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Rationale to continue approving placebo-controlled COVID-19 vaccine trials in LMICs

Rationale to continue approving placebo-controlled COVID-19 vaccine trials in LMICs
thelancet.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from thelancet.com Daily Mail and Mail on Sunday newspapers.

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Virginia biotech firm plans to create hundreds of NH jobs at new Hudson facility


NH Business Review
MicroGEM acquires Nashua company to scale up production of new rapid Covid test system
January 28, 2021
A Virginia-based molecular diagnostics company has acquired engineering firm Jump Start Manufacturing LLC of Nashua, NH, in a move that the company says will mean the creation of hundreds of new jobs at a new facility in Hudson, NH, where it will scale production of its  new Covid-19 testing system.
The company, MicroGEM of Charlottesville, Va., said the 52,000-square-foot Hudson facility, in tandem with another new 69,000-square-foot plant in Ogden, Utah, will give it the capability of producing 160,000 tests per day.
The company said it expected that a total of about 500 new jobs will be created at the two locations, but it’s not immediately clear exactly how many of those jobs will be in New Hampshire. ....

New Hampshire , United States , Thomas Moran , Jeff Chapman , Drug Administration For Emergency Use Authorization , Jump Start Manufacturing , Jump Start , Drug Administration , Emergency Use , National Institutes , Rapid Acceleration , புதியது ஹாம்ப்ஷயர் , ஒன்றுபட்டது மாநிலங்களில் , தாமஸ் மோரன் , ஜெஃப் சாப்மேன் , குதி தொடங்கு உற்பத்தி , குதி தொடங்கு , அவசரம் பயன்பாடு , தேசிய நிறுவனங்கள் , விரைவான விரைவுபடுத்துதல் ,

FluroTech Expands nanoComposix Mandate; Initiating Covid-19 Test Performance Evaluation and Validation


FLURF) (“FluroTech” or the “Company”), is pleased to announce that, FluroTest Ltd. (“FluroTest”) has retained San Diego-based nanoComposix, a leading life sciences nanotechnology company that specializes in R&D and manufacturing of lateral flow rapid tests, to immediately begin lab performance studies for FluroTest’s rapid antigen testing pandemic defense platform. This move builds upon previously announced and ongoing optimization efforts, bringing FluroTest one step closer to submitting to the U.S. Food and Drug Administration for Emergency Use Authorization (EUA).
Having already recorded
successful proof of concept studies at Albany Medical College’s immunology laboratories, these performance and validation studies will be conducted in accordance with the FDA requirements for antigen testing, including but not limited to; assessments for sensitivity, specificity, limit of detection, cross-reactivity and interfering substances using inactivated viral cul ....

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QIAGEN N.V.: QIAGEN Plans to Resubmit EUA Submission in the U.S. for QIAreach SARS-CoV-2 Antigen Test in the First Quarter of 2021


(2)
QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that it plans to resubmit in the first quarter of 2021 its QIAreach SARS-CoV-2 Antigen Test to the U.S. Food and Drug Administration for Emergency Use Authorization to detect SARS-CoV-2 antigens in people with active infections in 15 minutes.
This comes after QIAGEN decided to proactively withdraw the first submission made in November 2020 for this product to address a chemistry-related issue. QIAGEN believes it has resolved the issue, and data is now being collected for submission to the FDA. The eHub used to read out test results is not affected. ....

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vaccine | What Did You Say?


November 9, 2020 6:49 AM
A COVID-19 vaccine developed by Pfizer Incorporated and BioNTech SE has been found to be more than 90 percent successful in large-scale trails against the coronavirus. In a press release made by Pfizer, the development team announced that their vaccine candidate had successfully deterred the spread of COVID-19 in thousands of trials and was now being submitted before the United States Food and Drug Administration for Emergency Use Authorization. Per the release, of the 43,000 test subjects, only 94 returned with positive COVID-19 cases less than a percent of participants.
The Trump administration had made a deal in June with Pfizer to ensure that the vaccine would be made free to 100 million Americans, upon successful development. ....

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