While the FDA’s approach to evaluating safety and efficacy in the development and review of COVID-19 vaccines for the U.S. market will be at the center of its Oct. 22 advisory committee meeting, the panel also will be asked to discuss the practicalities, and ethics, of continuing to conduct trials once a candidate has been granted an emergency use authorization.

COVID-19 continues to dominate biopharma nonprofit collaborations and grants in 2020, with the pandemic accounting for 85% of projected values reported this year, most of which have posted since the start of July.

LONDON - The world’s first COVID-19 human challenge trial is due to start in London next year, after the government announced £33.6 million (US$42.5 million) funding for the project. In the initial phase, the aim is to establish the dose of SARS-CoV-2 needed to cause infection and to characterize the immune response to virus. That will lead on to tests of individual COVID-19 vaccines, in which volunteers will be challenged with the effective dose of SARS-CoV-2 one month after inoculation.

CAJICA, Colombia – The Russian vaccine candidate Sputnik V, developed by Moscow’s Gamaleya National Research Institute of Epidemiology and Microbiology to prevent the SARS-CoV-2 virus that causes COVID-19, is undergoing phase III trials in Venezuela under complete secrecy.

In July a major initiative of the International Federation of Pharmaceutical Manufacturers and Associations, designed to combat the rising tide of antimicrobial resistance and accelerate the pace at which new antibiotics are discovered and brought to market, was announced. The $1 billion AMR Action Fund, supported by 23 pharma companies, was created “because there was a clear realization that we have no time to spare to address the lack of innovation in this area,” said Martin Bott, interim general manager of the fund, who described the progress being made with the fund in a fireside chat at this week’s virtual BIO Investor Forum.