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Settlements Don’t Close the Door: Antitrust Claims Follow IPR Challenges in Life Sciences

In the ongoing case of Carefirst of Maryland Inc. v. Johnson & Johnson, the plaintiffs successfully overcame a motion to dismiss. At the heart of the case is J&J’s legal strategy against biosimilar competitors, including...more

FDA Approves Generic Fluorescein Injection

On September 26, 2023, Nexus Pharmaceuticals, LLC announced that it had received approval from the U.S. Food and Drug Administration (FDA) for Fluorescein Injection, USP. Nexus Pharmaceuticals is a maker of generic drugs....more

A Patent for Controlling Access to Drugs Is Not Listable in the Orange Book

The “Orange Book”, more formally known as Approved Drug Products with Therapeutic Equivalence Evaluations, identifies U.S. Food and Drug Administration (FDA) approved drug products as well as any related patent and...more

Janssen Biologic Tremfya Secures FDA Approval Following Use of Priority Review Voucher

On July 13, 2017, the U.S. Food and Drug Administration approved Tremfya (guselkumab), a biologic manufactured by Janssen Biotech, for the treatment of moderate-to-severe plaque psoriasis patients who are candidates for...more

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