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.

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

World of DTC Marketing

JUNE 1, 2021

SUMMARY: The FDA is coming under intense pressure to approve Biogen’s Alzheimer’s drug, but Aaron S. ” For Biogen, the stakes are high as approval is likely to earn tens of millions, of to billions, in profits but is hope a reason to approve a drug over science? .” Biogen needs a new drug revenue badly.

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

Bio Pharma Dive

JUNE 30, 2021

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

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What is Biogen and can they repair their reputation?

World of DTC Marketing

SEPTEMBER 24, 2021

SUMMARY: If I were to ask you, “what type of company is Biogen?” Biogen has lost its way and is in desperate need of a corporate rebranding. This week two colleagues, who worked at Biogen, left the company because they knew that the ax was coming after the failure of Aduhelm. Biogen is in trouble.

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STAT+: The FDA has approved a new Alzheimer’s drug, but wide access may depend on CMS easing restrictions

STAT News

JANUARY 6, 2023

Food and Drug Administration has granted accelerated approval to the widely anticipated Alzheimer’s drug from Eisai and Biogen, a key question is the extent to which payers — private and public — will cover the treatment. Such decisions are based on myriad factors, starting with the average $26,500 price tag.

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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.

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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. Biogen reported $1.6 That dragged down Biogen’s overall revenues, which fell 18% to $2.2

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

XTalks

JULY 12, 2021

head of research and development at Biogen, in a statement from the company. The FDA’s approval of Biogen’s Alzheimer’s drug about a month ago on June 7 sparked harsh criticism because although the drug has been shown to reduce amyloid beta plaques in the brain (a surrogate endpoint), there was no clear associated clinical benefit.

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The current pharma business model is unsustainable

World of DTC Marketing

SEPTEMBER 7, 2022

In pharma, growth depends on new products with hefty price tags when over 80% of voters want lower costs for their prescription drugs. Biogen’s failure should be a warning to other pharma companies. Now Biogen is a shell of a company selling off assets to survive.

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FDA begins review of Samsung Bioepis/Biogen’s Lucentis biosimilar

pharmaphorum

NOVEMBER 19, 2020

Novartis/Genentech’s eye drug Lucentis could be the next big blockbuster to face competition from cheaper biosimilars after its US patent expired this year – and Samsung Bioepis and Biogen are closing in after the FDA accepted a filing for their cut-price rival.

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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

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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. Biogen and Eisai have another go appeared first on. Here we go again. The post Exit Aduhelm, enter lecanemab.

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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. Under the FDA’s accelerated approval pathway , Biogen has several years to conduct a required confirmatory post-approval clinical trial.

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Free access to Zolgensma curbed, says Novartis

pharmaphorum

JANUARY 9, 2023

Along with Zolgensma – which made its debut in 2019 – Biogen has had approval to market its antisense-based therapy Spinraza (nusinersen) since 2016, while Roche got a green light for its orally-administered therapy Evrysdi (risdiplam) in 2020. .

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NICE reaches a deal with Roche on access to oral SMA drug Evrysdi

pharmaphorum

NOVEMBER 19, 2021

The agreement has been hailed by patient associations, as it adds to current treatment options for the progressive muscle wasting disease – Biogen’s injectable Spinraza (nusinersen) and one-shot gene therapy with Novartis’ Zolgensma (onasemnogene abeparvovec) – which are also backed by NICE.

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The FDA and Aduhelm: WTF?

World of DTC Marketing

JUNE 23, 2021

Alzheimer’s really is a devastating diagnosis, and if Biogen had actually produced a game-changing product to slow its worst symptoms, it would have an immeasurable impact on millions of lives. Not to mention the $56,000 annual price tag. What’s more, 40 percent of those subjects suffered side effects, including severe brain swelling.

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Leading innovators in peptide nano-particle conjugates for the pharmaceutical industry

Pharmaceutical Technology

MAY 15, 2023

Innovation S-curve for the pharmaceutical industry Peptide nano-particle conjugates is a key innovation area in the pharmaceutical industry By tagging peptides with nanoparticles, peptide nano-particle conjugates allow enhanced control over their biological behaviour, overcoming intrinsic limitations of the individual materials.

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

XTalks

APRIL 18, 2024

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. Previously, Roche secured an FDA breakthrough tag for another one of its Alzheimer’s blood tests that detects levels of pTau-181 and ApoE4 (apolipoprotein e4).

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NICE ‘no’ to Roche’s risdiplam for SMA not unexpected, says patient group

pharmaphorum

JUNE 2, 2021

The orally-administered drug is the third approved treatment for SMA after Biogen’s injectable Spinraza (nusinersen) and Novartis’ one-shot gene therapy Zolgensma (onasemnogene abeparvovec), which was administered to the first NHS patient this week. — Spinal Muscular Atrophy UK (@SMA_UK_) June 2, 2021.

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J&J builds case for antidepressant Spravato with head-to-head trial

pharmaphorum

NOVEMBER 24, 2022

One issue has been the cost of the drug, with health technology assessment agency NICE in the UK and the ICER organisation in the US both concluding its price tag means it is not a cost-effective option for health systems. The post J&J builds case for antidepressant Spravato with head-to-head trial appeared first on.

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New Rare Disease Drugs and Research Advancements

XTalks

FEBRUARY 27, 2024

Developed by Reata Pharmaceuticals, which Biogen acquired later that year, it is the first and only treatment for the condition, which is classified as an ultra-rare neuromuscular condition that damages the nervous system to affect movement. Sarepta hopes to clarify Elvidys’ effectiveness in older children in a confirmatory trial.

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

XTalks

AUGUST 23, 2021

However, Biogen will still need to conduct additional studies to demonstrate to the FDA that aducanumab has clinical benefit. With a $56,000 price tag for a year’s worth of treatment, Aduhelm is far from the most expensive drug on the market. This is another case in which careful clinical trial design is of the utmost importance.

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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.

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Prescription drug prices are out of cotrol

World of DTC Marketing

JUNE 16, 2021

The pharma industry has been riding a wave of public approval since they developed a vaccine to fight COVID-19, but that goodwill is going to be short lived thanks, in part, to the $56,000 price tag of Biogen’s new drug and insulin that too many people still can’t afford.

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Clinical Research Informer

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

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

Trending Sources

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

What is Biogen and can they repair their reputation?

STAT+: The FDA has approved a new Alzheimer’s drug, but wide access may depend on CMS easing restrictions

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

Biogen’s Aduhelm rollout goes from bad to worse

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

The current pharma business model is unsustainable

FDA begins review of Samsung Bioepis/Biogen’s Lucentis biosimilar

Biogen updates on its confirmatory Aduhelm trial

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

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

Free access to Zolgensma curbed, says Novartis

NICE reaches a deal with Roche on access to oral SMA drug Evrysdi

The FDA and Aduhelm: WTF?

Leading innovators in peptide nano-particle conjugates for the pharmaceutical industry

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

NICE ‘no’ to Roche’s risdiplam for SMA not unexpected, says patient group

J&J builds case for antidepressant Spravato with head-to-head trial

New Rare Disease Drugs and Research Advancements

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

Viagra ‘should be tested as Alzheimer’s therapy’

Prescription drug prices are out of cotrol

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