1. Pink Sheet
  2. >>Market Access

Pink Sheet Podcast: Taking A Look Back, And Forward, With US FDA’s Project Orbis

 
• By Pink Sheet Team

Pink Sheet reporters and editors in the US and Europe consider the growth and impact of Project Orbis after a year in which two major regulators joined the program, but several countries did not keep up with the US approval pace.

teamwork
Could Project Orbis expand beyond oncology in the coming years? • Source: Shutterstock

Pink Sheet senior writers Derrick Gingery and Eliza Slawther, Senior Editor Sue Sutter, Managing Editor Bridget Silverman, and Executive Editor Nielsen Hobbs discuss recent revelations about the approval totals among the Project Orbis partners compared to the US Food and Drug Administration and European Medicines Agency (:45), the program’s ongoing impact on global harmonization (9:15), and its potential to grow beyond oncology (16:49) in a look back at the program’s eventful year.

Open Media

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 Market Access

GLP-1 Pricing ‘Paradigm Shift’ Possible, But Would It Meet Trump’s MFN Goals?

 
• By Cathy Kelly

For the Trump Administration, the blockbuster GLP-1 drugs for obesity have become a poster child for the disparity between US and foreign prices.

Japan Price Cuts For Epkinly and Lunsumio Following CEA

 
• By Lisa Takagi

Japan is cutting more drug reimbursement prices following cost effectiveness analysis and is applying the methodology to a new group of products including Wegovy and Leqembi.

Rocky Rollout Spells Trouble for Medicare Prescription Payment Plan

 
• By Lauren Flynn Kelly

Enrollment in the new Medicare Prescription Payment Plan was lower than expected in the first year and well below CMS expectations, and invoicing data indicates members are slow to pay.

PBM Investigation, Enforcement Action ‘Critical Priorities’ At FTC, Chair Says

 
• By Cathy Kelly

The new FTC chair addressed concerns that staffing cuts will undermine the commission’s commitment to pharmacy benefit manager oversight.

More from Pink Sheet

How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By Ewan Townsend

If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

‘The Question Is, What’s Going To Happen Next?’ – The Future For Biosimilars In Europe

 
• By Dave Wallace

With European biosimilars developers buoyed by recent regulatory moves, Medicines for Europe’s Isabell Remus and Julie Maréchal-Jamil discuss the next steps forward for the industry.