EDITORIAL SECTION

Articles

Real-World Evidence in Pharmaceutical Drug Development

For most of the past halfcentury the randomised controlled trial has been the undisputed gatekeeper of pharmaceutical value It remains the gold standard for establishing causality and nothing in this article suggests otherwise Yet the controlled trial answers a narrow question under artificial conditions does a drug work in a carefully selected population managed by expert investigators over a fix...

Quality by Design Is a Mindset, Not a Milestone

Every medicine is a promise about consistency The tablet dispensed in Milan next spring must behave exactly like the one tested in a trial four years earlier and like the ten million made between them

Digital Bioprocessing: AI and Automation in Biologics Manufacturing

For most of the modern biologics era a mammalian cell culture batch was managed the way a ship is navigated in fog a fixed course periodic position checks and very little ability to correct midvoyage Operators set a feed strategy pulled offline samples once or twice a day and waited for the analytics to say whether the batch had drifted By the time a titre shortfall or a glycosylation shift appear...

Data Security Challenges in Pharma IT: Safeguarding Sensitive Information

The pharmaceutical industry faces several data security challenges in its IT infrastructure primarily related to safeguarding sensitive information The nature of the data regulatory requirements and the increasing sophistication of cyber threats

B2B Pharma Magazines: Sponsored Thought Leadership Strategies for Brand Authority

The pharmaceutical industry has never been short of innovation Every year brings breakthroughs in biologics advanced therapies AIdriven drug discovery manufacturing automation precision medicine and digital health

Enhancing Drug Quality and Efficiency with Smart Manufacturing

Smart manufacturing development leads the pharmaceutical industry toward a substantial industrial shift Current regulatory oversight has created production cost challenges that manufacturers face while managing drug safety requirements for highquality medicine production What are the methods by which technology can change the production methods of drugs What position does automation and artificial...

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