Off Script: A Pharma Manufacturing Podcast

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.

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 — Emergent donates 50,000 doses of mpox vaccine to Africa 

The bad — FDA rejects Regeneron blood cancer bispecific antibody 

The ugly — China indicts Astellas exec for espionage 

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 Ascendis hypoparathyroidism drug 

The bad — FDA rejects Lykos MDMA PTSD drug 

The ugly — Judge blocks Novartis bid to stop generic blockbuster heart drug 

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 — Amneal gets FDA nod for Parkinson’s pill 

The bad — Novo Nordisk withdraws bid for Wegovy label expansion in heart failure 

The ugly — FDA delays decision on BeiGene Tevimbra as a first-line therapy 

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 Adaptimmune engineered cell therapy 
The bad — FDA puts clinical hold on vTv Therapeutics diabetes program 
The ugly — Sanofi sues Sarepta over manufacturing patents for Duchenne gene therapy 

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 Sun Pharma hair loss drug 
The bad — FDA issues harsh warning letter to Indian CDMO Brassica 
The ugly — EMA issues negative opinion on Eisai-Biogen Alzheimer's drug