Pink Sheet Podcast: Makena Withdrawal Hearing Nears, In-Person Meetings At US FDA, User Fees Released
Pink Sheet reporters and editor discuss new developments in the Makena withdrawal case, FDA taking small steps toward resuming in-person meetings at its headquarters, and the agency finally releasing the FY 2023 user fee rates.
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Successive waves of Alzhiemer’s therapies are going to be needed, David Ricks said as his company awaits Phase III data on donanemab, the last of three late-stage anti-amyloid drugs to report results.
Final guidance excludes stool banks, putting in place more limited enforcement discretion regarding the requirement of an investigational new drug application for use of fecal transplants to treat C. diff infections, likely paving way for shift to any FDA-approved product.