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Off Script: A Pharma Manufacturing Podcast
모두 재생(하지 않음)으로 표시
Manage series 2941835
Pharma Manufacturing에서 제공하는 콘텐츠입니다. 에피소드, 그래픽, 팟캐스트 설명을 포함한 모든 팟캐스트 콘텐츠는 Pharma Manufacturing 또는 해당 팟캐스트 플랫폼 파트너가 직접 업로드하고 제공합니다. 누군가가 귀하의 허락 없이 귀하의 저작물을 사용하고 있다고 생각되는 경우 여기에 설명된 절차를 따르실 수 있습니다 https://ko.player.fm/legal.
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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86 에피소드
모두 재생(하지 않음)으로 표시
Manage series 2941835
Pharma Manufacturing에서 제공하는 콘텐츠입니다. 에피소드, 그래픽, 팟캐스트 설명을 포함한 모든 팟캐스트 콘텐츠는 Pharma Manufacturing 또는 해당 팟캐스트 플랫폼 파트너가 직접 업로드하고 제공합니다. 누군가가 귀하의 허락 없이 귀하의 저작물을 사용하고 있다고 생각되는 경우 여기에 설명된 절차를 따르실 수 있습니다 https://ko.player.fm/legal.
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!
…
continue reading
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1 Editor’s (re)View: Is the biopharma industry’s glass half empty or half full? 4:47
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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…

1 Life sciences manufacturers overwhelmingly embrace smart tech: global survey 5:00
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Smart manufacturing is “nearly universal” with 95% of manufacturers saying they are using or evaluating smart technology, according to a new survey from Rockwell Automation. Greg Slabodkin Read by Brittany Duncan

1 Flow state: The evolving shape of continuous manufacturing 15:11
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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…

1 [Solutions Spotlight] Hydrogenation: Bridging the gap between nitration and phosgenation 18:15
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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 hazardous chemistries: nitration and phosgenation. Learn more about Valsynthese: https://www.valsynthese.ch/…

1 Editor’s (re)View: BMS, Merck, Roche see manufacturing flexibility as key to dealing with tariffs 4:26
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The three Big Pharma companies on their earnings calls this week tried to reassure investors that they have the global footprints to mitigate the effects of tariffs.

1 Thermo Fisher opens cell therapy center, FDA cites Aurobindo site, Trump probes pharma imports ahead of tariffs [The good, the bad, the ugly] 4:13
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The good — Thermo Fisher opens center to boost cell therapy development The bad — FDA cites Aurobindo plant after Raleigh inspection The ugly — Trump probes pharma imports as tariff threat looms

1 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] 4:10
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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.…

1 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] 3:18
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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…

1 Axplora expands ADC capacity, Merck KGaA CDMO business slump, FDA issues a warning letter to Granules India [The good, the bad, the ugly] 3:44
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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…

1 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] 3:54
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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…

1 Novartis boosts Slovenia investment to $3.6B, Trump tariffs could unsettle biopharma FDI, FDA warns Global Calcium, blocks US imports [The good, the bad, the ugly] 4:24
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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 boosts Slovenia investment to $3.6B The bad — Trump tariffs unsettle biopharma FDI The ugly — FDA warns Global Calcium, blocks US imports

1 FDA approves Opdivo subcutaneous version, Marinus Pharmaceuticals sells operations, Novo Nordisk pushes back against compounding pharmacies [The good, the bad, the ugly] 3:19
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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…

1 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] 2:58
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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…

1 FDA approves Imkeldi oral solution, Alector axes workforce, Novartis announcnes layoffs [The good, the bad, the ugly] 3:12
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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 Imkeldi oral solution The bad — Alector axes workforce The ugly — Novartis announcnes layoffs

1 FDA grants Regenxbio accelerated path for Duchenne, Neurogene reports death in Rett trial, Halozyme drops Evotec bid [The good, the bad, the ugly] 3:19
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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…
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Off Script: A Pharma Manufacturing Podcast

1 PTC secures FDA nod, Kronos Bio halts CDK9 development, Marinus slashes 45% of workforce amid setbacks [The good, the bad, the ugly] 3:13
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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…
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Off Script: A Pharma Manufacturing Podcast

1 Ascendis, Novo ink partnership, Court blocks Sun Pharma launch, FDA moves to delist phenylephrine [The good, the bad, the ugly] 3:35
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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
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Off Script: A Pharma Manufacturing Podcast

1 MilliporeSigma expands ADC manufacturing, EU fines Teva, AZ exec under investigation in China [The good, the bad, the ugly] 2:57
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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
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Off Script: A Pharma Manufacturing Podcast

1 [Extended Release] Antibiotic resistance crisis and the global efforts against superbugs 14:59
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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.…
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Off Script: A Pharma Manufacturing Podcast

1 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] 3:10
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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…
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Off Script: A Pharma Manufacturing Podcast

1 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] 2:50
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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
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Off Script: A Pharma Manufacturing Podcast

1 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] 2:58
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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…
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Off Script: A Pharma Manufacturing Podcast

1 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] 4:00
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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…
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Off Script: A Pharma Manufacturing Podcast

1 FDA approves BMS schizophrenia drug, bluebird bio announces layoffs, J&J talc subsidiary files for bankruptcy [The good, the bad, the ugly] 3:37
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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
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Off Script: A Pharma Manufacturing Podcast

1 [Extended Release] Schizophrenia treatment barriers, KarXT, and the future of neuroscience 17:28
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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.…
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Off Script: A Pharma Manufacturing Podcast

1 Novo Nordisk shares phase 2a obesity trial data, Achilles Therapeutics ends TIL-based therapy, Express Scripts sues FTC [The good, the bad, the ugly] 3:24
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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…
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Off Script: A Pharma Manufacturing Podcast

1 [Solutions Spotlight] Optimizing contamination control in pharma facilities 12:32
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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/…
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Off Script: A Pharma Manufacturing Podcast

1 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] 3:34
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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…
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Off Script: A Pharma Manufacturing Podcast

1 Pfizer, Valneva share phase 2 Lyme vax data, IN8bio axes workforce, AstraZeneca employees detained in China [The good, the bad, the ugly] 4:12
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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
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Off Script: A Pharma Manufacturing Podcast

1 FDA approves Illumina cancer biomarker test, BioMarin reveals more layoffs, FDA hits API maker Global Calcium with 483 [The good, the bad, the ugly] 3:30
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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
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