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ACADIA Pharmaceuticals Inc.

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Amylyx Relyvrio: Pricing, Compounding, And The Shadow Of Makena

The new ALS product is a fixed-dose combo of two ingredients – sodium phenylbutyrate and taurursodiol – that some patients currently are compounding. Amylyx says it will explore ‘all options’ in addressing that, noting its strong IP for Relyvrio, but also committing to access.

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Heightening Focus On Hemp, Cannabis, US FDA Hires Norman Birenbaum As Public Health Advisor

Hemp industry and private attorneys glad Birenbaum, who was the chief cannabis policy advisor to governors of New York and Rhode Island, given prominent role at FDA that could spur regulatory action.

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Amylyx’s Relyvrio Could See Fast Sales Growth, But Also Spark Pricing Debate

The FDA gave full approval based on a Phase II study, without the need for Phase III confirmatory data, for Amylyx’s ALS drug Relyvrio but the $158,000 WAC could spark a debate over pricing.

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