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Improving FDA's COVID-19 vaccine authorization and approval process
worldpharmanews
September 02, 2020
On March 28, the Food and Drug Administration (FDA) exercised its Emergency Use Authorization (EUA) authority to allow the use of hydroxychloroquine for the treatment of COVID-19.
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Oxford Biomedica enters Covid-19 vaccine manufacturing deal
pharmaceutical-technology
September 02, 2020
Oxford Biomedica will reserve capacity for the vaccine candidate in up to three manufacturing suites at its Oxbox facility.
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Phase III trials of AstraZeneca COVID-19 vaccine candidate begins in US
expresspharma
September 02, 2020
AZD1222 is already undergoing late-stage clinical trials in Britain, Brazil and South Africa, with additional trials planned in Japan and Russia.
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Novavax and Canada reach agreement in principle for 76 mn doses of COVID-19 vaccine
expresspharma
September 02, 2020
Novavax has announced that it has reached an agreement in principle with the Government of Canada to supply up to 76 million doses of NVX-CoV2373, Novavax’ COVID-19 vaccine.
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US FDA willing to give EUA for COVID-19 vaccines before Phase III trials
expresspharma
September 01, 2020
FDA Commissioner also said that it is not a blanket approval and will be subject to benefits outweighing the risks.
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Akers and Premas note positive proof-of-concept data of Covid-19 vaccine
pharmaceutical-technology
August 31, 2020
Akers Biosciences and Premas Biotech have reported positive proof-of-concept data from animal studies of their PRAK-03202 vaccine candidate against Covid-19.
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Hackensack Meridian Health Enrolling Individuals for COVID-19 Vaccine Clinical Trial
americanpharmaceuticalreview
August 31, 2020
Hackensack Meridian Health is now enrolling individuals in a COVID-19 vaccine clinical trial.
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Sinovac’s COVID-19 vaccine candidate get emergency use approval in China
expresspharma
August 31, 2020
Sinovac Biotech’s coronavirus vaccine candidate CoronaVac was approved for emergency use as part of a programme in China to vaccinate high-risk groups such as medical staff, a person familiar with the matter said.
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Beximco signs deal with Serum Institute of India for COVID-19 vaccines
expresspharma
August 31, 2020
Beximco Pharmaceuticals from Bangladesh announced investment in the Serum Institute of India (SII) for priority access to COVID-19 vaccines being developed by the Indian pharma manufacturer.
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UQ’s Covid-19 vaccine shows effectiveness in preclinical studies
pharmaceutical-technology
August 28, 2020
The University of Queensland (UQ) in Australia has reported positive data from preclinical tests of its Covid-19 vaccine candidate conducted by Viroclinics-DDL in the Netherlands.