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Tag Archives: FDA

Engility Highlights 3Q Contract Bookings in ‘Best-Value’ Strategy Shift Versus LPTA

Engility Corp. (NYSE: EGL) described to investors Thursday three third quarter contract wins and the loss of another as examples of its shift toward pursuits of larger “best-value” programs versus lowest-price, technically-acceptable work. A slide in the company’s third quarter earnings call presentation highlighted its potential five-year, $369 million contract announced in October for engineering and technical services …

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Engility Lands $112M FDA Computational Science, Bioinformatics Services IDIQ; Lynn Dugle Comments

The Food and Drug Administration has awarded Engility (NYSE: EGL) a potential five-year, $112 million indefinite-delivery/indefinite-quantity contract to provide computational science and bioinformatics services for the FDA’s gene-based drug discovery and development programs. Engility said Thursday it will help the FDA operate, secure and maintain scientific computing environments and systems designed …

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Emergent BioSolutions Gets $199M HHS Funds to Mature Anthrax Vaccine Candidate

The Department of Health and Human Services has awarded Emergent BioSolutions a five-year, $198.7 million contract to further mature the development of an anthrax vaccine in preparation for a Food and Drug Administration license. The HHS office of the assistant secretary for preparedness and response’s Biomedical Advanced Research and Development …

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Sanofi Pasteur Receives Potential $173.4M HHS Contract to Develop Inactivated Zika Vaccine

The Department of Health and Human Services has awarded a potential $173.6 million contract to Sanofi Pasteur for work to develop inactivated vaccine candidate that could help prevent Zika virus infection and associated birth defects. HHS said Monday the contract has a $43.2 million base value that covers process development, scale up, clinical trial material production …

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BARDA to Support Altimmune Anthrax Vaccine Clinical Trials Under $120M Contract

Altimmune has received a potential five-year, $120.2 million contract from the Biomedical Advanced Research and Development Authority to conduct clinical trials on an experimental vaccine against anthrax. The Gaithersburg, Maryland-based immunotherapeutic company will test its NasoShield intranasal anthrax vaccine through Phase 1 clinical studies under the contract’s base term worth approximately $14.3 …

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Siemens Zika Virus Detection Kit Receives Emergency Authorization From FDA

TYSONS CORNER, VA, Aug. 3, 2016 — Siemens has received emergency use authorization from the Food and Drug Administration for the company’s VERSANT Zika RNA 1.0 Assay Kit that aims to detect the presence of the Zika virus in plasma, blood and urine samples, ExecutiveBiz reported Tuesday. The company said Monday its healthcare diagnostics subsidiary will distribute the molecular …

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Triple-i Lands Potential $100M FDA Contract for Web Content Mgmt System Support

Information Innovators Inc. has secured a potential five-year, $100 million contract from the Food and Drug Administration to provide web content management system support services. Triple-i said Tuesday the new blanket purchase agreement seeks to expand the services the company provided under a previous contract, as well as support fda.gov and FDA’s efforts to publish data on the internet. …

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Emergent BioSolutions Lands BARDA Task Order for Zika Vaccine Development

The Biomedical Advanced Research and Development Authority has awarded Emergent BioSolutions (NYSE: EBS) a potential $21.9 million task order to develop and produce a vaccine against Zika virus for use in the first phase of a clinical trial. The company said Monday the order has a base period of 30 months …

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FDA Clears Siemens Robotic X-Ray System for Clinical Exams

TYSONS CORNER, VA, December 1, 2015 — The U.S. Food and Drug Administration has granted clearance to Siemens for its Multitom Robotic Advanced X-ray, which provides three-dimensional images for clinical examinations, ExecutiveBiz reported Monday. The diagnostic imaging system has two robotic arms and adjustable positioning functions and produces images that reflect a patient’s natural …

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NIAID Taps SRI International for $100M Radiation Exposure Drug Dev’t Contract; Polly Chang Comments

The National Institute of Allergy and Infectious Diseases has awarded a division of SRI International a potential five-year, $100 million contract to develop therapies for radiation exposure. SRI Biosciences will carry out preclinical testing, good manufacturing practice development, stability studies, human clinical trials and formulation development work for NIAID under …

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