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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
![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]](https://pbcdn1.podbean.com/imglogo/image-logo/9655061/Security_14__hjvhxj_300x300.jpg)
Apr 14, 2025
Apr 14, 2025
4 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 — 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.
![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]](https://pbcdn1.podbean.com/imglogo/image-logo/9655061/Security_14__hjvhxj_300x300.jpg)
Mar 26, 2025
Mar 26, 2025
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 — Cellares, Cabaletta validate automated CAR T production
The bad — FDA warns Aspen over sterility issues
The ugly — FDA rejects Hengrui, Elevar cancer combo again
![Axplora expands ADC capacity, Merck KGaA CDMO business slump, FDA issues a warning letter to Granules India [The good, the bad, the ugly]](https://pbcdn1.podbean.com/imglogo/image-logo/9655061/Security_14__hjvhxj_300x300.jpg)
Mar 17, 2025
Mar 17, 2025
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 — 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
![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]](https://pbcdn1.podbean.com/imglogo/image-logo/9655061/Security_14__hjvhxj_300x300.jpg)
Feb 25, 2025
Feb 25, 2025
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 — 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
![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]](https://pbcdn1.podbean.com/imglogo/image-logo/9655061/Security_14__hjvhxj_300x300.jpg)
Feb 18, 2025
Feb 18, 2025
4 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 — Novartis boosts Slovenia investment to $3.6B
The bad — Trump tariffs unsettle biopharma FDI
The ugly — FDA warns Global Calcium, blocks US imports
![FDA approves Opdivo subcutaneous version, Marinus Pharmaceuticals sells operations, Novo Nordisk pushes back against compounding pharmacies [The good, the bad, the ugly]](https://pbcdn1.podbean.com/imglogo/image-logo/9655061/Security_14__hjvhxj_300x300.jpg)
Jan 7, 2025
Jan 7, 2025
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 Opdivo subcutaneous version
The bad — Marinus Pharmaceuticals sells operations
The ugly — Novo Nordisk pushes back against compounding pharmacies
![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
