News & Analysis as of

Food and Drug Administration (FDA) Summary Judgment FDA Approval

Robins Kaplan LLP

Liquidia Techs., Inc. v. FDA - Updated 5.2.25

Robins Kaplan LLP on

Nature of the Case and Issue(s) Presented: FDA refused to approve Liquidia’s drug product, Yutrepia because another company, UTC, maintained marketing exclusivity. Liquidia sued FDA, and UTC intervened. The court granted...more

Jones Day

California Supreme Court Will Review Novel Negligence Theory for Pharmaceutical Manufacturers

Jones Day on

The Situation: The California Supreme Court recently granted review of a California Court of Appeal decision, Gilead Life Sciences, Inc. v. The Superior Court of the City and County of San Francisco, that made waves in the...more

ArentFox Schiff

California Supreme Court to Review Newly Created Duty to Market a “Safer” Product Even in the Absence of a Defect

ArentFox Schiff on

On May 1, the California Supreme Court granted Gilead Science Inc.’s request to review a California appellate court’s holding that the pharmaceutical manufacturer must defend against negligence claims stemming from its...more

Robins Kaplan LLP

ANDA Litigation Settlements - Fall 2019

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Please see full Chart below for more information....more

McDermott Will & Schulte

Second Circuit Affirms Dismissal of Sham Citizen Petition Claim, Summary Judgment on False Advertising Claims **WEB ONLY**

Addressing Sherman Act and Lanham Act claims arising out of an Abbreviated New Drug Application (ANDA), the US Court of Appeals for the Second Circuit upheld the district court’s dismissal of the plaintiffs’ Sherman Act claim...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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