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Amylyx Pharmaceuticals, Inc.

http://amylyx.com

Latest From Amylyx Pharmaceuticals, Inc.

Biogen Prepares More Doubtful Phase III Results For FDA Scrutiny, This Time In ALS

After the Aduhelm controversy, Biogen has another neurodegenerative disease drug which so far can only show efficacy against surrogate biomarkers – will the FDA be swayed again this time?

Clinical Trials Commercial

US FDA Panel To Weigh Whether Copiktra’s Benefit-Risk Profile In Hematologic Cancers Has Changed

Adverse trend in overall survival, tolerability concerns, and uncertainty regarding the dose suggest the PI3K inhibitor's benefit-risk profile in its current indications is unfavorable, FDA says. Secura Bio asserts OS data are confounded and safety issues are the same as at initial approval.

Advisory Committees Drug Review

Amylyx’s ALS Pledge Vs. FDA’s Obscure Withdrawal Authority: Which Holds More Power?

Office of Neuroscience Director Billy Dunn touted FDA’s ability to withdraw approval for AMX0035 if subsequent data indicate a lack of substantial evidence of effectiveness. However, this provision appears to have been infrequently used and involves a potentially time-consuming hearing.

Advisory Committees Drug Approval Standards

ICER Pushes ALS Drug Makers To Moderate Launch Price While Awaiting Confirmatory Data

The US drug pricing watch dog issued a final assessment on Amylyx's AMX0035 and Mitsubishi Tanabe's Radicava for ALS.

Pricing Debate Neurology
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