The Biden administration has posted a request for information (RFI) about the conditions necessary for the in vitro diagnostic industry to sustain testing capacity for communicable disease outbreaks, although the letter commits to no specific actions. The Advanced Medical Technology Association responded to the RFI with the recommendation that the administration quickly commit to the provision of resources as a means of ensuring that “market volatility will no longer determine test availability.”
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bonalive, Evoendo, Novacyt, Oncimmune.
As the Biden administration continues to play musical chairs with key U.S. federal health leadership positions, its latest move is naming Francis Collins to serve as science adviser to the president and co-chair of the President’s Council of Advisers on Science and Technology.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acadia, Avenue, Biontech, Celcuity, GBT, Hemogenyx, Hillstream, Jixing, Lexeo, Mirati, Moderna, Pfizer, Revive, Sirnaomics, Swanbio.
More than 100 million people worldwide are thought to have post-acute COVID-19 syndrome, roughly 40% of everyone on the planet who’s had COVID. Now, thousands of them are beginning to cycle through clinical and preclinical studies designed to get a better look at this little understood aspect of the pandemic.
The number of biopharma deals with nonprofits or government entities has dropped over last year, partly due to fewer COVID-19-related alliances, but the activity in 2022 is still strong in comparison to pre-pandemic years.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascletis, Axcella, Avion, Bavarian Nordic, Cidara.
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