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Trade Secrets In Court: Are Dissolution Specifications That FDA Gave Vanda Proprietary?

 
• By Brenda Sandburg

Court of Federal Claims lets Vanda’s suit against the agency go forward but notes a ruling for the company could undermine FDA’s ability to provide assistance to other brand name and generic manufacturers.

Trade secrets
Court rules portion of Vanda's trade secrets suit against US FDA may proceed • Source: Shutterstock

The US Court of Federal Claims expressed concern that Vanda Pharmaceuticals, Inc.’s trade secrets claims against the US Food and Drug Administration could negatively impact the agency’s ability to assist drug manufacturers with their applications, though it allowed some of them to proceed.

Vanda sued FDA last year claiming the agency disclosed trade secret information about its manufacturing processes for Fanapt (iloperidone) and...

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Lupin Concedes To Harmony On Generic Wakix With 2030 Launch Agreement

 
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Lupin became the latest ANDA sponsor to settle patent-infringement litigation over Harmony Biosciences’ Wakix (pitolisant hydrochloride), which has been touted as a potential blockbuster.

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US Supreme Court Wants Solicitor General Input On Hikma Skinny Label Case

 
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Repurposed Drugs: EU Pharma Reform Offers Boost, But Payers ‘Must Recognize Health Gains’

 
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Incentives for repurposed drugs proposed as part of the EU pharma reform package are a “great step forward,” but more recognition is needed from payers and regulators to leverage the benefits of these medicines, experts say.

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