Pink Sheet Podcast: Monkeypox Vaccine EUA, Drug Pricing Bill Fallout, US FDA’s IT Upgrade
Pink Sheet reporters and editor discuss the new monkeypox vaccine EUA, the potential impact of drug pricing legislation, and how things may have been different if the FDA already had a desired technology upgrade.
You may also be interested in...
Pink Sheet Podcast: Finally, A US FDA User Fee Deal, ‘Pandemic Is Over’ Take-Aways, Tpoxx Development Issues
Pink Sheet reporters and editor discuss the impact of the long wait for a user fee deal to be negotiated, how the FDA will interpret President Biden’s statement that the COVID-19 pandemic is over, and concerns with the clinical development of the monkeypox treatment Tpoxx.
The FDA had picked grantees for the initial round of biosimilar regulatory science research, but told them not to start major activities until the user fee reauthorization was assured. Congress now appears to have reached deal for a ‘practically clean’ reauthorization.
US FDA's Vaccines and Related Biological Products Advisory Committee endorses Rebyota for recurrent C. difficile infection; most panelists prefer a product whose manufacturing will be regulated, even one with lingering concerns about efficacy or safety, over the current landscape.