Category: Industry

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...
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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...
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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...
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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...
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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...
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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...
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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...
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Industry Pharmaceutical Sci&Tech

Combination Drugs-Synergistic Therapy

A combination drug, or a fixed-dose combination (FDC), is a medication that includes two or more active ingredients combined into a single dosage form. Synergy occurs when drugs utilized in combination lead to a combined total effect...
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Industry Pharmaceutical

An article to learn the Chinese new drug industry

We all heard the Chinese biotechs are booming. I am always wondering if there are  statiscal data to learn about the innovative drug development in China. Recently, a research article titled “Chinese innovative drug R&D trends in...
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Industry Pharmaceutical

The status quo of antitivrus drugs

Developing effective antiviral drugs is a complex task due to the rapid evolution of viruses. Viruses can develop resistance to antiviral drugs, making it necessary to continually develop new treatments. Additionally, viruses often rely on host...
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