Beyond Sterile - The Quiet Complexity of Non-Sterile Outsourcing
Regulatory Consistency Enables Global Patient Access
How New Oligonucleotide Modalities Are Reshaping Preclinical Development
How Misaligned Pharma and Diagnostic Timelines Are Slowing Targeted Therapy Access
Managing Biopharma R&D Pipelines in an Era of Scientific Innovation
EDITORIAL SECTION
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STRATEGY
Strategic Positioning for M&A
The biotechnology sector is characterised by a constant influx of small highly specialised companies
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RESEARCH DEVELOPMENT
Cytiva Laboratory capsule filters
Our singleuse selfcontained filtration solutions help reduce contamination risk and lower manual handling
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CLINICAL TRIALS
Virtual Clinical Trials
Virtual digital and decentralized are all descriptions of the novel ways that using technology changes
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Bio Pharma
Biosimilars and Biobetters
Biosimilars are biologic medical products that are essentially identical to an original product manufactured
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MANUFACTURING
Transformative Convergence of AI in Pharmaceutical Manufacturing
The pharmaceutical manufacturing industry is on the cusp of a revolutionary transformation driven by
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Information Technology
Transformative Impact of Artificial Intelligence on Clinical Trials
Artificial Intelligence AI has rapidly evolved from a futuristic concept to a transformative tool across various industries
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EXPERT Talk
Pharma's Medical Affairs Bridge: From Field Insights and Stakeholder Needs to Global Scientific Strategy
Medical Affairs has evolved from being primarily a supportive and educational function to becoming a strong strategic partner earlier on Through ongoi...
Advisory Board
.webp "Juris Hmelnickis")
.webp "Eiman Shafa")
KNOWLEDGE BANK
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Articles
Pharmaceutical Quality Management in the American Drug Manufacturing Industry: FDA Standards, Quality Systems and Process Control
Imagine a plant that makes a blood pressure tablet Every batch passes its final test but nobody noticed that the blending step has been drifting for months One day a batch fails dissolution Then another Then the FDA shows up
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Techno Trends
Lilly’s Jaypirca Gains FDA Approval for First-Line CLL/SLL Treatment
Eli Lilly and Company has received approval from the US Food and Drug Administration FDA for an additional indication for Jaypirca pirtobrutinib in adults with previously untreated chronic lymphocytic leukaemia CLL or small lymphocytic lymphoma SLL without a known p deletion The approval enables Jaypirca to be used as a firstline treatment
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Projects
Genentech Begins US$750 Million Expansion of Oregon Manufacturing Facility
Genentech a member of the Roche Group has started construction on a US million expansion of its manufacturing facility in Hillsboro Oregon The squarefoot project will double the existing sites footprint and increase US production capacity for advanced drug delivery devices
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Research Insights
Identification of flavonoids from natural products against hyperlipidaemia through computational approaches
Over the centuries hyperlipidaemia has been recognised as a major risk factor contributing to cardiovascular disease CVD Current research increasingly explores natural compounds such as flavonoids for their potential lipidlowering effects This study evaluated pharmacological potential
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White Papers
Post-Translational Modifications in Drug Discovery: From Molecular Regulation to Clinical Impact
For decades the central dogma of molecular biology has anchored our understanding of cellular function DNA to RNA to protein But this linear view is incomplete A growing body of evidence shows that much of biologys complexity
TOP ARTICLES
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1
Vectorizing Hope: The Art and Science of Gene Therapy Vector Manufacturing
Kate Williamson
Gene therapy vector manufacturing is a dynamic field merging art and science to address genetic disorders. It involves precise vector design, production, and quality control. Challenges like safety an...
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2
How to Successfully Enter the American Pharma Market?
Kate Williamson
Entering the North American pharmaceutical market demands a comprehensive strategy. Understanding FDA regulations, conducting thorough market analysis, building strategic partnerships, adapting to hea...
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3
Future-Proofing Pharmaceutical Manufacturing: AI, Automation, and Digital Transformation
Lakshmi
American pharmaceutical manufacturing is entering its most consequential modernization since the adoption of good manufacturing practice. Artificial intelligence, advanced automation and connected dat...
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4
Mass Spectrometry Techniques in Pharmaceutical Analysis: A Pathway to Improved Drug Quality
Kate Williamson
Mass spectrometry (MS) plays a vital role in pharmaceutical analysis, ensuring drug quality, safety, and regulatory compliance. It excels in drug compound identification, quantitative analysis, impuri...
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5
Efficiency and Quality in Pharma: Leveraging Lean Six Sigma Integration
Kate Williamson
This article explores the integration of Lean Six Sigma principles in the pharmaceutical industry to enhance efficiency and quality. It covers benefits such as improved process efficiency, enhanced pr...
press releasesRead more...
Global Pharmaceutical Company Commits to a Dual-Site Deal with AGC Biologics Exceeding €0.5 Billion
AGC Biologics has expanded its existing longterm manufacturing agreement with a global pharmaceutical company adding a second supply node at the CDMOs Copenhagen facility The expansion which builds on the existing agreement anchored at AGC Biologics
Newleos Announces $15.5 Million NIH Grant and Receipt of FDA Fast Track Designation for NTX-2001 to Treat Substance Use Disorders
Newleos Therapeutics Inc a clinicalstage biotechnology company developing innovative treatments for neuropsychiatric disorders today announced that the National Institute on Drug Abuse NIDA part of the National Institutes of Health NIH has awarded the company up to million to fund the development o...
Guardian Pharmacy Services Acquires Van’s Institutional Pharmacy, Expanding Footprint in Tennessee and Kentucky
Guardian Pharmacy Services Inc one of the nations largest and most innovative longterm care LTC pharmacy services companies today announced the acquisition of Vans Institutional Pharmacy an LTC pharmacy based in Martin Tenn The addition grows Guardians Tennessee operations to five pharmacies
Immunome Announces EMA Validation of Marketing Authorization Application for Varegacestat for the Treatment of Adults with Desmoid Tumors
Immunome Inc a clinicalstage targeted oncology company committed to developing firstinclass and bestinclass targeted cancer therapies today announced that the European Medicines Agency EMA has validated the Marketing Authorization Application MAA for varegacestat an investigational oral oncedaily ga...
Events Read more...
02 - 04
Nov 2026Pharma Forum EMEA 2026
Dom Pedro Lisboa Hotel, Lisbon...
02 - 04
Nov 2026Cancer R&D 2026
Houston, TX, USA
03 - 05
Nov 202610th Dermatology Drug Development
Boston, Massachusetts at The C...
03 - 04
Nov 2026PDA Aseptic Processing of Biopharma Conference
Sheraton Grand Incheon Hotel,...
04 - 05
Nov 2026Advanced Therapies USA
Hynes Convention Center, Bosto...
05 - 05
Nov 2026PDA Contamination Control Strategy Workshop
Sheraton Grand Incheon Hotel,...
09 - 11
Nov 202611th Microbiome Movement USA Summit
The Colonnade Hotel, Boston, M...
10 - 11
Nov 2026Extractables & Leachables Europe
Parkhotel Schӧnbrunn, Vienna,...
LATEST NEWSRead more...
Moleculent Introduces Glimt, the First Automated Instrument for Functional Profiling of Cell-Cell Interactions in Human Tissue
Moleculent AB the life sciences technology company pioneering functional profiling today announced Glimt an automated platform that detects cellcell interactions directly in formalinfixed paraffinembedded FFPE tissue The Glimt platform is now available to selected academic
Rhythm Pharmaceuticals and LG Chem Enter into Amendment to Bivamelagon Exclusive License Agreement
Rhythm Pharmaceuticals Inc announced an amendment to the global exclusive license agreement with LG Chem Ltd for bivamelagon an investigational oral smallmolecule melanocortin receptor MCR agonist The Company also announced a fiveyear term loan facility led by KKR
SCIEX Launches LeadScape Compatible with SCIEX OS Software to Accelerate High-Throughput Drug Candidate Evaluation
SCIEX a Danaher company and leader in life science analytical technologies today announced the launch of LeadScape compatible with SCIEX OS software a new highthroughput workflow solution that accelerates drug candidate evaluation Developed by Sound Analytics the software
Denali Therapeutics Receives 2026 Prix Galien USA Award for AVLAYAH® (tividenofusp alfa-eknm) as Best Biotechnology Product
Denali Therapeutics Inc announced that AVLAYAH tividenofusp alfaeknm has been recognized as the Best Biotechnology Product of by The Galien Foundation AVLAYAH is the first biologic approved by the US Food and Drug Administration FDA that is specifically designed to cross the bloodbrain barrier and...
Doximity Launches DoseCheck to Catch Dangerous AI Drug Dosing Errors Before They Reach Doctors
Doximity Inc the leading digital platform for US medical professionals has launched DoseCheck a free additional safety layer in Doximity Ask that instantly checks every AIgenerated medication dosing claim against a structured drug database to reduce treatment
Celularity and Vesalius Longevity Labs Sign Exclusive Collaboration for Peptual® Peptide APIs Manufactured in the United States
Celularity Inc a longevityfocused regenerative and cellular medicine company and Vesalius Longevity Labs Inc Vesalius a leading global peptide and longevity brand today announced that they have entered into an exclusive manufacturing agreement to establish a dedicated firstofitskind US final stage
