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FDA Approval Summary Judgment Pharmaceutical Industry

Jones Day

California Supreme Court Will Review Novel Negligence Theory for Pharmaceutical Manufacturers

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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

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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 & Emery

ANDA Update - October 2015

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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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