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
From Static PDFs to Usable Digital Forms in Pharmaceutical Operations
Walk through the quality compliance or operations function of almost any pharmaceutical manufacturer and youll find PDF forms everywhere from deviation reports change controls and training records to supplier questionnaires audit checklists and equipment logs Many of these documents exist as PDF files but functionally still behave like paper Someone prints them fills them in by hand
The Future of Pharma Data Management: Creating Unified Platforms for Innovation
Ask a European pharmaceutical executive where the companys data actually lives and the honest answer is usually in about forty places under a dozen owners described in half a dozen vocabularies Research holds assay and translational data Clinical holds trial and subject data
Beyond Manual Literature Screening: From AI Automation to Decision Preparation in Pharmacovigilance in Europe
As of August the EU AI Act is generally applicable although some obligations for highrisk AI systems apply at later dates For pharmacovigilance organisations a key consideration is to determine the role and classification of each AI system under the Act rather than assuming that AI used in PV is automatically classified as highrisk AIliteracy requirements are already applicable while provider and...
Role of Artificial Intelligence in Pharmaceutical Industry
The global AI in the pharma market expanded to a size of nearly million in The market is anticipated to increase at a rate of from million in to million in Researchers claim that the application of these technologies enhances decisionmaking maximizes creativity increases the effectiveness of research and clinical trials
Prescription Drugs and Personalized Medicine: A New Era in Pharma
The field of medicine is rapidly evolving and one of the most exciting advancements is personalized medicine This approach tailors medical treatment to the individual characteristics of each patient
Access to Affordable Medicines: A Persistent Challenge for Europe
The problem of affordable medicines has been topical in Europe for many years Despite the fact that there are well developed health units in many regions of the world and particularly in this continent the health challenges of the population have not been fully met especially in access to affordable basic medicines This problem is relevant not only to the patients but also to the stability of heal...
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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 Future of Pharma Data Management: Creating Unified Platforms for Innovation
Lakshmi
Europe's pharmaceutical data agenda is being rewritten by three converging forces: the European Health Data Space, the rewrite of GMP Annex 11 and the new artificial intelligence annex, and regula...
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2
Beyond Manual Literature Screening: From AI Automation to Decision Preparation in Pharmacovigilance in Europe
Andreas Hofmann
Artificial intelligence can increasingly extract, structure, and compare pharmacovigilance-relevant information from scientific literature. The key question is no longer whether AI can support literat...
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3
Role of Artificial Intelligence in Pharmaceutical Industry
Priya Patel
The application of artificial intelligence (AI) in the pharmaceutical and biomedical industries has grown significantly during the past few years. Modern technology has been used by the pharmaceutical...
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4
Prescription Drugs and Personalized Medicine: A New Era in Pharma
Kate Williamson
Personalized medicine is revolutionizing healthcare by tailoring treatments to individual genetic, environmental, and lifestyle factors. This approach enhances the effectiveness of prescription drugs,...
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5
Access to Affordable Medicines: A Persistent Challenge for Europe
Kate Williamson
High accessibility to medicines is still a concern in Europe due to increasing costs and variability in price per country and a lack of legislation to mitigate the problem. The problem of high prices...
press releases Read more...
Enveda Collaborates with Anthropic to Accelerate Drug Development
Enveda a biotechnology company using AI to translate natures chemistry into new medicines today announced results from its collaboration with Anthropic to streamline critical documentation processes in drug development Working with Claude Enveda developed AIenabled workflows to review Good Manufactu...
Pythia Labs Launches with AI-Designed Antibodies for Hard-to-Drug Targets
Pythia Labs a biotechnology company building frontier AI models for therapeutic discovery today announced its launch alongside a preprint in bioRxiv introducing Pythia the allatom generative model at the core of its antibody design platform Pythias technology is built to create antibodies against ta...
Genmab and Incyte Announce Clinical Trial Collaboration in Metastatic Colorectal Cancer
Genmab AS and Incyte announced a clinical trial collaboration to evaluate petosemtamab Genmabs investigational IgGbispecific antibody targeting the epidermal growth factor receptor EGFR and leucinerich repeat containing Gproteincoupled receptor LGR in combination with INCB Incytes investigational p...
CasZyme and Cirena to Collaborate on Developing Longer Guide RNAs to Optimise Cas12l Performance
CasZyme and Cirena have today signed an agreement that will see the two companies collaborate on further optimising the editing efficiency of CasZymes Casl CRISPR nuclease in humanrelevant applications using Cirenas synthetic nt guide RNAs
Events Read more...
28 - 30
Oct 2026BIOPLUS-INTERPHEX KOREA 2026
COEX, Seoul
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...
LATEST NEWS Read more...
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...
Stevanato Group and Aptar Pharma Collaborate to Help Accelerate Pre-Filled Syringe System Selection
Stevanato Group SpA a leading global provider of drug containment drug delivery and diagnostic solutions to the pharmaceutical biotechnology and life sciences industries today announced a collaboration with Aptar Pharma to provide systemlevel data supporting earlier evaluation of prefilled syringe c...
Sacituzumab Tirumotecan (Sac-TMT) Reduced the Risk of Death by 32% and the Risk of Disease Progression or Death by 41% Compared to Chemotherapy in Patients With Recurrent Endometrial Cancer
Merck known as MSD outside of the United States and Canada today announced the first presentation of results from the pivotal Phase TroFuse trial evaluating sacituzumab tirumotecan sacTMT an investigational TROPdirected antibodydrug conjugate ADC being developed in collaboration with KelunBiotech i...
Tempus Receives IVDR Certification for xR RNA Sequencing for Solid Tumor Profiling
Tempus AI Inc announced that its xR assay has received certification under the European Unions In Vitro Diagnostic Regulation IVDR as a Class C in vitro diagnostic device The certification covers Tempus quality management system for nextgeneration sequencing devices for cancer genomic profiling to s...
Georgiamune and Menarini Group Enter Exclusive Global License and Collaboration Agreement for GIM-621, a First-in-Class Oral Immuno-Oncology Agent
The Menarini Group a leading international pharmaceutical and diagnostics company and Stemline Therapeutics Inc Stemline a whollyowned subsidiary of the Menarini Group focused on bringing transformational oncology treatments to cancer patients along with Georgiamune Inc a clinicalstage biotechnology...
LGM Pharma Acquires Sannova Analytical, Expanding cGMP Analytical and GLP Bioanalytical Services
LGM Pharma a leading provider of tailored API sourcing contract analytical testing and drug development services today announced it has acquired Sannova Analytical a contract research laboratory headquartered in Somerset NJ The acquisition expands LGM Pharmas analytical testing services business by...






