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February 5, 2021

Coronavirus company news summary – J&J submits EUA to FDA for Covid-19 vaccine – Regulators start a rolling review of Novavax’s vaccine

By Allie Nawrat

5 February 2021

Johnson & Johnson (J&J) announced that its subsidiary Janssen has submitted an emergency use authorisation application to the US Food and Drug Administration (FDA) for its investigational single-shot Covid-19 vaccine candidate. The submission followed J&J achieving top-line efficacy and safety results in its Phase III ENSEMBLE clinical trial.

Novavax announced multiple regulatory agencies, including in the UK, the European Union, the US and Canada, will begin the rolling review process for authorisation of NVX-CoV2373, its Covid-19 vaccine. While the reviews are underway, the company will complete its pivotal Phase III trials in the UK and US and continue to share data with the regulatory agencies.

Sunshine Biopharma and the University of Georgia (UGA) have signed an exclusive license agreement for two Covid-19 drugs, which the UGA had earlier developed and patented. The entities will advance the development of the two compounds, as part of the agreement, along with Sunshine’s own SBFM-PL4 compound. The next steps will be to test the efficacy of these compounds in stopping the progression of disease in transgenic mice.

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