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Pharmaceutical Industry › Food and Drug Administration (FDA) › AstraZeneca

Venable LLP

FDA Approves Second Soliris® (eculizumab) Interchangeable Biosimilar - Samsung Bioepis’s Epysqli® (eculizumab-aagh)

Venable LLP on

On July 19, 2024, the FDA approved the second biosimilar of Alexion / AstraZeneca’s Soliris® (eculizumab), Samsung Bioepis’s Epysqli® (eculizumab-aagh), approximately one year after Samsung Bioepis announced the FDA...more

Haug Partners LLP

10 Years after Actavis, the Cases that Follow Tell a Story

Haug Partners LLP on

I. Introduction - No pharmaceutical antitrust decision has had more impact than the Supreme Court’s 2013 decision in Federal Trade Commission v. Actavis, a decision which officially defined the term “reverse payment...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, April 2021 # 4

Hogan Lovells on

In Washington: The Consumer Financial Protection Bureau (CFPB) on Monday proposed a rule ordering debt collectors to inform tenants about their rights under a federal eviction ban if they’ve been unable to pay rent during the...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, April 2021 # 2

Hogan Lovells on

In Washington: On April 13, the Centers for Disease Control (CDC) and Prevention and Federal Drug Administration (FDA) paused the production of the Johnson & Johnson vaccine after six women participants in the U.S. developed...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, March 2021 # 12

Hogan Lovells on

In Washington: President Biden on Tuesday began what is expected to be a weeks-long sales pitch to tout the new coronavirus relief package. Biden visited Smith Flooring in Chester, Pennsylvania, a small business that received...more

Robins Kaplan LLP

AstraZeneca AB v. Mylan Pharms. Inc.

Robins Kaplan LLP on

BECAUSE DELAWARE WAS AN IMPROPER VENUE FOR DEFENDANT MYLAN, AND DEFENDANT 3M DEMONSTRATED THAT VARIOUS FACTORS WEIGHED IN FAVOR OF A TRANSFER, THE CASE WAS TRANSFERRED TO THE NORTHERN DISTRICT OF WEST VIRGINIA. Case...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

Robins Kaplan LLP

AstraZeneca LP v. Breath Ltd.

Robins Kaplan LLP on

Case Name: AstraZeneca LP v. Breath Ltd., 2015-1335, 2015 U.S. App. LEXIS 7525 (Fed. Cir. May 7, 2015) - Drug Product and Patent(s)-in-Suit: Pulmicort Respules® (budesonide inhalation suspension); U.S. Patent No....more

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