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Clinical Trials › Appeals › FDA Approval

Robins Kaplan LLP

Jazz Pharms., Inc. v. Avadel CNS Pharms., LLC

Robins Kaplan LLP on

Case Name: Jazz Pharms., Inc. v. Avadel CNS Pharms., LLC, Nos. 2024-2274, 2024-2277, 2024-2278, 2025 WL 1298920 (Fed. Cir. May 6, 2025) (Circuit Judges Lourie, Reyna, and Taranto presiding; Opinion by Lourie, J.) (Appeal from...more

Knobbe Martens

Federal Circuit Review | May 2025

Knobbe Martens on

In Jazz Pharmaceuticals, Inc. v. Avadel Cns Pharmaceuticals, LLC, Appeal No. 24-2274, the Federal Circuit held that injunctions prohibiting the initiation of new clinical trials for paper NDA drugs before patent expiration...more

Fish & Richardson

Federal Circuit Reverses Injunction That Barred Clinical Trials in Jazz v. Avadel

Fish & Richardson on

The Federal Circuit recently considered the scope of a permanent injunction that prohibited a drug manufacturer from conducting certain clinical and regulatory activities in Jazz Pharmaceuticals, Inc. v. Avadel CNS...more

Perkins Coie

Ninth Circuit Rejects Securities Fraud Thesis That Did Not “Make a Whole Lot of Sense”

Perkins Coie on

In its June 10, 2020, opinion in Nguyen v. Endologix, the U.S. Court of Appeals for the Ninth Circuit applied the plausibility standard to a plaintiff’s securities fraud claims and affirmed the district court’s dismissal,...more

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