New COVID Therapeutic Development Hitting Regulatory Wall At US FDA
FDA trial design criteria pose challenges for new COVID therapeutic development, frustrating companies and NIH and prompting a tense meeting earlier this summer, according to audio obtained by the Pink Sheet.
You may also be interested in...
Sponsors want more endpoint clarity as current state of government pandemic response, along with scientific and regulatory hurdles, is constraining efforts to refill a shrinking COVID medicine cabinet and could create vulnerabilities for future pandemics.
Mucosal and other new vaccines in development should target infection and transmission prevention, as White House’s Ashish Jha calls for them to be ‘better than terrific.’ But with the market transitioning to a flu-like status, incentives for big investments seem limited.
Siga CSO Dennis Hruby talked with the Pink Sheet about the company’s plans for development of Tpoxx for monkeypox in the US. If the necessary emergency declaration is made that would let FDA issue EUAs, the company would likely try to apply with its current clinical trial-less data set.