Aduhelm, One Year Later: US FDA’s Credibility, Accelerated Approval Pathway Feel The Bite From Alzheimer’s Drug Approval
June 7 marks the one-year anniversary of the accelerated approval of Biogen’s aducanumab, an event that still reverberates throughout the drug development community. While the FDA continues to defend the approval, experts say the backlash has caused the agency to become more reluctant to use the expedited pathway. Meanwhile, Alzheimer’s patients find themselves where they were a year ago: without ready access to a disease-modifying therapy.
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After the Aduhelm controversy, Eisai/Biogen, Roche and Lilly are lining up Phase III results for their candidates which, against the odds, they hope could finally represent real progress in Alzheimer’s treatment. Scrip takes a look at the key questions surrounding the field as the drugs await their fate.
Califf: Industry Should Be Reminded Of US FDA’s Separate Development Advice, Application Assessment Roles
Experts wonder why the FDA Commissioner commented on a system seemingly working fine, but Califf says it is necessary to remember the potential conflict between the two roles.
Senate appropriations bill would take back some of increase House offered Center for Drug Evaluation and Research and other FDA programs, setting up negotiations as start of FY2023 nears.