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First Amendment Suit: FDA Draws The Line At Amarin's Heart Disease Claim

 
• By Brenda Sandburg

Trying to forestall preliminary injunction, FDA's Woodcock doesn't object to Amarin's reprint distribution, but says firm needs strong incentive to complete its cardiovascular outcomes study.

Amarin Pharmaceuticals Inc.’s suit seeking a court order to allow it to tell doctors about the unapproved use of its fish oil pill Vascepa (icosapent) “is a frontal assault” on the framework for new drug approval, FDA contends.

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More from Legal & IP

Lilly Targets Sale Of Repackaged, Redosed Zepbound, Mounjaro In Lawsuit

 
• By Cathy Kelly

Eli Lilly is seeking an injunction barring a weight loss clinic from dispensing modified versions of its GLP-1 products.

Mifepristone Filing Supports 2023 US FDA Actions, But Experts Caution Against Overanalyzing

 
• By Sarah Karlin-Smith

Filing in the Whole Women’s Health mifepristone case defends the FDA’s 2023 decision on the abortion pill safety program, but experts warn it does not necessarily signal the Trump Administration position in other mifepristone cases attempting to restrict medication abortion access.

Supreme Court May Be Next After Federal Circuit Refuses To Rehear Teva Inhaler Patents Case

 
• By Urtė Fultinavičiūtė

Teva was forced to delist its ProAir HFA inhaler patents from the FDA’s Orange Book by mid-March after the Federal Circuit denied its petition for en banc rehearing. Will the Supreme Court listen?

HHS Wants 340B Rebate Debate Out Of Courts, Returned To Government

 
• By Cathy Kelly

An HHS legal brief argues company lawsuits seeking immediate clearance to use rebates in 340B are premature and that the department has merely used a ‘measured approach’ in weighing the possibility. Past experience suggests otherwise, a pricing expert said.

More from Pink Sheet

China Plans Clinical Data Protection By Product Category For First Time

 
• By Xu Hu

After almost seven years, China’s NMPA has once again published draft measures for clinical trial data protection, opening these up to public comments. While specific protection periods by drug category are proposed, some clarifications are still needed.

FDA Reorganization Proposal A ‘Mindless Approach To Centralization,’ Woodcock Says

 
• By Sue Sutter

Plan to reorganize the agency into five offices was designed by someone who does not understand the FDA, former long-time agency official Janet Woodcock says. The proposal would eliminate highly specialized expertise in favor of “a big team of generalists,” former Principal Deputy Commissioner Joshua Sharfstein says.

US FDA Staff’s Union President Calls For More Support From Industry

 
• By Sarah Karlin-Smith

Industry should be more vocal about the harms the recent reduction-in-force will have on getting drugs to market, NTEU Chapter 282 President Anthony Lee said in an interview with Pink Sheet.