Pharma Pulse: Novo Nordisk Plant Faces FDA Scrutiny, Off-Label GLP-1 Use Grows, and AbbVie Expands Psychiatry Pipeline

This episode of Pharma Pulse covers FDA findings of contamination and safety lapses at Novo’s Bloomington manufacturing plant, the rise of off-label GLP-1 prescribing and its equity challenges, and AbbVie’s acquisition of bretisilocin to advance treatments for major depressive disorder.

Welcome to Pharma Pulse, a Pharmaceutical Commerce podcast where we bring you the latest insights shaping patient access, supply chain/logistics, data & tech, and healthcare innovation. I’m your host, and today we’re covering FDA safety concerns at a major Novo Nordisk facility, the growing trend of off-label GLP-1 prescribing, and AbbVie’s latest move to expand its psychiatry pipeline.

  • The FDA has reported contamination and safety lapses at Novo Nordisk’s manufacturing plant in Bloomington, IN. Inspectors found problems with microbial contamination and gaps in quality control processes. While Novo has stated it is working to resolve the issues, the findings raise concerns about potential supply chain disruptions and highlight the importance of stringent manufacturing oversight.
  • In other news, new research shows a sharp increase in off-label prescribing of GLP-1 therapies, such as those originally developed for diabetes, now being widely used for weight loss and other conditions. Experts say the trend underscores both the clinical potential and the risks of inequitable access, as high demand strains supply, and insurance coverage remains inconsistent. The findings add urgency to the broader discussion about affordability, fair distribution, and the need for clearer guidelines on GLP-1 use.
  • Lastly, AbbVie is set to acquire the investigational therapy bretisilocin for major depressive disorder. The move expands AbbVie’s psychiatry pipeline at a time of rising global demand for novel treatments in mental health. With depression affecting millions worldwide and significant unmet need for effective therapies, this acquisition signals AbbVie’s commitment to advancing neuroscience innovation as part of its long-term growth strategy.

From manufacturing oversight to access challenges and pipeline expansion, these stories reflect the pressures and opportunities shaping today’s pharmaceutical industry.

That’s it for this episode of Pharma Pulse. For more insights on trends transforming pharmaceutical access and care delivery, visit pharmaceuticalcommerce.com.

Thanks for listening—until next time, stay well and stay informed.

You can catch Pharma Pulse directly on AudioboomSpotify, or iHeart.