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Regeneron Awarded $407 Million in Amgen Antitrust Suit

On May 15, 2025, a jury returned a verdict finding Amgen Inc. (“Amgen”) liable for antitrust violations and awarding Regeneron Pharmaceuticals, Inc. (“Regeneron”) over $400 million in damages....more

FDA to Phase Out Animal Testing for Monoclonal Antibodies and other Drugs

On April 10, 2025, the U.S. Food and Drug Administration (FDA) announced it will be phasing out the current requirements for animal testing in the development of monoclonal antibody therapies and other drugs, replacing them...more

FDA Approves Biocon Biologics’ Bevacizumab Biosimilar

On April 10, 2025, Biocon Biologics Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved JOBEVNE™ (bevacizumab-nwgd), a new bevacizumab biosimilar referencing Genentech’s AVASTIN®.  JOBEVNE™ is a...more

Teva and Samsung Bioepis Announce U.S. Launch of EPYSQLI® (eculizumab-aagh), a SOLIRIS® Biosimilar

On April 7, 2025, Teva Pharmaceuticals and Samsung Bioepis Co., Ltd. announced the U.S. launch of EPYSQLI® (eculizumab-aagh), a biosimilar referencing Alexion Pharmaceuticals’ SOLIRIS®....more

Amgen Files Three IPR Petitions Challenging Bristol-Myers Squibb Anti-PD1 and Anti-CTLA-4 Antibody Combination Method of Treatment...

On February 28, Amgen, Inc. (“Amgen”) filed three petitions for inter partes review, challenging the validity of all claims in three patents assigned to Bristol-Myers Squibb Co. (“BMS”). The claims of all three patents are...more

Amgen and Celltrion Settle Denosumab BPCIA Case

​​​​​​​On January 23, 2025, the District Court for the District of New Jersey entered a Consent Judgment and Injunction in view of a settlement agreement between Amgen and Celltrion resolving the BPCIA litigation regarding...more

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