Pharmaceutical

GLP Pharmaceutical Sci&Tech

The challenges and solutions of testing peptide drugs in Ames assay

The Ames assay (OECD 471) is the standard first step for genotoxicity screening. However, testing a peptide drug in an Ames assay is technically challenging because the assay was originally designed for small, stable, non-nutritional chemicals. When...

Pharmaceutical Sci&Tech

The comparison of the two FDA approved aptamers

The two FDA-approved aptamer drugs, Macugen (pegaptanib) and Avacincaptad Pegol (ZIMURGA), represent two distinct generations in pharmaceutical history. Macugen, approved in 2004, was the pioneer—the first aptamer to market—but ultimately lost its dominance in the Wet AMD market to more...

Biotech Pharmaceutical Regulation

Top CMC Pitfalls in Biologics IND Application and How to Avoid Them

Filing an Investigational New Drug (IND) application for a biologic—be it a monoclonal antibody, recombinant protein, or vaccine—is a high-stakes milestone. While the Chemistry, Manufacturing, and Controls (CMC) section is critical, many applications face delays due...

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...