Author: ChemRealm

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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Pharmaceutical Sci&Tech

Formulation Methods for Poorly Soluble Drugs

In the development of innovative drugs, poorly soluble candidate drugs of BCSII and BCSIV account for nearly 90%. And statistics show that about 40% of currently marketed drugs are poorly soluble compounds. Due to the poor oral absorption...
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Pharmaceutical Regulation Sci&Tech

Implement New Approach Methodologies (NAMs) in Drug Development 

The landscape of drug development is evolving, with a growing emphasis on reducing and replacing animal testing. New Approach Methodologies (NAMs) are at the forefront of this shift, offering innovative, non-animal methods to assess drug safety...
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Pharmaceutical Regulation

What are drugs made in the US

There’s no strict legal definition of “Made in USA” for drugs enforced by the FDA. However, we can still refer to some regulation requirements to help understand how they are generally categorized in relation to their origin: 1....
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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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Pharmaceutical Sci&Tech

Why Nav1.8 inhibitor is non-addictive pain killer

Journavx (VX-548, Suzetrigine) was approved in 2025 as the only new non-opoid painkiller in the past two decades. As we know it is a Nav1.8 inibitor, here we explain why Nav1.8 inhibitors won’t cause addiction(Disclaimer: based on 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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Molecule Digest Pharmaceutical

Molecule Digest: Suzetrigine

  What is Suzetrigine Suzetrigine is the generic drug name for brand drug, Journavx. In Jan. 2025, FDA approved Vertec Pharmaceuticals to market the Journavx, a 50 mg tablet to treat short-term (acute) moderate to severe pain. As an...
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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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