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....
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...
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...
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...
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...
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...
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...
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...
Chemical Molecule Digest Pharmaceutical

The Medicinal Value of D-Amino Acids

Despite the dominance of L-amino acids, D-amino acids are not mere curiosities. They have been found in various biological systems, often playing critical roles.   D-Amino Acids in Nature Previously referred to as “unnatural” amino acids, D-amino...
Industry Pharmaceutical PopSci

Are drugs too expensive?

  The question of whether prescription drugs are too expensive is a complex one. While there’s no simple answer, it’s clear that the cost of many medications has risen dramatically in recent years. This has led...