Off Script: A Pharma Manufacturing Podcast

[Extended Release] Schizophrenia treatment barriers, KarXT, and the future of neuroscience

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.

Novo Nordisk shares phase 2a obesity trial data, Achilles Therapeutics ends TIL-based therapy, Express Scripts sues FTC [The good, the bad, the ugly]

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 

[Solutions Spotlight] Optimizing contamination control in pharma facilities

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/

Roche wins FDA approval for subcutaneous cancer immunotherapy, Moderna to cut $1.1B in R&D expenses, Teva settles $80M opioid case with Baltimore [The good, the bad, the ugly]

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 

Pfizer, Valneva share phase 2 Lyme vax data, IN8bio axes workforce, AstraZeneca employees detained in China [The good, the bad, the ugly]

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 

FDA approves Illumina cancer biomarker test, BioMarin reveals more layoffs, FDA hits API maker Global Calcium with 483 [The good, the bad, the ugly]

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 

Pharma’s new age of longevity

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.

Emergent donates 50k doses of mpox vaccine to Africa, FDA rejects Regeneron blood cancer bispecific antibody, China indicts Astellas exec for espionage [The good, the bad, the ugly]

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 

FDA approves Ascendis drug, Lykos PTSD treatment rejected, Novartis bid blocked [The good, the bad, the ugly]

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 

Amneal's Parkinson's pill approved, Novo Nordisk withdraws Wegovy approval expansion bid, FDA delays BeiGene Tevimbra decision [The good, the bad, the ugly]

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