1. Pink Sheet

US Supreme Court Preview: ‘Skinny’ Labels, FTC, And FCA – But No Tecfidera As Biogen Loses Bid

 
• By Brenda Sandburg

Teva’s carve-out fight with GSK over generic Coreg will see the Solicitor General weigh in. Amgen and Juno’s patent petitions remain pending, and the high court stays a Federal Circuit decision invalidating Novartis’ Gilenya patent.

US Supreme Court interior
US Supreme Court opens term seeking Solicitor General's views in 'skinny label' case • Source: Shutterstock

Teva Pharmaceuticals USA Inc. may have a chance to reverse the contentious “skinny label” ruling on generic label carve-outs since the US Supreme Court has asked the Solicitor General to weigh in on the case, Teva v. GlaxoSmithKline LLC.

In its first order list for the term, which began on 3 October, the court noted that it has invited the Solicitor General to file a brief expressing the views of the United States on the dispute

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Legal & IP

More from Pink Sheet

Mayne’s Nextstellis Promo Wrong To Suggest Better Safety Than Other Contraceptives, FDA Says

 
• By Sue Sutter

A professional slide deck for the drospirenone/estetrol oral contraceptive inappropriately suggests it is safer than other estrogen-containing products and understates risks, Office of Prescription Drug Promotion said in the first “untitled” letter issued since reductions-in-force.

US HHS Deputy Nominee Talks AI, Not FDA, In Confirmation Hearing

 
• By Ramsey Baghdadi

Silicon Valley investor Jim O’Neill’s Senate confirmation hearings showcased the unique background of someone with government and tech experience and avoided discussions of his past statements about lowering the bar for regulatory approval.

US FDA Waiting On Guidance Agenda Future As HHS Seeks Regulation Cuts

 
• By Derrick Gingery

The FDA continues to wait for a decision on whether its priority guidances will be published as HHS asks the public for potential regulation cuts to fulfill President Trump’s executive order.