Tailored Artificial Intelligence (AI)
Cloud-Native Drug Discovery
Relatively Speaking
From the “AI Pilot Graveyard” to Enterprise- Grade Impact
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
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
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
European Pharmaceutical Legal Frameworks: Compliance, Legislation and Regulatory Obligations
If youve ever opened the EUs pharmaceutical rulebook and felt your eyes glaze over youre not alone Directives regulations guidelines delegated acts it can feel like reading a legal maze with no exit sign
How Can Smart Packaging Revolutionize Pharma with Track-and-Trace Solutions?
Did you know that smart packaging has the potential to revolutionize the pharmaceutical industry With trackandtrace solutions this innovative technology can enhance transparency safety and efficiency in the pharma supply chain
Exploring the Versatility of Using 3D Spheroid Models in Research
Cell culture technology forms the foundation of modern biological and pharmaceutical research For many years twodimensional culture systems have served as standard experimental models for studying cellular behavior disease mechanisms and therapeutic responses Although these models contribute significantly to scientific discovery they cannot fully replicate the structural and functional complexity...
Why Europe Is Becoming a Strategic Hub for Advanced API Manufacturing
For most of the past three decades API manufacturing was treated as a line item to be minimised Molecules moved east margins improved and European sites were consolidated sold or quietly retired The logic was sound as long as global supply chains behaved predictably They no longer do Pandemicera disruptions recurring shortages of antibiotics and other essential medicines
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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
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...
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2
European Pharmaceutical Legal Frameworks: Compliance, Legislation and Regulatory Obligations
Kate Williamson
EU pharmaceutical law governs how medicines are authorized, manufactured, distributed and monitored across Europe. This guide explains key legislation, including Directive 2001/83/EC and the Clinical...
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3
How Can Smart Packaging Revolutionize Pharma with Track-and-Trace Solutions?
Kate Williamson
Smart packaging with track-and-trace solutions is revolutionizing the pharmaceutical industry by enhancing supply chain transparency, preventing counterfeit drugs, and improving patient safety. Techno...
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4
Exploring the Versatility of Using 3D Spheroid Models in Research
Venkata Reddy Pothireddy
Three-dimensional (3D) spheroid models provide physiologically relevant alternatives to conventional two-dimensional (2D) cell cultures by better reproducing cell-to-cell and cell-to-matrix interactio...
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5
Why Europe Is Becoming a Strategic Hub for Advanced API Manufacturing
Lakshmi
Europe's active pharmaceutical ingredient (API) landscape is being reshaped by a rare alignment of policy, technology and boardroom priorities. A provisional deal on the Critical Medicines Act, an...
press releases Read more...
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
Fortrea and Omico Collaboration to Advance Biomarker-led Oncology Drug Development
Fortrea a leading global contract research organization CRO and Omico Australias leading precision oncology screening and trial matching organization today announced a collaboration to accelerate precision oncology research by helping connect cancer patients to biomarkermatched clinical trials By co...
ZEGFROVY® (sunvozertinib) now available in the US for patients with previously treated non-small cell lung cancer with EGFR exon 20 insertion mutations
AstraZeneca today announced the US availability of ZEGFROVY sunvozertinib for the treatment of adults with locally advanced or metastatic nonsmall cell lung cancer NSCLC whose tumors have epidermal growth factor receptor EGFR exon insertion mutations as detected by an FDAapproved test
Events Read more...
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...
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,...
LATEST NEWS Read more...
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...
AI Proteins Announces Research Collaboration and License Agreement With Astellas Pharma to Discover and Develop Novel Miniprotein-Based Therapeutics Valued at Over $400 Million
AI Proteins Inc a biotechnology company that utilizes computational de novo protein design to create therapeutic miniproteins today announced it has entered into a Research Collaboration and License Agreement with Astellas Innovation Management LLC an affiliate of Astellas Pharma Inc TSE to discove...
Okomera Announces Trade Agreement with Servier to Use Tumor Miniaturization Technology in Cancer Research
Okomera a TechBio company that personalizes cancer management with its technology combining minivatars tumor microfluidics and AI imaging today announced the signing of a commercial agreement with Servier an independent international pharmaceutical group
