42 episodes

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. Off Script is hosted by Pharma Manufacturing editors Karen Langhauser and Meagan Parrish.

Off Script: A Pharma Manufacturing Podcast Pharma Manufacturing

    • News

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. Off Script is hosted by Pharma Manufacturing editors Karen Langhauser and Meagan Parrish.

    AZ's Tagrisso shines in phase 3 trial, BMS layoffs, FDA violations at Jiangsu Hengrui site [The good, the bad, the ugly]

    AZ's Tagrisso shines in phase 3 trial, BMS layoffs, FDA violations at Jiangsu Hengrui site [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 —  AstraZeneca’s Tagrisso delivers 84% progression-free survival in trialThe bad — BMS to let go of 863 employees at NJ site The ugly — FDA inspection uncovers multiple violations at Jiangsu Hengrui Pharmaceuticals site

    • 3 min
    J&J depression drug aces trial, Takeda plans layoffs, FDA delays review of Sanofi-Regeneron's Dupixent [The good, the bad, the ugly]

    J&J depression drug aces trial, Takeda plans layoffs, FDA delays review of Sanofi-Regeneron's Dupixent [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 — J&J depression drug aces late-stage trialThe bad — Takeda plans layoffs at Massachusetts sitesThe ugly —  FDA delays review of Sanofi-Regeneron's Dupixent in COPD

    • 3 min
    Mining pharma's reshoring rush

    Mining pharma's reshoring rush

    When the pandemic hit and Americans found themselves looking to China for critical medical supplies, the idea of reshoring — a concept that had drifted along the currents of the manufacturing sector for over a decade — embedded itself into pharma discourse with renewed luster.
    During this podcast, Chief Content Director Karen Langhauser will share a summary of our most recent cover story, Mining pharma's reshoring rush, and discuss where the industry stands amid the U.S. movement to bring the manufacturing of generic drugs, APIs and ingredients home.
     

    • 4 min
    FDA approves biosim to Regeneron Eylea, Evotec exits gene therapy, J&J reports deaths in radioligand trial [The good, the bad, the ugly]

    FDA approves biosim to Regeneron Eylea, Evotec exits gene therapy, J&J reports deaths in radioligand trial [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 first interchangeable biosims to Regeneron Eylea The bad — Evotec exits gene therapyThe ugly —  J&J reports deaths in early-stage radioligand trial

    • 3 min
    FDA approves Amgen's T-cell engager for lung cancer, BioMarin announces layoffs, FDA delays Ascendis drug review [The good, the bad, the ugly]

    FDA approves Amgen's T-cell engager for lung cancer, BioMarin announces layoffs, FDA delays Ascendis drug review [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 Amgen T-cell engager for small cell lung cancer The bad — BioMarin announces 170 layoffs The ugly — FDA delays review of Ascendis hypoparathyroidism drug

    • 3 min
    Vertex submits NDA for CF drug, MacroGenics reports ADC prostate cancer trial patient deaths, FTC extends review of Novo-Catalent deal [The good, the bad, the ugly]

    Vertex submits NDA for CF drug, MacroGenics reports ADC prostate cancer trial patient deaths, FTC extends review of Novo-Catalent deal [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 —  Vertex submits NDA for CF drugThe bad — MacroGenics reports patient deaths in prostate cancer ADC trial The ugly — FTC extends review of Novo-Catalent deal

    • 4 min

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