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
Digital Twins: The Future Blueprint for Pharmaceutical Production
Digital Twins have revolutionized the pharmaceutical industry by providing virtual replicas of physical assets and processes This innovative technology offers a comprehensive view of manufacturing
Data Security Challenges in Pharma IT: Safeguarding Sensitive Information
The pharmaceutical industry faces several data security challenges in its IT infrastructure primarily related to safeguarding sensitive information The nature of the data regulatory requirements and the increasing sophistication of cyber threats
Biosimilars in Europe: Expanding Access and Reducing Costs
The use of biosimilars as a part of modern health care systems is also fairly important especially in the context of the European Union as they can enhance the availability of the required treatments and reduce the costs of the health care sector As biologic medicines are recognized as firstline treatments for critical illnesses such as cancer autoimmune diseases and rheumatoid arthritis biosimila...
Digital Biomarkers and Wearables: Transforming Clinical Trial Data Collection
A participant enrolled in a week pharmaceutical trial may spend fewer than six hours inside a clinical site The remaining odd hours of that year the stairs the fatigue the broken nights the good days and the collapsed ones pass unrecorded Clinical development has quietly accepted this trade for decades building enormous capital decisions on a handful of supervised snapshots taken under artificia...
Pharmaceutical Quality Management in Europe: GMP Systems, Quality Control and Manufacturing Standards
A tablet that works in a lab means little if the next batch is slightly different Pharmaceutical quality management exists to make sure every pack in every pharmacy matches the one that was tested and approved In Europe that promise is backed by one of the most mature regulatory frameworks in the world Whether you run a small contract manufacturer in Ireland or a large sterile plant in Germany EU...
AI-Native R&D: Transforming Drug Discovery Through Intelligent Automation
For four decades pharmaceutical research productivity has moved stubbornly in the wrong direction A new medicine still takes ten to fifteen years to reach patients at a capitalised cost approaching US billion
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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
A drug repurposing screen reveals dopamine signaling as a candidate therapeutic pathway for PIGA-CDG
PIGACDG is a congenital disorder of glycosylation caused by pathogenic partial lossoffunction variants in the PIGA gene PIGA encodes an enzyme responsible for the catalytic transfer of Nacetylglucosamine
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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
Data Security Challenges in Pharma IT: Safeguarding Sensitive Information
Kate Williamson
The pharmaceutical sector encounters intricate data security challenges in its IT setup, encompassing data sensitivity, regulatory compliance, cybersecurity threats, supply chain risks, and insider th...
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2
Biosimilars in Europe: Expanding Access and Reducing Costs
Kate Williamson
Biosimilars are indeed cheaper versions of original biologic drugs and have been embraced the European countries as a strategy to making available affordable lifesaving treatments while at the same ti...
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3
Digital Biomarkers and Wearables: Transforming Clinical Trial Data Collection
Lakshmi
Clinical development still measures patients in short, scheduled bursts while disease unfolds continuously. Sensor-derived digital biomarkers close that gap, converting everyday movement, sleep and ph...
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4
Pharmaceutical Quality Management in Europe: GMP Systems, Quality Control and Manufacturing Standards
Sarah Richards
European pharmaceutical quality rests on EU GMP, a risk-based quality system and rigorous quality control. This article explains how EudraLex Volume 4, Qualified Persons, data integrity and Annex 1 sh...
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5
AI-Native R&D: Transforming Drug Discovery Through Intelligent Automation
Lakshmi
Artificial intelligence has moved beyond pilot projects into the architecture of pharmaceutical research itself. This article examines the shift from AI-enabled to AI-native R&D, in which closed-l...
press releases Read more...
Oryzon announces authorization in Spain of VIVALDI, a collaborative clinical study with CETLAM to evaluate iadademstat in combination with standard-of-care therapy in high-risk newly-diagnosed AML subpopulations
Oryzon Genomics SA a clinicalstage biopharmaceutical company and global leader in epigenetics today announced that VIVALDI a Phase Ib pilot study sponsored by CETLAM Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplsicas has been authorized in Spain
Aarvik Therapeutics Announces Milestone Achievement, Partnership Update, and Presentations on MUTTA™ and AQUALINK™ Platforms at the 17th Annual WADC Conference
Aarvik Therapeutics Aarvik an innovative ADCfocused biotechnology company dedicated to engineering precision medicines for cancer therapy is pleased to announce important updates to its partnership efforts Dosing of the first patient in a Phase trial in the US for AVPADC
Syndax’s Revuforj® (revumenib) Wins Prestigious 2026 Prix Galien USA Award for Best Product for Rare/Orphan Diseases
Syndax Pharmaceuticals a commercialstage biopharmaceutical company advancing innovative cancer therapies today announced that Revuforj revumenib has been recognized as the Best Product for RareOrphan Diseases of by The Galien Foundation The Galien Foundation fosters
Massive Bio and Global Leadership in Oncology & Wellness (GLOW) Announce Partnership to Expand Access to Clinical Trial Information for Patients and Caregivers
Massive Bio an agentic AI and realworld data RWD company advancing oncology drug development commercialization and access to precision medicine today announced a partnership with Global Leadership in Oncology Wellness GLOW a c nonprofit dedicated to bridging the gap between patients
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 NEWS Read more...
Evestia Clinical Acquires Emtex Life Science to Further Enhance its Global Full-Service Clinical Research Capabilities
Evestia Clinical a leading independent global specialist Contract Research Organization CRO today announced the acquisition of Emtex Life Science Emtex a specialist regulatory medical writing company headquartered in Belgium The acquisition strengthens Evestia
UroGen Announces First Patient Dosed in Phase 1 Trial of UGN-501, an Investigational Next-Generation Oncolytic Virus for Non-Muscle Invasive Bladder Cancer
UroGen Pharma Ltd a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers today announced that the first patient was dosed with UGN a nextgeneration investigational oncolytic virus The Phase trial will evaluate the safety tolera...
Graviton BioScience and CinRx Pharma Form CinRock Pharma to Advance ROCK2-Targeted Therapies for Cardiovascular Disease
Graviton BioScience Corporation Graviton and CinRx Pharma CinRx today announced the formation of CinRock Pharma CinRock a jointly governed biopharmaceutical company established to accelerate the development of novel ROCKtargeted therapies for patients with cardiovascular diseases
Pretzel Therapeutics Receives UK Regulatory Authorization to Advance PX578 Into Clinical Development in Patients for the Treatment of POLG-Mediated Primary Mitochondrial Disorders
Pretzel Therapeutics Inc a clinicalstage biotechnology company advancing a new class of medicines designed to restore mitochondrial function improve cellular energetics and impede disease progression across a range of neurological and rare diseases today announced that the Medicines and Healthcare p...
TME Pharma Signs Binding Exclusive Negotiation Agreement with Japanese TMS Co., Ltd.
TME Pharma NV Euronext Growth Paris ALTME a biotechcompany with clinical assets for brain cancer and eye diseases is pleased to announce a significant next step in the strategic options for its leading oncology asset NOXA olaptesed pegol
Twist Bioscience Launches MRD Express with Rapid Turnaround Time
Twist Bioscience Corporation a midcap growth and value biotech company today launched Twist MRD Express custom panels manufactured at scale with a rapid turnaround time starting within one day Twist MRD Express custom panels enable cancer researchers to investigate tumorassociated genomic variants






