EDITORIAL SECTION

Articles

Innovative Pricing Models in the EU: Making Medicines Affordable for All

Pricing policies are important determinants in delivering sufficiently cheap medicines in all the member nations of the EU High costs of meeting the required medical care together with arising independent differentiated technological improvements have rendered exhausted pricing structures as uncompetitive tools for fairness New mechanisms of pricing have been introduced

The Future of Oncology Clinical Trials: Adaptive, Biomarker-Led, and AI-Enabled

Oncology now absorbs close to a third of the industrys active development pipeline and a comparable share of its research budget It also carries the worst odds in medicine A molecule entering firstinhuman cancer studies has historically had a midsingledigit probability of reaching approval against roughly double that across other therapy areas For a European chief executive allocating capital acro...

Manufacturing mRNA, Cell, and Gene Therapies at Commercial Scale

Why Cell and Gene Therapies Fail in Europe After the Science Has Already Worked The uncomfortable statistic for anyone financing advanced therapies in Europe is not the clinical attrition rate It is the withdrawal rate after approval An analysis of advanced therapy medicinal products granted European marketing authorisation found that roughly one in five had subsequently been withdrawn and of th...

Pharma ABM Strategies for B2B Growth: Precision Targeting for Key Accounts

The pharmaceutical industry is making significant strides changing the way that company ies are identified engaged and converted into high value business customers In todays datadriven competitive world traditional mass marketing strategies are no longer effective In todays day and age pharmaceutical companies are embracing very personalized relationships ROI measurement and the expansion of their...

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...

The Permanent Prescription: Why Gene Therapy Is Rewriting the Rules of Drug Safety

Gene therapy has moved from laboratory promise to clinical reality offering something medicine has rarely been able to promise before a single treatment capable of curing a disease rather than merely managing it Yet this same quality of permanence is quietly undermining the safety systems the pharmaceutical industry has relied on for decades Adverse events can emerge a decade

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