Streamlining the Studies: New FDA Draft Guidance Aims to Speed Up Biosimilar Development
On Wednesday, the FDA issued a new draft guidance proposing to reduce the need for sponsors to conduct a comparative efficacy study (CES)...
Reflections on the 12th Annual Summit for Women Leaders in Life Sciences Law
We closed out July 2025 in Boston alongside several of our Axinn colleagues attending the American Conference Institute’s 12th Annual...
Entresto Trade Dress Dispute: No Injunctive Relief for Novartis
On July 15, 2025, Judge Evelyn Padin of the District of New Jersey denied Novartis’s motion for preliminary injunction, which would have...
FTC Peeling Back the Layers of the Orange Book
The Federal Trade Commission (FTC) is continuing to pursue pharmaceutical manufacturers for allegedly improperly listing patents in the...
Federal Circuit Holds Generic’s Hatch-Waxman Litigation Expenses Deductible
A March 21 Federal Circuit decision in Actavis Laboratories FL, Inc. v. United States, No. 23-1320 (Fed. Cir. Mar. 21, 2025) marked a...
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