Off Script: A Pharma Manufacturing Podcast

The three Big Pharma companies on their earnings calls this week tried to reassure investors that they have the global footprints to mitigate the effects of tariffs.

The good — Thermo Fisher opens center to boost cell therapy development The bad — FDA cites Aurobindo plant after Raleigh inspection The ugly — Trump probes pharma imports as tariff threat looms

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.

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

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

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

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

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 

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

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

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

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

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

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

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 

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 

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 

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