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.
Medicare may rethink premium hike for pricey Alzheimer’s drug
Jan 10, 2022
The announcement comes shortly after Aduhelm maker Biogen cut the price of the drug by about half, from $56,000 to $28,000 a year.
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).
Biden pledges to lower prescription drug prices for Americans
Dec 07, 2021
But the biggest policy change — letting Medicare negotiate prices for prescription drugs — will not start to lower costs until 2025.
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.
Pricey Alzheimer drug drives spike in Medicare B premium: Officials
Nov 15, 2021
New premium will be $170.10 a month, and the $21.60 boost is the biggest increase ever in dollar amount, but not in percentage terms
Medicare mulls coverage for controversial drug for Alzheimer’s disease
Jul 13, 2021
CMS says a final decision on coverage is not likely until next spring.
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.
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.
House committees to investigate new Alzheimer’s disease drug approval
Jul 01, 2021
The FDA approved aducanumab earlier this month, despite advisory committee’s conclusion that there was not enough evidence to support its effectiveness.