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Biogen soars 64% after FDA approves first new Alzheimer's drug in 18 years

12 days ago   |   By Business Insider

Summary List Placement Shares of Biogen soared as much as 64% to their highest since 2015 on Monday after the US Food and Drug Administration approved the company's treatment for Alzheimer's disease .
The approval marks the first new drug for Alzheimer's in 18 years - and the first treatment cleared by American regulators to slow cognitive decline in people with Alzheimer's.
The drug, called aduhelm, is engineered to break down the sticky plaque that builds up in the brains of people with Alzheimer's. It was previously known as aducanumab.
The success of the Cambridge, Massachusetts-based...
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US approves first new Alzheimer's drug in 20 years

US approves first new Alzheimer's drug in 20 years

12 days ago   |   By Evening Standard

US government health officials have approved the first new drug for Alzheimer's disease in nearly 20 years, paving the way for its possible use in the UK.
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FDA grants historic approval to Alzheimer's drug designed to slow cognitive decline

12 days ago   |   By STAT

The Food and Drug Administration on Monday approved the first new treatment for Alzheimer's disease in nearly two decades, a landmark decision that has been eagerly awaited by millions of Americans diagnosed with the condition but that will be hotly contested by some in the scientific community who doubt the drug's effectiveness.
While other drugs treat symptoms of Alzheimer's, the new medicine, called Aduhelm, is the first to attack what some believe is an underlying cause of the disease and slow cognitive decline, albeit marginally. It does so by eliminating clumps of a toxic protein...
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Opinion: FDA's approval of aducanumab paves the way for ‘more momentous' Alzheimer's breakthroughs

12 days ago   |   By STAT

The Food and Drug Administration yanked the fight against Alzheimer's out of the mire with its approval of the first disease-modifying therapy. Although it's a modest first step, it paves the way for more momentous breakthroughs.
The drug - aducanumab by Biogen and Eisai - is a monoclonal antibody that clears a toxic protein called beta-amyloid from the brain. The drug can't reverse Alzheimer's-related damage once amyloid has seized a beachhead and symptoms of the disease emerge. Its promise lies in battling amyloid before it does irreversible harm.
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STAT+: By approving Biogen's Alzheimer's drug, the FDA is shifting its rules. That is a giant risk

12 days ago   |   By STAT

In order to approve a new Alzheimer's treatment, the Food and Drug Administration is rewriting its rulebook, an enormously risky move that could accelerate the public's access to medicines but upend the future of drug regulation, forcing the 114-year-old agency to do the equivalent of redesigning a fighter plane in mid-flight.
With its conditional clearance of Biogen's Aduhelm , the FDA is creating a framework that could require less certain evidence of safety and efficacy for medicines beyond Alzheimer's treatments. In doing so, it is choosing to alter many of its well-established...
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First drug to work on Alzheimer's approved with calls for NHS to offer it

First drug to work on Alzheimer's approved with calls for NHS to offer it

12 days ago   |   By The Mirror

Campaigners hope the Biogen drug - which can treat the underlying disease - could be offered on the NHS by next year, though some experts argue there is not enough evidence yet it actually works
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US officials approve new Alzheimer's treatment despite experts' concerns

12 days ago   |   By Belfast telegraph

US government health officials approved the first new drug for Alzheimer's disease in nearly 20 years, disregarding warnings from independent advisers that the much-debated treatment has not been shown to help slow the brain-destroying disease.
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Controversial Alzheimer's drug becomes first new treatment approved in US for 20 years

12 days ago   |   By The Independent

The US Food and Drug Administration on Monday approved the use of Aduhelm to treat Alzheimer's, the first medication of its kind approved in nearly 20 years. An outside panel of experts cautioned the FDA against approving the drug last year, warning that it wasn't effective enough for treatment.
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FDA approves first new Alzheimer's disease drug in close to 20 years - despite controversy over trial results

12 days ago   |   By The Sun


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Controversial new 'blockbuster' Alzheimer's drug approved by US regulators

Controversial new 'blockbuster' Alzheimer's drug approved by US regulators

12 days ago   |   By The Telegraph


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First new Alzheimer's treatment for almost 20 years approved in US

12 days ago   |   By Metro

US regulators have approved the first new Alzheimer's drug in nearly 20 years, against the advice of their own outside experts.
More follows.
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The FDA just approved the first new Alzheimer's drug in 18 years

The FDA just approved the first new Alzheimer's drug in 18 years

12 days ago   |   By Business Insider

Summary List Placement The Food and Drug Administration has approved Biogen's Alzheimer's disease treatment, ushering in the first new drug for the disease in nearly two decades.
The drug, which was previously known as aducanumab but will be sold under the brand name Aduhelm, is designed to erode the sticky plaque that builds up in the brains of Alzheimer's patients. Scientists theorize the substance kills brain cells and causes the memory loss characteristic to the disease.
An advisory committee voted in November that Biogen's tests failed to show the drug effectively treats Alzheimer's...
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