EDITORIAL SECTION
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STRATEGY
Smarter Pharma
Quality management systems QMS are the backbone of pharmaceutical manufacturing ensuring safe products
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RESEARCH DEVELOPMENT
Cytiva Laboratory capsule filters
Our singleuse selfcontained filtration solution
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CLINICAL TRIALS
Why Clinical Trials Need Digital Endpoints
According Citeline the average success rate for bringing a Phase candidate to market has dropped to an alltime low of just
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MANUFACTURING
Ensuring Quality and Compliance in Biopharma
Ensuring quality and regulatory compliance in the biopharmaceutical industry is critical to safeguarding product safety and efficacy
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Information Technology
The Cost of Bad Data
Modern pharmaceutical research generates an unprecedented volume of information Data from genomic sequencing
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Biopharma
Reimagining Global Biomanufacturing Capacity with Continuous and Modular Systems
Biotechnology is fueling the ongoing expansion of the global market for a broad array of goods
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EXPERT Talk
Compliance to Competitive Advantage in Pharma Supply
Compliance gets you through an audit Resilience gets medicines to patients on the day something unexpected happens The DSCSAs enhanced requirements took effect November but real interoperability required three more rounds of accommodation phased implementation with the smalldispenser
Advisory Board
KNOWLEDGE BANK
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Articles
B2B Lead Generation Pharma: High-ROI Tactics for European Markets
The European pharmaceutical industry can be called one of the most complicated and highly regulated markets in the world In the global market where a centralized approval system under the oversight of the European Medicines Agency EMA is required to the reimbursement systems specific to each country in Germany France Italy Spain and the Nordics market entry and market growth needs the accuracy of...
Achieving Full Digital Maturity in Pharma Manufacturing: A Paperless Transformation Guide
The pharmaceutical sector is changing radically as manufacturers do not rely on the past and dataintensive processes The vision of paperless pharma manufacturing is not a dream anymore it is a strategy based on the pressure of the regulators the complexity of operations and the need to accomplish faster and with accuracy production The center of this change is the digital pharma manufacturing and...
Cell and Gene Therapy's Trillion-Dollar Reckoning Is Here
Cell and gene therapies can cure diseases once thought untreatable Yet a string of commercial collapses now suggests that curing the patient and sustaining the business are two very different challenges and the industry is confronting the gap at last
Quality by Design Is a Mindset, Not a Milestone
Every medicine is a promise about consistency The tablet dispensed in Milan next spring must behave exactly like the one tested in a trial four years earlier and like the ten million made between them
Exploring the Versatility of Using 3D Spheroid Models in Research
Cell culture technology forms the foundation of modern biological and pharmaceutical research For many years twodimensional culture systems have served as standard experimental models for studying cellular behavior disease mechanisms and therapeutic responses Although these models contribute significantly to scientific discovery they cannot fully replicate the structural and functional complexity...
Fundamentals of Pharmaceutical Formulation Development
The process of changing an active drug substance into a safe and effective drug is much more complicated than it seems at first sight The core of this undertaking is pharmaceutical formulation development a science and strategic field that unites the pursuit of striking a scientific breakthrough and patient care Even the most promising drug molecule would not confer therapeutic benefits without be...
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Techno Trends
Lilly’s Olomorasib Gains FDA Breakthrough Therapy Status
Eli Lilly and Company has secured Breakthrough Therapy designation from the US Food and Drug Administration FDA for olomorasib an investigational medicine being developed for adults with advanced pancreatic cancer carrying a KRAS GC mutation
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Projects
Resilience and Lilly Expand Ohio Manufacturing Facility with US$750 Million Investment
Resilience a technologydriven contract development and manufacturing organisation CDMO has expanded its strategic partnership with Eli Lilly and Company to increase domestic production
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Research Insights
Induction of osteogenic differentiation of MSCs by GSK3β knockdown through GSK3β siRNAs transfection
The development of effective strategies for treating bone defects can be based on gene therapy methods aimed at regulating the differentiation of osteoprogenitor cells One of the approaches is to use siRNA mo
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whitepaper
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
TOP ARTICLES
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1
Achieving Full Digital Maturity in Pharma Manufacturing: A Paperless Transformation Guide
Kate Williamson
This article discusses how paperless pharma production is achieved to realize complete digital maturity, through automation, compliance-sourced software and integrated digital systems. It shows the ad...
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2
Cell and Gene Therapy's Trillion-Dollar Reckoning Is Here
Lakshmi
Cell and gene therapies are transforming medicine, but commercial sustainability remains their greatest challenge. Despite scientific breakthroughs and a rapidly expanding pipeline, many developers fa...
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3
Quality by Design Is a Mindset, Not a Milestone
Lakshmi
Quality by Design has been embedded in European regulatory expectation for nearly two decades, yet it is still widely treated as a dossier section rather than an operating philosophy. This article exa...
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4
Exploring the Versatility of Using 3D Spheroid Models in Research
Venkata Reddy Pothireddy
Three-dimensional (3D) spheroid models provide physiologically relevant alternatives to conventional two-dimensional (2D) cell cultures by better reproducing cell-to-cell and cell-to-matrix interactio...
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5
Fundamentals of Pharmaceutical Formulation Development
Kate Williamson
Drug innovation is a principal responsibility of pharmaceutical formulation development that provides the drug with stability, bioavailability, and adherence in the patients. Researchers can make mole...
press releases Read more...
Monod Bio Licenses AI-designed Protein Technologies to SignalChem Biotech for Custom Discovery Assays
Monod Bio a Seattlebased AIenabled protein design company and SignalChem Biotech Inc a whollyowned subsidiary of Sino Biological Inc SZSE today announced a nonexclusive licensing agreement
Nxera Pharma’s Partner Neurocrine Biosciences Receives IND Acceptance from the FDA for Phase 2 Study of NBI-1117567 for Alzheimer's Cognition
Nxera Pharma Co Ltd Nxera or the Company TSE announces that its partner Neurocrine Biosciences Inc Neurocrine has received IND Acceptance from the US Food and Drug Administration
U.S. FDA Approves Revolution Medicines’ RASONQUE™ (daraxonrasib), the First Broad RAS-Targeted Medicine in Metastatic Pancreatic Cancer
Revolution Medicines Inc a global commercialstage oncology company dedicated to discovering developing and delivering innovative medicines for patients with RASaddicted cancers
HepaRegeniX Receives Orphan Drug Designation for Darizmetinib for the Prevention of Post-Hepatectomy Liver Failure
HepaRegeniX GmbH a clinicalstage biotech company advancing novel therapies for acute and chronic liver diseases today announced that the US Food and Drug Administration FDA has granted Orphan Drug Designation
Events Read more...
03 - 05
Sep 20265th MENA Congress for Rare Diseases 2026
Beach Rotana Hotel, Abu Dhabi,...
14 - 16
Sep 202614 - 15
Sep 202616th American DDF Summit
Omni Boston Hotel at the Seapo...
15 - 17
Sep 2026COPD Drug Development Summit 2026
Street, Boston, MA 02210, USA
21 - 23
Sep 2026Cell & Gene Therapy World Conference
Miami, Florida, USA
21 - 23
Sep 2026Cancer R&D World Conference
Hilton Garden Inn Miami Dolphi...
22 - 23
Sep 2026PDA Advanced Parenteral Therapeutics & Quality
Illume Hotel Taipei, Taiwan
28 - 01
Sep 2026Discovery on Target 2026
Boston, MA, USA
LATEST NEWS Read more...
4basebio and Genezen Expand Collaboration on Synthetic DNA for Viral Vector Manufacturing
basebio PLC a specialist in enzymatically produced cellfree DNA for genetic medicines has expanded its collaboration with viral vector contract development and manufacturing organisation CDMO Genezen
Cronus Pharma Launches FDA-Approved Bioequivalent R
Cronus Pharma LLC has launched Robenacoxib Injection in the US offering an FDAapproved bioequivalent to ONSIOR robenacoxib Injection for veterinary use
Artis BioSolutions Launches mRNA and LNP Manufacturing Centre in Bilbao, Spain
Artis BioSolutions has launched its Genetic Medicines Centre of Excellence in Bilbao Spain expanding its development and manufacturing capabilities for genetic medicines
Lundbeck and EVERSANA Expand Partnership to Advance AI-Powered Commercialisation
Lundbeck a global pharmaceutical company focused on brain health and EVERSANA a provider of commercial services for the life sciences industry have announced a strategic partnership
Cambrex High Point Completes Regulatory Inspections to Support Commercial API Manufacturing
Cambrex a global contract development and manufacturing organisation CDMO has completed PreApproval Inspections PAIs at its High Point North Carolina facility by the US Food and Drug Administration FDA
ADARx Pharmaceuticals Receives FDA Fast Track Designation for Onvuzosiran for Hereditary Angioedema
ADARx Pharmaceuticals Inc has received Fast Track Designation from the US Food and Drug Administration FDA for onvuzosiran an investigational small interfering RNA siRNA therapy being developed to prevent attacks of hereditary angioedema HAE









