Clinical Research Informer

Biogen’s Alzheimer’s drug: What’s the price tag on hope?

World of DTC Marketing

JUNE 1, 2021

After aducanumab showed promise in 2016, Biogen launched two late-stage trials — then stopped them halfway through, in March 2019, when an analysis concluded the studies would not reach their goal of slowing cognitive and functional impairment in participants. Will they follow the science or will they put a price tag on hope?

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

pharmaphorum

DECEMBER 24, 2021

The anti-amyloid drug, which also claimed a breakthrough tag from the FDA in July, is being developed for the treatment of early-stage Alzheimer’s disease. The $56,000-a-year price tag for the drug, which has now been cut in half in the US, also hasn’t helped the drugmakers make a case for Aduhelm with US payers.

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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. 39 points on an 18-point scale that measures cognitive ability. Not to mention the $56,000 annual price tag.

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Jolly Good/Teijin Pharma develop VR digital therapeutics for depression

pharmaphorum

APRIL 26, 2021

In 2019 Cognitant and Addenbrook’s Hospital in Cambridge, UK piloted a programme that aimed to educate patients to improve adherence to rheumatoid arthritis medicines. It comprises more than 170 companies and employs 20,000 people across 20 countries worldwide.

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Grand Rounds November 17, 2023: Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications: Results from the Nudge Study (Michael Ho, MD, PhD; Sheana Bull, PhD)

Rethinking Clinical Trials

NOVEMBER 21, 2023

Tags #pctGR, @Collaboratory1 The post Grand Rounds November 17, 2023: Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications: Results from the Nudge Study (Michael Ho, MD, PhD; Sheana Bull, PhD) appeared first on Rethinking Clinical Trials. The study would then recalculate the gaps.

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Grand Rounds Ethics and Regulatory Series January 13, 2023: Ethical Considerations When Vulnerable Populations are Subjects in Pragmatic Trials (Emily A. Largent, JD, PhD, RN)

Rethinking Clinical Trials

JANUARY 19, 2023

Caregivers may also need to be enrolled and give their own consent as they may be more involved as the participant’s cognitive impairment worsens. Tags #pctGR, @Collaboratory1 The post Grand Rounds Ethics and Regulatory Series January 13, 2023: Ethical Considerations When Vulnerable Populations are Subjects in Pragmatic Trials (Emily A.

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

pharmaphorum

MAY 10, 2022

The FDA awarded a fast-track designation to lecanemab in December and has also given the drug breakthrough tag as a treatment for early-stage Alzheimer’s, and Biogen and Eisai will be hoping the drug can sidestep the controversy that engulfed Aduhelm from the moment it was approved.

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Pear claims breakthrough tag for alcohol use disorder DTx

pharmaphorum

NOVEMBER 24, 2021

The DTx – also known as Pear-009 – is still in the proof-of-concept trial stage, but draws on the same cognitive behavioural therapy (CBT) deployed in Pear’s commercial-stage products reSET and reSET-O for people living with substance and opioid use disorders. Photo by thom masat on Unsplash.

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

XTalks

JULY 12, 2021

The updated prescribing information states that the drug should be initiated in patients with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s dementia. On the other hand, Biogen is being aggressively questioned over its tacking on of such a hefty price tag for the drug.

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

XTalks

JUNE 9, 2021

This affects a person’s cognitive functions including memory and thinking and leads to problems including confusion, communication issues and a compromised ability to perform daily tasks. Aducanumab Controversy and Price Tag. Evidence for aducanumab’s efficacy has been highly contested.

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Biogen updates on its confirmatory Aduhelm trial

pharmaphorum

DECEMBER 17, 2021

Aduhelm (aducanumab) was approved by the FDA in June, but has been held back by a glacial rollout as clinicians have questioned the data on which the decision to clear the drug was based, plus a $56,000 per year price tag, which has in turn led to pushback by payers.

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

pharmaphorum

JUNE 8, 2021

It also takes issue with the decision to approve the drug for all Alzheimer’s patients, rather than just the patients with mild cognitive impairment (MCI) and mild dementia included in Biogen’s studies of the drug. The post FDA slammed over Aduhelm OK as Biogen takes heat for $56k price tag appeared first on.

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

XTalks

AUGUST 23, 2021

With this in mind, the AAIC 2021 panel shared their views on how both cognitive assessment and biomarker results should be disclosed to patients if they’re eligible for the approved therapy. With a $56,000 price tag for a year’s worth of treatment, Aduhelm is far from the most expensive drug on the market.

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Clinical Research Informer

Biogen’s Alzheimer’s drug: What’s the price tag on hope?

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

Trending Sources

The FDA and Aduhelm: WTF?

Jolly Good/Teijin Pharma develop VR digital therapeutics for depression

Grand Rounds November 17, 2023: Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications: Results from the Nudge Study (Michael Ho, MD, PhD; Sheana Bull, PhD)

Grand Rounds Ethics and Regulatory Series January 13, 2023: Ethical Considerations When Vulnerable Populations are Subjects in Pragmatic Trials (Emily A. Largent, JD, PhD, RN)

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

Pear claims breakthrough tag for alcohol use disorder DTx

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

Biogen updates on its confirmatory Aduhelm trial

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

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

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