Industry

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...

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...

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...

Biotech Industry

The foundations of a biotech startup

A biotech startup is a complex endeavor, requiring a strong foundation in science, business, and regulatory affairs.Here are the key elements: 1. A Strong Scientific Idea or Technology: Novelty: The technology should be novel and have the potential...

Industry Sci&Tech

Basic Jargon in Technology Licensing

When licensing technology from a university or partner company, several key terms (jargon))are crucial to understand. As a scientists or engineers you should familiarize yourself with these terms which typically appear in a technology transfer agreement (TTA). Below are the core...

Biotech Industry Pharmaceutical

Biotech Business Model：Hub-and-Spoke

The biotechnology business model is characterized by high risk, high reward, and a long development timeline. There is an increasing trend of “hub and spoke” business models, where companies have multiple subsidiary companies, each focused on...

Industry Pharmaceutical

What Sells Innovative Drugs

The landscape of innovative drug development is primarily shaped by First-in-Class (FIC) and Best-in-Class (BIC) molecules. FIC molecules, through their pioneering nature, define new therapeutic pathways, providing a crucial first-mover advantage. BIC molecules, on the other...

Biotech GLP Industry Pharmaceutical Regulation

Understanding about the FDA’s Embrace of New Approach Methodologies

In a landmark decision signaling a paradigm shift in pharmaceutical safety assessment, the U.S. Food and Drug Administration (FDA) announced on April 10, 2025, a plan to phase out the requirement for animal testing in the...

Industry Pharmaceutical

The “NewCo” Revolution: Fueling Chinese Biotech’s Global Ascent

China’s biotech sector is transforming through the “NewCo” model, a strategic spin-off approach designed to accelerate innovation and secure international investment. This model involves creating independent companies (“NewCos”) that house promising drug development assets, effectively decoupling...