Cases

24-598 Mosaic Health, Inc. v. Sanofi-Aventis U.S., LLC In the United States Court of Appeals for the Second Circuit August Term 2024 Argued: May 2, 2025 Decided: August 6, 2025 No. 24-598 MOSAI

No. 24-598 Mosaic Health, Inc. v. Sanofi-Aventis U.S., LLC In the United States Court of Appeals for the Second Circuit August Term 2024 Argued: May 2, 2025 Decided: August 6, 2025 Amended: October 15, 2025

MEMORANDUM AND ORDER TOWNES, District Judge: In January 2008, plaintiffs Sergeants Benevolent Association Health and Welfare Fund (“SBA”), New England Carpenters Health Benefits Fund (“NEC”) and Allied Services Division Welfare Fund (“ASD”) (collectively “Plaintiffs”) and others commenced this action on behalf of themselves and others similarly situated, principally alleging that defendants sanofi

UNDER SEAL MEMORANDUM OPINION KETANJI BROWN JACKSON, United States District Judge Table Of Contents I.BACKGROUND ... 69 A. Colchicine: A Drug For The Treatment Of Gout ... 69 B. FDA’s Drug Approval Framework: The Hatch-Waxman Amendments ... 71 1. NDAs, ANDAs, and 505(b)(2) NDAs ...71

KATHERINE POLK FAILLA, United States District Judge Plaintiffs Kate Doyle, National Security Archive ("NSA"), Citizens for Responsibility *35and Ethics in Washington ("CREW"), and Knight First Amendment Institute (collectively, "Plaintiffs") initiated this action against the United States Department of Homeland Security ("DHS") and the Executive O

489 F.Supp.2d 759 (2007) Karen CLARK, Plaintiff v. SANOFI-SYNTHELABO, INC., Defendant. Civil Action No. 3:05CV-344-S. United States District Court, W.D. Kentucky, at Louisville. March 15, 2007. *760 Samuel G. Hayward, Adams, Hayward & Welsh, Louisville, KY, for Plaintiff. Clay M. Stevens, Leslie M. Cronen, Thompson Mil

OPINION & ORDER PAUL A. ENGELMAYER, District Judge: In these related cases brought under the securities laws, plaintiffs claim that the *517pharmaceutical company Sanofi, its predecessor Genzyme, and three company executives (collectively, “defendants,” “Sanofi,” or “the company”) made false and misleading statements about Lemtrada,

725 F.Supp.2d 92 (2010) SANOFI-AVENTIS et al., Plaintiffs, v. FOOD AND DRUG ADMINISTRATION et al., Defendants. Civil Action No. 09-1495 (RMU). United States District Court, District of Columbia. July 26, 2010. *93 Anthony Herman, Joshua D. Greenberg, Covington & Burling, Washington, DC, for Plaintiffs. Gerald Cooper Ke

In the United States Court of Federal Claims No. 19-1796C (E-filed: March 6, 2020) 1 _________________________________ ) AMAZON WEB SERVICES, INC., ) ) Plaintiff, ) ) Bid-Protest; Temporary Restraining v.

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA SANOFI-AVENTIS et al., : : Plaintiffs, : Civil Action No.: 09-1495 (RMU) : v. : Re Document No.: 26, 32, 34 : FOOD AND DRUG

ACCEPTED 15-25-00020-CV FIFTEENTH COURT OF APPEALS AUSTIN, TEXAS 6/6/2025 4:37 PM No. 15-25-00020-CV CHRISTOPHER A. PRINE

467 F.Supp.2d 285 (2006) RxUSA WHOLESALE, INC., Alden Surgical, Co., Inc., Atlantic Biologicals, Inc., Bell Medical Services, Inc., C.O. Truxton, Inc., Hygen Pharmaceuticals, Inc., Medex Medical, Inc., Medsource Direct, Inc., Mika Pharmaceuticals, Inc., and Stat Pharmaceuticals, Inc., Plaintiffs, v. DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S. Food and Drug Administration, Defendants. No. 06-CV-5086 (JS)(AKT).

In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS Filed: October 12, 2021 ************************* HAROLD JACKSON as administrator of * PUBLISHED the Estate of STEPHANIE JACKSON, * * No. 16-1194V Petitioner, * * Special Master Nora Beth Dorsey v.

In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 14-236V Filed: March 4, 2021 ************************* * * VICTORIA NIFAKOS, * * * TO BE PUBLISHED Petitioner, *

United States Court of Appeals FOR THE DISTRICT OF COLUMBIA CIRCUIT Argued November 7, 2022 Decided January 10, 2023 No. 22-5202 SANDOZ INC., APPELLANT v. XAVIER BECERRA, IN HIS OFFICIAL CAPACITY AS SECRETARY OF HEALTH AND HUMAN SERVICES, ET AL., APPELLEES Appeal from the United States District Court for the Distr

In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 15-260V Filed: December 20, 2018 To be Published ************************************* S.E.H., * * Petitioner, *

In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS ************************* CATHERINE GERTRUDE McCABE, * * No. 13-570V Petitioner, * Special Master Christian J. Moran * v. * Filed: May 17, 2018 * SECRETARY OF HEALTH

OPINION STARK, United States District Judge: Plaintiffs — UCB, Inc., UCB BioPharma SPRL, Research Corporation Technologies, Inc., and Harris FRC Corporation (collectively, “Plaintiffs”) — allege that Defendants — Accord Healthcare, Inc., Intas Pharmaceuticals Ltd., Alembic Pharmaceuticals, Ltd., Amneal Pharmaceuticals LLC, Amneal Pharmaceuticals of New York, LLC, Aurobindo Pharma Ltd., Auro-bindo Pharma USA,

In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 13-215V (Filed: September 1, 2017) * * * * * * * * * * * * * * * ALESSANDRA GIANNETTA, * To Be Published * Petitioner, * Meningococcal Vaccine; Menactra;

In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 11-577V Filed: May 24, 2019 To be Published ************************* D.G., * * Petitioner, *