FEATURE ARTICLES
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
- 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
- 2026 CDMO Forecast: The 7 Shifts Sponsors Need To Prepare For
PHARMA ONLINE WHITE PAPERS
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![GettyImages-943533420_medical_storage]( "Outsourcing Stability Storage: A Cost-Effective And Quality-Driven Approach")
Outsourcing Stability Storage: A Cost-Effective And Quality-Driven ApproachPartnering with a leader in outsourced stability storage is revolutionizing the pharmaceutical and medical device industry by saving costs and resources, and ensuring product quality and compliance.
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Aseptic Process Design And Simulation Under Annex 1 Guidelines1/9/2026
Gain insight into how Annex 1 reshapes aseptic process validation, as well as into risk reduction by design and why isolators are redefining modern sterile manufacturing standards.
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The 5 Ws Of A Human Factors Strategy3/31/2025
A human factors strategy ensures medical products are safe, effective, and compliant by integrating user-focused design early, reducing risks, and optimizing regulatory approval processes.
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Five Essentials For Accurate Oligonucleotide Chemistry3/4/2024
Explore five key areas in oligonucleotide chemistry where improvements will have a huge influence on your synthesis quality.
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The Role Of A Consulting Firm In The IND Process6/10/2025
Navigate the complex IND process with expert guidance and discover how early FDA engagement can accelerate your path to clinical trials.
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From Open Cleanrooms To Closed Systems – What Is Driving The Change?3/14/2025
Aseptic processing is evolving. Regulatory changes and technological advancements are driving a shift from open cleanrooms to closed systems for sterile drug manufacturing.
PHARMA ONLINE APP NOTES & CASE STUDIES
- Alternative Two-Step Mixed-Mode Approach To A mAb Purification Process
- BioIVT Collaborates With IDBS To Deploy IDBS E-WorkBook And Reduce Study Cycle Times
- Functional Characterization Of 3D Assembled Neurospheres
- Implementing A Disaster Recovery Plan
- Lentiviral Vector Characterization For Cell And Gene Therapy Manufacturing
NEWSLETTER ARCHIVE
- 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
- 02.10.26 -- New ISPE Framework Targets Uncertainty In Pharma's AI Deployment
- 02.10.26 -- The Future Of Pharma Manufacturing Starts With Digitalization
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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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.
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Is A Cybersecurity Boom On The Horizon? KPMG Survey Shows Surge In Cybersecurity Investment As AI Threats Redefine Risk2/5/2026
A cybersecurity boom appears imminent as businesses invest to defend against a new generation of sophisticated, AI-driven threats. According to the 2025 KPMG Cybersecurity Survey, a staggering 99% of security leaders plan to increase their cybersecurity budgets over the next two to three years, signaling that cybersecurity is no longer just a priority but a critical business imperative.
