FEATURE ARTICLES
FDA's accelerated approval guidance kicked off a rebalancing of new drug approval pathways. Since its 2024 release, the agency has been building on it in a few key areas.
- Causal Mechanism And Effect Analysis (CMEA): FMEA's Simpler, Effective Alternative
- Making Mental Health Drugs: Promising Therapies And Manufacturing Challenges
- The Stepwise Path Lilly Mapped From Paper To Digital Logbooks
- A 5-Step Foundation For Early CQV Involvement
- Building Quality Into Radiopharmaceuticals: A Look At EMA's Recent Guideline
- Overcoming 3 Key Challenges Of Working With CDMOs For Radiopharmaceuticals
- Selecting The Right eQMS To Maximize Quality Maturity
PHARMA ONLINE WHITE PAPERS
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![Copyright-GettyImages-451356291]( "IP Considerations In Drug Development For Biotech Companies")
IP Considerations In Drug Development For Biotech CompaniesIntegrate a strategic intellectual property approach early in drug development to streamline research, uncover opportunities, and maximize the return on your investment.
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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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SMB Technology: Optimizing API Purification6/13/2025
Explore how Simulated Moving Bed (SMB) technology can enhance API production while overcoming common misconceptions about chromatographic purification.
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Transformative Innovation: Advancing Drug Development Using In Silico Modeling3/4/2026
Explore how predictive modeling and in silico strategies can turn complex data into actionable insights that accelerate drug development and reduce risk across the development lifecycle.
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ADC Development Grows More Complex — SPR Insights Bring Clarity4/14/2026
Explore how real-time kinetic analysis reveals how conjugation, linker chemistry, and drug loading influence antibody–antigen interactions, while enabling sensitive detection of anti-drug antibodies.
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Alleviate Compliance Risks With Your EAM/CMMS3/2/2026
Discover how unified asset management enhances audit readiness by connecting maintenance, calibration, and quality insights, as well as how integrated workflows reduce compliance risk.
PHARMA ONLINE APP NOTES & CASE STUDIES
- Developing A Project Management Office (PMO) At A Small Manufacturing Site
- Customer Story: Emergent BioSolutions Enhances Aseptic Filling Process
- BioIVT Collaborates With IDBS To Deploy IDBS E-WorkBook And Reduce Study Cycle Times
- Benchmarking Filtration Performance Of TFF Cassettes
- Method Development For Forced Degradation Of GLP-1 Agonist
NEWSLETTER ARCHIVE
- 05.05.26 -- March 2026 — CDMO Opportunities And Threats Report
- 05.02.26 -- Quality Assurance Product Showcase
- 05.01.26 -- ISPE Announces 2026 FOYA Winners
- 04.30.26 -- The Hidden Operational Cost Contained In Every Small Molecule Portfolio
- 04.30.26 -- STREAM Edition: Selecting Equipment And Technology
INDUSTRY NEWS
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![rating service, satisfaction-GettyImages-2221603596]( "ISPE Announces 2026 FOYA Winners")
ISPE Announces 2026 FOYA WinnersThese awards recognize pharmaceutical and biopharmaceutical manufacturing projects that demonstrate excellence across innovation, operations, supply chain, Pharma 4.0, and social impact.
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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.
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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Compact & Powerful Double Planetary Mixer For Lab And Pilot-Scaling4/30/2026
ROSS has delivered an ergonomic and powerful Double Planetary Mixer Model DPM-10 engineered for high-viscosity and specialty material processing in laboratory and pilot-scale operations.
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AES Cleanroom Technology appoints John Groth As Chief Revenue Officer4/27/2026
AES Cleanroom Technology, a leading provider of modular cleanroom design, manufacturing, and construction solutions for the life sciences and biopharmaceutical industries, has appointed John Groth as Chief Revenue Officer as demand grows for flexible, high-performance manufacturing environments across pharma and biotech.
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Navigating Change: Key Industry Insights At PHARMAP 20264/27/2026
The Pharmaceutical Manufacturing and Packaging Congress (PHARMAP) 2026 brought together senior industry leaders on 20-21 April in Amsterdam for two days of focused discussion on the forces reshaping pharmaceutical manufacturing. Held in partnership with Astellas Pharma Europe, GSK, ESTEVE, Laboratoires Théa and Recipharm, the Congress covered global manufacturing strategies, supply chain resilience, packaging innovation and many other topics.
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AbbVie Announces $1.4 Billion North Carolina Campus To Expand U.S. Pharmaceutical Manufacturing Capacity4/27/2026
AbbVie today announced a $1.4 billion investment to build a 185-acre pharmaceutical manufacturing campus in Durham, North Carolina. The state-of-the-art campus will integrate advanced manufacturing and laboratory technologies with artificial intelligence (AI) to support the production of AbbVie's immunology, neuroscience and oncology medicines.
