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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
Episodes
![MilliporeSigma expands ADC manufacturing, EU fines Teva, AZ exec under investigation in China [The good, the bad, the ugly]](https://pbcdn1.podbean.com/imglogo/image-logo/9655061/Security_14__hjvhxj_300x300.jpg)
Wednesday Nov 06, 2024
Wednesday Nov 06, 2024
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
![[Extended Release] Antibiotic resistance crisis and the global efforts against superbugs](https://pbcdn1.podbean.com/imglogo/image-logo/9655061/Security_14__hjvhxj_300x300.jpg)
Wednesday Oct 30, 2024
[Extended Release] Antibiotic resistance crisis and the global efforts against superbugs
Wednesday Oct 30, 2024
Wednesday Oct 30, 2024
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.
![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]](https://pbcdn1.podbean.com/imglogo/image-logo/9655061/Security_14__hjvhxj_300x300.jpg)
Monday Oct 28, 2024
Monday Oct 28, 2024
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
![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]](https://pbcdn1.podbean.com/imglogo/image-logo/9655061/Security_14__hjvhxj_300x300.jpg)
Monday Oct 21, 2024
Monday Oct 21, 2024
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
![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]](https://pbcdn1.podbean.com/imglogo/image-logo/9655061/Security_14__hjvhxj_300x300.jpg)
Monday Oct 14, 2024
Monday Oct 14, 2024
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
![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]](https://pbcdn1.podbean.com/imglogo/image-logo/9655061/Security_14__hjvhxj_300x300.jpg)
Monday Oct 07, 2024
Monday Oct 07, 2024
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
![FDA approves BMS schizophrenia drug, bluebird bio announces layoffs, J&J talc subsidiary files for bankruptcy [The good, the bad, the ugly]](https://pbcdn1.podbean.com/imglogo/image-logo/9655061/Security_14__hjvhxj_300x300.jpg)
Monday Sep 30, 2024
Monday Sep 30, 2024
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
![[Extended Release] Schizophrenia treatment barriers, KarXT, and the future of neuroscience](https://pbcdn1.podbean.com/imglogo/image-logo/9655061/Security_14__hjvhxj_300x300.jpg)
Thursday Sep 26, 2024
Thursday Sep 26, 2024
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]](https://pbcdn1.podbean.com/imglogo/image-logo/9655061/Security_14__hjvhxj_300x300.jpg)
Monday Sep 23, 2024
Monday Sep 23, 2024
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](https://pbcdn1.podbean.com/imglogo/image-logo/9655061/Security_14__hjvhxj_300x300.jpg)
Thursday Sep 19, 2024
[Solutions Spotlight] Optimizing contamination control in pharma facilities
Thursday Sep 19, 2024
Thursday Sep 19, 2024
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/