Off Script: A Pharma Manufacturing Podcast - podcast cover

Off Script: A Pharma Manufacturing Podcast

Pharma Manufacturingpharmamanu.podbean.com
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!
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Episodes

Editor’s (re)View: Is the biopharma industry’s glass half empty or half full?

While macroeconomic uncertainty weighs on the sector, there are glimmers of hope in some areas of pharmaceutical outsourcing and services. Greg Slabodkin Read by Brittany Duncan Read Article Here: https://www.pharmamanufacturing.com/editors-review/article/55299879/editors-review-is-the-biopharma-industrys-glass-half-empty-or-half-full...

Jul 01, 20255 minEp. 86

Flow state: The evolving shape of continuous manufacturing

While the pharmaceutical industry has been slow to adopt continuous manufacturing, it appears to be gaining momentum. Greg Slabodkin Read by Brittany Duncan Enjoy the article Here: https://www.pharmamanufacturing.com/all-articles/article/55295669/flow-state-the-evolving-shape-of-continuous-manufacturing...

Jun 23, 202515 minEp. 84

[Solutions Spotlight] Hydrogenation: Bridging the gap between nitration and phosgenation

Hydrogenation can serve as a critical link in chemical synthesis, particularly between nitration and phosgenation. When integrated strategically, it helps enable safer, more efficient production processes. To better understand this connection, we spoke with Dr. Luca Mantilli, R&D Chemist at Valsynthese, the fine chemicals division of Société Suisse des Explosifs Holding (SSE). Dr. Mantilli discussed how hydrogenation was implemented to bridge the gap between two of the company’s core hazardo...

May 12, 202518 minEp. 83

Novartis to invest $23B in US sites, US urged to invest $15B in biotech counter to China, Trump warns of major pharma tariffs [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 — Novartis to invest $23B in U.S. manufacturing and R&D, including seven new sites The bad — U.S. urged to invest $15B to counter China’s biotech rise The ugly — Trump signals ‘major’ tariffs on pharma, urging manufacturing shift back to U.S.

Apr 14, 20254 minEp. 80

Cellares, Cabaletta validate automated CAR T production, FDA warns Aspen over sterility issues, rejects Hengrui, Elevar cancer combo again [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 — Cellares, Cabaletta validate automated CAR T production The bad — FDA warns Aspen over sterility issues The ugly — FDA rejects Hengrui, Elevar cancer combo again

Mar 26, 20253 minEp. 79

Axplora expands ADC capacity, Merck KGaA CDMO business slump, FDA issues a warning letter to Granules India [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 — Axplora expands its antibody-drug conjugate (ADC) manufacturing capacity to support growing demand. The bad — Merck KGaA’s CDMO business reports a decline The ugly — The FDA issues a warning letter to Granules India over manufacturing violations

Mar 17, 20254 minEp. 78

Eli Lilly expands manufacturing to boost supply, FDA blocks imports from two Indian API makers, ICU Medical recalls potassium chloride injection bags over labeling error [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 — Eli Lilly expands manufacturing to boost supply The bad — FDA blocks imports from two Indian API makers over manufacturing violations The ugly — ICU Medical recalls potassium chloride injection bags over labeling error

Feb 25, 20254 minEp. 77

FDA approves Opdivo subcutaneous version, Marinus Pharmaceuticals sells operations, Novo Nordisk pushes back against compounding pharmacies [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 Opdivo subcutaneous version The bad — Marinus Pharmaceuticals sells operations The ugly — Novo Nordisk pushes back against compounding pharmacies

Jan 07, 20253 minEp. 74

EU approves Novo-Catalent acquisition, CDMO National Resilience announces layoffs, FDA investigates blood cancer reports in gene therapy patients [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 — EU approves Novo-Catalent acquisition The bad — CDMO National Resilience announces layoffs The ugly — FDA investigates blood cancer reports in gene therapy patients

Dec 13, 20243 minEp. 73

FDA grants Regenxbio accelerated path for Duchenne, Neurogene reports death in Rett trial, Halozyme drops Evotec bid [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 grants Regenxbio accelerated approval pathway for Duchenne gene therapy The bad — Neurogene reports patient death in Rett syndrome gene therapy trial The ugly — Halozyme withdraws acquisition proposal for Evotec

Nov 26, 20243 minEp. 71

[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.

Oct 30, 202415 minEp. 67

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

Oct 28, 20243 minEp. 66

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

Oct 14, 20243 minEp. 64

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

Oct 07, 20244 minEp. 63

[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 ...

Sep 26, 202417 minEp. 61

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

Sep 23, 20243 minEp. 60

[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 manag...

Sep 19, 202413 minEp. 59

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

Sep 16, 20244 minEp. 58
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