Off Script: A Pharma Manufacturing Podcast

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

Ascendis, Novo ink partnership, Court blocks Sun Pharma launch, FDA moves to delist phenylephrine [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 — 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]

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

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]

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]

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]

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]

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]

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