News & Analysis as of August 15, 2025

Healthcare › Regulatory Reform › Orphan Drugs

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10 For 10: Top Compliance Stories For the Week Ending, July 26, 2025
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DOJ Addresses AI in Corporate Compliance Programs — The Good Bot Podcast
AGG Talks: Cross-Border Business Podcast - Episode 27: U.S. Healthcare Reimbursement Guidance for Foreign Life Sciences Companies
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Congress Expands Orphan Drug Exemptions From Medicare Price Negotiations

Jones Day on 7/29/2025

The One Big Beautiful Bill Act ("OBBB") expands exemptions for orphan drugs from mandatory Medicare price negotiations and modifies their eligibility timeline....more

Rare Disease Therapies Gain Momentum With Regulatory Support and Continued Market Growth

Knobbe Martens on 6/20/2025

The landscape for rare disease treatments appears to be evolving rapidly, thanks to a confluence of regulatory momentum and a booming market forecast. Statements from key federal figures in recent months combined with market...more

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