No More Needles in Haystacks: Congress Requires FDA to Explain Q1/Q2 Sameness
Last week, on February 3, 2026, Congress passed the Consolidated Appropriations Act (“the Act”), providing generic drug manufacturers...
Here We Go Again: Third Round of Inflation Reduction Act Drugs Listed
Pursuant to the Inflation Reduction Act (the “IRA”), the Secretary of Health and Human Services (“HHS”) and the Center for Medicare &...
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...
Compounding Problems: Recent Decisions on Tirzepatide Highlight Interplay Between FDA Anti-Compounding Enforcement and Private Intellectual Property Rights
Earlier this month, a federal district court denied the Outsourcing Facilities Association’s preliminary injunction motion, which sought...
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