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
A Closer Look at Pharmacological Interventions: Treatment Overview
Pharmacological interventions are a cornerstone of modern healthcare encompassing a diverse array of medications designed to treat alleviate or prevent various medical conditions
The Next Growth Strategy: Scaling GLP-1 Manufacturing and Global Market Expansion
For most of the past four years the strategic conversation around GLP receptor agonists was a demand story Prescriptions outran forecasts waiting lists formed pharmacy shelves emptied and the commercial debate centred on reimbursement prescriber behaviour and how far the obesity indication could stretch That conversation has changed Demand for incretin therapies is now the most predictable variabl...
Considerations and Functional Elements of Closed Systems: Isolators and Single Use Systems
Advances in technology have demonstrated the feasibility of using isolators and singleuse systems SUS in routine pharmaceutical manufacturing operations particularly in aseptic processing Their implementation has significantly reduced the risk of chemical particulate and microbiological contamination
The Role of Technology in Enhancing Patient Acceptance and Satisfaction
Technology has revolutionized every aspect of our lives and healthcare is no exception From electronic health records EHRs to telemedicine and wearable devices advancements in technology
Navigating European Pharma Regulations: A B2B Perspective
The pharmaceutical industry in the European region practices one of the most regulating laws in the entire world Therefore regulations encompassing these areas are of prime importance for BB companies that need to achieve market entry and maintain compliance Thus this guide is meant to decompartmentalize the array of European pharma regulations and create
Why AI Is Changing What Good Validation Looks Like
The comprehensive landmark report and framework set out seven principles for using AI safely in pharmacovigilance together advocating a riskbased approach to governance validation and more Here ArisGlobals Jason Bryant highlights some of the guidances main assumptions as recently distilled in a podcast with Denny Lorenz a core member of the CIOMS XIV working group
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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
The Next Growth Strategy: Scaling GLP-1 Manufacturing and Global Market Expansion
Lakshmi
Incretin medicines have moved from a supply crisis into a scale contest. For European pharmaceutical and biotech leaders, growth in this class now rests on industrial decisions: synthesis route, purif...
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2
Considerations and Functional Elements of Closed Systems: Isolators and Single Use Systems
Dr. Humberto Vega
Dr. Bassem Gayed
Mr. Frank E. Matos
Technological advances have enabled the routine use of isolators and single-use systems in manufacturing, especially in aseptic processing, reducing chemical, particulate, and microbiological contamin...
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3
The Role of Technology in Enhancing Patient Acceptance and Satisfaction
Kate Williamson
In today's rapidly evolving healthcare landscape, technology plays a pivotal role in enhancing patient acceptance and satisfaction. The integration of innovative technologies not only improves the...
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4
Navigating European Pharma Regulations: A B2B Perspective
Kate Williamson
Navigating European pharmaceutical regulations can be complex for B2B companies. This guide helps to facilitate for instance aspects like marketing authorization, clinical trials and pharmacovigilance...
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5
Why AI Is Changing What Good Validation Looks Like
Jason Bryant
As AI becomes embedded in everyday pharmacovigilance, validation is only the starting point. This article examines how CIOMS XIV reframes responsible AI around continuous monitoring, proportionate ove...
press releases Read more...
INOVIO Announces FDA Accelerated Approval of VOCERYQ™, an Immunotherapy to Reduce the Frequency of Surgery in Adults with Recurrent Respiratory Papillomatosis (RRP)
INOVIO a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPVrelated diseases cancer and infectious diseases today announced that the US Food and Drug Administration FDA has granted accelerated approval for VOCERYQ doruxapapogene ral...
Helsinn announces UK MHRA approval of AKYNZEO® Oral Suspension
Helsinn Healthcare SA a global pharmaceutical group focused on supporting patients with cancer and chronic diseases today announced that the UK Medicines and Healthcare products Regulatory Agency MHRA has granted approval for the oral suspension formulation of AKYNZEO netupitantpalonosetron for the...
Transcripta Bio Announces Research Collaboration to Advance Discovery of New Treatments for Autism Spectrum Disorder
Transcripta Bio an AIpowered drug discovery company focused on neurological and neuromuscular diseases today announced a knowhow agreement with Mayo Clinic focused on the molecular characterization of autism spectrum disorder ASD The collaboration seeks to combine Mayo Clinics clinical genomics and...
Carterra and Grenova Robotics Integrate Carterra Vega™ with KX2 Collaborative Robot to Create Automated HT-SPR Work Cell
Carterra and Grenova Robotics today announced the integration of Carterra Vega highthroughput surface plasmon resonance HTSPR platform with Grenova Robotics KX collaborative robot to create an automated work cell for drug discovery laboratories The integrated system enables researchers
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...
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
Strand Therapeutics Doses First Patients with STX-003, a Systemic Programmable mRNA Therapy Designed for Tumor-Selective Activation
Strand Therapeutics a clinicalstage biotechnology company pioneering programmable mRNA therapeutics today announced that the first patients have been dosed in ASCENT the Phase clinical trial of STX STX is an intravenously delivered selfreplicating mRNA therapy designed
Idorsia and SPV investors partner to unlock the blockbuster potential of TRYVIO/JERAYGO with a targeted launch in specialists
Idorsia Ltd announced a proposed commercialization partnership between Idorsia and noteholders in Idorsia Investments SARL SPV designed to unlock the substantial global commercial opportunity of TRYVIO JERAYGO aprocitentan the first and only dual endothelin receptor antagonist approved for systemic
Roche strengthens cancer diagnostic portfolio with launch of test for differential diagnosis of mesothelioma
Roche announced today the global launch of the VENTANA BAP SP test This automated readytouse immunohistochemistry IHC assay provides a reliable highly specific diagnostic tool to help clinicians and pathologists accurately identify mesothelioma and distinguish it from other malignancies including no...






