Alexander Shaver Ph.D.

Alexander Shaver Ph.D.

Rothwell, Figg, Ernst & Manbeck, P.C.

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District Circuit Denies Novartis’s Request for Injunctive Relief Against MSN’s Generic Version of Entresto®

The District Court for the District of Delaware recently rejected Novartis’s effort to block MSN Pharmaceuticals from launching a generic version of Entresto® (sacubitril/valsartan), its top-selling heart failure medication....more

7/21/2025  /  Appeals , Biosimilars , FDA Approval , Generic Drugs , Injunctive Relief , Patent Infringement , Patent Litigation , Patents , Pharmaceutical Industry

How the U.S. Compares to Europe on Biosimilar Approvals and Products In the Pipeline – Updated May 2, 2025

FDA approves Omylco® (omalizumab), first biosimilar of Xolair®. After Q1, FDA and EMA on track for a record number of biosimilar authorizations in 2025....more

5/6/2025  /  Biosimilars , Drug Pricing , EU , FDA Approval , Government Agencies , Patents , Pharmaceutical Industry , Pharmaceutical Patents , Regulatory Agencies , Regulatory Requirements
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