Targeting Antiviral Mechanisms of Action
Introduction Antiviral drugs play a central role in treating viral infections, reducing disease progression and preparing for future outbreaks. While vaccines can help prevent…
Pharmacovigilance And Regulatory Affairs
Executive Summary The boundary between pharmacovigilance and regulatory affairs has never been thinner. As health authorities accelerate the digitization of safety reporting, tighten electronic…
Biosimilars Accelerated: The Evidence That Drives Approval
Executive Summary Biosimilars have advanced from a promising idea to a proven pathway for expanding patient access to biologic therapies and easing pressure on…
Expanding Drug Labels with Real World Evidence
Introduction Real-world evidence (RWE) is accelerating drug development by using routinely collected patient health data, known as real-world data (RWD), to deliver insights beyond…
Advancing Early-Stage Oncology Drugs: Progress, Pressure and the Path to Better Trials
A Rapidly Evolving Development Environment Cancer remains one of the world’s most urgent health challenges. Nearly 20 million new cancer cases and approximately 9.7…
The Frontiers of Obesity Treatment
Introduction As global obesity rates continue to rise, the search for effective treatments is more critical than ever. Obesity is associated with an increased…
Understanding and Navigating Changes to Clinical Trial Management in the European Union
Executive Summary As of January 31, 2025, interventional clinical trials with medicinal products conducted in the European Union and European Economic Area are managed…
Therapeutic RNAs: Past, Present, and Future
Introduction RNA based drugs are a promising new class of therapeutics with tremendous potential for treating a wide range of diseases. There are various…
Bioanalysis of mRNA
About Messenger Ribonucleic Acid (mRNA) Current mRNA (messenger ribonucleic acid) research has rapidly driven the discovery and production of this new therapeutic. Modified mRNAs…
Therapeutic Oligonucleotide Metabolite Identification, Profiling and Quantitation
Introduction Therapeutic oligonucleotides (ONTs) are a diverse class of sequence-directed nucleic acid-based medicines that include antisense oligonucleotides (ASOs), small interfering RNAs (siRNAs), splice-modulating oligonucleotides,…