Announcements at the second Global COVID-19 Summit included a technology licensing agreement for vaccine and diagnostic products developed by the US NIH, a new partnership to boost the use of testing and antiviral treatments in less wealthy countries, and a flurry of new funding pledges from organizations and companies alike.
A new consortium has been launched to promote the use of COVID-19 testing and antiviral treatment programs in lower-income countries (LMICs) to help shape the response to COVID-19 and other future pandemics.
Initially, the public-private consortium plans to support a “test-and-treat” demonstration program covering four countries to be identified over the coming weeks, with
The label that Novavax's COVID-19 vaccine was slated to receive before political officials held up the approval was broader than was granted 16 May.
US FDA Commissioner Martin Makary’s call for placebo-controlled trials to confirm the efficacy of COVID-19 boosters is drawing a lot of criticism, but former Commissioner Robert Califf also supported the idea.
Pink Sheet sister publication In Vivo spoke to the former FDA commissioner about the recent layoffs and their impact on vaccine and other product development.
New CBER Director Prasad will "unleash a massive" framework on vaccines, FDA Commissioner Marty Makary said 15 May, raising questions about the impact on products nearing approval.
The Oncologic Drugs Advisory Committee will vote on the risk-benefit of UGN-102 for low-grade, intermediate-risk, non-muscle invasive bladder cancer based on data from a single-arm trial, but the FDA also seeks input on requiring randomized studies for future treatments.
A US Supreme Court ruling in favor of the agency in an e-cigarette case has implications for drugs and other medical products as the justices decided not to disturb the FDA’s ‘change in position’ authority, while also creating a complex new landscape.
US FDA Commissioner Martin Makary’s call for placebo-controlled trials to confirm the efficacy of COVID-19 boosters is drawing a lot of criticism, but former Commissioner Robert Califf also supported the idea.
