FEATURE ARTICLES
The Trump administration has effectively merged national security, trade policy, and drug quality. Now, foreign manufacturers lacking deals face paying a "quality tax."
- New ISPE Framework Targets Uncertainty In Pharma's AI Deployment
- Novo's Path To The First GLP-1 Weight Loss Pill
- The 5-Layer Fix For AI Failure In Pharmaceutical Manufacturing
- Why Use Total Organic Carbon Analysis For Cleaning Validation?
- December 2025 — CDMO Opportunities And Threats Report
- 5 FDA Approval Categories In 2025
- A 2025 Pharma Look Back and Look Forward: Editor Style
PHARMA ONLINE WHITE PAPERS
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![GettyImages-89952787_cows]( "Challenges In Developing Medical Devices From Animal-Based Biomaterials In China")
Challenges In Developing Medical Devices From Animal-Based Biomaterials In ChinaBovine collagen, valued for biocompatibility and versatility, is gaining attention for medical devices in China as regulatory barriers ease, though safety assurances remain crucial.
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Choosing The Right PCD Configuration For Reliable Sterility Assurance10/16/2025
Accurate PCD configuration ensures sterility assurance. Learn how to align validation strategies with ISO standards, optimize cycle efficiency, and select the right BI format for EO sterilization success.
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GMP Compliance For Pharmaceuticals And Medical Devices3/14/2025
Good Manufacturing Practice (GMP) ensures products meet quality standards for their intended use, which covers all aspects of production. Explore how Ideagen supports GMP compliance across nine titles.
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ICH E6(R3) In Effect: Transforming Quality Management For CGT Trials1/29/2026
Discover how the updated ICH E6(R3) guideline supports the speed and complexity of CGT manufacturing, enabling flexible, risk‑based decisions and quality systems built to scale therapies safely.
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2024 Global Biopharma Sustainability Review9/3/2024
What steps is the biopharma industry taking to enhance sustainability? What challenges does biopharma encounter? And how can the entire industry draw lessons from the companies setting the standard?
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Enabling Digital Twins With Computational Fluid Dynamics Modeling1/16/2025
Embrace the transformative power of predictive modeling and digital twin technology to optimize bioprocess efficiency, ensure product quality, and drive innovation in biopharmaceutical manufacturing.
PHARMA ONLINE APP NOTES & CASE STUDIES
- Optimization Of The Freeze Drying Process
- Lentiviral Vector Characterization For Cell And Gene Therapy Manufacturing
- Navigating Regulatory Compliance: A Success Story In The Pharma Industry
- Optimized Processes: A Guide To Lyophilization Cycle Development
- Development Of An Effective LC-MS/MS Cleaning Validation Method
NEWSLETTER ARCHIVE
- 02.13.26 -- It's Copy/Paste In Fleet Management Manufacturing
- 02.13.26 -- Smarter Pharma Production Starts Here: Automation, Efficiency & Speed
- 02.12.26 -- STREAM Edition: Data Governance And Regulations For AI Use In GMP With Peter Baker
- 02.11.26 -- Sharpen Your Chromatography Performance
- 02.11.26 -- Unlock Expert Insights On Scalable Manufacturing, Tech Transfer, And Outsourcing
INDUSTRY NEWS
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![FDA Logo on phone screen-GettyImages-2208861549]( "Høeg In, Pazdur Out At The FDA")
Høeg In, Pazdur Out At The FDAWhat an eventful week it has been at the FDA, with Richard Pazdur, M.D., resigning after weeks in his position as director of Center for Drug Research and Evaluation (CDER), and his vacancy being quickly filled by acting director Tracy Beth Høeg, M.D.
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![business peope negotiating-GettyImages-637902194]( "9 Drugs Granted Fast Track By FDA's Voucher Program")
9 Drugs Granted Fast Track By FDA's Voucher ProgramWith targets like pancreatic cancer, deafness, blindness, infertility and vaping addiction, these drugs were chosen due to an unmet need, addressing a public health crisis, boosting domestic manufacturing or increasing affordability.
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![Pharmaceutical sorting machine, pills-GettyImages-1499814881]( "Leaders In The Excipient Market: Region And Type")
Leaders In The Excipient Market: Region And TypeThough North America led the market with a 38.32% market share of $3.15 billion in 2024, Asia Pacific is expected to have the fastest growth in the upcoming years.
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![GettyImages-2189405678-GLP-1-obesity]( "Pfizer Strengthens Obesity Foothold With Metsera Acquisition")
Pfizer Strengthens Obesity Foothold With Metsera AcquisitionAfter discouraging efforts to bring two oral obesity drugs to market—danuglipron and lotiglipron—this acquisition launches Pfizer back into the obesity therapeutic game.
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![weight loss, diabetes, insulin pen-GettyImages-2196049931]( "FDA Cracks Down On GLP-1 Imports")
FDA Cracks Down On GLP-1 ImportsGLP-1 bulk drug substances must be detained without physical examination (DWPE) unless they are on a list (Green List) of approved foreign GLP-1 manufacturers.
PHARMACEUTICAL ONLINE CONTENT COLLECTIONS
Explore how sterility assurance, including sterilization validation and environmental monitoring, is essential for controlling microbial contamination in mammalian cell production to ensure patient safety. Check out the latest e-book from Pharmaceutical Online.
More Content CollectionsSUPPLIER NEWS
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JHS CEO Chris Preti Receives 2026 Person Of Influence Award2/12/2026
Spokane, WA. - The Spokane Journal of Business named Chris Preti, CEO of Jubilant HollisterStier (JHS), as one of its 2026 People of Influence.
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Subcutaneously Administered Nanotrastuzumab Matches Performance Of Herceptin HYLECTA In Minipig Study2/12/2026
Nanoform Finland Plc, the medicine performance-enhancing company, announced the results from a preclinical study designed to compare the tolerability and pharmacokinetics of Nanotratsuzumab, a nanoformed, novel, hyaluronidase-free, non-aqueous nanoparticle suspension of trastuzumab for subcutaneous delivery versus Herceptin HYLECTA™, a co-formulated product with Halozyme’s proprietary hyaluronidase enzyme marketed by Roche/Genentech.
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A New Chapter In ROIS Commercial Leadership2/11/2026
ROIS today announced the appointment of Kimberlee Steele as Chief Commercial Officer, effective from 1 March 2026.
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New AI Solution From Catalyx Slashes Line Clearance Time And Boosts Manufacturing Efficiency2/10/2026
With production bottlenecks costing life sciences manufacturers millions in lost productivity, Catalyx today unveiled OpenLine LineClearance Assistant™ 3.0, a breakthrough AI-powered solution addressing this issue. The new solution transforms line clearance into a fully automated digital process, accelerating product changeover time, minimizing downtime, and maximizing operational efficiency.
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KeyPlants AB Expands Production Capacity With New Facility In Götene, Sweden2/9/2026
KeyPlants AB is strengthening its global production capacity through a significant expansion into Götene, Sweden. In response to a recently secured large-scale order and an increasingly strong project pipeline, the company is establishing operations at the Götenehus industrial site under a four-year lease agreement with Forshem Fastigheter.
