ASPR

Vir Biotechnology Provides Corporate Update and Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Thursday, February 22, 2024

Vir Biotechnology, Inc. (Nasdaq: VIR) today provided a corporate update and reported financial results for the fourth quarter and full year ended December 31, 2023.

Key Points: 
  • Vir Biotechnology, Inc. (Nasdaq: VIR) today provided a corporate update and reported financial results for the fourth quarter and full year ended December 31, 2023.
  • Complete 24-week treatment data for 30 participants per regimen is expected in the fourth quarter of 2024.
  • The MARCH Part B trial is ongoing with 48-week end of treatment data expected in the fourth quarter of 2024.
  • Revenues: Total revenues for the quarter ended December 31, 2023 were $16.8 million compared to $49.4 million for the same period in 2022.

RedHill's Opaganib Selected for Evaluation by BARDA and NIH Countermeasures Programs

Retrieved on: 
Tuesday, March 5, 2024

The overall evaluation will also include assessment of opaganib's efficacy against sub-chronic fibrosis and acute respiratory distress syndrome (ARDS) resulting from Sulfur Mustard exposure.

Key Points: 
  • The overall evaluation will also include assessment of opaganib's efficacy against sub-chronic fibrosis and acute respiratory distress syndrome (ARDS) resulting from Sulfur Mustard exposure.
  • "With the alarming increase in global geo-political instability, the opportunity to evaluate opaganib as a potential vital protective agent against chemical attack is inspiring.
  • "Opaganib is the first selective sphingosine kinase-2 (SPHK2) inhibitor investigational drug targeting sphingolipid metabolism to be evaluated as a chemical countermeasure.
  • Opaganib, a novel oral, small molecule pill with a five-year shelf-life, is easy to administer and distribute for use against potential chemical weapon attack, if approved by the FDA.

EverGlade Funding Alert - $300 Million Funding Opportunity Announced for CHIPS National Advanced Packaging Manufacturing Program (NAPMP)

Retrieved on: 
Monday, March 4, 2024

HOUSTON, March 4, 2024 /PRNewswire/ -- The U.S. government, through CHIPS for America, has announced a groundbreaking funding opportunity aimed at bolstering domestic research and development (R&D) in advanced semiconductor packaging materials and substrates. The initiative, part of the National Advanced Packaging Manufacturing Program (NAPMP), is set to inject approximately $300 million into innovations spanning semiconductor-based materials to glass and organics. This funding opportunity marks a significant step in the U.S.'s commitment to maintaining and advancing its leadership in the global semiconductor industry.

Key Points: 
  • The initiative, part of the National Advanced Packaging Manufacturing Program (NAPMP), is set to inject approximately $300 million into innovations spanning semiconductor-based materials to glass and organics.
  • This funding opportunity marks a significant step in the U.S.'s commitment to maintaining and advancing its leadership in the global semiconductor industry.
  • "This funding opportunity represents a pivotal moment for the U.S. semiconductor industry.
  • If your company has considered applying for CHIPS funding, your federal funding journey starts here.

EverGlade Consulting Funding Alert: ARPA-H Transitions to Mission Office-Specific Innovation Solutions Openings to Allow Funding Under Cooperative Agreements and OTAs

Retrieved on: 
Thursday, February 22, 2024

HOUSTON, Feb. 22, 2024 /PRNewswire/ -- The Advanced Research Projects Agency for Health ("ARPA-H") recently announced a shift in how the agency will fund health-related technology research and development. ARPA-H will transition to Mission Office-Specific Innovation Solutions Openings (ISOs) to allow funding under cooperative agreements and "other transactions". This change provides flexibility outside the traditional grant and contract structure governed by Federal Acquisition Regulation, making it possible for non-traditional government contractors to apply for and receive ARPA-H funding.

Key Points: 
  • ARPA-H will transition to Mission Office-Specific Innovation Solutions Openings (ISOs) to allow funding under cooperative agreements and "other transactions".
  • Effective March 14, 2024, ARPA-H will close the current Open-Office BAA and transition to Mission Office ISOs.
  • Effective March 14, 2024, ARPA-H will close the current Open-Office Broad Agency Announcement (BAA) and transition to Mission Office ISOs.
  • If your company is interested in pursuing ARPA-H funding and navigating the changes implemented with Mission Office ISOs, EverGlade Consulting is the right partner to help.

Crossject provides strategic update on priorities for 2024

Retrieved on: 
Tuesday, February 6, 2024

Focusing on regulatory filings and accelerating U.S. commercialization efforts

Key Points: 
  • Focusing on regulatory filings and accelerating U.S. commercialization efforts
    Contract of up to $155 million with BARDA for U.S. stockpiling continues to advance
    Dijon, France February 6, 2024 –530 pm CET Crossject (ISIN: FR0011716265; Euronext: ALCJ), a specialty pharma company developing needle-free auto-injectors for emergency situations, provides a summary of recent milestones reached and an update on its strategic priorities for 2024.
  • Syneos Health has a strong U.S. presence and significant expertise in commercializing new therapies for Crossject, as it approaches filing for regulatory approval.
  • In 2024, Crossject will especially focus on regulatory approvals for ZEPIZURE® and accelerating market access efforts in the United States.
  • We are working closely with our strategic partners market access activities in the US,” said Patrick Alexandre, CEO of Crossject.

Spectral AI Begins Enrollment in Pivotal Study to Validate DeepView AI® for Burn Injuries

Retrieved on: 
Thursday, January 11, 2024

DALLAS, Jan. 11, 2024 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (NASD:MDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in clinical wound care, announces the enrollment of the first patient in the pivotal study to validate DeepView AI® using its proprietary imaging technology for burn size and healing assessment.

Key Points: 
  • DALLAS, Jan. 11, 2024 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (NASD:MDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in clinical wound care, announces the enrollment of the first patient in the pivotal study to validate DeepView AI® using its proprietary imaging technology for burn size and healing assessment.
  • This pivotal study is expected to be the final clinical trial before seeking FDA marketing authorization for the burn indication in 2025 and will be conducted in burn centers and emergency departments across the US, enrolling both adults and pediatric patients.
  • The study will help us validate DeepView’s game-changing AI to accurately assess burn wound healing potential on day-one which could lead to early treatment decisions,” said Jeffrey C. Carter, MD, FACS, the lead investigator for the study.
  • The findings and conclusions have not been formally disseminated by HHS and should not be construed to represent any agency determination or policy.

MediWound Announces that FDA has Accepted for Review the Supplement to the NexoBrid BLA to Include Pediatric Patients with Severe Thermal Burns

Retrieved on: 
Tuesday, January 9, 2024

YAVNE, Israel, Jan. 09, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully integrated biopharmaceutical company focused on next-generation enzymatic therapeutics for tissue repair, today announced that the U.S. Food and Drug Administration (FDA) has completed their filing review and accepted a supplement to the NexoBrid® biologics license application (sBLA) for the removal of eschar in pediatric patients with deep partial- and/or full-thickness thermal burns.

Key Points: 
  • NexoBrid, a topically administered biological drug that enzymatically removes nonviable burn tissue, received FDA approval in the U.S. in December 2022 for eschar removal in adult patients with deep partial-thickness and/or full-thickness thermal burns.
  • The sBLA seeks to expand the label for NexoBrid to include both adult and pediatric burn patients of all ages.
  • “The acceptance of the NexoBrid sBLA filing by the FDA marks an important milestone for MediWound and reinforces our commitment to redefine the standard of care for the treatment of severe burns across all age groups,” said Ofer Gonen, CEO of MediWound.
  • “NexoBrid is already approved for the adult and pediatric populations in Europe and Japan, and we look forward to working with the FDA, alongside our partner Vericel, throughout the sBLA review process.”

EverGlade Consulting Celebrates Continued Growth with New Office Opening in Washington, D.C.

Retrieved on: 
Wednesday, January 10, 2024

CHARLESTON, S.C., Jan. 10, 2024 /PRNewswire/ -- EverGlade Consulting, a leader in consultancy for government contractors across life sciences, technology, health, and defense industries, proudly announces the opening of its newest office in Washington, D.C. Situated at the bustling Industrious location at 650 Massachusetts Avenue NW, this expansion is a testament to EverGlade's sustained growth and commitment to offering expert consulting services.

Key Points: 
  • This move allows EverGlade to be in close proximity to key government agencies, enhancing its ability to provide immediate, informed, and comprehensive consulting services.
  • If your company has considered applying for government 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.
  • For additional information about EverGlade Consulting, reach out to:
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Advanced Technology International selected to manage new BARDA Biopharmaceutical Manufacturing Preparedness Consortium

Retrieved on: 
Thursday, January 4, 2024

SUMMERVILLE, S.C., Jan. 4, 2024 /PRNewswire/ -- Advanced Technology International (ATI) has been awarded an Other Transaction (OT) Agreement by the Biomedical Advanced Research and Development Authority ( BARDA ), part of the Administration for Strategic Preparedness (ASPR) and Response within the U.S. Department of Health and Human Services, to serve as the consortium manager for the new 10-year Biopharmaceutical Manufacturing Preparedness Consortium (BioMaP-Consortium).

Key Points: 
  • SUMMERVILLE, S.C., Jan. 4, 2024 /PRNewswire/ -- Advanced Technology International (ATI) has been awarded an Other Transaction (OT) Agreement by the Biomedical Advanced Research and Development Authority ( BARDA ), part of the Administration for Strategic Preparedness (ASPR) and Response within the U.S. Department of Health and Human Services, to serve as the consortium manager for the new 10-year Biopharmaceutical Manufacturing Preparedness Consortium (BioMaP-Consortium).
  • The BioMaP-Consortium aims to improve and expand the industrial and manufacturing base for medical countermeasures during and in between public health emergencies.
  • The BioMaP-Consortium is comprised of industry partners across the drug and vaccine manufacturing supply chain, including manufacturers of required raw materials and consumables, suppliers of drug substance manufacturing and fill finish services, and developers of innovative manufacturing technologies.
  • "We are honored to be selected to support BARDA in accelerating the development and delivery of these lifesaving medical countermeasures."

Thermo Fisher Scientific’s PPD Clinical Research Business Selected by BARDA to Support Phase II Platform Clinical Trial to Treat Acute Respiratory Distress Syndrome (ARDS)

Retrieved on: 
Thursday, December 21, 2023

The PPD clinical research business of Thermo Fisher Scientific Inc., the world leader in serving science, has been selected by the Biomedical Advanced Research and Development Authority (BARDA) to implement the first BARDA-supported Phase II platform clinical trial to investigate multiple therapeutic options for the treatment of acute respiratory distress syndrome (ARDS).

Key Points: 
  • The PPD clinical research business of Thermo Fisher Scientific Inc., the world leader in serving science, has been selected by the Biomedical Advanced Research and Development Authority (BARDA) to implement the first BARDA-supported Phase II platform clinical trial to investigate multiple therapeutic options for the treatment of acute respiratory distress syndrome (ARDS).
  • BARDA is part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS).
  • Under this contract, the PPD clinical research business will implement a large Phase II clinical trial over three years.
  • The PPD clinical research business will support the clinical trial with its deep capabilities and expertise in end-to-end platform clinical trials, seamless biomarker testing, and critical care, drug depot and laboratory services.