The Latest Breaking News from Biogen

FDA’s approval of Biogen Alzheimer’s drug slammed in report

U.S. health officials’ approval process for Biogen Inc.’s controversial Alzheimer’s drug was “rife with irregularities,” raising serious concerns about protocol lapses at the agency, congressional investigators said.

Tribune News Service · Dec 30, 2022

Probe: Alzheimer's drug approval 'rife with irregularities'

The Food and Drug Administration's contentious approval of a questionable Alzheimer's drug is taking another hit

The Independent UK · Dec 29, 2022

House report questions FDA’s approval of Alzheimer’s drug

WASHINGTON — A joint investigation released Thursday by House Democrats identified unusual collaboration between Food and Drug Administration officials and drugmaker Biogen, highlighting potential problems in the agency’s approval of the controversial Alzheimer’s drug Aduhelm.

Tribune News Service · Dec 29, 2022

Lisa Jarvis: That blockbuster Alzheimer’s drug? It’s not a cure

Biogen Inc. and Eisai Co. caused a stir in September when they announced positive results in a late-stage trial for a closely watched Alzheimer’s drug, lecanemab. Doctors tempered their excitement, though, until they could scrutinize the full peer-reviewed data.

Tribune News Service · Dec 1, 2022

Data shows drug slowing Alzheimer’s but doubts over effect remain

Lecanemab modestly slows disease’s inevitable worsening, but it remains unclear how much of a difference it will make.

Al Jazeera · Nov 30, 2022

‘Momentous breakthrough’: New Alzheimer’s drug lives up to bold claims, with caveats

Data supports claims that a new drug reduced cognitive and functional decline in Alzheimer's patients by 27 per cent in a clinical trial.

The New Daily · Nov 30, 2022

Study: Alzheimer's drug shows modest success slowing declines in memory, thinking

In a large study, the experimental Alzheimer's drug lecanemab reduced the rate of cognitive decline by 27 percent in people in the early stages of the disease.

WEKU · Nov 30, 2022

Alzheimer's drug sparks hot debate over benefits as risks like brain bleeding emerge

Eisai Co. unveiled much-anticipated findings on its experimental Alzheimer’s drug, providing tinder for the hot debate over whether its modest efficacy is worth potential risks that include serious brain bleeding.

Tribune News Service · Nov 30, 2022

Drug slows Alzheimer's but can it make a real difference?

New data shows an experimental Alzheimer's drug modestly slowed the brain disease's inevitable worsening

The Independent UK · Nov 30, 2022

Safety concerns hang over new Alzheimer's treatment

Two deaths linked to the drug may present a more complicated path to approval.

Axios · Nov 29, 2022