Off Script: A Pharma Manufacturing Podcast

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  

The good — Roche snags breast cancer FDA nod 

The bad — FDA places clinical hold on Kezar lupus nephritis drug trial 

The ugly — FDA rejects Zealand Pharma hypoglycemia drug over manufacturing reinspection 

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  

The good — Gilead inks deal with generics manufacturers to expand HIV drug access 

The bad — J&J announces layoffs at New Brunswick headquarters 

The ugly — Amgen sued for hiding $10.7B tax bill 

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  

The good —FDA approves BMS schizophrenia drug 

The bad — bluebird bio announces layoffs 

The ugly —J&J talc subsidiary files for bankruptcy

Join senior editor Andrea Corona and Sam Clark, CEO and founder of Terran Biosciences, for a discussion on KarXT's landmark approval, schizophrenia treatment barriers, prodrugs, and more. 

Extended Release is an Off Script series that allows us to revisit conversations with our sources to explore new developments, gain deeper insights, and provide updates on the impact of their work. Each episode goes beyond the initial story, offering a richer understanding of key topics and ongoing innovations in the pharma industry.

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  

The good — Novo Nordisk shares phase 2a trial data for obesity treatment 

The bad — Achilles Therapeutics to discontinue TIL-based therapy 

The ugly — Express Scripts files lawsuit against FTC 

Drugmakers face stringent regulations to ensure that products remain free from contaminants that could compromise safety and efficacy. Effective contamination control requires meticulous monitoring of environmental conditions, rigorous testing of products, and implementation of robust cleaning and sterilization procedures.

To better understand these challenges, we sat down with Emily Alkandry, analytical services and quality control manager and Gabrielle Wilson, sterility assurance program manager at Saint-Gobain Life Sciences about the importance of comprehensive contamination control strategies for ensuring product quality and regulatory compliance.

Learn more about Saint-Gobain Life Sciences: https://www.lifesciences.saint-gobain.com/

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  

The good — Roche snags FDA nod for subcutaneous cancer immunotherapy 

The bad — Moderna to cut R&D expenses by $1.1B 

The ugly — Teva reaches $80M opioid settlement with Baltimore 

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  

The good — Pfizer, Valneva share phase 2 positive Lyme vax data 

The bad — IN8bio axes workforce, halts trial 

The ugly — AstraZeneca employees detained in China 

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:  

The good — FDA approves Illumina cancer biomarker test 

The bad — BioMarin reveals more layoffs 

The ugly — FDA hits API maker Global Calcium with 483 

The concept of healthspan has recently gained new attention in the pharma industry and rightfully so, given the surprisingly large chasm in the U.S. between average years lived (77.5) and average years lived in good health (63.9). Facing a growing demographic of unhealthy seniors, a handful of innovative biotechs are reframing the longevity discussion: Rather than treat the symptoms of aging one disease at a time, what if we could instead focus on the root causes, enabling treatment of multiple chronic diseases simultaneously? 

During this podcast, Chief Content Director Karen Langhauser will share a summary of our most recent cover story, discussing the compelling new research and novel genetic medicines that may help close the gap between healthspan and lifespan.