Off Script: A Pharma Manufacturing Podcast

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 Adaptimmune engineered cell therapy  The bad — FDA puts clinical hold on vTv Therapeutics diabetes program  The ugly — Sanofi sues Sarepta over manufacturing patents for Duchenne gene therapy 

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 Sun Pharma hair loss drug  The bad — FDA issues harsh warning letter to Indian CDMO Brassica  The ugly — EMA issues negative opinion on Eisai-Biogen Alzheimer's drug 

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 — Genentech's oral weight loss drug shows promise  The bad — FDA denies accelerated approval for Agenus' cancer drug  The ugly — Orexo's opioid overdose drug rejected 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 — Pfizer advances once-daily obesity pill  The bad — FDA rejects Novo Nordisk once-weekly insulin  The ugly — FTC releases long-awaited report on PBMs 

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 Eli Lilly Alzheimer’s drug full approval  The bad — FDA rejects Rocket gene therapy  The ugly — Eisai, BMS end ADC partnership 

By integrating a Quality by Design (QbD) approach, developers can design robust packaging from the outset,  drastically reducing development time and costs. Understanding how moisture affects a product is key, allowing developers to use industry-accepted and validated models to predict and address potential stability issues early in the design phase, thereby reducing the need for prolonged probe 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 — Verona wins FDA nod for COPD  The bad — FDA issues CRL to Merck-Daiichi lung cancer ADC  The ugly — Glenmark recalls 114 batches of potassium chloride capsules 

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 twice-yearly HIV shot delivers zero infections in trial  The bad — Takeda epilepsy drug misses endpoints in trials  The ugly — Eli Lilly goes after counterfeiters 

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 AdComm backs Eli Lilly Alzheimer’s drug The bad — Pfizer gene therapy fails phase 3 Duchenne trial The ugly — Talc plaintiffs seek restraining order on J&J bankruptcy tactic

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 trial The bad — BMS to let go of 863 employees at NJ site  The ugly — FDA inspection uncovers multiple violations at Jiangsu Hengrui Pharmaceuticals site

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 trial The bad — Takeda plans layoffs at Massachusetts sites The ugly —  FDA delays review of Sanofi-Regeneron's Dupixent in COPD

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 p...

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 therapy The ugly —  J&J reports deaths in early-stage radioligand trial

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

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 drug The bad — MacroGenics reports patient deaths in prostate cancer ADC trial  The ugly — FTC extends review of Novo-Catalent deal

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 — Neurocrine wins FDA nod for 'sprinkle' Ingrezza formulation  The bad — Moderna, Metagenomi end gene editing collab The ugly — Emergent announces layoffs, closes sites 

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 wins rare cancer pediatric indication for Lutathera The bad — BMS unveils cost-saving initiative, layoffs The ugly — McKinsey under fire for alleged role in opioid crisis  

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 — GSK antibiotic hits phase 3 goals in gonorrhea The bad — Genentech ends $3B Adaptimmune T-cell collab The ugly — Par Pharmaceutical recalls Treprostinil injection for potential contamination

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 — BMS schizophrenia drug shines in phase 3 trial The bad — Novartis to axe 680 jobs The ugly — Lilly compounding suit dismissed

Politics, whether we like them or not, weigh heavy on manufacturing’s future. In case you haven’t heard, it is an election year! Which means, global trade, regulations, immigration, national security and taxation will all be part of the national discourse, and all of those topics touch on manufacturing in one way or another. During this podcast, we will share a discussion courtesy of our sister br...

Editor's Review: Week of April 1 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 — Basilea Pharmaceutica receives FDA approval for its IV antibiotic The bad — Verve Therapeutics halts gene editing trial, again The ugly — Amylyx removes ALS treatment from market

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 Akebia Therapeutics' Vafseo anemia drug The bad — Bristol Myers Squibb's Crohn's disease drug disappoints  The ugly — FDA rejects Regeneron Pharmaceuticals lymphoma treatment 

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 — Orchard gene therapy wins first FDA nod for rare pediatric disease The bad — Abiomed recalls heart pump instructions due to perforation risks  The ugly — J&J files lawsuit against a former employee for allegedly taking over 1,000 files to Pfizer

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 — Madrigal wins first FDA nod for NASH The bad — Acadia abandons plans to expand pimavanserin indications  The ugly — BIO backs BIOSECURE Act, boots WuXi

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 — Boehringer Ingelheim to cap out-of-pocket inhaler prices The bad — Amylyx ALS drug falls short in phase 3 trial The ugly — FDA delays Eli Lilly Alzheimer's drug decision with last-minute AdComm