Off Script: A Pharma Manufacturing Podcast

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

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

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

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]

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

[Extended Release] Defining zero emissions buildings

Join senior editor Andrea Corona and Nate Bolton, Engineering Design Manager at Genesis EIC, as they discuss the U.S. Department of Energy (DOE) new definition for zero emissions buildings (ZEB), offering a clear roadmap for sustainable design and construction. 

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. 

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 

 

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

FDA approves Imkeldi oral solution, Alector axes workforce, Novartis announcnes layoffs [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 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]

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]

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