EDITORIAL SECTION

Articles

The Evolving Role of AI in Pharmaceutical Commercial Strategy

For most of the past decade the pharmaceutical industry told its artificial intelligence story from the laboratory bench Molecule generation protein structure prediction and trial simulation captured the headlines and the capital Yet the economics of this industry have never been settled in discovery alone

Accelerated Approval Pathways: Speed Without the Stumbles

When a therapy for a devastating disease sits finished in a laboratory while patients wait the arithmetic of a traditional approval timeline becomes unbearable Europes accelerated approval pathways were built precisely for this moment to compress the distance between a promising molecule and a prescription pad

How Predictive Maintenance Reduces Downtime in Pharma Plants

The pharmaceutical industry is always under stress to enhance the reliability of the production adherence to the regulations and quality of the products without raising the prices and to maintain a continuous supply Machinery malfunctions are not merely a setback in this highstakes game they may compromise batch integrity postpone life and death treatments and put pressure on the market promises

Reshaping Biologics Production Integrating Human Intelligence, AI, and Digital Twins for a Resilient Biologics Future

Biological medicines are not manufactured They are cultivated Every monoclonal antibody plasmaderived immunoglobulin and biosimilar molecule begins its journey inside a living cell That origin creates a category of operational challenge with no equivalent in smallmolecule production the product is the process Variations in temperature pH dissolved oxygen or nutrient concentration do not merely aff...

From Molecule to Market: Building a Regulatory-Ready Manufacturing Strategy

Every pharmaceutical executive can recite the journey from molecule to market Far fewer can say with confidence at which point in that journey their manufacturing strategy became capable of withstanding a regulatory inspection The distinction matters more than it once did Approval timelines are compressing

Strategic Risk Management in Pharmaceutical Supply Networks

Ask a European pharmaceutical executive team how many qualified suppliers stand behind its ten highestvalue products and the answer arrives quickly and precisely Ask how many of those suppliers would still be shipping if a single industrial estate lost power for six weeks and the room falls silent That silence is the strategic problem in one sentence

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

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

Research Insights

One-month physicochemical stability study of idarubicin prepared in polyolefin-type bags for the treatment of hematological diseases

Idarubicine is a mainstay of the treatment strategy for hematological cancer The literature lacks stability data that comply with current preparation practices and recommendations for conducting stability studies

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