Sci&Tech

Molecule Digest Pharmaceutical Sci&Tech

The Nonclinical Studies Lead to the First FDA Approved PROTAC-Veppanu

As a PROTAC (Proteolysis-Targeting Chimera), vepdegestrant represents a novel class of heterobifunctional degraders, and its non-clinical package focused heavily on its unique mechanism and potential for off-target effects. Based on the FDA approval documentation for VEPPANU...

Pharmaceutical Regulation Sci&Tech

VEPPANU A Breakthrough of PROTAC

The drug ARV-471, now known by its generic name vepdegestrant and brand name VEPPANU, has made history. As of May 1, 2026, it became the first-ever PROTAC (Proteolysis-Targeting Chimera) to receive FDA approval. Discovered through the pioneering work at Arvinas and detailed in...

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...

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...

Industry Regulation Sci&Tech

Comparative Summary of QSAR Platforms

This table provides a high-level comparison of the five key in silico tools based on their methodology, pros, cons, cost, and regulatory standing. Tool Primary Mechanism Key Advantage Key Disadvantage Regulatory Acceptance Cost/Access DEREK Nexus Rule-Based Expert System...

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 PopSci Sci&Tech

A Personal View on the Business of AI Guided Chemical Synthesis

Observing the growing link between AI and chemical synthesis, the business potential is significant. AI promises faster, safer, cheaper, and more innovative chemical creation. However, widespread commercial use faces hurdles. A key business driver is AI’s...