Biogen Inc. and partner Eisai Co. Ltd. on July 29 revealed the design of an upcoming study of their controversial Alzheimer’s treatment, Aduhelm.
Biogen reportedly withdrew a paper that analyzed data from the clinical trials of the Alzheimer’s drug Aduhelm that the company submitted to JAMA after the medical journal requested edits before publication.
One of the eagerly anticipated presentations at the 2021 Alzheimer’s Association International Conference in Denver and virtually is Biogen and the company’s partner Eisai on their controversial drug Aduhelm (aducanumab). Biogen is also presenting new data on a different Alzheimer’s drug with another partner, Ionis Pharmaceuticals.
Anthem Inc. is closely watching for guidance from the U.S. Food and Drug Administration and all available clinical evidence on Biogen Inc.’s Aduhelm to determine the health insurance provider’s coverage policy on the newly approved Alzheimer’s drug.
The U.S. government started a review process for national Medicare coverage of Biogen Inc.’s Alzheimer’s drug Aduhelm that was approved during June 2021 by the country’s health regulator.
The U.S. Food and Drug Administration on July 9 called for an independent federal probe into its representatives’ interactions with Biogen Inc. that led to approval of the company’s Alzheimer’s disease drug during June 2021.
Biogen Inc. on July 8 said the U.S. Food and Drug Administration narrowed use of the company’s Alzheimer’s drug after the regulatory agency drew sharp criticism for its broad approval of the drug in June 2021 without proof of clear benefit against the disease.
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.
The U.S. Food and Drug Administration granted breakthrough therapy designation to Japanese company Eisai and partner Biogen’s experimental therapy lecanemab for patients with early Alzheimer’s.
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.