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FTC/Industry Showdown Over Orange Book Patent Listings Could Come In 2024

 
• By Brenda Sandburg

GlaxoSmithKline, Amneal and Kaleo delist patents on inhalers and autoinjectors in drug-device combination products in response to FTC criticism. But AstraZeneca, Boehringer Ingelheim, and Teva hold firm, teeing up legal battles if the Commission takes enforcement action.

ftc orange book patents
Battles over Orange Book patent listings seem likely as companies reject FTC claims of improper listings. • Source: Nielsen Hobbs; the Pink Sheet | Shutterstock images

The US Federal Trade Commission’s muscling into the arena of Orange Book patent listings could put pressure on the US Food and Drug Administration to finally issue guidance on whether sponsors can list drug delivery devices. It could also lead to litigation if the FTC takes enforcement action against companies that decline to delist patents the agency deems to be improperly listed.

In one of the most surprising actions of 2023, the FTC sent letters to eight drug manufacturers contending they had...

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Precision Underlines US FDA’s 2025 Cancer, Neuroscience Candidates

 
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More Heart, Less Skin: US FDA’s 2025 Novel Approvals Should Reflect Pipeline Shifts

 
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US FDA To Advisory Committee Industry Reps: Don’t Talk Too Much

 
• By Sue Sutter

Nonvoting industry representative’s presence at Pediatric Advisory Committee meeting was required by statute, the agency said, a de facto acknowledgement that an April directive precluding industry reps from sitting on advisory committees has had little practical effect.

New US FDA Biologics License Pathway Could Be Missing Link To Reduce Animal Testing

 
• By Bridget Silverman

Akin to the 505(b)(2) NDA, a new biologic pathway could reduce the need for animal testing, FDA toxicologist says. Expanded use of generally accepted scientific knowledge (GASK), which few sponsors have attempted despite a 2023 draft guidance, would also help.

Capricor Gets Complete Response For DMD Cell Therapy: Unconvincing Data Or New Attitude At FDA?

 
• By Joseph Haas

Seven weeks before its action date and a month after an advisory committee was hastily cancelled, Capricor gets a CRL for its cell therapy deramiocel in DMD-related cardiomyopathy citing efficacy and manufacturing concerns. It has a Phase III study nearing readout, though.