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.
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 senior editor Andrea Corona and Nate Bolton, Engineering Design Manager at Genesis EIC, as they discuss the U.S. Department of Energy (DOE) new definition for zero emissions buildings (ZEB), offering a clear roadmap for sustainable design and construction. 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.
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 developments, gain deeper insights, and provide updates on the impact of their work.
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 goes beyond the initial story, offering a richer understanding of key topics and ongoing innovations in the pharma industry.
oin 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, analytical services and quality control manager and Gabrielle Wilson, sterility assurance program manager at Saint-Gobain Life Sciences about the importance of comprehensive contamination control strategies for ensuring product quality and regulatory compliance. Learn more about Saint-Gobain Life Sciences: https://www.lifesciences.saint-gobain.com/
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
The concept of healthspan has recently gained new attention in the pharma industry and rightfully so, given the surprisingly large chasm in the U.S. between average years lived (77.5) and average years lived in good health (63.9). Facing a growing demographic of unhealthy seniors, a handful of innovative biotechs are reframing the longevity discussion: Rather than treat the symptoms of aging one disease at a time, what if we could instead focus on the root causes, enabling treatment of multiple chronic diseases simultaneously? During this podcast, Chief Content Director Karen Langhauser will share a summary of our most recent cover story, discussing the compelling new research and novel genetic medicines that may help close the gap between healthspan and lifespan.
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 — Emergent donates 50,000 doses of mpox vaccine to Africa The bad — FDA rejects Regeneron blood cancer bispecific antibody The ugly — China indicts Astellas exec for espionage
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 Ascendis hypoparathyroidism drug The bad — FDA rejects Lykos MDMA PTSD drug The ugly — Judge blocks Novartis bid to stop generic blockbuster heart 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 — Amneal gets FDA nod for Parkinson's pill The bad — Novo Nordisk withdraws bid for Wegovy label expansion in heart failure The ugly — FDA delays decision on BeiGene Tevimbra as a first-line 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 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
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
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 stability testing and potential reformulations or packaging redesign. To understand more about the issues at hand, senior editor Andrea Corona recently spoke with Adrian Possumato, president and Chris Gilmor, director of sales, at Sanner of America. Learn more about Sanner of America: https://www.sanner-group.com/
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 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.
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 — Eli Lilly compounding pharmacy lawsuit dismissed by Florida judge
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 brand, IndustryWeek, as part of their livestream program, Production Pulse. The broadcast features insights from Pharma Manufacturing's chief content director Karen Langhauser as well as from editors on Machine Design and Food Processing.
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