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Food and Drug Administration (FDA) › Appellate Courts

Greenbaum, Rowe, Smith & Davis LLP

First Circuit Decision Regarding Anti-Kickback Statute Standard Widens Circuit Split and Creates Potential for Supreme Court...

Greenbaum, Rowe, Smith & Davis LLP on

The U.S. Court of Appeals for the First Circuit, in United States v. Regeneron, has joined the Sixth and Eighth Circuits in adopting the “but-for” standard to find that a violation of the Anti-Kickback Statute (AKS) triggers...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Federal Circuit Denies Teva’s Request for En Banc Rehearing in Orange Book Patent Dispute

Rothwell, Figg, Ernst & Manbeck, P.C. on

In our previous articles, we reported that the Federal Circuit affirmed the district court’s decision on December 20, 2024 ordering Teva Pharmaceuticals (“Teva”) to delist certain patents related to Teva’s ProAir® HFA...more

Robins Kaplan LLP

Purdue Pharma L.P. v. Accord Healthcare, Inc.

Robins Kaplan LLP on

OxyContin® (oxycodone HCl) - Case Name: Purdue Pharma L.P. v. Accord Healthcare, Inc., No. 2023-1953, 2024 WL 5244764 (Fed. Cir. Dec. 30, 2024) (Circuit Judges Prost, Reyna, and Taranto presiding; Opinion by Prost, J.)...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Federal Circuit Stays Teva v. Amneal Ruling

Rothwell, Figg, Ernst & Manbeck, P.C. on

In our previous article, we reported that the Federal Circuit affirmed the district court’s decision requiring Teva to delist certain patents related to its Teva’s ProAir® HFA metered-dose inhaler from the FDA’s Orange...more

Seward & Kissel LLP

Juul in Denial? Crypto Cash Out, J&J Wait Continues and Healthcare Hard Times Roll On

Seward & Kissel LLP on

Juul Prepares to Seek Financing for Potential Bankruptcy Process | The Wall Street Journal - Juul Labs Inc. has begun discussions with lenders for financing that could assist the company through a potential Chapter 11...more

Faegre Drinker Biddle & Reath LLP

“Fruit Puree” Held a Fair Game First Ingredient in Fruit Snacks Label by California Court of Appeal

Faegre Drinker Biddle & Reath LLP on

The California Court of Appeal, First Appellate District, recently affirmed judgment in favor of a fruit snack manufacturer who claimed “fruit” was stated to be the first ingredient on a front label but listed “fruit puree”...more

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