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Food and Drug Administration (FDA) Prescription Drugs 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

Hogan Lovells

Coronavirus: The Hill and the Headlines, October 2020 # 15

Hogan Lovells on

In Washington: After several consecutive days of talks between House Speaker Nancy Pelosi (D-CA) and Treasury Secretary Steven Mnuchin it appears increasingly likely that Congress will have to wait to consider any COVID-19...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

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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