News & Analysis as of

Food and Drug Administration (FDA) Loper Bright Enterprises v Raimondo Pharmaceutical Industry

Mayer Brown

In Neurelis v. Brenner, The FDA’s “Indication-Specific” View of Orphan Exclusivity is (Again) Struck Down

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The legal battle over the scope of orphan drug exclusivity continues, as the U.S. Food and Drug Administration (“FDA”) has recently lost a second case concerning the exclusivity provisions of the Orphan Drug Act (“ODA”)....more

American Conference Institute (ACI)

[Event] 21st Annual Conference on Paragraph IV Disputes - April 29th - 30th, New York, NY

Attend ACI's 21st Annual Conference on Paragraph IV Disputes and join leaders from brand and generic pharmaceutical companies, renowned outside counsel, esteemed members of the judiciary, government, and academia to: -...more

Venable LLP

Venable’s BiologicsHQ Monthly Injection - December 2024

Venable LLP on

Welcome to Venable’s BiologicsHQ Monthly Injection - December 2024....more

Fuerst Ittleman David & Joseph

Lilly v. FDA: Two Stories Collide to Make this GLP-1 Case a Tale of Our Time

I recently learned of Eli Lilly & Co.’s (“Lilly”) recent lawsuit against FDA from Nicole DeFeudis, who interviewed me for her Endpoints News story about the case. Lilly’s lawsuit, filed in September 2024 in the Southern...more

Latham & Watkins LLP

New FDA Brief in Supreme Court Tobacco Case Puts Spotlight on Post-Chevron Regulatory Landscape

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FDA says its authority to implement the TCA is not limited by Loper Bright, but suggests that future guidance documents may be limited. On August 26, 2024, the US Food and Drug Administration (FDA or the Agency) filed its...more

Venable LLP

Venable’s BiologicsHQ Monthly Injection - August 2024

Venable LLP on

Welcome to Venable’s BiologicsHQ Monthly Injection – August 2024...more

Epstein Becker & Green

Recent Supreme Court Decisions and the DSCSA

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The recent Supreme Court decisions of SEC v. Jarkesy and Loper Bright Enterprises v. Raimondo have the potential to meaningfully impact the implementation and enforcement of the Drug Supply Chain Security Act (“DSCSA”) as...more

Spilman Thomas & Battle, PLLC

The Health Record - Healthcare Law Insights, Issue 3, July 2024

Welcome to our third issue of The Health Record - our healthcare law insights e-newsletter! We are winding down the summer with our talented group of law students and they have continued to research and write, shadow...more

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