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Amylyx Pharmaceuticals, Inc.

http://amylyx.com

Latest From Amylyx Pharmaceuticals, Inc.

US FDA’s ALS Science Strategy Includes Near-Term Rare Neurodegenerative Disease Task Force

Five-year plan includes multi-phased approach to ALS at the same time that Amylyx’s AMX0035 is pending review with a late September decision deadline; action plan’s mid-term priorities for FY 2023-2024 include a cell and gene therapies safety project.

Drug Approval Standards Rare Diseases

Amylyx ALS Drug May Drive Medicare Part D Redesign Efforts Based On Cost Sharing Concerns

Medicare could be an important payer for the eagerly awaited drug because the program covers ALS treatments for patients under 65 as well as older ones. Meanwhile, a draft Institute for Clinical and Economic Review raises questions about the drug's cost effectiveness.

Medicare Health Technology Assessment

Aduhelm, One Year Later: US FDA’s Credibility, Accelerated Approval Pathway Feel The Bite From Alzheimer’s Drug Approval

June 7 marks the one-year anniversary of the accelerated approval of Biogen’s aducanumab, an event that still reverberates throughout the drug development community. While the FDA continues to defend the approval, experts say the backlash has caused the agency to become more reluctant to use the expedited pathway. Meanwhile, Alzheimer’s patients find themselves where they were a year ago: without ready access to a disease-modifying therapy.

Approvals Review Pathway

Aduhelm, One Year Later: US FDA’s Credibility, Accelerated Approval Pathway Feel The Bite From Alzheimer’s Drug Approval

June 7 marks the one-year anniversary of the accelerated approval of Biogen’s aducanumab, an event that still reverberates throughout the drug development community. While the FDA continues to defend the approval, experts say the backlash has caused the agency to become more reluctant to use the expedited pathway. Meanwhile, Alzheimer’s patients find themselves where they were a year ago: without ready access to a disease-modifying therapy.

Approvals Review Pathway
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