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FDA outlines rescission of Breakthrough Therapy Designation

Last week, the U.S. Food and Drug Administration (FDA) issued the draft guidance “Considerations for Rescinding Breakthrough Therapy Designation,” which outlines how FDA will...


FDA finalizes guidance on Orphan Drug “sameness” of gene therapies

Recently, the U.S. Food and Drug Administration’s (FDA’s) Office of Orphan Product Development published the four-page final guidance “Interpreting Sameness of Gene...


Federal Circuit affirms GSK labeling carve-out ruling in favor of innovator

Earlier this month, in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., a panel of the U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed (2-1) upon rehearing its...


Biden signs bill limiting new drug exclusivity awards to innovations in active moiety

On April 23, U.S. President Biden signed into law two bills meant to lower prescription drug prices by limiting new drug exclusivity awards and promoting biosimilars. The Ensuring...


Life sciences and health care horizons 2021

Companies in the life sciences and health care industry navigated unparalleled challenges in 2020. The pandemic forced the development and adoption of new technologies and innovations...


New Orange & Purple Book laws increase transparency of patent information for drugs, biologics

On January 5, 2021, President Trump signed into law H.R. 1503, the "Orange Book Transparency Act of 2020," which amends provisions governing the types of patents and...


Final FDA combination product guidance encourages application-based feedback pathways

The U.S. Food and Drug Administration (FDA) recently finalized its guidance entitled “Requesting Food and Drug Administration Feedback on Combination Products,” stressing as it...


Labeling carve-out does not shield generic drug makers from induced infringement claims, CAFC rules

The U.S. Court of Appeals for the Federal Circuit (CAFC) recently decided (2-1) in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc. that a labeling carve-out by a generic drug...

Insights and Analysis

FDA Guidance on Combination Product Agreement Meetings lacks specificity, comments say
Registered Content

The public comment period recently closed for the draft guidance “Requesting FDA Feedback on Combination Products,” which describes the methods by which combination product...

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