News & Analysis as of

GlaxoSmithKline FDA Approval

Benesch

Dialysis & Nephrology Digest - November 2025

Benesch on

The final rule for the 2026 Medicare Fee Schedule was released by the Centers for Medicare and Medicaid Services (CMS) on October 31, and it appears to have been finalized almost exactly as it was proposed. ...more

Morrison & Foerster LLP

Liability for Brand Drug Manufacturers All But Clear

Earlier this month, a federal district court in Illinois denied GlaxoSmithKline’s (GSK) renewed summary judgment motion based on federal preemption of failure-to-warn claims in an opinion setting tough standards for brand...more

McDermott Will & Emery

ANDA Update - October 2015

McDermott Will & Emery on

Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more

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