Clinical Research Informer

FDA slammed over Aduhelm OK as Biogen takes heat for $56k price tag

pharmaphorum

JUNE 8, 2021

The FDA “has failed in its responsibility to protect patients and families from unproven treatments with known harms” in approving Biogen’s Alzheimer’s disease drug Aduhelm. ICER points to brain swelling and potential bleeding seen in approximately 30% of patients treated with aducanumab.

Drugs

Drugs Marketing FDA Approval Trials

ICER stands by view on Biogen's Aduhelm, says sharp price cut needed

Bio Pharma Dive

JUNE 30, 2021

The influential nonprofit maintains that the clinical trial evidence supporting Aduhelm is insufficient to prove a health benefit. But if some efficacy is assumed, ICER argues Biogen's $56,000 price tag is far too high.

Clinical Trials

Clinical Trials Clinical Trials Trials

What is Biogen and can they repair their reputation?

World of DTC Marketing

SEPTEMBER 24, 2021

This week two colleagues, who worked at Biogen, left the company because they knew that the ax was coming after the failure of Aduhelm. More importantly, they felt the company should never have launched Aduhelm. Physicians and insurers are rejecting Aduhelm because it should never have been approved in the first place.

Drugs

Drugs Pharma Companies Doctors Doctor

Biogen, Eisai Alzheimer’s drug lecanemab fast tracked by FDA

pharmaphorum

DECEMBER 24, 2021

Biogen and Eisai head towards the end of the year with some much-needed good news in their Alzheimer’s programmes, as the FDA awards a fast-track designation to lecanemab, their follow-up to recently approved Aduhelm. The post Biogen, Eisai Alzheimer’s drug lecanemab fast tracked by FDA appeared first on.

Drugs

Drugs FDA Approval Trials Marketing

The FDA and Aduhelm: WTF?

World of DTC Marketing

JUNE 23, 2021

SKIMMERS SUMMARY: Jefferies analysts found doctors have shown strong interest in prescribing Aduhelm for about 35% of early-stage Alzheimer’s patients with mild cognitive impairment after surveying 50 U.S. Biogen’s Aduhelm won FDA approval after discovering that some patients on higher dosages had displayed improvement of.39

Drugs

Drugs FDA Approval Doctors Doctor

Biogen’s Aduhelm rollout goes from bad to worse

pharmaphorum

OCTOBER 21, 2021

Analysts were predicting sales of Biogen’s recently approved Alzheimer’s therapy Aduhelm may start to gather a little momentum in the third quarter, but the drug seems to be going into reverse. Vounatsos also insisted that Aduhelm’s price tag has not been a factor discouraging treatment with the drug.

Sales

Sales Doctors Doctor Gene Therapy

Biogen updates on its confirmatory Aduhelm trial

pharmaphorum

DECEMBER 17, 2021

Biogen and partner Eisai have said they will provide details next March for the confirmatory trial that will be needed to upgrade the drug’s accelerated approval for controversial Alzheimer’s drug Aduhelm to a full one. Only a few patients have been getting treated with Aduhelm since launch, with Biogen reporting sales of $1.6

Trials

Trials Sales Marketing FDA Approval

Exit Aduhelm, enter lecanemab. Biogen and Eisai have another go

pharmaphorum

MAY 10, 2022

With Aduhelm largely sidelined, Biogen and Eisai are hoping for a better fortunes with their next Alzheimer’s disease therapy lecanemab, which is now fully filed with the FDA. The post Exit Aduhelm, enter lecanemab. Here we go again. Biogen and Eisai have another go appeared first on.

FDA Approval

FDA Approval Trials Clinical Trials Clinical Trials

Roche’s Early Alzheimer’s Blood Test Gets FDA Breakthrough Device Designation

XTalks

APRIL 18, 2024

The approval of amyloid-beta-targeting therapies like Leqembi and recently discontinued Aduhelm (aducanumab) have come with controversy around their clinical effectiveness. Joint makers Biogen and Eisai decided to pull Aduhelm because of the continuing questions and lower-than-expected uptake by insurers and providers due to its high cost.

Clinical Trials

Clinical Trials Clinical Trials In-Vitro Protein

FDA Trims Broad Label for Biogen’s Alzheimer’s Drug Amidst Harsh Criticism

XTalks

JULY 12, 2021

The US Food and Drug Administration’s (FDA) recent approval of Biogen’s Alzheimer’s drug Aduhelm (aducanumab) was met with a lot of backlash, prompting the health agency to narrow its recommendation of the drug for mild forms of the disease. head of research and development at Biogen, in a statement from the company.

Drugs

Drugs Clinical Trials Clinical Trials Trials

Biogen’s Aducanumab Becomes First Drug Approved for Alzheimer’s in Nearly 20 Years Despite Controversy

XTalks

JUNE 9, 2021

Biogen has been working vigorously over the past couple of years to get its potentially disease-modifying drug Aduhelm (aducanumab) approved for Alzheimer’s disease, and it has finally happened. Aducanumab Controversy and Price Tag. Evidence for aducanumab’s efficacy has been highly contested.

Drugs

Drugs Clinical Trials Clinical Trials Trials

AAIC 2021: Six Ways the Approval of Aducanumab Will Change Alzheimer’s Clinical Trials

XTalks

AUGUST 23, 2021

AAt this year’s Alzheimer’s Association International Conference ( AAIC ), entire sessions were dedicated to discussions of Biogen’s recently-approved, controversial drug Aduhelm (aducanumab), but their focus wasn’t what you’d expect. This is another case in which careful clinical trial design is of the utmost importance.

Clinical Trials

Clinical Trials Clinical Trials Trials Drugs

Viagra ‘should be tested as Alzheimer’s therapy’

pharmaphorum

DECEMBER 7, 2021

That finding could provide some comfort to Biogen and Eisai, whose recently-approved amyloid-targeting drug Aduhelm (aducanumab) is struggling to gain traction in the market on the back of unconvincing efficacy data, safety concerns and a high price tag.

Drugs

Drugs Clinical Trials Clinical Trials Scientist

Clinical Research Informer

FDA slammed over Aduhelm OK as Biogen takes heat for $56k price tag

ICER stands by view on Biogen's Aduhelm, says sharp price cut needed

Trending Sources

What is Biogen and can they repair their reputation?

Biogen, Eisai Alzheimer’s drug lecanemab fast tracked by FDA

The FDA and Aduhelm: WTF?

Biogen’s Aduhelm rollout goes from bad to worse

Biogen updates on its confirmatory Aduhelm trial

Exit Aduhelm, enter lecanemab. Biogen and Eisai have another go

Roche’s Early Alzheimer’s Blood Test Gets FDA Breakthrough Device Designation

FDA Trims Broad Label for Biogen’s Alzheimer’s Drug Amidst Harsh Criticism

Biogen’s Aducanumab Becomes First Drug Approved for Alzheimer’s in Nearly 20 Years Despite Controversy

AAIC 2021: Six Ways the Approval of Aducanumab Will Change Alzheimer’s Clinical Trials

Viagra ‘should be tested as Alzheimer’s therapy’

Stay Connected