FEATURE ARTICLES
Discover the worldwide impacts of China’s zero-tariff policy on Indian pharmaceutical drugs.
- Makary Talks Faster Drug Reviews, 'Continuous Trials,' DTC Ads
- Process Validation: Working Toward Harmonization Of Terms Used To Identify Validation Lots
- ISPE Awards 8 Innovative Pharma Facilities
- The Transition To E-Labeling Is More Than Uploading PDFs
- Are You Still Evaluating CMOs When You Really Need A CDMO?
- Program Manager Alignment And Integration: Best Practices When Working With A CDMO
- New Guide Aims To Build Robust Framework For Digital Validation Tools
PHARMA ONLINE WHITE PAPERS
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![GettyImages-1455725431-production-vials-vaccine]( "Validation And Qualification Approach In New Annex 1 Revision")
Validation And Qualification Approach In New Annex 1 RevisionThe 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.
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Transitioning Your Product From Phase 1 To Phase 2 Clinical Studies12/13/2024
Strategic partnerships can streamline your transition from Phase 1 to Phase 2 clinical studies, ensuring optimized dosage forms, seamless scale-up, and alignment with patient and study requirements.
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Molecular Approaches To Streamline Cell Therapy Product Analytical Testing9/26/2025
Learn how rapid molecular methods of cell therapy testing like qPCR for mycoplasma, sterility, and lentiviral quantification are key to accelerating product release and timely treatment delivery.
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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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Finding An Optimal Harvest Solution By Considering Cost And Sustainability7/10/2024
Choosing the right harvest solution is pivotal in the pursuit of efficient and sustainable bioproduction. Explore the benefits of a single-use centrifuge over traditional depth filtration methods.
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Design Testing Strategies To Develop A Drug-Device Combination Product8/27/2024
Leveraging the expertise and experience of a trusted partner can reduce risk and accelerate the time to market for drug-device combination products by creating an optimal Validation Master Plan.
PHARMA ONLINE APP NOTES & CASE STUDIES
- Rapid Thermal Stability Screening And Selection Of Monoclonal Antibody Drug Products
- Leveraging A Modern HPLC System For Peptide Drug Substances Analysis
- HPLC Analysis Of Ashwagandha Supplements Using Alliance™ iS HPLC System
- Column Selection For RPLC-UV Impurity Analysis
- 384-Well Microplate Time Resolved Fluorescence (TRF) Immunoassay
NEWSLETTER ARCHIVE
- 11.08.25 -- Pharmaceutical Online Best Of October
- 11.07.25 -- Roll Call In The Oral GLP-1 Race
- 11.06.25 -- Still managing CMC activities manually? There's a better way.
- 11.06.25 -- Pfizer Strengthens Obesity Foothold With Metsera Acquisition
- 11.06.25 -- STREAM Edition: Designing For Future Flexibility And Adaptability
INDUSTRY NEWS
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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.
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![Dollar Icon from Medical pills-GettyImages-1708867150]( "Oregon Court Upholds Drug Price Transparency Law")
Oregon Court Upholds Drug Price Transparency LawThe law was first enacted in 2018, followed by a lawsuit by Pharmaceutical Research and Manufacturers of America (PhRMA) in 2019, claiming an infringement of free speech for pharmaceutical companies and violation of public property. PhRMA asked the court to bar Oregon from enforcing the law.
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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CDMO Codis Launches As Commercial Spray Drying And Amorphous Solid Dispersions Provider10/31/2025
Codis officially launches as a new global CDMO specializing in commercial-scale spray drying, amorphous solid dispersions (ASD), and particle engineering technologies. Formed through the integration of Particle Dynamics in the US and the Haverhill, UK spray drying facility previously operated by EUROAPI, Codis combines decades of regulatory expertise and manufacturing strength under one brand.
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Eli Lilly Announces $1.2 Billion Investment To Expand Puerto Rico Manufacturing Site For Next-Gen Oral Medicines10/30/2025
Eli Lilly and Company (NYSE: LLY) announced today a planned investment of more than $1.2 billion to expand and modernize its Lilly del Caribe manufacturing site in Carolina, Puerto Rico. This new investment will integrate advanced technologies and expand production capacity within the existing campus to support the company's growing portfolio of oral solid medicines in cardiometabolic health, neuroscience, oncology and immunology.
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Apeloa Successfully Passes 20th FDA Inspection With No Action Indicated10/30/2025
Following a rigorous and comprehensive evaluation process, Apeloa Pharmaceutical has successfully passed its 20th US FDA inspection, a top achievement in the industry that underscores Apeloa’s exemplary quality and management standards.
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Tema Sinergie Acquires Majority Stake In Aseptic Filling OEM 6Bio10/29/2025
TEMA Sinergie S.p.A., a global leader in isolation systems for the Radiopharma and Biotech Pharma industries, today announced the acquisition of a majority stake in 6Bio, a Spanish company specialized in high-performance aseptic filling technology.
