EDITORIAL SECTION

Articles

How to Optimize Batch Production in European Pharmaceutical Manufacturing?

Efficient and highquality batch production is crucial for success in the European pharmaceutical industry This short introduction explores key strategies for optimizing manufacturing processes

Drug Approval Strategies and Regulatory Pathways in the Pharmaceutical Industry

Getting a new medicine to patients is never just a scientific achievement Its also a regulatory one A molecule can be brilliant in the lab and still stall for years if the drug approval process isnt planned properly from day one Thats why across the pharmaceutical industry regulatory strategy has quietly become just as important as clinical data itself

From Lab to Market: The Journey of a New Drug

The process of synthesizing a new drug takes many years and several phases and all of them are important for the drug safety and efficacy Which from the first identification in a lab to the final approval of use by the public is a process that takes over years and this involves work done by scientists various agencies and other health care givers

Oral Obesity Medicines: How Pills Could Change the European GLP-1 Market

For a decade the European obesity market has been defined by a needle a fridge and a specialist clinic In July that definition broke The European Commission granted marketing authorisation for a oncedaily mg oral semaglutide tablet making it the first GLP receptor agonist

Advanced Robotics and Autonomous Operations in Pharma Production

Walk the production floor of almost any modern European pharmaceutical site and you will find robots already at work Sixaxis arms denest syringe tubs Gantries load and unload lyophilisers Autonomous mobile units ferry pallets between the warehouse and the dispensary Robotics arrived in pharmaceutical manufacturing more than two decades ago and in the purely mechanical sense the argument was won lo...

Bispecific Antibodies: Transforming the Future of Oncology

For two decades bispecific antibodies occupied an awkward position in pharmaceutical oncology strategy scientifically compelling commercially unproven and persistently difficult to manufacture That characterisation no longer holds Nineteen bispecific antibodies have been approved globally and combined sales of the class passed twelve billion dollars in with several products now anchoring

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