Pharmaceutical

Chemical Pharmaceutical Sci&Tech

Aptamer Drug Development Status and Pipeline

The development of therapeutic aptamers has evolved from a niche technology challenged by pharmacokinetic (PK) issues (stability and renal clearance) to a robust platform. While only two RNA aptamers are currently FDA-approved, the pipeline contains dozens...

Industry Pharmaceutical Regulation Sci&Tech

PBPK Modeling -The Computational Engine Driving Modern Drug Safety

The pharmaceutical industry is undergoing a paradigm shift, moving towards New Approach Methodologies (NAMs) to reduce reliance on traditional animal models. At the forefront of this shift is Physiologically Based Pharmacokinetic (PBPK) modeling, a mechanism-driven computational approach...

Biotech Industry Pharmaceutical Regulation

List of 2025 FDA New Drug Approvals

In 2025， FDA granted 44 novel drug approvals。This list summarizes the landmark novel therapeutic approvals, categorized by molecular modality and therapeutic area. Drug Name (Active Ingredient) Modality Company Indication Mechanism of Action (MoA) Key Highlights Journavx (Suzetrigine) Small Molecule Vertex...

Biotech Pharmaceutical

Aptamer Drugs: The Next Generation of “Chemical Antibodies

Aptamers are a class of therapeutic molecules often called “chemical antibodies” because they perform the same function as traditional antibody drugs (binding to a target), but they are made from an entirely different material: short strands of nucleic...

Biotech Pharmaceutical Sci&Tech

A Comprehensive Analysis of ADME Challenges for PROTACs

Proteolysis-targeting chimera (PROTAC) molecules have emerged as a revolutionary approach in drug discovery, offering the potential to selectively degrade target proteins. However, their design, characterized by a bivalent structure comprising a target protein-binding ligand (warhead), an E3...

Chemical GLP Pharmaceutical Regulation Sci&Tech

New Approach Methodologies for Chemical Safety Assessment

Within fields like toxicology and drug development, embracing New Approach Methodologies (NAMs) is no longer optional but crucial for professionals seeking to remain at the forefront of their disciplines. Understanding and applying these innovative, human-relevant techniques...

Chemical Pharmaceutical Sci&Tech

Radiolysis in Pharmaceutical Development: Impact on Radionuclide Drugs and Mitigation Strategies

A Simple Explanation What is Radiolysis? Radiolysis is like a chemical breakdown caused by high-energy radiation . This radiation can split molecules apart . In water, this process creates very reactive particles. How Does it...

Pharmaceutical Sci&Tech

Conventional or Microtracer method in human ADME

Notes from the Journal Article: Human Absorption, Distribution, Metabolism, and Excretion Studies: Conventional or Microtracer? Sean Xiaochun Zhu, Drug Metabolism and Disposition, DOI: https://doi.org/10.1016/j.dmd.2025.100067 This article provides a detailed review of a forthcoming publication in Drug Metabolism and Disposition...

Pharmaceutical Sci&Tech

Basics of Biomarker

What is a Biomarker? The term “biomarker” is composed of “biological” and “marker.” Different disciplines have slightly different definitions for biomarkers, but the general concept is consistent. The National Institutes of Health (NIH) in the...

Chemical Industry Pharmaceutical Regulation

The Ames Test: Unraveling Mutagenic Potential

The Ames test, a cornerstone of genetic toxicology, serves as a crucial tool for identifying potential mutagens and carcinogens. Several regulatory guidelines govern the conduct and interpretation of Ames tests, including OECD Test Guideline 471: This guideline provides...