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Pink Sheet Podcast: SubQ Drugs And Price Negotiations, GLP-1s In Court, US FDA Approach To Black Box AI

 
• By Derrick Gingery, Sarah Karlin-Smith, Cathy Kelly, and Nielsen Hobbs

Pink Sheet reporter and editors discuss an emerging pharma strategy to avoid Medicare price negotiations, legal wrangling related to compounding GLP-1 drugs for obesity and diabetes, and the varying opinions of FDA officials on the acceptability of artificial intelligence models that are not fully explainable.

Pink Sheet podcast
Will the FDA successfully defend its GLP-1 shortage decision? • Source: Citeline/Shutterstock

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Cathy Kelly and Interim Editor-in-Chief Nielsen Hobbs discuss an new pharma strategy to create subcutaneous injectable versions of drugs that can avoid Medicare price negotiations (:25), the legal wrangling to maintain an official shortage of GLP-1 drugs for diabetes and weight loss, which would continue allowing the products to be compounded (14:20), and potential concerns with the US Food and Drug Administration’s varying opinions on the black box nature of some artificial intelligence models (29:08).

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

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Pink Sheet Podcast: More US FDA Departures, Makary On Combined AE Database, ‘Conditional’ Approval

 
• By Derrick Gingery, Sarah Karlin-Smith, and Sue Sutter

Pink Sheet reporter and editors discuss the most recent senior staff departures at the FDA and their impact on the agency, as well as Commissioner Martin Makary’s plans for a new approval pathway and a combined adverse event database as outlined in an interview with a podcast host.

Pink Sheet Podcast: Understanding The US FDA Reduction-In-Force And Its Long-Term Impact

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors discuss how the massive layoffs will reshape the FDA and its impact on the drug and biologics industries.

Pink Sheet Podcast: Understanding The Impact Of The Latest HHS Layoffs On The US FDA

 
• By Derrick Gingery, Sarah Karlin-Smith, and Sue Sutter

Pink Sheet reporter and editors discuss how staff may not be the only thing the FDA could lose with the latest layoffs announced by the Health and Human Services Department.

Pink Sheet Podcast: US FDA Productivity Complaints Emerge, Internal Return To Office Headaches

 
• By Derrick Gingery, Sarah Karlin-Smith, and Nielsen Hobbs

Pink Sheet reporter and editors discuss industry worries about delays in the FDA’s work since the Trump Administration took office, as well as the chaotic return of staff to a White Oak headquarters that cannot handle them.

More from Compliance

US FDA’s Advanced Manufacturing Designation Lifts Off With Cellares Cell Shuttle

 
• By Bridget Silverman

Cellares’ fully automated cell therapy manufacturing platform is the first system to receive an Advanced Manufacturing Technology designation from US FDA

Pharma Still Nervous While Riding Trump’s Tariff Rollercoaster

 
• By Jessica Merrill

The rollout of Trump’s plan has been a policy whiplash, but despite a 90-day pause on tariffs, the US president still appears to be holding a grudge with industry over drug pricing.

Pipeline To Product – What Is Driving Cell And Gene Therapy Progress In India?

 
• By Vibha Ravi

US-based Colossal Labs has claimed to bring back the dire wolf from extinction. While the science is not as dramatic in India yet, cell and gene therapies are making progress as treatments for cancer and other diseases. Pink Sheet takes a look at what is driving CGT success and growth.