EDITORIAL SECTION

Articles

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

Why Leading Pharma Professionals Rely on the Pharma Focus Europe E-Newsletter

The network of the pharmaceutical and life sciences in Europe is undergoing a radical transformation There are changes in the regulatory environments a rise in the pace of innovation a shift in leadership and a change in the distribution production and development of therapies by the use of digital technologies In this environment no longer will access to timely credible and context rich informati...

The Role of Robotics and AI in Pharmaceutical Automation

The pharmaceutical industry experiences a revolutionary change while speed precision and safety remain vital in the current times What is pharmaceutical automation The integration of robotics in pharmacy and artificial intelligence AI functions as technology to streamline all pharmaceutical processes starting from drug development through distribution The innovations in pharmaceutical practice pre...

Navigating Gene Therapy Regulations: Compliance Strategies for Successful Implementation

Gene therapy holds immense promise for treating a wide range of genetic disorders and diseases However its implementation requires strict adherence to regulatory guidelines to ensure safety efficacy and ethical considerations

mRNA and Oligonucleotide Therapeutics: Emerging Synergies in Genetic Medicine

MRNA therapies work by introducing synthetic mRNA encoding a therapeutic protein enabling transient protein expression that can replace deficient enzymes stimulate immune responses or facilitate gene editing This additive approach is beneficial for diseases caused by lossoffunction mutations or when temporary protein expression is desired

The Rise of Continuous Clinical Trials: Redefining Drug Development

The conventional clinical trial is a disposable asset A sponsor writes a protocol for a single compound activates a network of sites recruits a control group reads out and then dismantles everything it has built When the next candidate arrives often in the same disease often at the same hospitals

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

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

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