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J&J Oklahoma Judgement May Set Benchmark For Massive Opioid Resolution

 
• By Brenda Sandburg

Judge orders J&J to pay $572m for one-year abatement plan; the state had proposed $12bn over 20-year period. J&J's gamble on a trial has so far not succeeded, since it is now facing more than twice the payout that Purdue agreed to in a settlement.

Judge or auction gavel on Oklahoma US of America waving flag background. 3d illustration - Illustration

Johnson & Johnson lost a gamble in going to trial over Oklahoma's claims it helped create the opioid crisis as a district court judge issued a $572m judgement against the company to fund a one-year abatement plan. The sum is $300m more than Purdue agreed to pay in its settlement with the state but a fraction of the $12.8bn the state estimated it would cost to ameliorate the crisis over a 20-year period.

Oklahoma alleged that J&J and its Janssen Pharmaceuticals Inc. unit engaged in a false, misleading, and deceptive marketing campaign...

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Lupin Concedes To Harmony On Generic Wakix With 2030 Launch Agreement

 
• By Dean Rudge

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.

US FDA Teases Disclosure Program, But Industry Has Seen This Before

 
• By Derrick Gingery

Center for Biologics Evaluation and Research Director Vinay Prasad said Commissioner Martin Makary wants to release previously inaccessible FDA documents, but previous commissioners have made the same pronouncements only to make little progress.

PCMA, CVS, Cigna File Lawsuits Over ‘Dangerous’ Arkansas PBM Law

 
• By Tim Casey

The suits are an early test of the Arkansas law banning company ownership of PBMs and pharmacies in the state, as other states consider similar legislation.

US FTC Continues Effort To Eliminate Orange Book’s Improper Patent Listings

 
• By Urtė Fultinavičiūtė

In a somewhat surprising move, President Trump’s Federal Trade Commission is continuing a crusade to delist improper listings from the FDA’s Orange Book. Law firm Polsinelli’s chair Chad Landmon discussed the impact of the move on the generic drug industry.

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UK’s Decentralized Manufacturing Rules Designed To Allow For ‘Future Developments’

 
• By Eliza Slawther

The UK drug regulator acknowledges that technology will “move on” and, as such, has designed its decentralized manufacturing regulation to be as “enduring” as possible. Experts from the MHRA explain what products are covered by the new framework and how it has been future-proofed.

Global Guideline Signals ‘Paradigm Shift’ For Pregnant And Breastfeeding Women, Says EMA

 
• By Anabel Costa-Ferreira

The European Medicines Agency expects the International Council for Harmonization’s new guideline will help address the critical lack of data on the use of medicinal products in pregnant and breastfeeding populations.

Profit-Sharing AI Model Proposed To Boost Korean Drug R&D

 
• By Jung Won Shin

A differentiated profit-sharing model to accelerate the use of AI in drug development using clinical and patient data is being proposed in South Korea, but the idea faces multiple practical challenges