New Rx instructions tighten use of controversial Alzheimer’s disease drug
Jul 08, 2021
Major changes to prescribing instructions are rare, especially so soon after approval; it change could curb the drug’s use.
Few older adults knowledgeable about aducanumab for Alzheimer’s disease
Feb 25, 2022
Less than one-quarter of older adults report they would want to take 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.
Medicare monthly premiums to drop for seniors
Sep 28, 2022
The fee cuts come at the same time as seniors receive a Social Security cost-of-living increase for 2023 of up to 9 or 10%.
FDA advisers support new Alzheimer’s drug
Jun 11, 2024
A US Food and Drug Administration advisory panel voted unanimously on Monday to recommend that the benefits of a new drug for Alzheimer’s outweigh its harms, which can include brain swelling and...
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.