‘Operation Warp Speed’ aims to deliver a COVID-19 vaccine by year-end: Bloomberg
April 30, 2020
By Neozene

This article originally appeared in FiercePharma and was written by Eric Sagonowsky Biopharma players worldwide have committed big money and talent to the hunt for a COVID-19 vaccine, striking some unprecedented partnerships along the way. Behind the scenes, another joint effort has been taking shape at the White House, Bloomberg reports. The Trump administration is working up a Manhattan Project-style joint initiative, bringing biotech, pharma and federal agencies together to speed up the work—and let the U.S. government take on the financial risks. Dubbed “Operation Warp Speed,” the project’s goal

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Congress Urges FDA to Better Scrutinize COVID-19 Antibody Tests
April 27, 2020
By Neozene

This article originally appeared in FierceBiotech and was written by Conor Hale Members of Congress have called on the FDA to re-evaluate its stance toward COVID-19 antibody tests. Since mid-March, the agency has allowed diagnostic developers to bring their products to market without any outside evaluation that the results they produce are accurate. Instead, these manufacturers can proceed after validating the tests themselves, but they are not required to share those results. Companies must also print labels saying their antibody tests are not FDA approved or authorized and should not be used

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Roche slates COVID-19 antibody blood test for early May
April 17, 2020
By Neozene

This article originally appeared in FierceBiotech and was written by Conor Hale Roche announced plans to launch its own COVID-19 antibody blood test early next month as a complement to its previous high-throughput test for active infections authorized by the FDA in March. The company’s Elecsys Anti-SARS-CoV-2 serology test is designed to identify people who have previously been infected by the virus, especially those who may not have displayed symptoms, by detecting the body’s immune response to the infection. “Every reliable test on the market serves its purpose for healthcare systems

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