Claim OwnershipOff Script: A Pharma Manufacturing Podcast
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Description
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.
70 Episodes
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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.
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, 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
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