FEATURE ARTICLES
International Society for Pharmaceutical Engineering members developed the guide to offer a risk-based framework for evaluating, implementing, and maintaining AI systems.
- 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
- A Deeper Look At Pharma's Structural Supply Chain Vulnerability
- Top 7 AI Lessons Learned
PHARMA ONLINE WHITE PAPERS
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![GettyImages-1938555104-laboratory-equipment-scientist-windows]( "Advancing Drug Development With Optimized LC-MS/MS Bioanalysis")
Advancing Drug Development With Optimized LC-MS/MS BioanalysisExplore the critical role of sample preparation optimization and the application of liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) in bioanalytical method development.
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Inspecting On The Edge — Understanding Punch Tip Wear7/30/2024
Why is a horizontal optical comparator highly recommended for tablet manufacturers as a measuring tool for punch tip inspection, and what strategies can be used to detect, reduce, and prevent tip wear?
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EMA Support For Rare Disease Therapies6/10/2025
Review how the EMA supports rare disease drug development through regulatory and financial incentives for therapies that meet strict eligibility and ongoing compliance criteria.
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Overcoming Challenges To High-Concentration Formulation Development3/25/2025
Explore how the S-HiCon™ platform optimizes high-concentration therapeutic antibody formulations, overcoming stability and manufacturability challenges to deliver safe, effective therapies.
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Solving The Silicone Challenge In Pre-Fillable Syringes8/27/2024
Discover a technology platform that is revolutionizing the pre-fillable syringe market by solving the challenge of silicone sensitivity, ensuring stability for sensitive drugs.
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Validation And Qualification Approach In New Annex 1 Revision2/21/2025
The new Annex 1 revision emphasizes validation and qualification for sterile drug production. Ensure product quality and contamination control by learning about in-depth requirements for premises and equipment.
PHARMA ONLINE APP NOTES & CASE STUDIES
NEWSLETTER ARCHIVE
- 02.03.26 -- Novo's Path To The First GLP-1 Weight Loss Pill
- 02.03.26 -- Composable MES For Pharma
- 01.30.26 -- The 5-Layer Fix For AI Failure In Pharmaceutical Manufacturing
- 01.29.26 -- 5 FDA Approval Categories In 2025
- 01.29.26 -- STREAM Edition: Lessons In Scaling Regenerative Medicine Manufacturing With Organogenesis's Patrick Bilbo
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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Eli Lilly To Build New $3.5B Injectable Drug Manufacturing Site Supporting GLP-1 Therapies In Pennsylvania2/2/2026
Eli Lilly and Company (NYSE: LLY) today announced plans to invest more than $3.5 billion in a new manufacturing facility in the Lehigh Valley, Pennsylvania.
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Halo Pharma To Become A Stand-Alone Drug Product Contract Development And Manufacturing Organization (CDMO)1/27/2026
Halo Pharma, a leading CDMO specializing in drug product pharmaceutical development and manufacturing services, will become a stand-alone business as a result of the sale of the Noramco API and associated businesses to Siegfried.
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Eurofins CDMO Alphora Announces Development & Implementation Of AI-Powered Salt And Co-Crystal Screening Software1/26/2026
Developed by Eurofins CDMO Alphora, in collaboration with a local university, this cutting-edge machine learning platform provides highly accurate predictions of salt and co-crystal formation for APIs and intermediates.
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Coating Place Announces Leadership Appointments To Support Next Phase Of Growth1/23/2026
As Coating Place celebrates its 50th anniversary, the company continues to build on its long-standing reputation as the industry leader in Wurster-based fluid bed technology for controlled release and taste masking applications.
