Off Script: A Pharma Manufacturing Podcast

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 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 devel...

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 

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

Join senior editor Andrea Corona and Sam Clark, CEO and founder of Terran Biosciences, for a discussion on KarXT's landmark approval, schizophrenia treatment barriers, prodrugs, and more.  Extended Release is an Off Script series that allows us to revisit conversations with our sources to explore new developments, gain deeper insights, and provide updates on the impact of their work. Each episode...

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 — Novo Nordisk shares phase 2a trial data for obesity treatment  The bad — Achilles Therapeutics to discontinue TIL-based therapy  The ugly — Express Scripts files lawsuit against FTC 

Drugmakers face stringent regulations to ensure that products remain free from contaminants that could compromise safety and efficacy. Effective contamination control requires meticulous monitoring of environmental conditions, rigorous testing of products, and implementation of robust cleaning and sterilization procedures. To better understand these challenges, we sat down with Emily Alkandry, ana...

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 FDA nod for subcutaneous cancer immunotherapy  The bad — Moderna to cut R&D expenses by $1.1B  The ugly — Teva reaches $80M opioid settlement with Baltimore 

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 — Pfizer, Valneva share phase 2 positive Lyme vax data  The bad — IN8bio axes workforce, halts trial  The ugly — AstraZeneca employees detained in China 

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 Illumina cancer biomarker test  The bad — BioMarin reveals more layoffs  The ugly — FDA hits API maker Global Calcium with 483