From the “AI Pilot Graveyard” to Enterprise- Grade Impact
Relatively Speaking
Early-Phase Oncology Trials Shaping the Future of Cancer Research
Controlling Polysorbate Degradation
Accelerating Cross-Sector Integration in Pharma and Nutraceuticals
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
Building Patient-Centric Clinical Trials: Technologies, Strategies, and Regulatory Considerations
Patientcentricity in clinical trials represents a crucial cultural and operational transformation in the development and evaluation of new treatments The patient experience has evolved from a secondary consideration to a central priority in trial design driven by
The Cost of Uncertainty: How Analytical Chemistry Drives Billion-Dollar Decisions in Pharma
In pharmaceutical development uncertainty is not an abstract scientific inconvenience It has a cost a timeline a regulatory consequence and ultimately a patient impact A promising medicine may have strong biological rationale compelling early data and significant commercial potential yet still face a fundamental question do we truly understand the product well enough to develop manufacture approve...
Trustworthy AI in Drug Discovery: From Innovation to Regulatory Readiness
Artificial intelligence is entering a new phase in drug discovery After years of enthusiasm for predictive models generative chemistry and automated screening attention is shifting from what AI can generate to whether its outputs can be trusted
Pre-Formulation Studies and Analytical Techniques in Pharmaceutical Formulation Development
Development of pharmaceutical formulations is a very important phase in the drug development process which lies between a drug molecule that is discovered and a dose form that can be commercially developed It is a process that involves designing optimizing and validating drug products to make sure that they are safe effective and able to be taken by patients Preformulation studies form a significa...
Advanced 3D Cell Models: Moving from Promise to Practice in Drug Discovery
Over the past decade organoids spheroids and other advanced D cell models have transformed how researchers approach disease modelling and drug development Their ability to better reflect human biology than traditional D cultures has generated significant enthusiasm across pharmaceutical research yet widespread adoption remains a work in progress
What Drug Manufacturers Should Know About Process Validation and Continued Process Verification
For many years a signed process validation report felt like an ending The batches had passed the protocol was closed and the plant moved on to routine supply Regulators abandoned that view some time ago Europes process validation guideline states plainly that validation should not be viewed as a oneoff event while the US framework treats commercial manufacturing as a stage of validation
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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 Cost of Uncertainty: How Analytical Chemistry Drives Billion-Dollar Decisions in Pharma
Nithya Karakala
Analytical chemistry reduces uncertainty across pharmaceutical development by generating reliable data that supports critical decisions in quality, safety, manufacturing, and regulatory compliance. Ad...
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2
Trustworthy AI in Drug Discovery: From Innovation to Regulatory Readiness
Antonio Lavecchia
This article examines how AI-driven drug discovery is moving from experimental innovation toward trustworthy, regulatory-ready implementation. It discusses validation, interpretability, data integrity...
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3
Pre-Formulation Studies and Analytical Techniques in Pharmaceutical Formulation Development
Sarah Richards
Analytical methods and pre-formulation studies play a key role in the development of pharmaceutical formulations, as they give necessary information about the properties of the drug, excipient compati...
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4
Advanced 3D Cell Models: Moving from Promise to Practice in Drug Discovery
Nicola Bevan
Advanced 3D cell models have been hailed as the future of drug discovery for more than a decade, yet their routine use in pharmaceutical research remains surprisingly limited. As organoids, spheroids...
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5
What Drug Manufacturers Should Know About Process Validation and Continued Process Verification
Lakshmi
Process validation has moved from a pre-launch exercise to a lifelong obligation, and Europe's GMP rules on the subject are being rewritten. This article explains what continued process verificati...
press releases Read more...
Laboratoires Pierre Fabre and XtalPi Announce an AI-Driven Collaboration Focused on Drug Discovery
Laboratoires Pierre Fabre and XtalPi are pleased to announce an agreement under which they will collaborate on the discovery of novel clinical candidates across a number of research programs in the field of oncology potentially dermatology and rare diseases
Essential Pharma and Nordmark announce new partnership and UK availability of Norzyme® (pancreas powder) 25,000 gastro-resistant capsules for pancreatic exocrine insufficiency
Essential Pharma Limited a UKheadquartered specialty pharmaceutical company focused on specialty care and rare disease and Nordmark Pharma GmbH Nordmark a Germanheadquartered pharmaceutical company focused on developing and manufacturing active ingredients and medicines
Sino Biological Advances AI-Designed Molecule Validation with 4RISETM
AI can generate protein candidates at an unprecedented speed but experimental validation remains essential to determine whether they properly express bind targets and demonstrate the desired biological properties Sino Biological Inc Shenzhen Stock Exchange SZ a global leader in recombinant protein t...
Biocodex Invests €15 Million in a New Industrial Platform for Live Biotherapeutic Products
Biocodex an independent French pharmaceutical company announces a million investment to develop an industrial platform in Beauvais France dedicated to Live Biotherapeutic Products LBPs derived from the microbiome Building on more than years of expertise in living microorganisms microbiota fermenta...
Events Read more...
09 - 11
Nov 202611th Microbiome Movement USA Summit
The Colonnade Hotel, Boston, M...
10 - 11
Nov 2026Extractables & Leachables Europe
Parkhotel Schӧnbrunn, Vienna,...
10 - 10
Nov 2026Women in AI
Real Chemistry, 2nd Floor, Lon...
11 - 13
Nov 2026Frontiers in Cancer Science 2026
One Farrer Hotel,1 Farrer Park...
11 - 12
Nov 2026Medical Device Project and Portfolio Management
Chicago, IL, USA
16 - 17
Nov 2026Analytics for Smarter Decisions in Pharma
London, UK
24 - 25
Nov 2026BioPharma Deals - The Survival Series
Munich, Germany
24 - 27
Nov 2026Pharmtech & Ingredients 2026
Crocus Expo, Pavilion 2, Mosco...
LATEST NEWS Read more...
Oncovita Granted Orphan Drug Designation For MVdeltaC in Mesothelioma by the European Commission
Oncovita a French biotechnology company specialized in therapeutic and prophylactic vaccines today announced that the European Commission has granted orphan medicinal product designation to its lead investigational candidate MVdeltaC for the treatment of mesothelioma
DeepLife and 3billion partner to discover small-molecule therapeutics against genetic modifier targets across multiple diseases
DeepLife a Parisbased techbio company developing AIpowered digital twins of human cells and billion an AIpowered genomics company specializing in rare disease diagnostics and drug discovery today announced a codevelopment collaboration to discover and develop new smallmolecule therapeutics
Portal Innovations and Altitude Lab Partner to Strengthen Utah’s Life Sciences Startup Ecosystem
Portal Innovations a venture development platform supporting earlystage life sciences companies today announced a strategic partnership with Altitude Lab to strengthen the resources available to life sciences entrepreneurs in Salt Lake City Through the partnership Altitude Lab will relocate its acce...
MRM Health and Biocodex establish strategic partnership to strengthen future commercial supply capabilities for CORAL®-based medicines
MRM Health a clinicalstage biotech developing microbiomebased therapies for immunemediated diseases and Biocodex an independent French pharmaceutical company with more than years of experience in the microbiome field today announced the launch of a strategic partnership to establish specialized man...
Breakthrough Therapy Designation granted by the FDA for daridorexant in pediatric insomnia disorder
Idorsia Ltd announced that the US Food and Drug Administration FDA has granted Breakthrough Therapy Designation to daridorexant for the treatment of insomnia disorder in patients to
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
