Biotech

Biotech Pharmaceutical PopSci Sci&Tech

Five Takeaways from The Evolving Landscape of Drug Targets

A landmark study by Halip et al. in Nature Reviews Drug Discovery provides a comprehensive, quantitative map of the global drug target landscape. Drawing from DrugCentral data and regulatory review archives, the authors analyze the molecular mechanism-of-action (MoA)...

Biotech Industry Pharmaceutical Sci&Tech

The Medchem Strategies in PROTAC Optimization

Proteolysis Targeting Chimeras (PROTACs) have transformed drug discovery by shifting small-molecule therapeutics from an occupancy-driven paradigm (blocking active sites) to an event-driven catalytic mechanism (degrading target proteins). However, translating initial “hitting pairs” into clinical-stage candidates presents unique challenges. Living in...

Biotech Molecule Digest Pharmaceutical

Molecule Digest:Rasonque

1. What is Rasonque? Rasonque (Daraxonrasib, RMC-6236) is an oral, first-in-class, multi-selective tri-complex “molecular glue” inhibitor designed to selectively target and shut down the active, GTP-bound (“ON”) state of RAS proteins. Developed by Revolution Medicines, it gained breakthrough prominence...

Biotech GLP Pharmaceutical Regulation

Should biomarker bioanalytical methods be validated for a non-clinical tox study

The short answear is: Yes, biomarker bioanalytical methods must be validated for animal toxicity studies, but the rigor of that validation is determined by how the data will be used to make safety or regulatory decisions. In a GLP...

Biotech Pharmaceutical Regulation

Brief summary of safety pharmacology studies

The assessment of safety pharmacology is primarily governed by the ICH S7A (Core Battery) and ICH S7B (Cardiovascular) guidelines. These studies are designed to investigate potential undesirable pharmacodynamic effects on vital functions before human exposure. Here is the comprehensive list...

Biotech Pharmaceutical Regulation

Top CMC Pitfalls in Biologics IND Application and How to Avoid Them

Filing an Investigational New Drug (IND) application for a biologic—be it a monoclonal antibody, recombinant protein, or vaccine—is a high-stakes milestone. While the Chemistry, Manufacturing, and Controls (CMC) section is critical, many applications face delays due...

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...

Biotech Pharmaceutical

Aptamer Drugs: The Next Generation of “Chemical Antibodies

Aptamers are a class of therapeutic molecules often called “chemical antibodies” because they perform the same function as traditional antibody drugs (binding to a target), but they are made from an entirely different material: short strands of nucleic...

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...

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...