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

Medicare Part B ASP Proposal Sets ‘Guardrails’ Around Bona Fide Service Fee Reporting

 
• By Cathy Kelly

Average sales prices, and Medicare spending on some drugs, would be expected to be lower, CMS says in the Physician Fee Schedule proposed rule.

Italy To Reward Locally Conducted R&D In Innovative Medicines Fund Revamp

 
• By Francesca Bruce

Antibiotics that tackle antimicrobial resistance are to be automatically included in Italy’s Innovative Medicines Fund, which is designed to provide quick access to innovative medicines.

Merck’s Keytruda Gains Medicare Negotiation Reprieve With Expanded Orphan Exemption

 
• By Cathy Kelly

Bristol Myers Squibb’s Opdivo and Merck's Welireg also could benefit from the delay in Medicare price negotiation process eligibility.

Leqembi Facing 15% Price Cut In Japan

 
• By Lisa Takagi

Japan looks set to press ahead with a reimbursement price cut for Eisai's Alzheimer's drug Leqembi following a cost-effectiveness review, despite differences with the company over methodology.

More from Pink Sheet

A Record Year For US FDA Approvals? Commissioner Says It’s Possible

 
• By Michael McCaughan

FDA Commissioner Martin Makary suggested 60 new molecular entities could be approved in 2025, which appears possible, but can the strained staff deliver?

PharmaMar Withdraws EU Aplidin Filing After Regulatory Rollercoaster

 
• By Eliza Slawther

PharmaMar has voluntarily withdrawn its marketing authorization application for Aplidin to treat multiple myeloma in the EU – almost a decade after it first filed the drug for EU approval and following years of court proceedings.

Italy To Reward Locally Conducted R&D In Innovative Medicines Fund Revamp

 
• By Francesca Bruce

Antibiotics that tackle antimicrobial resistance are to be automatically included in Italy’s Innovative Medicines Fund, which is designed to provide quick access to innovative medicines.