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Alzheimer's Food and Drug Administration (FDA)

Cozen O'Connor

Bipartisan AGs Advocate for Unrestricted Access to Alzheimer’s Disease Treatment for Medicare, Medicaid Patients

Cozen O'Connor on

A bipartisan coalition of 26 AGs, led by Oklahoma AG Drummond and Minnesota AG Ellison, wrote a letter to the Centers for Medicare & Medicaid Services (CMS) and HHS urging them to provide full, unrestricted coverage of an...more

Goodwin

Medicare Agrees to Limited Payment for New Alzheimer’s Drug

Goodwin on

On January 11, 2022, the Centers for Medicare and Medicaid Services (CMS) released a proposed National Coverage Determination (NCD) decision memo limiting Medicare coverage for Biogen’s new Alzheimer’s drug, Aduhelm. Under...more

Wilson Sonsini Goodrich & Rosati

FDA Grants Historic Approval for Alzheimer's Disease Therapy in Permissive Decision

On June 7, 2021, the U.S. Food and Drug Administration (FDA) approved Biogen, Inc.'s Aduhelm (aducanumab) to treat Alzheimer's disease through the FDA Accelerated Approval Program in a landmark decision. The FDA's approval...more

Rivkin Radler LLP

CBD Health Claims Raise FTC’s Hackles (And Prompt Class Action Suits)

Rivkin Radler LLP on

Near the end of 2020, in mid-December, the Federal Trade Commission (FTC) launched what it referred to as “Operation CBDeceit,” a law enforcement sweep challenging allegedly unproven representations that CBD products could...more

Womble Bond Dickinson

Therapeutic Drugs and the Blood Brain Barrier: How to Break on Through to the Other Side

Womble Bond Dickinson on

We have all seen the headlines on traumatic brain injuries (TBI) and litigation – they run the gamut from sports injuries to motor vehicle accidents. What we don’t hear about is one of the biggest obstacles in treating brain...more

McGuireWoods LLP

Washington Healthcare Update

McGuireWoods LLP on

This Week: CMS Releases Guidance on Fast Track Process for 1115 Waivers for Medicaid and CHIP... Healthcare.gov CEO Sends Letter to State Insurance Commissioners Concerning 2016 Premium Decisions... Medicare Board of Trustees...more

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