1. Pink Sheet
  2. >>Legal & IP

Legal News: Teva V. FDA, Pay-For-Delay, Citizen Petitions, User Fee Scheme

 
• By Brenda Sandburg

US court tosses Teva suit seeking generic Restasis exclusivity. FTC loses appeal challenging Shire's citizen petitions, settles Solvay pay-for-delay case. DoJ resolves FCA case alleging company made deal to avoid paying FDA user fees for two NDAs.

Courthouse Pillars & Stairs

The pharma industry has had a busy week in court. Perhaps most significantly, a US district court rejected Teva Pharmaceutical Industries Ltd.'s claims that it has the right to 180-day exclusivity for its generic version of Restasis (cyclosporine), noting that FDA has yet to grant even tentative approval to a pending ANDA and it is unknown whether Teva will clear forfeiture hurdles.

In a Feb. 26

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

Trump Administration Push For Dismissal, Transfer Of Mifepristone Case Leaves Overhang For Pharma

 
• By Sarah Karlin-Smith

The Trump Administration requested a dismissal or transfer of a lawsuit seeking to tighten the safety requirements for the abortion pill mifepristone on procedural grounds, which still leaves the administration's position on the case's merits unclear.

Viatris Agrees To $335m Opioid Settlement Ending US State, Local Government Cases

 
• By Dean Rudge

Viatris joined Hikma and Amneal, in signing agreements for cash settlements that resolve allegations its practices fueled the US’ deadly opioid epidemic.

How States And Courts Could Insulate America From An Anti-Vaccine Executive Branch

 
• By Sarah Karlin-Smith

The mood at the World Vaccines Congress in Washington, D.C. was bleak given Robert F. Kennedy Jr.’s rise to lead the Trump Administration’s Health and Human Services Department, but vaccine lawyers offered an optimistic outlook and ideas for countering his vaccine agenda.

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.

More from Pink Sheet

US FDA Expands Surprise Foreign Inspections But Loses Associate Commissioner Michael Rogers

 
• By Sue Sutter

Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.

Sponsors Like START Rare Disease Pilot, Will Prasad Maintain Its Momentum?

 
• By Kate Rawson

Sponsors reported faster development times for products that joined the pilot program intended to speed rare disease treatments in CBER.

EU HTA Regulation: ‘Stepping Beyond’ JCAs May Be Needed For Very Rare Disease Drugs

 
• By Francesca Bruce

Cooperation between health technology assessment bodies across the EU will lead to a better joint clinical assessment process over time, but patients cannot afford a lengthy wait for improvements, speakers at a cell & gene therapy conference said.