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Two Phase III trials in US to evaluate efficacy of mAbs against COVID-19
europeanpharmaceuticalreview
August 13, 2020
Two randomised Phase III clinical trials to test mAbs against COVID-19 are now enrolling healthy adults in the US, the NIH has announced.
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FDA Revokes EUA for Autobio Diagnostics' Anti-SARS-CoV-2 Rapid Test
americanpharmaceuticalreview
August 13, 2020
The U.S. Food and Drug Administration (FDA) revoked the emergency use authorization (EUA) of the Autobio Diagnostics Co. Ltd.'s Anti-SARS-CoV-2 Rapid Tests.
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FDA issues Emergency Use Authorization to Vela Diagnostics' Coronavirus PCR Test
americanpharmaceuticalreview
August 12, 2020
Vela Diagnostics announced the manual version of its coronavirus PCR test has obtained Emergency Use Authorization from the U.S. Food and Drug Administration (FDA).
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Orion Biotechnology Receives Funding to Test OB-002 for COVID-19
americanpharmaceuticalreview
August 11, 2020
Orion Biotechnology Canada announced it is receiving advisory services and conditional funding from the National Research Council Industrial Research Assistance Program (NRC IRAP), to support the development of Orion’s lead compound, OB-002 ...
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FDA Authorizes First Tests that Estimate Antibodies from Past SARS-CoV-2 Infection
americanpharmaceuticalreview
August 10, 2020
The U.S. Food and Drug Administration (FDA) authorized the first two COVID-19 serology tests that display an estimated quantity of antibodies present in the individual’s blood.
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Avacta Partners with BBI Solutions
contractpharma
August 10, 2020
BBI will manufacture the rapid SARS-CoV-2 antigen test that is being developed.
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J&J Announces Agreement with U.S. Government for 100 Million Doses of Investigational COVID-19 Vaccine
americanpharmaceuticalreview
August 07, 2020
Johnson & Johnson announced its Janssen Pharmaceutical Companies have entered into an agreement with the U.S. government for the large scale domestic manufacturing and delivery in the U.S. of 100 million doses of Janssen’s SARS-CoV-2 investigational ...
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Locking down shape-shifting spike protein aids development of COVID-19 vaccine
worldpharmanews
August 06, 2020
The experimental vaccine against SARS-CoV-2 that was the first to enter human trials in the United States has been shown to elicit neutralizing antibodies and a helpful T-cell response with the aid of a carefully engineered spike protein that mimics ...
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COVID-19 DNA Vaccine Targeting SARS-CoV-2 Proven Effective in Non-Human Primates
americanpharmaceuticalreview
August 06, 2020
INOVIO announced its COVID-19 DNA vaccine INO-4800 targeting SARS-CoV-2 was effective in protecting non-human primates (NHPs; specifically rhesus macaques) from live virus challenge 13 weeks after the last vaccination.
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J&J Wins $1B U.S. Contract for SARS-CoV-2 Vax
contractpharma
August 06, 2020
To provide large scale domestic manufacturing and delivery in the U.S. of 100 million doses of Janssen's SARS-CoV-2 investigational vaccine.