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International

Deena Beasley

Analysis: Rival treatments may help justify FDA gamble with Biogen Alzheimer's drug

Jun 18 2021

Data from clinical trials of three experimental Alzheimer's disease drugs expected to start emerging next year could help shed light on whether U.S. regulators were justified in their controversial approval of a Biogen Inc treatment without clear evidence that it works.

First patient receives controversial Biogen Alzheimer's drug

Jun 17 2021

A U.S. hospital on Wednesday gave the first infusion of an expensive, controversial new Alzheimer's drug from Biogen Inc before Medicare had even said what it will pay for - and with some doctors upset by its approval last week. | Video

First patient set to receive controversial Biogen Alzheimer's drug

Jun 16 2021

June 16 A U.S. hospital on Wednesday will give the first infusion of an expensive, controversial new Alzheimer's drug from Biogen Inc before Medicare had even said what it will pay for - and with some doctors upset by its approval last week.

Analysis: U.S. FDA faces mounting criticism over Alzheimer's drug approval

Jun 11 2021

In approving the first new Alzheimer's drug in nearly 20 years, the U.S. Food and Drug Administration is taking its biggest risk yet with a strategy that allows new therapies onto the market without strong evidence that they work, regulatory and scientific experts say. | Video

Two members of U.S. FDA advisory panel resign over Alzheimer's drug approval

Jun 09 2021

Two members of a panel of outside advisors to the U.S. Food and Drug Administration have resigned in protest at the agency's decision to approve Biogen Inc's Aduhelm for treatment of Alzheimer's disease despite the committee’s recommendation against doing so.

U.S. approval of Biogen Alzheimer's drug sends shares soaring, hailed as 'big day" for patients

Jun 07 2021

(Reuters) -U.S. regulators on Monday approved Biogen Inc's aducanumab as the first treatment to attack a likely cause of Alzheimer's disease despite controversy over whether the clinical evidence proves the drug works, sending its shares soaring. | Video

Explainer: What does FDA approval of Biogen's Alzheimer's drug mean for patients?

Jun 07 2021

The U.S. Food and Drug Administration has approved Biogen's aducanumab, the first drug to target an underlying cause of Alzheimer's disease. The drug, to be sold under the brand Aduhelm, is the first new approval of an Alzheimer's drug since 2003 and the only treatment designed to slow progression of the mind-robbing disease.

U.S. FDA set to rule on controversial Biogen Alzheimer's drug

Jun 07 2021

June 7 The U.S. FDA on Monday is expected to give its thumbs up or down on Biogen Inc's aducanumab, a decision that will affect the future of Alzheimer's disease research and treatment and show the agency's willingness to approve badly needed medicines based on less than definitive data.

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