-Concept Study Evaluating DeepView® Technology in Journal of Burn Care & Research

Retrieved on: 
Tuesday, June 13, 2023
Health, Medical Devices, Technology, Health Technology, Software, General Health, Artificial Intelligence, Interim, Surgeon, Biomedical Advanced Research and Development Authority, AIM, Office of Inspector General, U.S. Department of Health and Human Services, Education, Human services, Concept, Policy, Administration for Strategic Preparedness and Response, Research, Burn, Spectral, SMD, Trial of the century, Administration, Development, Wound healing, Journal, American Burn Association, Artificial intelligence, Diagnosis, Burns, BARDA, Medical device, Nursing

The study is available at the Journal of Burn Care & Research online .

Key Points: 
  • The study is available at the Journal of Burn Care & Research online .
  • Wensheng Fan, Chief Executive Officer of Spectral MD, said: “I am delighted that the positive results from our first clinical study evaluating DeepView® for burn wound healing assessment have been published in the peer-reviewed Journal of Burn Care & Research.
  • The Journal of Burn Care & Research is the official publication of the American Burn Association and provides the latest information on advances in burn research and education.
  • JE Thatcher et al., Clinical Investigation of a Rapid Non-invasive Multispectral Imaging Device Utilizing an Artificial Intelligence Algorithm for Improved Burn Assessment, Journal of Burn Care & Research, 2023;, irad051, https://doi.org/10.1093/jbcr/irad051

AVITA Medical Announces FDA Approval of RECELL for Treatment of Full-Thickness Skin Defects

Retrieved on: 
Thursday, June 8, 2023
Infection, ASPR, Avita Medical, Surgeon, AVH, Office of Inspector General, U.S. Department of Health and Human Services, HHS, USG, Administration for Strategic Preparedness and Response, Skin cancer, Skin, Scar, ASX, Federal, Regenerative medicine, Pain, Administration, Development, PMA, Patient, Standard of care, Burns, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BARDA, Breakthrough, Food, Tooth discoloration, Medical device, Medical imaging, Pharmaceutical industry

“This is a landmark approval representing an inflection point for AVITA Medical,” said Jim Corbett, AVITA Medical Chief Executive Officer.

Key Points: 
  • “This is a landmark approval representing an inflection point for AVITA Medical,” said Jim Corbett, AVITA Medical Chief Executive Officer.
  • “We had a high level of confidence in the FDA’s approval timeline of RECELL for the treatment of skin defects,” continued Mr. Corbett.
  • Currently, skin grafting is the standard of care for full-thickness skin defects, including post-trauma and post-surgical skin reconstruction.
  • The PMA supplement approval follows the original PMA approval of the RECELL System for the treatment of severe burns in September 2018.

BioTools Innovator Announces Top 19 Life Sciences Companies Named to the 2023 Cohort

Retrieved on: 
Tuesday, June 6, 2023
Professional Services, Health, Health Technology, Start-Up, Research, Science, Biotechnology, Biomedical Advanced Research and Development Authority, Drug development, Therapy, Abraxis BioScience, Johnson & Johnson, Danaher, RCT, Thermo Fisher Scientific, Catalent, Mass spectrometry, AstraZeneca, Standard BioTools, Qiagen, Microfluidics, Becton, Dickinson and Company headquarters, Development, Research Corporation, Mesa, Vitrification, Cell, Growth, BARDA, Black Snow, Pharmaceutical industry, Management, Fine chemical, Mobile phone, Caesarea, Genentech, Agilent Technologies

BioTools Innovator , the first accelerator focused on life science tools and diagnostics to advance cutting-edge research and improve human health, announced today that 19 companies have been selected to participate in its annual program.

Key Points: 
  • BioTools Innovator , the first accelerator focused on life science tools and diagnostics to advance cutting-edge research and improve human health, announced today that 19 companies have been selected to participate in its annual program.
  • The BioTools Innovator Accelerator is a four-month virtual program providing startups with in-depth, customized mentorship and support from senior industry leaders, funding opportunities, and engagement with peers and advisors.
  • From a pool of more than 260 applicants from 31 countries and 34 U.S. states, the top 19 companies were selected to participate in the BioTools Innovator Accelerator.
  • “BioTools Innovator was launched to provide life science entrepreneurs guidance from experienced industry leaders in biotools and diagnostics to help them be successful,” said Kathryn Zavala, managing director of BioTools Innovator.