Biogen

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Biogen Abandons Aduhelm After Problem-Filled Launch
Maker Gives Up
on Alzheimer's Drug

Maker Gives Up on Alzheimer's Drug

Approval process, pricing, and murky benefits contributed to Aduhelm's failure on the market

(Newser) - Biogen announced Wednesday that it is stopping its clinical trials of an Alzheimer's drug, will no longer sell it, and is forsaking the ownership rights. Along with federal regulators, the company had faced major criticism over the development and pricing—at $56,000 per year—of Aduhelm. Biogen said...

Japan's Dementia Treatment 'Has Now Entered a New Era'

Country with rapidly aging population OKs its first Alzheimer's drug

(Newser) - Japan's Health Ministry has approved Leqembi, a drug for Alzheimer's disease that was jointly developed by Japanese and US pharmaceutical companies. As the AP reports, it's the first drug for treatment of the disease in a country with a rapidly aging population. Developed by Japanese drugmaker Eisai...

After Aduhelm Debacle, New Alzheimer's Drug Emerges

Biogen, partner Eisai: Clinical trial for lecanemab shows promising 27% slowing of cognitive decline

(Newser) - Last year, the FDA approved aducanumab , marketed as Aduhelm , a controversial drug made by Biogen and its Japanese partner Eisai to treat Alzheimer's. Things didn't go well, though, with expert opposition to the costly medication and a final death blow to its place in the market after Medicare...

Maker Cuts Price of Alzheimer's Drug in Half

The medication wasn't catching on at more than $50K per year, Biogen says

(Newser) - Biogen is slashing the price of its Alzheimer's treatment in half, months after it debuted to widespread criticism over an initial cost that could reach $56,000 annually. The drugmaker said Monday that it will cut the wholesale acquisition cost of the drug by about 50% next month. That...

iPhones of the Future May Keep Tabs on Your Mental Health

Apple has teamed up with Biogen, UCLA to study depression, anxiety, cognitive decline

(Newser) - We rely on our devices for practically everything these days, and Apple apparently hopes we'll soon check our iPhones to get a better handle on our mental health. The tech giant has previously teamed up with UCLA on mental health research, and with pharmaceuticals company Biogen on studying cognitive...

2 Health Care Systems Won't Use Aduhelm Yet

Cleveland Clinic, Mount Sinai wait for results of investigation into FDA approval process

(Newser) - Although a new drug for treating Alzheimer's cleared the Food and Drug Administration's approval process, a pair of large health systems say it has not cleared theirs. The Cleveland Clinic and Mount Sinai Health System in New York won't administer Aduhelm to patients until they have more...

FDA Approval of Alzheimer's Drug to Be Reviewed

Agency chief fears damage to public confidence in process

(Newser) - The acting head of the Food and Drug Administration wants the agency's inspector general to conduct an independent review of the agency's approval of a new drug to treat Alzheimer's. The approval process, which one outside adviser had called a "sham" as he resigned, has been...

FDA Walks Back Broad Alzheimer's Drug Advice

After criticism, agency says label will limit candidates to those with mild symptoms

(Newser) - After being widely criticized for approving the use of a new drug to treat all Alzheimer's patients, despite only limited evidence that it works, the Food and Drug Administration has stepped back from that decision. The agency announced its new instructions Thursday that say Aduhelm is intended only for...

New Alzheimer's Drug Spurs Big Concerns, an Investigation

2 House committees launch inquiry into approval, cost of Biogen's Aduhelm

(Newser) - It was supposed to have been a "cause for celebration," but instead, it's become a "catastrophe in the making." That's Axios' recent take on Aduhelm , the costly new Alzheimer's drug that was approved by the Food and Drug Administration despite major reservations from...

Cost of Alzheimer's Drug Could Push Medicare to the Brink

Biogen product would nearly double program's medication budget, though it might not work

(Newser) - The Food and Drug Administration's approval of a new drug to treat Alzheimer's disease could have enormous implications not just for patients, but for Medicare—even pushing the program toward collapse. FDA approval historically has meant Medicare will cover the cost of the medication, but with Biogen's...

Reagan's Daughter Has a Fear About Alzheimer's Drug

What if Aduhelm keeps people in an awful state of limbo, asks Patti Davis

(Newser) - Ronald Reagan's daughter is raising a concern about Aduhelm , the first new drug approved to treat Alzheimer's in nearly 20 years. In an essay at USA Today , Patti Davis recalls the "heartbreaking" early stages of her father's disease. He would struggle to come up with a...

FDA Advisers Quit Over Alzheimer's Drug: 'Sham Process'

They're not happy the agency OK'd Biogen's Aduhelm against panel's recommendation

(Newser) - The week kicked off with controversy swirling around aducanumab, the drug being marketed by Biogen as Aduhelm to treat Alzheimer's disease. The drama continues, with two members of an advisory panel to the Food and Drug Administration stepping down over the agency's decision to OK the drug against...

That New Alzheimer's Drug Costs Way More Than Expected
Analysts Blindsided by Price
of New Alzheimer's Drug
the rundown

Analysts Blindsided by Price of New Alzheimer's Drug

A year of Biogen's Aduhelm will run $56K

(Newser) - Monday brought the big news that the FDA had approved the first new Alzheimer’s drug in 20 years. Then came news of its price tag. That would be $56,000 for a year's worth of Aduhelm, also known as aducanumab (a user's out-of-pocket cost would depend on...

Biogen Soars 40% After FDA Approves New Drug
Biogen Soars 40% After
FDA Approves New Drug
MARKETS

Biogen Soars 40% After FDA Approves New Drug

Firm was biggest gainer in S&P 500

(Newser) - Stocks clawed back much of their early losses and ended mixed on Wall Street Monday. The S&P 500 slipped less than 0.1% and the Nasdaq rose 0.5%. The subdued opening to the week follows several choppy weeks as investors continue to gauge the economy’s recovery and...

FDA Approves Controversial New Alzheimer's Drug

Biogen's aducanumab receives green light, despite questions about effectiveness

(Newser) - Big news in the world of Alzheimer's: The FDA on Monday approved the first new treatment in nearly 20 years, disregarding warnings from independent advisers that the drug hasn't been shown to help slow the brain-destroying disease, per the AP . The drug aducanumab is made by Biogen and...

One Business Conference Leads to 20K COVID Cases
From a Single Get-Together,
20K COVID Cases
in case you missed it

From a Single Get-Together, 20K COVID Cases

Researchers say Biogen's February meeting in Boston was a super-spreader event

(Newser) - When the drug company Biogen held a conference at a Boston hotel on Feb. 26-27, the US had a grand total of 15 coronavirus cases on the books, notes the Washington Post . That would change quickly, of course, and a new study demonstrates how events like this international conference helped...

Sofa-Treating Chemical Reborn as Major MS Drug

Analyst predicts $1.7B in Tecfidera sales by 2015

(Newser) - As a sofa-treating agent, dimethyl fumarate gave people blisters and rashes, but now it's getting a second chance—as a much ballyhooed multiple sclerosis drug called Tecfidera, whose sales could be enormous. Among doctors, there's "a strong consensus that Tecfidera offers a more favorable clinical profile than...

Company Pulls Drug for Lou Gehrig's Disease

Biogen ends development after it fails drug trial

(Newser) - An experimental drug that showed promise of becoming the first effective treatment for Lou Gehrig’s Disease is being pulled by its manufacturer because it performed miserably in a major drug trial. Biogen says its drug, dexpramipexole, did nothing to improve the condition of patients or extend their lives, reports...

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