BARDA

Prenosis Inc. Receives BARDA Contract to Study Utility of Its Sepsis Diagnostic Tool

Retrieved on: 
Wednesday, June 7, 2023
Infection, ASPR, Partnership, Society, Biomedical Advanced Research and Development Authority, Housing, Office of Inspector General, U.S. Department of Health and Human Services, HHS, Sepsis, HBD, Society of Critical Care Medicine, EMR, TED (conference), Human services, Administration for Strategic Preparedness and Response, Research, Electronic health record, Biomarker, American Thoracic Society, Administration, Plasma, Development, Hospital, Data, Patient, Physician, Risk, Medicine, Cancer, Biosafety, Entrepreneurship, American Association for Clinical Chemistry, FDA, Health, BARDA, Medtech, MDDI, Critical Care Medicine (journal), Medical device, Medical imaging, Pharmaceutical industry

CHICAGO, June 7, 2023 /PRNewswire/ -- Prenosis Inc., an artificial intelligence company enabling precision medicine in acute care, announced today it has been awarded a contract from the Biomedical Advanced Research and Development Authority (BARDA), a component of the Administration for Strategic Preparedness and Response (ASPR), within the U.S. Department of Health and Human Services (HHS), a U.S. government agency.

Key Points: 
  • Prenosis has built a large, rapidly growing dataset and biobank from patients with sepsis and other infections.
  • By leveraging its proprietary dataset and AI/ML techniques, Prenosis is creating precision medicine solutions, starting with a sepsis diagnostic tool.
  • Prenosis' Sepsis ImmunoScore™ intends to enable true precision medicine for infection in hospitals.
  • The Sepsis ImmunoScore™ is a pathogen-agnostic, host-based digital diagnostic (HBD) that uses clinical parameters and protein biomarkers to assess a patient's risk of sepsis within 24 hours.

EverGlade Consulting Funding Alert: Effect of Fiscal Responsibility Act on Project Next Gen BARDA Funding

Retrieved on: 
Monday, June 5, 2023
ASPR, Biomedical Advanced Research and Development Authority, USG, Defense, SARS-CoV-2, COVID-19, Management consulting, BAA, AOI, DTRA, ARPA, CDC, Development, Tax Equity and Fiscal Responsibility Act of 1982, DARPA, Public health, Organic acid, Federation, Therapy, BARDA, NIH, News, Fiscal, Pharmaceutical industry

CHARLESTON, S.C., June 5, 2023 /PRNewswire/ -- The Fiscal Responsibility Act of 2023 aims to reduce USG spending by $2.1 trillion, with an additional $1.5 trillion in mandated savings over the next two years. The bill reclaims $28 billion of unutilized COVID-19 funds and cuts an additional $400 million from the CDC's "Global Health Fund," which channels taxpayer funds to China. Collectively, these cuts represent the largest rollback of federal spending in American history.

Key Points: 
  • In a bit of good news for contractors, BARDA and ASPR funding, specifically Project Next Gen and the newly formed IBx team remain largely intact.
  • Funding for Project Next Generation Vaccines & Therapeutics remains largely intact and is expected to continue with its anticipated obligations.
  • "Given the success of Project Warp Speed, it is no surprise that Project Next Gen received bipartisan support in this negotiation," stated EverGlade Consulting Founder, Eric Jia-Sobota.
  • EverGlade Consulting is a national consulting firm helping clients navigate the federal landscape.

MediWound Reports First Quarter 2023 Financial Results and Provides a Company Update

Retrieved on: 
Tuesday, May 30, 2023
Operating cost, Biomedical Advanced Research and Development Authority, Table, VLU, Event, European Operations Management Association, Conference call, Bank statement, Eastern Time Zone, Bromelain (pharmacology), European Medicines Agency, Tax, Deep Insight, HERE, Forecasting, EMA, Development, Incidence, EBITDA, Patient, Investment, NEXT, Depreciation, Mouth ulcer, Growth, Research, Phase, FDA, Adjustment, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BARDA, Conference, Food, Safety, Corporate development, Pharmaceutical industry, Management, Renewable energy, Video game, Bookkeeping, Vericel

YAVNE, Israel, May 30, 2023 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announced financial results for the first quarter ended March 31, 2023 and provided a corporate update.

Key Points: 
  • Importantly, MediWound is now in a strong financial position, with over $57 million in cash.
  • This provides the company with ample resources to effectively execute its corporate initiatives and drive continuous innovation," stated Ofer Gonen, Chief Executive Officer of MediWound.
  • First Quarter 2023 Highlights and Recent Developments:
    The Company’s global Phase III clinical study for EscharEx is expected to begin in the fourth quarter of 2023.
  • The Company utilized $1.8 million to fund its operating activities in the first quarter of 2023.

Clarametyx Biosciences Announces Changes to Its Scientific Advisory Board

Retrieved on: 
Tuesday, May 30, 2023
Biotechnology, Pharmaceutical, Health, SAB, Biomedical Advanced Research and Development Authority, Community-acquired pneumonia, University, Biochemistry, Senior, Vaccination, Virology, Sir, Infection, University of Cambridge, American Academy, Research, Science, Development, Sanofi Pasteur, Therapy, BARDA, Biofilm, University of Oxford, Microbiology, Pharmaceutical industry, Lefamulin

(“Clarametyx”), a clinical stage biotechnology company developing targeted, immune-enabling biologic therapies to counter persistent infections associated with biofilms, today announced the appointment of Dr. Jeffrey Almond to the company’s scientific advisory board (SAB).

Key Points: 
  • (“Clarametyx”), a clinical stage biotechnology company developing targeted, immune-enabling biologic therapies to counter persistent infections associated with biofilms, today announced the appointment of Dr. Jeffrey Almond to the company’s scientific advisory board (SAB).
  • He was previously the global head of research at Sanofi Pasteur, and a professor at the University of Reading.
  • He has published extensively in the field of virology and vaccination and has served in numerous advisory roles addressing significant global viral and bacterial microbiological threats.
  • Prior to joining UroGen, Dr. Seltzer served as Chief Medical Officer of Nabriva Therapeutics where she was responsible for the company’s clinical development of Xenleta (lefamulin) for community-acquired pneumonia.

T2 Biosystems Announces First Quarter 2023 Financial Results

Retrieved on: 
Tuesday, May 23, 2023
Workforce, Total, Panel, Medical Affairs Bureau, International, Hospital, COVID-19, Research, LOD, Sale, Sepsis, CDC, Candida auris, ATM, Mortality, Growth, FDA, BARDA, Pharmaceutical industry, Vaccine, Cryptocurrency

LEXINGTON, Mass., May 23, 2023 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO) (the “Company”), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced financial results for the first quarter ended March 31, 2023.

Key Points: 
  • LEXINGTON, Mass., May 23, 2023 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO) (the “Company”), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced financial results for the first quarter ended March 31, 2023.
  • Achieved first quarter total revenue of $2.1 million, including sepsis and related product revenue of $1.7 million and research contribution revenue of $0.4 million.
  • Cost of product revenue for the first quarter of 2023 was $4.0 million, a 35% decrease compared to the prior year period, driven by decreased COVID-19 test sales.
  • The Company raised $1.0 million in net proceeds through ATM sales in the first quarter of 2023 and in February 2023, raised $11.0 million, net through a common stock and warrants sale.

T2 Biosystems Announces FDA 510(k) Submission for the T2Biothreat Panel

Retrieved on: 
Tuesday, May 23, 2023
Burkholderia pseudomallei, Plague, Biomedical Advanced Research and Development Authority, U.S. Department of Defense Strategy for Operating in Cyberspace, Public, Infection, Office of Inspector General, U.S. Department of Health and Human Services, Administration for Strategic Preparedness and Response, Tularemia, Typhus, Glanders, Yersinia pestis, Melioidosis, Bacillus anthracis, Burkholderia mallei, Administration, Development, Francisella tularensis, Biological warfare, Public health, Patient, Rickettsia prowazekii, Bacillus, Mortality, Health, FDA, Anthrax, Regulation of tobacco by the U.S. Food and Drug Administration, BARDA, Food, Vaccine, Pharmaceutical industry

LEXINGTON, Mass., May 23, 2023 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for the Company’s T2Biothreat™ Panel.

Key Points: 
  • LEXINGTON, Mass., May 23, 2023 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for the Company’s T2Biothreat™ Panel.
  • The FDA submission follows the recently completed U.S. clinical evaluation that demonstrated very high sensitivity and specificity, and included 350 contrived positive samples and over 470 negative blood samples from both healthy and febrile subjects.
  • "This FDA submission marks an important milestone in our commitment to protect Americans from the threat of deliberate or naturally occurring outbreaks of biothreat pathogens,” stated John Sperzel, Chairman and CEO of T2 Biosystems.
  • The T2Biothreat Panel is able to detect the aforementioned biothreat pathogens within 4 hours and provide clinicians with the needed information to appropriately treat infected patients.

Indivior Announces U.S. Food and Drug Administration Approval of OPVEE® (nalmefene) Nasal Spray, An Opioid Overdose Rescue Medicine for Natural and Synthetic Opioids Like Fentanyl

Retrieved on: 
Tuesday, May 23, 2023
LSE, TACO, Biomedical Advanced Research and Development Authority, Central nervous system, Conseil de prévention et de lutte contre le dopage, Emergency, Human services, Opioid, Administration, Development, Acquisition, Patient, Hypoventilation, Risk, Administration for Strategic Preparedness and Response, Purdue University, NIDA, National Institute on Drug Abuse, Ageing, FDA, MPH, Death, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BARDA, Opioid overdose, Fentanyl, News, Food, Drug, Pharmaceutical industry, MD, Indivior

RICHMOND, Va., May 22, 2023 /PRNewswire/ -- Indivior PLC (LSE: INDV) today announced that the U.S. Food and Drug Administration (FDA) approved OPVEE® (nalmefene) nasal spray for the emergency treatment of known or suspected opioid overdose induced by natural or synthetic opioids in adults and pediatric patients aged 12 years and older, as manifested by respiratory and/or central nervous system depression.2 OPVEE contains nalmefene, an opioid receptor antagonist that provides fast onset and long duration reversal of opioid-induced respiratory depression, which is the primary cause of opioid overdose injury and death.2,3,4  OPVEE was designed to address the challenges of today's opioid crisis.

Key Points: 
  • "OPVEE's FDA approval represents a significant achievement in the development of new treatment options to address today's era of opioid overdoses that are driven by powerful synthetic opioids, such as fentanyl," said Mark Crossley, CEO, Indivior.
  • The duration of action of nalmefene is as long as most opioids, including fentanyl.
  • "With OPVEE, first responders will have a fast and long-acting rescue medication option to combat the current opioid epidemic and save lives."
  • In fact, it uses the same device as currently available nasal overdose reversal agents on the market."

Spectral MD Announces Podium Presentation at 2023 American Burn Association Annual Conference

Retrieved on: 
Thursday, May 18, 2023
General Health, Health Technology, Health, United States Department of Health and Human Services, Biomedical Advanced Research and Development Authority, AIM, BIAS, Human services, Physician, Administration for Strategic Preparedness and Response, Light, Burn, Spectral, SMD, Associate, Administration, Development, Literature, IRB, Deep, Algorithm, FACS, Artificial intelligence, Regulation of tobacco by the U.S. Food and Drug Administration, BARDA, Conference, Food, Wound healing, Medical device, Medical imaging, Nursing, MD

The presentation will be delivered by Jeffrey Carter, MD, FACS, Medical Director of University Medical Center New Orleans Burn Center & Associate Professor of Surgery at LSU Health New Orleans School of Medicine, and Chief Medical Consultant of Spectral MD.

Key Points: 
  • The presentation will be delivered by Jeffrey Carter, MD, FACS, Medical Director of University Medical Center New Orleans Burn Center & Associate Professor of Surgery at LSU Health New Orleans School of Medicine, and Chief Medical Consultant of Spectral MD.
  • The objective of the IRB-approved, prospective Burn Injury Assessment Study (BIAS) was to evaluate the performance of burn care professionals in determining areas of non-healing tissue in burn wounds.
  • In this study, participating burn care professionals were presented with five burn images to review and provide input on an electronic tablet at two regional and national burn conferences.
  • The results showed that participating burn care professionals recorded 73% accuracy in assessing burn healing, which is consistent with prior studies from literature.

AVITA Medical Reports First Quarter Financial Results and Affirms Full Year Guidance

Retrieved on: 
Thursday, May 11, 2023
Avita Medical, AVH, Anticipation, Senior, Telephone, Chief commercial officer, ASX, Regenerative medicine, EBITDA, PMA, Growth, Vitiligo, FDA, BARDA, Global Sales Law Project, Pharmaceutical industry, Management

Further, we are on track to submit our PMA supplement to the FDA for RECELL GO by the end of the second quarter.

Key Points: 
  • Further, we are on track to submit our PMA supplement to the FDA for RECELL GO by the end of the second quarter.
  • Mr. Bromley and Ms. Garner will report directly to Jim Corbett, Chief Executive Officer of AVITA Medical.
  • The gross profit margin was increased by 8% to 84% compared to 76% for the first quarter of 2022.
  • Authorized for release by the Chief Executive Officer of AVITA Medical, Inc.

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

Retrieved on: 
Thursday, May 11, 2023
Biotechnology, Finance, Health, Professional Services, Pharmaceutical, Patent, RSE, Biomedical Advanced Research and Development Authority, CV, Therapy, U.S. Department of Defense Strategy for Operating in Cyberspace, SG, Orion Corporation, Human services, United States Patent and Trademark Office, Ganaxolone, Office of Inspector General, U.S. Department of Health and Human Services, Lennox–Gastaut syndrome, API, Forest Law Enforcement and Governance Program, GAAP, Eugnosta tenacia, Medication, Development, Administration, Patient, Investment, Administration for Strategic Preparedness and Response, Marinus, Epilepsy, MAD, Security (finance), Research, FDA, BARDA, Pharmaceutical industry, Medical device, Fine chemical, Cryptocurrency, TSC, RAISE

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 first quarter ended March 31, 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 first quarter ended March 31, 2023.
  • Entered exclusive distribution and supply agreement with Biologix for ganaxolone in select markets in the Middle East and North Africa.
  • Recognized $3.3 million in net product revenues for the three months ended March 31, 2023.
  • Net product revenue consists of ZTALMY product sales, which was launched in the U.S. in the third quarter of 2022.