European Countries Issue Alzheimer’s Biomarker Warning
Biogen/Eisai’s Alzheimer’s drug aducanumab could face difficulties with health technology appraisal institutes should it win approval in the EU.
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Emerging Company Profile: Swedish biotech AlzeCure is developing a portfolio of small-molecule drug candidates for diseases affecting the central nervous system, including Alzheimer’s disease and pain.
Two groups of smaller European countries have agreed to collaborate on tackling challenges relating to accessing expensive new medicines.
Aducanumab Accelerated Approval Reflects US FDA Flexibility But Raises Doubts About Confirmatory Trial
Biogen/Eisai Alzheimer’s drug wins agency nod on basis of amyloid plaque reduction, a surprising use of the accelerated approval pathway that was not considered by an FDA advisory committee; approval raises feasibility questions about confirmatory trial and daunting prospect of market withdrawal if studies fail to verify clinical benefit.