Off Script: A Pharma Manufacturing Podcast

The Off Script podcast offers in-depth interviews and discussions with industry experts about hot-button topics in pharma, and goes behind the scenes of Pharma Manufacturing’s print and online coverage, which follows the industry’s biggest issues surrounding scale-up, technology innovations, regulations and more. Off Script is hosted by Pharma Manufacturing editors Karen Langhauser and Meagan Parrish.

PTC secures FDA nod, Kronos Bio halts CDK9 development, Marinus slashes 45% of workforce amid setbacks [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 — PTC secures FDA nod for brain-targeted gene therapy  The bad —  Kronos Bio halts CDK9 development The ugly —  Marinus slashes 45% of workforce amid setbacks

11-21
03:13

Ascendis, Novo ink partnership, Court blocks Sun Pharma launch, FDA moves to delist phenylephrine [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 — Ascendis, Novo ink partnership The bad — Court blocks Sun Pharma launch The ugly — FDA moves to delist phenylephrine

11-14
03:35

MilliporeSigma expands ADC manufacturing, EU fines Teva, AZ exec under investigation 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 — MilliporeSigma expands ADC manufacturing  The bad — EU fines Teva The ugly — AZ exec under investigation

11-06
02:57

[Extended Release] Antibiotic resistance crisis and the global efforts against superbugs

Join senior editor Andrea Corona and Emily Wheeler, Director of Infectious Disease Policy at the Biotechnology Innovation Organization (BIO), as they discuss the urgency of tackling antimicrobial resistance and the coordinated global efforts needed to save the struggling market of antibiotics.  Extended Release is an Off Script series to revisit conversations with our sources and explore new developments, gain deeper insights, and provide updates on the impact of their work. 

10-30
14:59

Nucleus RadioPharma expands production with new sites, FDA issues CRL to Camurus' hormone disorder drug, NHS rejects Eli Lilly's Alzheimer's drug over cost [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 — Nucleus RadioPharma expands production with new sites  The bad — FDA issues CRL to Camurus' hormone disorder drug  The ugly — NHS rejects Alzheimer's drug over cost concerns 

10-28
03:10

FDA approves AbbVie 24-hour Parkinson’s treatment, Sage Therapeutics axes workforce, FDA halts Novavax's COVID-flu vax trials [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 AbbVie 24-hour Parkinson’s treatment  The bad — Sage Therapeutics axes workforce  The ugly — FDA halts Novavax's COVID-flu vaccine trials 

10-21
02:50

Roche gets FDA nod for breast cancer combo, Kezar’s lupus drug trial on hold, Zealand Pharma’s hypoglycemia drug rejected over manufacturing [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 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 

10-14
02:58

Gilead inks deal with generics manufacturers to expand HIV drug access, J&J announces layoffs, Amgen sued for hiding $10.7B tax bill [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 — 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 

10-07
04:00

FDA approves BMS schizophrenia drug, bluebird bio announces layoffs, J&J talc subsidiary files for bankruptcy [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 BMS schizophrenia drug  The bad — bluebird bio announces layoffs  The ugly —J&J talc subsidiary files for bankruptcy

09-30
03:37

[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.

09-26
17:28

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 

09-23
03:24

[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/

09-19
12:32

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 

09-16
03:34

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 

09-09
04:12

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 

09-03
03:30

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.

08-28
04:15

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 

08-26
03:41

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 

08-19
03:21

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 

08-12
02:59

FDA approves Adaptimmune therapy, halts vTv diabetes program; Sanofi sues Sarepta over Duchenne patents [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 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 

08-05
03:58

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