Alzheimer’s blood test, Aducanumab approval issues, Medicare coverage of brain scans that diagnose dementia, Some at higher risk for Alzheimer’s
Should residents’ access to Alzheimer’s drug be restricted?
By
Lois A. Bowers
Jan 18, 2022
You have until Feb. 10 to share your comments with CMS about its recent proposal related to Alzheimer’s drug aducanumab (Aduhelm).
Ethical considerations explored for aducanumab in Alzheimer’s disease
Nov 19, 2021
Grounds are insufficient to offer aducanumab (Aduhelm) for moderate, advanced Alzheimer’s dementia or for individuals without biomarker evidence of brain ß-amyloid, according to a position statement.
Expert panel publishes first recommendations on appropriate use of Alzhemier’s drug Aduhelm
By
Kimberly Bonvissuto
Jul 27, 2021
A panel of experts in the Alzheimer’s field this morning published the first recommendations for the appropriate use of aducanumab (Aduhelm), the controversial new drug to treat early, mild disease.
ARIA described from clinical trials of aducanumab for Alzheimer’s disease
Dec 10, 2021
Amyloid-related imaging abnormalities-edema seen on brain MRI was the most common adverse event in participants receiving high-dose aducanumab (Aduhelm).
Medicare will cover new class of Alzheimer’s drugs if fully approved by FDA, with limits
Jun 02, 2023
Drug makers also will have to gather and keep data in a registry showing how the drugs are working in the real world.
FDA approves second drug for Alzheimer’s disease, despite safety concerns
Jan 06, 2023
The approval of lecanemab-irmb (Leqembi) comes after controversial approval in 2021 of aducanumab (Aduhelm), which met with criticism over concerns about that drug’s effectiveness, safety and pricing.
FDA head asks for investigation into Alzheimer’s disease drug approval
Jul 12, 2021
The request follows reports that Biogen and the FDA held off-the-books meetings before the drug’s approval that may have violated FDA protocol.
Senate committee backs Califf nomination to head FDA
Jan 14, 2022
Among those who voted against Califf’s nomination were Democrats who expressed concerns about his links to pharmaceutical companies.
3 FDA advisory panel members resign in wake of controversial approval of new Alzheimer’s drug
By
Kimberly Bonvissuto
Jun 11, 2021
Three members of a Food & Drug Administration advisory panel resigned this week over the agency’s controversial decision on Monday to approve a novel therapy for Alzheimer’s disease.