Off Script: A Pharma Manufacturing Podcast

By Pharma Manufacturing

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Subscribers: 9
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Episodes: 115

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!

Episode Date
Modular Flow Chemistry and the Future of Continuous Manufacturing
Dec 09, 2025
The Economics Behind U.S. Generic Drug Manufacturing: Part Two
Nov 25, 2025
The Economics Behind U.S. Generic Drug Manufacturing: Part One
Nov 20, 2025
CGT Manufacturing Challenges and Opportunities
Nov 11, 2025
The State of CDMO Funding: 2025 in Review (Part Two)
Nov 04, 2025
The State of CDMO Funding: 2025 in Review (Part One)
Oct 28, 2025
Corporate compliance involves more than just cGMP and quality
Oct 17, 2025
Charting Pharma Manufacturing Trends: Part Two
Oct 14, 2025
Charting Pharma Manufacturing Trends: Part One
Oct 07, 2025
Editor’s (re)View: It matters if Big Pharma is fudging its US investment numbers
Sep 16, 2025
Can CDMOs keep up with the increasing demand for GLP-1 medications?
Sep 10, 2025
FDA’s program to speed up US manufacturing buildouts is short on detail
Aug 26, 2025
New Jersey remains hot life sciences hub despite macroeconomic, funding headwinds
Aug 19, 2025
Critical Timing: Hikma’s Billion-Dollar U.S. Investment
Jul 15, 2025
Editor’s (re)View: Is the biopharma industry’s glass half empty or half full?
Jul 01, 2025
Life sciences manufacturers overwhelmingly embrace smart tech: global survey
Jun 26, 2025
Flow state: The evolving shape of continuous manufacturing
Jun 23, 2025
[Solutions Spotlight] Hydrogenation: Bridging the gap between nitration and phosgenation
May 12, 2025
Editor’s (re)View: BMS, Merck, Roche see manufacturing flexibility as key to dealing with tariffs
Apr 30, 2025
Thermo Fisher opens cell therapy center, FDA cites Aurobindo site, Trump probes pharma imports ahead of tariffs [The good, the bad, the ugly]
Apr 21, 2025
Novartis to invest $23B in US sites, US urged to invest $15B in biotech counter to China, Trump warns of major pharma tariffs [The good, the bad, the ugly]
Apr 14, 2025
Cellares, Cabaletta validate automated CAR T production, FDA warns Aspen over sterility issues, rejects Hengrui, Elevar cancer combo again [The good, the bad, the ugly]
Mar 26, 2025
Axplora expands ADC capacity, Merck KGaA CDMO business slump, FDA issues a warning letter to Granules India [The good, the bad, the ugly]
Mar 17, 2025
Eli Lilly expands manufacturing to boost supply, FDA blocks imports from two Indian API makers, ICU Medical recalls potassium chloride injection bags over labeling error [The good, the bad, the ugly]
Feb 25, 2025
Novartis boosts Slovenia investment to $3.6B, Trump tariffs could unsettle biopharma FDI, FDA warns Global Calcium, blocks US imports [The good, the bad, the ugly]
Feb 18, 2025
FDA approves Opdivo subcutaneous version, Marinus Pharmaceuticals sells operations, Novo Nordisk pushes back against compounding pharmacies [The good, the bad, the ugly]
Jan 07, 2025
EU approves Novo-Catalent acquisition, CDMO National Resilience announces layoffs, FDA investigates blood cancer reports in gene therapy patients [The good, the bad, the ugly]
Dec 13, 2024
FDA approves Imkeldi oral solution, Alector axes workforce, Novartis announcnes layoffs [The good, the bad, the ugly]
Dec 09, 2024
FDA grants Regenxbio accelerated path for Duchenne, Neurogene reports death in Rett trial, Halozyme drops Evotec bid [The good, the bad, the ugly]
Nov 26, 2024
PTC secures FDA nod, Kronos Bio halts CDK9 development, Marinus slashes 45% of workforce amid setbacks [The good, the bad, the ugly]
Nov 21, 2024
Ascendis, Novo ink partnership, Court blocks Sun Pharma launch, FDA moves to delist phenylephrine [The good, the bad, the ugly]
Nov 14, 2024
MilliporeSigma expands ADC manufacturing, EU fines Teva, AZ exec under investigation in China [The good, the bad, the ugly]
Nov 06, 2024
[Extended Release] Antibiotic resistance crisis and the global efforts against superbugs
Oct 30, 2024
Nucleus RadioPharma expands production with new sites, FDA issues CRL to Camurus' hormone disorder drug, NHS rejects Eli Lilly's Alzheimer's drug over cost [The good, the bad, the ugly]
Oct 28, 2024
FDA approves AbbVie 24-hour Parkinson’s treatment, Sage Therapeutics axes workforce, FDA halts Novavax's COVID-flu vax trials [The good, the bad, the ugly]
Oct 21, 2024
Roche gets FDA nod for breast cancer combo, Kezar’s lupus drug trial on hold, Zealand Pharma’s hypoglycemia drug rejected over manufacturing [The good, the bad, the ugly]
Oct 14, 2024
Gilead inks deal with generics manufacturers to expand HIV drug access, J&J announces layoffs, Amgen sued for hiding $10.7B tax bill [The good, the bad, the ugly]
Oct 07, 2024
FDA approves BMS schizophrenia drug, bluebird bio announces layoffs, J&J talc subsidiary files for bankruptcy [The good, the bad, the ugly]
Sep 30, 2024
[Extended Release] Schizophrenia treatment barriers, KarXT, and the future of neuroscience
Sep 26, 2024
Novo Nordisk shares phase 2a obesity trial data, Achilles Therapeutics ends TIL-based therapy, Express Scripts sues FTC [The good, the bad, the ugly]
Sep 23, 2024
[Solutions Spotlight] Optimizing contamination control in pharma facilities
Sep 19, 2024
Roche wins FDA approval for subcutaneous cancer immunotherapy, Moderna to cut $1.1B in R&D expenses, Teva settles $80M opioid case with Baltimore [The good, the bad, the ugly]
Sep 16, 2024
Pfizer, Valneva share phase 2 Lyme vax data, IN8bio axes workforce, AstraZeneca employees detained in China [The good, the bad, the ugly]
Sep 09, 2024
FDA approves Illumina cancer biomarker test, BioMarin reveals more layoffs, FDA hits API maker Global Calcium with 483 [The good, the bad, the ugly]
Sep 03, 2024
Pharma’s new age of longevity
Aug 28, 2024
Emergent donates 50k doses of mpox vaccine to Africa, FDA rejects Regeneron blood cancer bispecific antibody, China indicts Astellas exec for espionage [The good, the bad, the ugly]
Aug 26, 2024
FDA approves Ascendis drug, Lykos PTSD treatment rejected, Novartis bid blocked [The good, the bad, the ugly]
Aug 19, 2024
Amneal's Parkinson's pill approved, Novo Nordisk withdraws Wegovy approval expansion bid, FDA delays BeiGene Tevimbra decision [The good, the bad, the ugly]
Aug 12, 2024
FDA approves Adaptimmune therapy, halts vTv diabetes program; Sanofi sues Sarepta over Duchenne patents [The good, the bad, the ugly]
Aug 05, 2024
FDA approves Sun Pharma hair loss drug, FDA issues warning letter to Brassica, EMA rejects Eisai-Biogen Alzheimer's drug [The good, the bad, the ugly]
Jul 29, 2024
Genentech's oral weight loss drug shows promise; FDA denies accelerated approval for Agenus' cancer drug; Orexo's opioid overdose drug rejected again [The good, the bad, the ugly]
Jul 22, 2024
Pfizer advances obesity pill, FDA rejects Novo insulin, FTC releases PBM report [The good, the bad, the ugly]
Jul 15, 2024
Lilly Alzheimer’s drug gets full approval, Rocket gene therapy rejected, Eisai, BMS end ADC partnership [The good, the bad, the ugly]
Jul 08, 2024
[Solutions Spotlight] Streamlining oral dose packaging design
Jul 03, 2024
Verona wins COPD nod, FDA rejects Merck-Daiichi ADC, Glenmark recalls potassium chloride capsules [The good, the bad, the ugly]
Jul 01, 2024
Gilead HIV shot delivers zero infections, Takeda epilepsy drug misses endpoints, Lilly goes after counterfeiters [The good, the bad, the ugly]
Jun 24, 2024
FDA backs Lilly Alzheimer’s drug; Pfizer Duchenne gene therapy fails; Talc plaintiffs seek J&J bankruptcy restraining order [The good, the bad, the ugly]
Jun 18, 2024
AZ's Tagrisso shines in phase 3 trial, BMS layoffs, FDA violations at Jiangsu Hengrui site [The good, the bad, the ugly]
Jun 10, 2024
J&J depression drug aces trial, Takeda plans layoffs, FDA delays review of Sanofi-Regeneron's Dupixent [The good, the bad, the ugly]
Jun 03, 2024
Mining pharma's reshoring rush
May 29, 2024
FDA approves biosim to Regeneron Eylea, Evotec exits gene therapy, J&J reports deaths in radioligand trial [The good, the bad, the ugly]
May 28, 2024
FDA approves Amgen's T-cell engager for lung cancer, BioMarin announces layoffs, FDA delays Ascendis drug review [The good, the bad, the ugly]
May 20, 2024
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]
May 13, 2024
Neurocrine wins FDA nod for 'sprinkle' Ingrezza, Moderna-Metagenomi deal ends, Emergent's layoffs [The good, the bad, the ugly]
May 06, 2024
Novartis wins rare cancer pediatric indication, BMS layoffs, McKinsey under fire [The good, the bad, the ugly]
Apr 29, 2024
GSK antibiotic hits phase 3 goals, Genentech-Adaptimmune collab ends, Par Pharma recall [The good, the bad, the ugly]
Apr 22, 2024
BMS schizophrenia drug shines, Novartis axes jobs, Lilly compounding suit dismissed [The good, the bad, the ugly]
Apr 22, 2024
2024 election's impact on manufacturing
Apr 12, 2024
Basilea grabs FDA nod, Verve halts gene editing trial, Amylyx pulls ALS drug [The good, the bad, the ugly]
Apr 08, 2024
[The good, the bad, the ugly] Editor's Review week of March 25
Apr 01, 2024
[The good, the bad, the ugly] Editor's Review week of March 18
Mar 25, 2024
[The good, the bad, the ugly] Editor's Review week of March 11
Mar 18, 2024
[The good, the bad, the ugly] Editor's Review week of March 4
Mar 11, 2024
[The good, the bad, the ugly] Editor's Review week of February 29
Mar 05, 2024
[The good, the bad, the ugly] Editor's Review week of February 23
Mar 01, 2024
Raising a modern CDMO
Feb 27, 2024
[Solutions Spotlight] Meeting today’s container closure integrity requirements
Sep 21, 2023
[Solutions Spotlight] Ensuring quality during a syringe surge
Aug 09, 2023
[Solutions Spotlight] Overcoming drug formulation challenges
Jan 19, 2023
[Solutions Spotlight] Bringing pharma’s asset management into the digital age
Oct 26, 2022
[Solutions Spotlight] How to overcome challenges in ophthalmic formulations
Oct 17, 2022
[Solutions Spotlight] How digitalization can provide a competitive advantage
Jun 17, 2022
[Solutions Spotlight] Stop the stall: The time is now for predictive maintenance in pharma
May 24, 2022
[Solutions Spotlight] A groundbreaking approach to BET testing
Nov 23, 2021
[Solutions spotlight] A better way to measure critical attributes in bioreactors
Oct 26, 2021
[Solutions Spotlight] Special delivery: Lipid nanoparticles usher in new treatments
Oct 04, 2021
[Solutions Spotlight] Harnessing AI to improve workplace ergonomics
Aug 09, 2021
Is it time to call the dogs off drug testing?
Jun 16, 2021
Drugs down the drain
May 24, 2021
[Solutions Spotlight] Elevating quality inspection with AI
Apr 30, 2021
Inside the FDA’s fateful Alzheimer’s decision
Mar 19, 2021
Growing the biologic drug supply
Feb 26, 2021
Will the FDA keep moving at this breakneck pace?
Feb 01, 2021
Pharma's wild ride through 2020
Dec 30, 2020
Saving the shrinking pipeline for antibiotics
Nov 16, 2020
Reaching undecided vaxxers: Can pharma simultaneously advance vaccines and public trust
Nov 02, 2020
[Solutions Spotlight] Pharma’s drive towards more sustainable packaging
Oct 29, 2020
Pharma's next big hurdle — distributing vaccines
Oct 19, 2020
The United States of Generics
Oct 05, 2020