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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
![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]](https://pbcdn1.podbean.com/imglogo/image-logo/9655061/Security_14__hjvhxj_300x300.jpg)
Dec 13, 2024
Dec 13, 2024
2 min
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
![FDA approves Imkeldi oral solution, Alector axes workforce, Novartis announcnes layoffs [The good, the bad, the ugly]](https://pbcdn1.podbean.com/imglogo/image-logo/9655061/Security_14__hjvhxj_300x300.jpg)
Dec 9, 2024
Dec 9, 2024
3 min
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
![FDA grants Regenxbio accelerated path for Duchenne, Neurogene reports death in Rett trial, Halozyme drops Evotec bid [The good, the bad, the ugly]](https://pbcdn1.podbean.com/imglogo/image-logo/9655061/Security_14__hjvhxj_300x300.jpg)
Nov 26, 2024
Nov 26, 2024
3 min
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
![PTC secures FDA nod, Kronos Bio halts CDK9 development, Marinus slashes 45% of workforce amid setbacks [The good, the bad, the ugly]](https://pbcdn1.podbean.com/imglogo/image-logo/9655061/Security_14__hjvhxj_300x300.jpg)
Nov 21, 2024
Nov 21, 2024
3 min
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
![Ascendis, Novo ink partnership, Court blocks Sun Pharma launch, FDA moves to delist phenylephrine [The good, the bad, the ugly]](https://pbcdn1.podbean.com/imglogo/image-logo/9655061/Security_14__hjvhxj_300x300.jpg)
Nov 14, 2024
Nov 14, 2024
3 min
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
![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)
Nov 6, 2024
Nov 6, 2024
2 min
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)
Oct 30, 2024
Oct 30, 2024
14 min
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)
Oct 28, 2024
Oct 28, 2024
3 min
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)
Oct 21, 2024
Oct 21, 2024
2 min
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)
Oct 14, 2024
Oct 14, 2024
2 min
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
