National Institutes of Health Clinical Center

Gritstone bio Reports Third Quarter 2023 Financial Results and Provides Corporate Updates

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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.

TrialAssure Uses Artificial Intelligence to Create Plain Language Summaries for 50,000 Studies Listed on ClinicalTrials.Gov

Retrieved on: 
Wednesday, October 18, 2023
Science, Literacy, Trial of the century, Clinical trial, National Institutes of Health Clinical Center, PLS, National Assessment of Educational Progress, Research, ClinicalTrials.gov, Disease, Reading, Health literacy, NIH, Language, European, Patient, Bangladesh Technical Education Board, Pharmaceutical industry, Medical device, EU

DETROIT, Oct. 18, 2023 /PRNewswire-PRWeb/ -- TrialAssure, an AI-technology leader in advancing clinical trial results disclosure and data sharing in the pharmaceutical industry, announced today that it has taken the proactive effort to create and publish clinical trial results in plain language summary (PLS) format, posting directly to TrialResults.com. This includes plain language summaries for every clinical trial that has had results posted on the National Institutes of Health's (NIH) ClinicalTrials.gov website since 2020 – nearly 50,000 documents.

Key Points: 
  • TrialAssure has taken the proactive effort to create and publish clinical trial results in plain language summary (PLS) format, posting directly to TrialResults.com.
  • This includes plain language summaries for every clinical trial that has had results posted on the National Institutes of Health's (NIH) ClinicalTrials.gov website since 2020 – nearly 50,000 documents.
  • This includes plain language summaries for every clinical trial that has had results posted on the National Institutes of Health's (NIH) ClinicalTrials.gov website since 2020 – nearly 50,000 documents.
  • The plain language summary documents will be released on TrialResults.com in the following five groupings by condition and/or disease:

The Children's Inn Announces $14 Million Grant from Merck Foundation

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Thursday, October 12, 2023
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"The Inn of Tomorrow would not be possible without the extraordinary support and our longstanding partnership with Merck," said Jennie Lucca, The Inn's CEO.

Key Points: 
  • "The Inn of Tomorrow would not be possible without the extraordinary support and our longstanding partnership with Merck," said Jennie Lucca, The Inn's CEO.
  • Including Merck's initial $3.7 million gift to build The Inn, the Merck Foundation and Merck have committed more than $35 million to support family programs and capital projects at The Inn that aim to reduce the burden of illness, make childhood possible and support the NIH clinical research mission.
  • Since its founding, The Inn has advanced important research to address critical unmet needs—a purpose we share at Merck," said Robert M. Davis, chairman and chief executive officer, Merck.
  • Established in 1957, the Merck Foundation is a private, charitable organization funded entirely by Merck.

LumiThera Receives Notice of Award for National Eye Institute Grant to Support a 3rd Year Extension to LIGHTSITE III, the U.S. Multi-Center Clinical Trial for Treating Dry Age-Related Macular Degeneration

Retrieved on: 
Wednesday, September 27, 2023
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The NIH/NEI grant supports an open-label human clinical trial in U.S. intermediate dry age-related macular degeneration (dry AMD) subjects that participated in the pivotal LIGHTSITE III trial.

Key Points: 
  • The NIH/NEI grant supports an open-label human clinical trial in U.S. intermediate dry age-related macular degeneration (dry AMD) subjects that participated in the pivotal LIGHTSITE III trial.
  • LIGHTSITE IIIB will treat patients for 4 rounds of treatment over fourteen months.
  • Sham patients in the previous study will be able to cross over and begin PBM treatment.
  • “We are excited to have the NIH/NEI partially support the further development endeavors of LumiThera as we bring the therapy to U.S. patients.”

The VasQ™ External Support Now FDA Cleared for Use in Creating Arteriovenous Fistulas

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Wednesday, September 27, 2023
Infection, Surgeon, Lamination, Freedom, De novo, Hospital, CVC, Ioctl, National Institutes of Health Clinical Center, Dialysis, TEL, Journal, Patient, Physician, Arteriovenous fistula, Journal of Vascular and Interventional Radiology, FDA, AVF, Vascular surgery, Safety, Fistula, Medical imaging

TEL AVIV, Israel, Sept. 27, 2023 /PRNewswire/ -- Laminate Medical Technologies (Laminate) has announced their flagship device, the VasQ External Vascular Support, has been cleared by the FDA for use to create arteriovenous fistulas (AVFs) for dialysis access.

Key Points: 
  • TEL AVIV, Israel, Sept. 27, 2023 /PRNewswire/ -- Laminate Medical Technologies (Laminate) has announced their flagship device, the VasQ External Vascular Support, has been cleared by the FDA for use to create arteriovenous fistulas (AVFs) for dialysis access.
  • No serious adverse event associated with the device was reported over the 2-year study.
  • Additional analysis comparing VasQ patients against claims data for traditional AVFs created by the same surgeons in the study reported statistically superior rates of functional success (confirmed use of the AVF for dialysis) and reduced need for additional procedures.
  • VasQ is a nitinol-based device implanted around the artery and vein during the surgical creation of an arteriovenous fistula.

The FNIH Awards 2023 Charles A. Sanders, M.D., Partnership Award to NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development, GSK, and the O’Neill Family

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Monday, September 18, 2023
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The Foundation for the National Institutes of Health (FNIH) has named the National Institutes of Health’s Eunice Kennedy Shriver National Institute of Child Health and Human Development, GSK, and the O’Neill Family as recipients of the 2023 Charles A. Sanders, M.D., Partnership Award .

Key Points: 
  • The Foundation for the National Institutes of Health (FNIH) has named the National Institutes of Health’s Eunice Kennedy Shriver National Institute of Child Health and Human Development, GSK, and the O’Neill Family as recipients of the 2023 Charles A. Sanders, M.D., Partnership Award .
  • The Partnership Award recognizes persons or organizations that have made significant contributions to the FNIH’s work in support of the mission of the National Institutes of Health (NIH).
  • The Azithromycin Prevention in Labor Use Study (A-PLUS) assessed low-cost, sustainable interventions to improve maternal and child health.
  • The Charles A. Sanders, M.D., Partnership Award is named for the former Chairman of the FNIH Board of Directors.

Wildfire Smoke is No Match for the New Oransi Mod+ HEPA Air Purifier That Delivers The Highest Smoke Removal Performance for the Lowest Price

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Monday, August 7, 2023
MSRP, Noise, International Forum Design, Atmosphere, Gas, International Design Excellence Awards, Red Dot, Volatile organic compound, Mod, Smoke, Air purifier, Dust, The International, Industrial Designers Society of America, Control, CADR, Air Products, ETL, Bacteria, System, Industrial, Virus, Allergen, Ozone, National Institutes of Health Clinical Center, Heating, ventilation, and air conditioning, Video game, Javits Center, COVID-19

RADFORD, Va., Aug. 7, 2023 /PRNewswire-PRWeb/ -- Oransi, a leading U.S.-based air purification company whose products are used in the National Institute of Health offices and also were selected to purify the air in the Javits Center field hospital in New York City during the peak of covid, today announced the release of its newest model in its Mod series - Mod+ HEPA Air Purifier (MSRP $294.99). With the highest smoke CADR rating for its size (363), the Mod+ delivers high efficiency for larger rooms with the lowest total cost of ownership. It is ideal for homes located in areas affected by wildfire smoke and high PM2.5. It provides two air changes per hour in rooms up to 1,361 square feet and an impressive five air changes per hour in rooms up to 563 square feet.

Key Points: 
  • With the highest smoke CADR rating for its size (363), the Mod+ delivers high efficiency for larger rooms with the lowest total cost of ownership.
  • It is ideal for homes located in areas affected by wildfire smoke and high PM2.5.
  • The Mod+ delivers superior air cleaning performance due to its no air by-pass feature.
  • Uses 90% less energy resulting in a lower electric bill when compared to competing air purifier brands.

Feinstein Institutes Researchers Discover Defensive Molecules That Can Worsen Inflammation in Sepsis

Retrieved on: 
Friday, July 21, 2023
Research, Science, Infection, Medicine, Neutrophil, Macrophage, Journal, Survival, Feinstein Institutes for Medical Research, Apan Jewellers, DRS, Multimedia, Inflammation, Cell, Doctor of Philosophy, Spleen, Patient, MD, Blood, Immune system, DSM-IV codes, APAN, Paper, Bacteria, Credit, Death, Immunosuppression, Radiation exposure, National Institutes of Health Clinical Center, White lung, Pharmaceutical industry, Medical device, Vaccine, Sepsis

In a potential therapeutic breakthrough, investigators at The Feinstein Institutes for Medical Research have identified a type of white blood cell that can worsen inflammation in sepsis and opens up new avenues of research to treat the deadly condition.

Key Points: 
  • In a potential therapeutic breakthrough, investigators at The Feinstein Institutes for Medical Research have identified a type of white blood cell that can worsen inflammation in sepsis and opens up new avenues of research to treat the deadly condition.
  • (Credit: Feinstein Institutes)
    Results of the study, led by Ping Wang, MD , professor and chief scientific officer at the Feinstein Institutes, were published today in the Journal of Clinical Investigation .
  • “APANs, when triggered, can result in devastating circumstances for patients who have sepsis,” said Dr. Wang, senior author of the paper.
  • Last year, Dr. Wang and co-principal investigators at the Feinstein Institutes received $3.8 million from the National Institute of Health to study sepsis and radiation exposure.

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

Retrieved on: 
Wednesday, July 12, 2023
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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.

Janux Therapeutics Appoints Zachariah McIver, D.O., Ph.D., Vice President, Clinical Development

Retrieved on: 
Monday, June 5, 2023
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Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms, today announced the appointment of Dr. Zachariah (“Zach”) McIver as Vice President, Clinical Development.

Key Points: 
  • Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms, today announced the appointment of Dr. Zachariah (“Zach”) McIver as Vice President, Clinical Development.
  • “Zach has extensive clinical research experience including leading the clinical development to maximize the value of bispecific T-cell engager assets across multiple hematologic and solid tumor malignancies,” said David Campbell, Ph.D., President and CEO of Janux Therapeutics.
  • “With TRACTr and TRACIr, Janux has built two very powerful platforms designed to overcome the toxicity and efficacy limitations of earlier generations of bispecific immunotherapies,” said Dr. McIver.
  • In addition to named programs, Janux is generating a number of unnamed TRACTr and TRACIr programs for potential future development.