Tag: Alzheimer

Clinical Trials, Research and Development

Another amyloid miss in Alzheimer’s as Roche’s crenezumab fails trial

June 16, 2022

Via: Pharmaphorum

The result isn’t a big surprise – Roche terminated two phase 3 trials of crenezumab in people with prodromal to mild sporadic Alzheimer’s in early 2019 after interim analyses found it would be futile to continue – but is another […]

FDA, Pricing, Regulations

Amid outcry over Aduhelm price, Biogen says it may consider ‘adjustment’

June 24, 2021

Via: Pharmaphorum

In a joint statement with Aduhelm (aducanumab) development partner Eisai, Biogen said it is expecting slow take-up of the drug and an eligible patent population of around 1-2 million people with mild Alzheimer’s in the US, saying it has no […]

Manufacturing, Research and Development

Biogen’s $1B Swiss plant scores regulatory nod as drugmaker awaits pivotal FDA decision on aducanumab

May 25, 2021

Via: FiercePharma

Despite a flurry of uncertainty surrounding Biogen’s Alzheimer’s hopeful aducanumab, the company has forged ahead with its launch preparations ahead of a pending FDA decision. Now, its Swiss manufacturing facility is a step closer to eventually churning out doses—should the […]

FDA, Regulations

FDA advisers reassert case against approval of Biogen’s Alzheimer’s drug

March 31, 2021

Via: Biopharma Dive

One of the most important decisions in the history of the Food and Drug Administration is quickly approaching. By early June, the agency should have a verdict on whether to approve aducanumab, a potentially first-of-its-kind treatment for Alzheimer’s disease that […]

FDA, Regulations

Biogen hits snag after Alzheimer’s drug fails to win support from FDA panel

November 6, 2020


A Food and Drug Administration panel on Friday unexpectedly declined to endorse Biogen’s experimental Alzheimer’s drug aducanumab in a setback for the pharmaceutical company. In an 8-1 vote, the panel said Biogen’s late-stage study didn’t provide “strong evidence” showing that […]

Clinical Trials, Research and Development

Alzheimer’s Immune Response Interactions Revealed

September 3, 2020

Via: Genetic Engineering and Biotechnology News

Alzheimer’s disease is a progressive form of dementia. When toxic proteins like beta-amyloid and tau accumulate in the brain, they form plaques and tangles. Researchers have been focusing on how brain plaque contributes to Alzheimer’s disease and what role they […]

FDA, Regulations

FDA Accepts Biogen’s BLA for Alzheimer’s Candidate Aducanumab

August 10, 2020

Via: Genetic Engineering and Biotechnology News

Biogen (BIIB) said its BLA for aducanumab, the Alzheimer’s disease candidate it is co-developing with Eisai, has been accepted for Priority Review by the FDA with a target action date of March 7, 2021—and a decision expected from the agency […]