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Biogen will stop selling its controversial Alzheimer’s drug Aduhelm
10 months, 3 weeks ago

Biogen will stop selling its controversial Alzheimer’s drug Aduhelm

Associated Press  

Biogen will stop selling its Alzheimer’s treatment Aduhelm, a drug once seen as a potential blockbuster that stumbled after its launch a few years ago. The company also is helping Japanese drugmaker Eisai sell another Alzheimer’s treatment, Leqembi, which received full FDA approval last summer. When Aduhelm debuted in 2021, it was the first new Alzheimer’s drug in nearly two …

Patients Drug Fda Biogen Leqembi Full Approval Aduhelm
US: FDA approves anti-Alzheimer's drug
1 year, 11 months ago

US: FDA approves anti-Alzheimer's drug

Hindustan Times  

The US Food and Drug Administration on Friday approved a new drug designed to slow cognitive decline in those suffering from Alzheimer's disease. It follows the approval of the anti-Alzheimer's drug Aduhelm, which a US congressional investigation criticized for alleged "irregularities." The FDA said in a statement that Leqembi and Aduhelm represent "an important advancement in the ongoing fight to …

Disease Drug Biogen Leqembi Fda Approved
Probe: Alzheimer’s drug approval ‘rife with irregularities’
1 year, 11 months ago

Probe: Alzheimer’s drug approval ‘rife with irregularities’

Associated Press  

WASHINGTON — The Food and Drug Administration’s contentious approval of a questionable Alzheimer’s drug took another hit Thursday as congressional investigators called the process “rife with irregularities.” The 18-month investigation by two House committees detailed “atypical collaboration” between FDA regulators and a company it’s supposed to oversee -- Aduhelm manufacturer Biogen. Thursday’s report urged the agency to “take swift action” …

Drug Fda Biogen Aduhelm
Alzheimer’s drug approval by FDA ‘rife with irregularities,’ probe finds
1 year, 11 months ago

Alzheimer’s drug approval by FDA ‘rife with irregularities,’ probe finds

LA Times  

The FDA’s contentious approval of the questionable Alzheimer’s drug Aduhelm took another hit, as congressional investigators called the process “rife with irregularities.” The Food and Drug Administration’s contentious approval of a questionable Alzheimer’s drug took another hit Thursday as congressional investigators called the process “rife with irregularities.” The 18-month investigation by two House committees detailed “atypical collaboration” between FDA regulators …

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Change at the top for Biogen after Alzheimer’s drug flops
2 years, 7 months ago

Change at the top for Biogen after Alzheimer’s drug flops

Associated Press  

Biogen will replace its CEO and largely abandon marketing of its controversial Alzheimer’s drug Aduhelm less than a year after the medication’s launch triggered a backlash from experts, doctors and insurers. For now, Biogen said it is “substantially eliminating” spending on Aduhelm as part of a $1 billion dollar cost-saving plan designed to refocus the company’s flagging biotech business. Aduhelm …

Medicare Company Drug Biogen Aduhelm
Op-Ed: The first treatment for Alzheimer’s taught us some hard lessons
2 years, 10 months ago

Op-Ed: The first treatment for Alzheimer’s taught us some hard lessons

LA Times  

An Alzheimer’s patient in a trial of aducanumab, also known as Aduhelm, has been receiving infusions since 2014. The Food and Drug Administration’s surprise approval of Aduhelm for the treatment of Alzheimer’s disease last year was a mess on practically every level. Because this was the first drug ever prescribed to fight the progression of Alzheimer’s, it revealed just how …

Treatment Trial Patients Drug Aduhelm Hard Lessons
Medicare limits coverage of $28,000-a-year Alzheimer’s drug
2 years, 11 months ago

Medicare limits coverage of $28,000-a-year Alzheimer’s drug

Associated Press  

WASHINGTON — Medicare said Tuesday it will limit coverage of a $28,000-a-year Alzheimer’s drug whose benefits have been widely questioned, a major development in the nation’s tug-of-war over the fair value of new medicines that offer tantalizing possibilities but come with prohibitive prices. “CMS has been and remains committed to providing the American public with a clear, trusted, evidence-based decision …

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Medicare limits coverage of $28,000-a-year Alzheimer’s drug
2 years, 11 months ago

Medicare limits coverage of $28,000-a-year Alzheimer’s drug

LA Times  

Medicare said Tuesday it will limit coverage of a $28,000-a-year Alzheimer’s drug whose benefits have been widely questioned, a major development in the nation’s tug-of-war over the fair value of new medicines that offer tantalizing possibilities but come with prohibitive prices. “Alzheimer’s disease is a devastating illness that has touched the lives of millions of American families,” Medicare administrator Chiquita …

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Biogen cuts the price tag on its Alzheimer’s drug in half
3 years ago

Biogen cuts the price tag on its Alzheimer’s drug in half

Associated Press  

Biogen is slashing the price of its Alzheimer’s treatment in half months after it debuted to widespread criticism for an initial cost that could reach $56,000 annually. Biogen CEO Michel Vounatsos said in a prepared statement that too many patients were not being offered the drug due to “financial considerations,” and their disease had progressed beyond the point where Aduhelm …

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Alzheimer’s drug Aduhelm is a key factor driving up Medicare premiums
3 years, 1 month ago

Alzheimer’s drug Aduhelm is a key factor driving up Medicare premiums

CNN  

CNN — When the US Food and Drug Administration approved a costly new drug for Alzheimer’s disease, Aduhelm, earlier this year, experts warned that all of Medicare’s more than 63 million enrollees could wind up paying the price. “This does show how just one drug could have a major impact on spending and premiums,” said Tricia Neuman, executive director of …

Medicare Premium Spending Drug Fda Cms Aduhelm
Column: How the FDA’s lousy judgment and a greedy drug company combined to hit Medicare members hard
3 years, 1 month ago

Column: How the FDA’s lousy judgment and a greedy drug company combined to hit Medicare members hard

LA Times  

The fallout from the Food and Drug Administration’s hasty approval of a new Alzheimer’s drug in June was predicted to be severe: Excessive pricing for a drug lacking strong evidence of effectiveness would impose heavy costs on the healthcare system nationwide, especially on Medicare. The coverage determination process is still underway, but Medicare officials said they’re duty-bound to “plan for …

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In quiet debut, Alzheimer’s drug finds questions, skepticism
3 years, 2 months ago

In quiet debut, Alzheimer’s drug finds questions, skepticism

Associated Press  

The first new Alzheimer’s treatment in more than 20 years was hailed as a breakthrough when regulators approved it more than four months ago, but its rollout has been slowed by questions about its price and how well it works. “It’s like a breath of fresh air,” said Dr. Stephen Salloway, a Rhode Island neurologist and Biogen consultant who is …

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Aduhelm: The hard math on the new $56,000 Alzheimer’s drug
3 years, 5 months ago

Aduhelm: The hard math on the new $56,000 Alzheimer’s drug

CNN  

A version of this story appeared in CNN’s What Matters newsletter. To get it in your inbox, sign up for free here CNN — The new Alzheimer’s drug Aduhelm costs $56,000 per person, per year – so much that it would affect the economics of Medicare. “In all studies in which it was evaluated, however, Aduhelm consistently and very convincingly …

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Biogen’s Aduhelm: US lawmakers launch investigation into FDA approval and price of new Alzheimer’s drug
3 years, 5 months ago

Biogen’s Aduhelm: US lawmakers launch investigation into FDA approval and price of new Alzheimer’s drug

CNN  

CNN — Two House committees have launched an investigation into the approval and pricing of the Alzheimer’s disease drug aducanumab, made by the company Biogen and sold under the brand name Aduhelm. “We have serious concerns about the steep price of Biogen’s new Alzheimer’s drug Aduhelm and the process that led to its approval despite questions about the drug’s clinical …

Disease Evidence Cnn Committee Drug Approval Fda
Alzheimer’s drug stirs hope for patients, worry for doctors
3 years, 5 months ago

Alzheimer’s drug stirs hope for patients, worry for doctors

LA Times  

Michele Hall, who has early Alzheimer’s, calls the new drug Aduhelm “the first tiny glimmer of hope” that she might have more quality time with her husband and their three adult children. In the weeks since a new Alzheimer’s drug was approved, hopeful patients have bombarded Dr. Alireza Atri with calls and emails about a treatment that has sparked both …

Disease Patients Early Drug Fda Biogen Aduhelm
Alzheimer’s drug stirs hope for patients, worry for doctors
3 years, 5 months ago

Alzheimer’s drug stirs hope for patients, worry for doctors

Associated Press  

In the weeks since a new Alzheimer’s drug was approved, hopeful patients have bombarded Dr. Alireza Atri with calls and emails about a treatment that has sparked both excitement and skepticism. “I don’t want to see people pull their mothers from nursing homes to get this treatment,” said Dr. Babak Tousi, a Cleveland Clinic geriatrician who consulted with Biogen and …

Disease Patients Early Drug Fda Biogen Aduhelm
Column: The FDA’s hasty approval of a new Alzheimer’s drug is looking worse than ever
3 years, 6 months ago

Column: The FDA’s hasty approval of a new Alzheimer’s drug is looking worse than ever

LA Times  

Following a year in which the Food and Drug Administration meekly allowed President Trump to denigrate its integrity and undermine its judgment, it wasn’t clear that the agency could fall even lower in public and professional esteem. The FDA’s widely criticized decision on June 7 to approve the new Alzheimer’s drug Aduhelm despite a nearly complete absence of evidence that …

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Why The FDA's Approval Of A New Alzheimer's Drug Should Worry You
3 years, 6 months ago

Why The FDA's Approval Of A New Alzheimer's Drug Should Worry You

Huff Post  

LOADING ERROR LOADING You might expect Mariah Robertson to applaud last week’s approval of a new drug for Alzheimer’s disease. In the meantime, the Aduhelm decision could set a precedent for how the FDA approaches other treatments ― an “enormously risky move,” as STAT writer Matthew Herper put it, “that could accelerate the public’s access to medicines but upend the …

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For Those Facing Alzheimer's, A Controversial Drug Offers Hope
3 years, 6 months ago

For Those Facing Alzheimer's, A Controversial Drug Offers Hope

NPR  

For Those Facing Alzheimer's, A Controversial Drug Offers Hope Enlarge this image toggle caption Biogen/AP Biogen/AP Soon after Phillip Lynn got married in 2014, he began to forget things. Sponsor Message "My jaw kind of hit the floor because this was the first one that we'd read about that actually does anything to address the disease, not just the side …

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Medicare copays for new Alzheimer’s drug could reach $11,500
3 years, 6 months ago

Medicare copays for new Alzheimer’s drug could reach $11,500

Associated Press  

WASHINGTON — A new $56,000-a-year Alzheimer’s drug would raise Medicare premiums broadly, and some patients who are prescribed the medication could face copayments of about $11,500 annually, according to a research report published Thursday. “At this price, the cost of this one drug alone could top all others covered by Medicare, if it is used widely,” said Tricia Neuman, coauthor …

Medicare Price Drug Fda Medication Biogen Aduhelm
Medicare Copays For New Alzheimer's Drug Could Reach $11,500 Annually
3 years, 6 months ago

Medicare Copays For New Alzheimer's Drug Could Reach $11,500 Annually

NPR  

Medicare Copays For New Alzheimer's Drug Could Reach $11,500 Annually Enlarge this image toggle caption Biogen via AP Biogen via AP WASHINGTON — A new $56,000-a-year Alzheimer's drug would raise Medicare premiums broadly, and some patients who are prescribed the medication could face copayments of about $11,500 annually, according to a research report published Thursday. "At this price, the cost …

Medicare Price Drug Fda Kaiser Biogen Aduhelm