Lilly Loses Neuroscience Chief To Johnson & Johnson
Eli Lilly & Co. continues to search for a new head of neurology research as its diagnostic drug Amyvid (florbetapir F 18 injection) nears its user fee goal date.
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Amyvid Training Issues Lead To Complete Response Letter, Could Force More Trials
FDA says consistent training program needed for market implementation of amyloid diagnostic. Lilly says issues will be resolved promptly.
Amyvid Approval Delay Seems Likely; Questions On Utility Of Training, Plaque Detection Itself Remain
It appears the training program for Amyvid may still need some work, but Eli Lilly & Co. remains confident the diagnostic will gain FDA approval.
Can Amyvid Be An Important Alzheimer's Product Without An Alzheimer's Indication?
Members of the FDA advisory committee that reviewed Avid Radiopharmaceuticals' Amyvid appear less enthusiastic about the product's immediate prospects than the firm itself, but actually could be more enthusiastic about the diagnostic's long-term utility than even the sponsor.