6 FORT DETRICK, MD – The U.S. Army Medical Materiel Development Activity, in partnership with BioFire Defense LLC, announced U.S. Food and Drug Administration marketing approvals for the Next Generation Diagnostics System Increment 1 Infectious Disease Panel, also known as the Global Fever Panel, and the associated External Control Kit.
The FilmArray® Global Fever Panel is a commercially available single-use, fully enclosed test for use with the BioFire® FilmArray 2.0 instrument to aid in the diagnosis of malaria, dengue fever, chikungunya fever and leptospirosis.
Although these diseases are rare in the United States, they are common in other parts of the world where U.S. Service Members are or may be deployed.
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PLYMOUTH MEETING, Pa., Jan. 6, 2021 /PRNewswire/ INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer and HPV-associated diseases, today announced positive efficacy results for an open-label Phase 2 trial of VGX-3100 to treat HPV-16 and HPV-18-associated vulvar dysplasia. A 25% or more reduction in HPV-16/18-associated vulvar HSIL (high-grade squamous intraepithelial lesion) was observed for 63% of trial participants (12 of 19) treated with VGX-3100 at six months post-treatment. Three out of the 20 participants with histology data (15%) resolved their vulvar HSIL and had no HPV-16/18 virus detectable in the healed area. By comparison, the spontaneous resolution of vulvar HSIL caused by HPV-16/18 is estimated to be only 2%. The trial also showed VGX-3100 to be safe and well-tolerated. Based upon these results INOVIO is planning
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Emergent BioSolutions and Mount Sinai Health System Announce Initiation of DOD-Funded Clinical Program to Evaluate COVID-19 Human
Mount Sinai
Emergent BioSolutions (NYSE: EBS) and Mount Sinai Health System today announced initiation of the clinical program to evaluate Emergent’s COVID-19 Human Hyperimmune Globulin (COVID-HIG) product candidate in the first of two Phase 1 studies to support its use for potential post-exposure prophylaxis in individuals at high risk of exposure to SARS-CoV-2, the virus that causes COVID-19, such as front-line health care workers and military personnel.
The first study will evaluate safety and pharmacokinetics of three dose levels administered as a single or repeat IV dose in healthy adults. The second study, once initiated, will evaluate safety, pharmacokinetics, and pharmacodynamics of two dose levels administered as a single IV dose to adults with SARS-CoV-2 infection, whether asymptomatic or with mild COVID-19.
Press release content from Globe Newswire. The AP news staff was not involved in its creation.
Emergent BioSolutions and Mount Sinai Health System Announce Initiation of DOD-Funded Clinical .
Emergent BioSolutionsDecember 29, 2020 GMT
GAITHERSBURG, Md. and NEW YORK, Dec. 29, 2020 (GLOBE NEWSWIRE) Emergent BioSolutions (NYSE: EBS) and Mount Sinai Health System today announced initiation of the clinical program to evaluate Emergent’s COVID-19 Human Hyperimmune Globulin (COVID-HIG) product candidate in the first of two Phase 1 studies to support its use for potential post-exposure prophylaxis in individuals at high risk of exposure to SARS-CoV-2, the virus that causes COVID-19, such as front-line health care workers and military personnel.
Home / Top News / Emergent BioSolutions and Mount Sinai Health System Announce Initiation of DOD-Funded Clinical Program to Evaluate COVID-19 Human Hyperimmune Globulin (COVID-HIG) Product Candidate for Prophylaxis
Emergent BioSolutions and Mount Sinai Health System Announce Initiation of DOD-Funded Clinical Program to Evaluate COVID-19 Human Hyperimmune Globulin (COVID-HIG) Product Candidate for Prophylaxis
GAITHERSBURG, Md. and NEW YORK, Dec. 29, 2020 (GLOBE NEWSWIRE) Emergent BioSolutions (NYSE: EBS) and Mount Sinai Health System today announced initiation of the clinical program to evaluate Emergent’s COVID-19 Human Hyperimmune Globulin (COVID-HIG) product candidate in the first of two Phase 1 studies to support its use for potential post-exposure prophylaxis in individuals at high risk of exposure to SARS-CoV-2, the virus that causes COVID-19, such as front-line health care workers and military personnel.