From the “AI Pilot Graveyard” to Enterprise- Grade Impact
Relatively Speaking
Early-Phase Oncology Trials Shaping the Future of Cancer Research
Accelerating Cross-Sector Integration in Pharma and Nutraceuticals
Controlling Polysorbate Degradation
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
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KNOWLEDGE BANK
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Articles
Understanding Pharmacodynamics: The Science behind Drug Action Mechanisms
In the complicated world of pharmacology pharmacodynamics is also a place that is a bridge between chemistry and physiology Drugs do something somewhere and this explains how they do it In a simple way pharmacodynamics studies the action of drugs the effects of drugs in terms of their biochemical and physiological effects and how the effects are generated
Pharma Safety in Sterile Fill-Finish: Ensuring Quality and Compliance
The sterile fillfinish process is the final step in pharmaceutical manufacturing before medications reach patients This process is particularly critical for injectable drugs because they bypass the bodys natural defense mechanisms
Brain Delivery of Biologics with Trojan Horse Shuttles: Remembering Paracelsus
Paracelsus in the th century established the principle of toxicology that the dose of a medicinal defines the difference between a remedy and a toxic effect
Pharmaceutical Serialization in Europe: Ensuring Safety in the Supply Chain
Over the past few years however Europes pharmaceutical companies have faced a rather challenging role of fighting counterfeiting of medicines and therefore their patients Serialization it is a system that uses a special code assigned to every product has become one of the salient solutions to tackle counterfeit drugs While serialization in terms
Cybersecurity in Pharma: The Threat No One Budgeted For
There is a particular kind of risk that organisations are bad at pricing the one that has never happened to them Pharmaceutical companies have spent a generation building sophisticated defences against the risks they know intimatelycontamination adulteration deviation recall Quality systems are mature inspectionready and deeply funded Cyber risk has never enjoyed that status It sat in the IT budge...
Circular Logistics: A Strategic Advantage for U.S. Pharmaceutical Supply Chains in an Era of Uncertainty
Temperaturerelated failures are estimated to cost the industry billion annually highlighting a nonnegotiable requirement for reliability product integrity and regulatory compliance For manufacturers
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Techno Trends
Alume Biosciences Secures FDA Breakthrough Therapy Designation for Bevonescein
Alume Biosciences has received Breakthrough Therapy Designation BTD from the US Food and Drug Administration FDA for bevonescein an investigational fluorescent drug being developed to support realtime nerve visualisation during head and neck surgery in adults Bevonescein is an intravenous fluorescent peptidedye conjugate that binds to nerve tissue
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Projects
SK pharmteco Plans More Than US$200 Million Investment in Small Molecule and Peptide Manufacturing
SK pharmteco is planning a fiveyear investment of more than US million to expand and modernise its pharmaceutical development and manufacturing operations in the United States The programme will strengthen capabilities for small molecules and peptides while supporting a more
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Research Insights
One-month physicochemical stability study of idarubicin prepared in polyolefin-type bags for the treatment of hematological diseases
Idarubicine is a mainstay of the treatment strategy for hematological cancer The literature lacks stability data that comply with current preparation practices and recommendations for conducting stability studies
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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
Pharma Safety in Sterile Fill-Finish: Ensuring Quality and Compliance
Kate Williamson
This comprehensive overview explores the critical aspects of ensuring safety and compliance in sterile fill-finish operations within the pharmaceutical industry. It discusses regulatory requirements,...
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2
Brain Delivery of Biologics with Trojan Horse Shuttles: Remembering Paracelsus
William M. Pardridge
The development of biologics for the treatment of neural disorders has been slow, because these large molecule drugs do not cross the blood-brain barrier (BBB). Solutions to the BBB drug delivery prob...
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3
Pharmaceutical Serialization in Europe: Ensuring Safety in the Supply Chain
Kate Williamson
Pharmaceutical serialization in Europe combats counterfeit drugs by assigning unique codes to each product, ensuring traceability throughout the supply chain. Under the Falsified Medicines Directive (...
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4
Cybersecurity in Pharma: The Threat No One Budgeted For
Lakshmi
Pharma spent a generation hardening itself against contamination and recall—while cyber risk stayed a forgotten IT line item. That framing has collapsed. Today's attackers don't just ste...
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5
Circular Logistics: A Strategic Advantage for U.S. Pharmaceutical Supply Chains in an Era of Uncertainty
Barbara Morgan
Pharmaceutical supply chains in the United States are under sustained pressure. Rising costs, inflation, shifting trade dynamics and ongoing global disruption are forcing companies to rethink how logi...
press releases Read more...
MacroGenics Announces First Patient Dosed in Phase 1 Study of MGC030 in Patients with Advanced Solid Tumors
MacroGenics Inc a clinicalstage biopharmaceutical company focused on developing innovative antibodybased therapeutics for the treatment of cancer today announced that the first patient has been dosed in the Phase study of MGC a firstinclass antibodydrug conjugate
Legend Biotech Announces U.S. FDA Clearance of IND Application for LB2501, an Investigational CD19/CD20 In Vivo CAR-T Therapy
Legend Biotech Corporation a global leader in cell therapy today announced that the US Food and Drug Administration FDA has cleared the investigational new drug IND application for LB an investigational in vivo CART therapy designed to generate CDCD dualtargeting chimeric antigen receptor T
Eikon Therapeutics Submits IND for Novel Androgen Receptor Antagonist EIK1006 in Prostate Cancer
Eikon Therapeutics Inc a latestage clinical biopharmaceutical company dedicated to developing innovative medicines to address serious unmet medical needs today announced the submission of an Investigational New Drug IND application to the US Food and Drug Administration FDA to evaluate EIK for the t...
Orvida Pharma Announces FDA Acceptance of KM-023 (ontivatrep) into Rare Disease Evidence Principles Process for Olmsted Syndrome
Orvida Pharma a clinicalstage biotechnology company developing first and bestinclass treatments for rare and severe genetic skin diseases today announced that the US Food and Drug Administration FDA has accepted KM ontivatrep the Companys lead oral investigational therapy for Olmsted syndrome
Events Read more...
21 - 23
Oct 2026Drug Formulation & Drug Delivery 2026
Paris, France
21 - 22
Oct 2026Advance Clinical Trials and Research 2026
Paris, France
22 - 23
Oct 2026PDA Aseptic Symposium 2026
Congress Square Nakanoshima, O...
26 - 28
Oct 2026ACHEMA Middle East 2026
RICEC, Riyadh, KSA, Saudi Arab...
26 - 28
Oct 2026World Orphan Drug Congress
RAI, Amsterdam, Netherlands
27 - 28
Oct 2026Pharma Manufacturing & Automation Convention 2026
Novotel Hyderabad Airport, Ind...
28 - 30
Oct 2026BIOPLUS-INTERPHEX KOREA 2026
COEX, Seoul
02 - 04
Nov 2026Pharma Forum EMEA 2026
Dom Pedro Lisboa Hotel, Lisbon...
LATEST NEWS Read more...
AtomVie Global Radiopharma Announces Strategic Partnership with Jubilant Radiopharma to Strengthen Logistics and Distribution in Clinical Trials
AtomVie Global Radiopharma a global contract developer and manufacturer CDMO for radiopharmaceuticals today announced a strategic partnership with Jubilant DraxImage Inc operating as Jubilant Radiopharma Jubilant Radiopharma to provide logistics approval and lastmile distribution services to support
Transcripta Bio Announces Research Collaboration to Advance Discovery of New ALS Treatments
Transcripta Bio an AIpowered drug discovery company focused on neurological and neuromuscular diseases today announced a research collaboration and licensing agreement with Mayo Clinic centered on amyotrophic lateral sclerosis ALS a fatal neurodegenerative disease with few effective treatments
Insitro Announces a Strategic Collaboration with AstraZeneca for AI-enabled Discovery of Novel Therapeutics for MASH and Cardiomyopathies
Insitro an AI company unlocking causal human biology to systematically generate highvalue therapeutics to treat grievous illness today announced a worldwide exclusive research collaboration agreement with AstraZeneca to discover novel targets and therapeutics in metabolic dysfunctionassociated steat...
Vir Biotechnology Enters Multi-Program Collaboration and License Agreement with Gilead Sciences to Discover and Develop Novel PRO-XTEN® Dual-masked T-cell Engagers for Solid Tumors
Vir Biotechnology Inc announced a collaboration and license agreement with Gilead to discover and engineer three novel PROXTEN dualmasked Tcell engager TCE development candidates targeting selected solid tumorassociated antigens Gilead will have an exclusive license to develop and commercialize
Genezen and Galibra Neuroscience Partner to Advance Gene Therapy for SSADH Deficiency Toward First-in-Human Trial
Genezen a gene therapy contract development and manufacturing organization CDMO and Galibra Neuroscience a biotechnology company developing transformative therapies for rare neurological disorders today announced a manufacturing partnership to advance Galibras GAL program an AAVbased gene therapy fo...
Zealand Pharma and Generate Biomedicines Enter Collaboration and License Agreement to Develop Protein Therapeutics Engineered with AI for Metabolic Diseases
Zealand Pharma AS a biotechnology company transforming the future of metabolic health today announced a multitarget strategic collaboration with Generate Biomedicines Inc Under the collaboration the companies intend to design and develop multispecific protein therapeutics
