1. Pink Sheet
  2. >>Regional Comparisons

Pink Sheet Podcast Special: Why The US Approves Most New Drugs Before The EU

 
• By Pink Sheet Team

Pink Sheet reporter and editors discuss the impact of a US and EU drug approvals analysis that found the US FDA still clears many novel products first, including most new cell and gene therapies and cancer treatments.

Pink Sheet podcast
Why has the EU only approved three of the 10 cell and gene therapies approved in the US? • Source: Citeline/Shutterstock

Pink Sheet Executive Editor Derrick Gingery, Managing Editor Bridget Silverman, Interim Editor in Chief Nielsen Hobbs, Executive Editor Ian Schofield, and Senior Writer Francesca Bruce consider the results of an analysis of regulatory tracker data that found the US continues to approve most novel drugs before the European Union. They discuss why the gap persists in cell and gene therapy, as well as oncology, even though regulatory agencies can review some of the applications at the same time as the US Food and Drug Administration.

Open Media

More On This Topic From The Pink Sheet

This and other podcasts are available on the Pink Sheetpodcast page, as well as the Citeline channel on Apple Podcasts, Google Podcasts, SoundCloud, TuneIn and Spotify Podcasts, and via smart speakers if one of these platforms has been set up as your default podcast provider.

More from Regional Comparisons

AstraZeneca Says Andexxa Will Not Convert To Full Approval, Quietly Reveals Complete Response

 
• By Sarah Karlin-Smith

Whether the FDA will seek withdrawal of the anticoagulant-reversal agent or request additional confirmatory data is unclear.

How The UK, EU, Canada, Australia And Japan Are Tackling Diversity In Clinical Trials

 
• By Vibha Sharma

As efforts to improve diversity in clinical trials gain momentum globally, the Pink Sheet asked regulators in the UK, the EU, Canada, Australia and Japan about their efforts to support representative enrolment. 

EU Revokes Intercept/Advanz’s Ocaliva Approval As Moment Of Reckoning Nears in US

 
• By Sue Sutter

The EU marketing authorization for the primary biliary cholangitis treatment has now been revoked. Meanwhile the drug's approval is in jeopardy in the US, where an advisory committee will opine on whether the accelerated approval drug has confirmed clinical benefit.

England Lags Behind Eight European Countries On Innovative Drug Availability

 
• By Eliza Slawther

In this third article of a series on new drug reimbursement recommendations by the HTA body NICE, the Pink Sheet finds that fewer innovative medicines are reimbursed in England than in eight other European nations.

More from Pink Sheet

Life After Loper: Vaping Case Shows US FDA Retains Considerable Deference

 
• By Craig Bleifer, Royce DuBiner, Max Bogost, Michael Brody, and Allyson Maur

A US Supreme Court ruling in favor of the agency in an e-cigarette case has implications for drugs and other medical products as the justices decided not to disturb the FDA’s ‘change in position’ authority, while also creating a complex new landscape.

US FDA COVID-19 Booster Strategy May Not Be As Controversial As It Seems

 
• By Michael McCaughan

US FDA Commissioner Martin Makary’s call for placebo-controlled trials to confirm the efficacy of COVID-19 boosters is drawing a lot of criticism, but former Commissioner Robert Califf also supported the idea.

EU Moment Of Truth For Obe-Cel And 10 Other New Medicines

 
• By Neena Brizmohun

Autolus’s CAR T therapy obe-cel is among the medicines that are this week due for an opinion by the European Medicines Agency on whether they should be marketed in the EU.