Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs discuss the impact of nationalism on the regulatory process, which entered the fray once again when news of a potential AstraZeneca-Bristol Myers Squibb merger broke (:58), as well as the US Food and Drug Administration’s IND reform pilot program (11:22), including the potentially influential role of external qualified research institutions (16:20) and the resources the pilot will require (20:29). More On These Topics From The Pink Sheet Oncology Overlap, Nationalism Cast Doubts On Potential AstraZeneca/BMS Merger: https://insights.citeline.com/pink-sheet/policy-regulation/oncology-overlap-nationalism-cast-doubts-on-potential-astrazenecabms-merger-NL65J53QYNF57GBW53AZGSYD54/ Merged AstraZeneca, BMS Would Have Deep Solid Tumor And Blood Cancer Portfolio: https://insights.citeline.com/pink-sheet/r-and-d/merged-astrazeneca-bms-would-have-deep-solid-tumor-and-blood-cancer-portfolio-IF4Z7IRHEFDIRDUAZTZP2PHEDM/ US FDA’s IND Reform Pilot Could Use External Partners To Speed Trial Set-Up: https://insights.citeline.com/pink-sheet/r-and-d/clinical-trials/us-fdas-ind-reform-pilot-could-use-external-partners-to-speed-trial-set-up-7QU7Y7US4FCJRLRWZWV4CLCQBA/

Drug Fix: Regulatory Nationalism And US FDA’s IND Reforms

Citeline Podcasts

Hello and welcome to another edition of Drug Fix, the Pink Sheets Pharma Regulatory Podcast. I'm Derek Ingerie, an Executive Editor at The Pink Sheet, and I'm joined by Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs. Today is August 7th, 2026. We appreciate your indulgence during our couple weeks off because of summer vacation and scheduling conflicts.

We're going to discuss an interesting complication that would have been expected had the AstraZeneca-Bristol-Meyers-SWIB merger gone through, as well as the additional detail we got this week on the new FDA IND Reform pilot program. Just a reminder to hit the like and subscribe buttons on Apple Podcasts and Spotify to make sure that you're getting every episode. And if you like what you heard, give us a five-star review. It really helps us out.

So the news of the AstraZeneca-BMS merger was a huge water cooler story on Monday morning after it broke the night before that discussions were underway. People were genuinely excited and intrigued by the possibility of a combined company worth $400 billion. It would have had a monster oncology portfolio, including some of the biggest franchises in space. But the story fizzled pretty much just as quickly as it emerged. And now reports are that the talks never happened.

So before that, those of us in the media, as we were all considering all the issues that went along with this, including the potential problems that could arise during the regulatory review of the merger. And part of that was the influence of nationalism and politics on this. So President Trump, as most of our listeners know, was elected in part because of his America first policies and his promises to bring back manufacturing to the US.

Drug Fix: Regulatory Nationalism And US FDA’s IND Reforms

Read the full transcript

The candid version is on a podcast,
not the earnings call.

Drug Fix: Regulatory Nationalism And US FDA’s IND Reforms

Read the full transcript

The candid version is on a podcast, not the earnings call.

The candid version is on a podcast,
not the earnings call.