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Premarket Biotech Digest: Gilead HIV, Eliquis Trial Errors, Clinical Trial Phases

2015-08-04 07:51:25| Biotech - Topix.net

This may be FDA 101 for some people, but many lay investors may not be aware of the precise details; so I am providing this brief note following the FDA itself. All new drugs and almost all drugs applying for new indications must go through a clinical research where it is tested in human subjects prior to FDA approval.

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Magellan Diagnostics Receives FDA Clearance for LeadCare Plus Clinical Lead Analyzer

2015-07-21 12:31:15| Industrial Newsroom - All News for Today

BILLERICA, Mass.,  Magellan Diagnostics, Inc., the leader in blood lead testing systems for both point-of-care and laboratory analysis, has received US Food and Drug Administration (FDA) 510(k) clearance to market the LeadCare Plus Blood Lead Testing System in the US for the quantification of lead levels in...

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Fabrico Medical to Exhibit Advanced Medical Converting Capabilities at the American Association for Clinical Chemistry Conference

2015-07-20 12:31:12| Industrial Newsroom - All News for Today

Rochester, NY - Fabrico Medical, a premier provider of converted materials and advanced assembly for the design-to-manufacture of medical devices and disposables, announces its participation in the American Association for Clinical Chemistry (AACC) Conference, Booth #4646, July 28 30, 2015, at Georgia World...

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Vaccine for West Nile Virus enters human clinical trials

2015-07-06 22:44:55| Biotech - Topix.net

A clinical trial of a new investigational vaccine designed to protect against West Nile Virus infection will be sponsored by the National Institute of Allergy and Infectious Diseases , part of the National Institutes of Health. The experimental vaccine was discovered and developed by scientists at the Oregon National Primate Research Center at Oregon Health & Science University in Portland.

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ABL Successfully Completes Drug Product Manufacture Of Ebola Vaccine For Clinical Trial

2015-07-01 08:22:45| drugdiscoveryonline Home Page

ABL, Inc. (ABL), a contract research and manufacturing organization to the biopharmaceutical industry, is pleased to announce the successful aseptic formulation and fill of an Ebola vaccine candidate for Emergent BioSolutions Inc. (EMERGENT)

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