M. Nielsen Hobbs
Latest From M. Nielsen Hobbs
Pink Sheet reporters and editors discuss increasing complete response letters for breakthrough designees, FDA changing course on statin use during pregnancy, and efforts to use pandemic innovations to improve clinical research going forward.
Pink Sheet reporters and editors discuss the implications of Aduhelm’s updated indication, CDER’s new drug approvals in the first half of 2021, and an FTC policy change that will make investigating pharma easier.
Acting Commissioner Woodcock says ‘we weren’t as flexible as we should be’ and notes that center directors are reviewing the criteria for rare disease assessments.
US FDA’s approval after a near-unanimous advisory committee vote against Biogen’s Alzheimer’s drug is central to many critics’ arguments, but the acting commissioner says that panel did not vote on the issue of accelerated approval, and that airing of internal agency disagreements could have influenced committee members.
Pink Sheet reporter and editors discuss whether emotion could be removed from US FDA advisory committees, adverse events and advancing science in gene therapy development, and Capitol Hill’s interest in the ongoing user fee negotiations.
The Biogen Alzheimer’s product saw its ‘likelihood of approval’ score from Biomedtracker change directions multiple times as it moved through clinical trials and US FDA review.