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The COVID-19 pandemic has led to many changes in how pharmaceutical companies develop vaccines.
More technologies and treatments are emerging for COVID-19—along with new variants.
Partnerships formed during the COVID-19 pandemic have provided a platform for change in assay development and transfers.
November 19, 2020
Almac Sciences has been granted an award by the COVID-19 Therapeutics Accelerator for the development of an efficient and scalable production process for remdesivir.
Moderna has reported that EMA's CHMP has started a rolling review of mRNA-1273—Moderna’s COVID-19 vaccine candidate.
November 18, 2020
The agency’s safety monitoring plan outlines how information that emerges after the authorization of COVID-19 vaccines will be collected and reviewed.
Pfizer and BioNTech’s BNT162b2 shows efficacy of 95%; the companies plan to submit a request, within days, to FDA for an EUA.
Stephen Hahn promises disclosure of supporting scientific data used to issue EUAs.
The guidance was published in connection with a safety monitoring plan for COVID-19 vaccines.
The event will be rescheduled for Oct. 19–21, 2021 at the Javits Center in New York City.
November 17, 2020
Moderna’s COVID-19 vaccine candidate can be distributed using widely available vaccine delivery and storage infrastructure.
November 16, 2020
Moderna CEO Stéphane Bancel says the company will submit EUA data for its vaccine candidate, mRNA-1273, which has shown efficacy of 94.5% in the first analysis of Phase III clinical test results.
November 10, 2020
FDA issued emergency use authorization for bamlanivimab for patients at risk for severe COVID-19.