BARDA

CSL Seqirus Announces Third U.S. Government Award in Relation to Influenza A(H5N8) Candidate Vaccine

Retrieved on: 
Monday, August 28, 2023
Astrakhan Declaration, United States Department of Health and Human Services, ASPR, Influenza, Partnership, Biomedical Advanced Research and Development Authority, HPAI, H5N8, Office of Inspector General, U.S. Department of Health and Human Services, HHS, Poultry, Human services, Administration for Strategic Preparedness and Response, H5N1, ASX, CSL, Government, CDC, Administration, Development, Acquisition, Korea Disease Control and Prevention Agency, Vaccine, WHO, FDA, Bird, BARDA, Virus, World Health Organization

This acquisition of a bulk lot will increase BARDA's stockpile of vaccine to support rapid response in an associated influenza pandemic.

Key Points: 
  • This acquisition of a bulk lot will increase BARDA's stockpile of vaccine to support rapid response in an associated influenza pandemic.
  • Under the terms of the agreement, CSL Seqirus will deliver one bulk lot of H5N8 A/Astrakhan antigen to support the U.S. government's pandemic response readiness.
  • CSL Seqirus used its cell-based influenza vaccine technology, as utilized for FDA-approved AUDENZ™ (Influenza A(H5N1) Monovalent Vaccine, Adjuvanted), to manufacture the H5N8 A/Astrakhan bulk vaccine at the company's Holly Springs, North Carolina, facility, which was built in partnership with BARDA.
  • CSL Seqirus established and will maintain the required pandemic readiness to deliver 150 million doses of cell-based pandemic influenza vaccine within six months of an influenza pandemic declaration in the U.S.

EverGlade Consulting DIU Funding Alert: New Commercial Solutions Opportunity for Tactically Responsive Space (TacRS) Systems

Retrieved on: 
Friday, August 25, 2023
ASPR, Defense Innovation Unit, Defense, United States Department of Defense, Management consulting, RPO, Multimedia, DOE, DTRA, Government, Thought, Public sector, DOD, DARPA, U.S. Department of Defense Strategy for Operating in Cyberspace, Ecosystem, BARDA, NIH, Renewable energy, Pursuit

CHARLESTON, S.C., Aug. 25, 2023 /PRNewswire/ -- In response to the increasing complexity of the space environment, the Defense Innovation Unit (DIU), has announced its pursuit of innovative commercial solutions for the development of Tactically Responsive Space (TacRS) systems. Recognizing the essential need for quick and dynamic responses to threats in space, the DoD is leading the way in advancing risk reduction for dynamic space systems.

Key Points: 
  • Recognizing the essential need for quick and dynamic responses to threats in space, the DoD is leading the way in advancing risk reduction for dynamic space systems.
  • The DoD's call for TacRS prototypes emphasizes the need for responsive, scalable space systems crucial to preserving U.S. leadership in space.
  • If your company has considered applying for DIU funding, EverGlade Consulting is the right partner to help make that application a reality.
  • EverGlade Consulting is a national consulting firm connecting public sector needs with private sector solutions.

Regeneron Announces Agreement with BARDA Supporting Development of Next-Generation Antibody Therapy for COVID-19 Prevention

Retrieved on: 
Tuesday, August 22, 2023
Vaccine, OT, Biomedical Advanced Research and Development Authority, Therapy, Office of Inspector General, U.S. Department of Health and Human Services, Life, HHS, Face, SARS-CoV-2, Public, COVID-19, Unitary state, Research, Antibody, Delta, Government, Administration, Development, Emergency Use Authorization, Risk, Administration for Strategic Preparedness and Response, Drug discovery, BARDA, Disease, Pharmaceutical industry, Regeneron Pharmaceuticals

TARRYTOWN, N.Y., Aug. 22, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the Biomedical Advanced Research and Development Authority (BARDA) has entered into an agreement with Regeneron to support clinical development, clinical manufacturing and the regulatory licensure process of a next-generation COVID-19 monoclonal antibody therapy for the prevention of SARS-CoV-2 infection.

Key Points: 
  • TARRYTOWN, N.Y., Aug. 22, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the Biomedical Advanced Research and Development Authority (BARDA) has entered into an agreement with Regeneron to support clinical development, clinical manufacturing and the regulatory licensure process of a next-generation COVID-19 monoclonal antibody therapy for the prevention of SARS-CoV-2 infection.
  • We believe Regeneron can once again apply our drug discovery and development expertise to help prevent disease in vulnerable populations.
  • Regeneron’s most advanced next-generation antibody candidate under this agreement is expected to enter clinical trials later this year.
  • The next-generation antibody project is being funded in part with federal funds from BARDA under OT number: HHSO100201700020C.

Revive Therapeutics Announces Initiation of Novel Bucillamine Formulation Development

Retrieved on: 
Tuesday, August 22, 2023
ASPR, Defence Research and Development Canada, Cell biology, CSE, University, Biomedical Advanced Research and Development Authority, Therapy, Biochemistry, Doctor of Philosophy, HHS, U.S. Department of Defense Strategy for Operating in Cyberspace, Public, Office of Inspector General, U.S. Department of Health and Human Services, University of Saskatchewan academics, Injury, Research, Infection, Postgraduate education, Central Department of Chemistry, Tribhuvan University, Disorder, DRDC, Assistant, Inflammation, RVV, Development, Graduate, Administration, Organ transplantation, Administration for Strategic Preparedness and Response, Acute respiratory distress syndrome, FDA, BARDA, Dean (education), Pharmaceutical industry, Science, Bucillamine

In addition, the Company may explore the use of the novel Bucillamine formulation as a potent antioxidant and anti-inflammatory treatment for orphan indications in rare inflammatory disorders such as ischemia-reperfusion injury resulting from solid organ transplantation.

Key Points: 
  • In addition, the Company may explore the use of the novel Bucillamine formulation as a potent antioxidant and anti-inflammatory treatment for orphan indications in rare inflammatory disorders such as ischemia-reperfusion injury resulting from solid organ transplantation.
  • The Company has entered into a sponsored research agreement with the University of Waterloo to develop a novel lyophilized Bucillamine injectable formulation for public health medical emergencies and rare inflammatory disorders.
  • Upon completion of the formulation development, which is expected by end-2023, the Company will seek to initiate research studies in line with the Company’s commitment to advancing the clinical and commercial development of Bucillamine through the following strategic initiatives:
    Target Indications: Novel Bucillamine in an injectable version to expand on its potential therapeutic utility targeting rare disorders such as ischemia-reperfusion injury (i.e.
  • At this time, the Company will only provide regular updates via press releases as information becomes available.

MediWound Reports Second Quarter 2023 Financial Results and Provides Company Update

Retrieved on: 
Tuesday, August 15, 2023
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YAVNE, Israel, Aug. 15, 2023 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announced financial results for the second quarter ended June 30, 2023, and provided a corporate update.

Key Points: 
  • Second Quarter 2023 Highlights and Recent Developments:
    Shipped NexoBrid finished product to Vericel for the U.S. commercial launch in June 2023.
  • Revenues: Revenues for the second quarter 2023 were $4.8 million, compared to $4.7 million in the second quarter of 2022.
  • Research and development expenses in the second quarter 2023 were $2.0 million compared to $2.2 million in the second quarter of 2022.
  • Operating Results: Operating loss in the second quarter of 2023 was $4.0 million, compared to a $3.7 million loss in the second quarter of 2022.

AVITA Medical Reports Second Quarter Financial Results

Retrieved on: 
Thursday, August 10, 2023
Biomedical Advanced Research and Development Authority, Avita Medical, AVH, Anticipation, Use of Free and Open-Source Software (FOSS) in the U.S. Department of Defense, Human services, Telephone, Office of Inspector General, U.S. Department of Health and Human Services, ASX, Research, Medical science liaison, Assistant, Regenerative medicine, Development, PMA, Patient, Growth, Vitiligo, FDA, BARDA, Medical device, Video game, Pharmaceutical industry

VALENCIA, Calif., Aug. 10, 2023 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH) (the “Company”), a regenerative medicine company leading the development and commercialization of first-in-class devices and autologous cellular therapies for skin restoration, today reported financial results for the second quarter June 30, 2023.

Key Points: 
  • VALENCIA, Calif., Aug. 10, 2023 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH) (the “Company”), a regenerative medicine company leading the development and commercialization of first-in-class devices and autologous cellular therapies for skin restoration, today reported financial results for the second quarter June 30, 2023.
  • “As anticipated, our expanded U.S. commercial organization was fully prepared for the FDA approval of full-thickness skin defects.
  • Gross profit margin decreased by 2% to 81% compared to 83% for the second quarter of 2022.
  • The Company will host a conference call to discuss the second quarter financial results and, recent business highlights on Thursday, August 10, 2023, at 1:30 p.m. Pacific Time.

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

Retrieved on: 
Thursday, August 10, 2023
Biotechnology, Neurology, Health, Pharmaceutical, Clinical Trials, RSE, Biomedical Advanced Research and Development Authority, Therapy, SG, U.S. Department of Defense Strategy for Operating in Cyberspace, European Commission Investment Plan for Europe, Human services, Office of Inspector General, U.S. Department of Health and Human Services, Lennox–Gastaut syndrome, API, CDKL5 deficiency disorder, Clinical trial, G&A, GAAP, Medication, TSC, Development, Administration, RAISE, European Commission, Patent, Patient, Investment, Administration for Strategic Preparedness and Response, Epilepsy, Ganaxolone, MAD, Growth, Security (finance), R, Research, BARDA, IND, Marigold, Pharmaceutical industry, Cryptocurrency, Fine chemical

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 second quarter ended June 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 second quarter ended June 30, 2023.
  • Recognized $4.2 million and $7.6 million in net product revenues for the three and six months ended June 30, 2023, respectively.
  • Net product revenue consists of ZTALMY product sales, which was launched in the U.S. in the third quarter of 2022.
  • At June 30, 2023, the Company had cash, cash equivalents, and short-term investments of $175.3 million, compared to $240.6 million at December 31, 2022.

Dyadic Announces Second Quarter 2023 Financial Results and Highlights Recent Company Progress

Retrieved on: 
Wednesday, August 9, 2023
Insurance, RBD, Marketing, Phibro Animal Health, Enzyme, Biomedical Advanced Research and Development Authority, G&A, Livestock, Influenza, Development, FBS, Protein, COVID-19 vaccine, Scripps Research, Patent, Rubic Ghasemi-Nobakht, Antigen, Neuraminidase, Research, Infection, Consultant, CGMP, Manuscript, Recombinant, FDA, BARDA, Safety, Vaccine, D, COVID-19, NA, CSR, Ministry, Serum albumin, Fundação para a Ciência e Tecnologia, Animal, Webcast, Encephalitis, Meningitis, Food, EDCL, Sale, Trial of the century, NIIMBL, Family, Pharmaceutical industry, Cryptocurrency, Rare-earth element, EU, Health, C1, Dyadic

The Last Patient Last Visit (LPLV) is scheduled for August 25, 2023, and the full clinical study report (CSR) is expected in Q4 2023.

Key Points: 
  • The Last Patient Last Visit (LPLV) is scheduled for August 25, 2023, and the full clinical study report (CSR) is expected in Q4 2023.
  • Uvax Bio (“Uvax”) – In June 2023, the Company has renewed and expanded its research collaboration with Uvax, a spin-off vaccine company from Scripps Research.
  • NIIMBL – During the NIIMBL annual meeting in June 2023, the Company presented data and research results generated from the NIIMBL Grant received by the Company under the previously announced White House’s American Rescue Plan, which ended successfully.
  • New Animal Health Partner – In June 2023, the Company entered a fully funded collaboration with a new animal health company to develop an antigen for livestock animals.

Matinas BioPharma Reports Second Quarter 2023 Financial Results and Provides a Business Update

Retrieved on: 
Wednesday, August 9, 2023
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BEDMINSTER, N.J., Aug. 09, 2023 (GLOBE NEWSWIRE) --  Matinas BioPharma (NYSE American: MTNB), a clinical-stage biopharmaceutical company focused on delivering groundbreaking therapies using its lipid nanocrystal (LNC) platform delivery technology, reports financial results for the three and six months ended June 30, 2023 and provides a business update.

Key Points: 
  • Matinas’ collaboration with National Resilience continues to focus on in vitro and in vivo delivery of mRNA and expects initial data later in 2023.
  • The Company reported no revenue for the second quarter of 2023 compared with $1.1 million of revenue for the second quarter of 2022, which was generated from the Company’s research collaborations with BioNTech SE.
  • Total costs and expenses for the second quarter of 2023 were $6.2 million compared with $7.0 million for the second quarter of 2022.
  • The net loss for the second quarter of 2023 was $6.1 million, or $0.03 per share, compared with a net loss for the second quarter of 2022 of $5.9 million, or $0.03 per share.

Cue Health Reports Second Quarter 2023 Financial Results

Retrieved on: 
Wednesday, August 9, 2023
Medical Devices, FDA, Health, Health Technology, Health Insurance, COVID-19, EUA, Biomedical Advanced Research and Development Authority, Optimism, Pharmacy, De novo, GAAP, COVID, EBITDA, RSV, Influenza, Growth, BARDA, Cue, Video game, Pharmaceutical industry, Security (finance)

Cue Health Inc. ("Cue") (Nasdaq: HLTH), a healthcare technology company, today reported financial results for the second quarter 2023.

Key Points: 
  • Cue Health Inc. ("Cue") (Nasdaq: HLTH), a healthcare technology company, today reported financial results for the second quarter 2023.
  • Submitted the Cue RSV Molecular Test as a De Novo submission to the FDA for at-home and point-of-care use during the second quarter.
  • These milestones, together with the early positive signs we’re seeing from Cue Lab and Cue Pharmacy, gives us optimism and confidence in the future of the Cue Health platform.”
    Revenue was $9.9 million for the second quarter of 2023.
  • GAAP net loss in second quarter of 2023 was $83.9 million and earnings per diluted share was a loss of $0.55 or an improvement of $0.12 from the second quarter of 2022.