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ISPOR Panelists: Can the FDA Advisory Committee Process Be Strengthened?

Panelists at the leading health economics and outcomes conference discuss whether the FDA's process for allowing outside experts to weigh in on drug approvals needs changes. ....

United States , Emory University , Joseph Daval , Genevieve Kanter , David Howard , Medicare Evidence Development , Rubix Health , Society For Health Economics , University Of Southern California , Outcomes Research , Medicare Advisory Committee , Advisory Committee , Program On Regulation , Coverage Advisory Committee , Harvard University , Professional Society , Health Economics , Chief Counsel , Image Credit , Affordable Care Act , Fda Advisory Committee ,

Biogen stock up as sales of Leqembi beat expectations

Biogen's Leqembi, the first drug to slow the progression of Alzheimer's, launched last year ....

United Kingdom , United States , Christopher Viehbacher , Drug Administration , Brian Snyder , Japan Based Eisai , Christopher Viehbacher , Spinal Muscular Atrophy ,

Aduhelm kaput in Alzheimer's, Biogen leans into Leqembi

Biogen Inc.’s problematic trip with Aduhelm (aducanumab-avwa) for Alzheimer’s disease at last came to an end as the company, probably surprising few on Wall Street, said it’s quitting sales and development of the amyloid-beta directed antibody. The drug won accelerated approval by the U.S. FDA in July 2021. ....

United Kingdom , Biogen Inc , Wall Street , Biogen Inc , Alzheimers Disease , Neurology Psychiatric ,

Aduhelm Went From Being Hailed A "Game Changer" To Becoming A Dud

Biogen announced it will discontinue marketing the Alzheimer’s drug Aduhelm. This ends the tortuous saga of a once-promising treatment for the memory-robbing disease. ....

New York , United States , Drug Administration , New York Times , Centers For Medicare , Eli Lilly , Clinical Trials On Alzheimer Disease Congress , Clinical Trials , Disease Congress , New England Journal , Alzheimers Disease , Beta Amyloid Plaque ,

It's Finally Over for Aduhelm, the Sketchy Alzheimer's Drug Everyone Hated

The FDA approved Biogen's $56,000 anti-amyloid drug in 2021, against the advice of outside experts. ....

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