Accelerated Access Pathway Archives

Lawmakers Plan to Investigate Approval, Pricing of Aduhelm

Accelerated Access Pathway, Alzheimer’s disease, Biogen, Clinical Trial Endpoints, Drug Pricing, FDA, House Committee on Oversight and Government Reform, New Drug Approvals, Peripheral and Central Nervous System Drugs Advisory Committee, Therapeutics

The House Committee on Oversight and Reform announced plans to investigate the approval and pricing of Biogen’s Alzheimer’s disease medicine Aduhelm (aducanumab), which has a list price of $56,000 per year.

June 28, 2021/by Andrew Humphreys

FDA documents show struggle over approval of new Alzheimer’s drug from Biogen

Accelerated Access Pathway, Alzheimer’s disease, Biogen, FDA, Therapeutics

The U.S. Food and Drug Administration released a sweeping series of memos revealing a clear struggle within the regulatory agency ahead of its controversial decision to approve Biogen’s Alzheimer’s drug Aduhelm.

June 22, 2021/by Andrew Humphreys