Primary source workflows for BD teams and investors. How to read SEC filings, track clinical trial changes, analyze FDA regulatory data, and monitor institutional positioning in biotech. Topics include SEC filing types (Form D, 13D/13G, Form 4, 8-K), FDA approval pathways and exclusivity data, clinical trial monitoring, and the regulatory mechanics behind biotech deals. We also publish original research on companies, technologies, and platforms, and general analysis on our blog.
In-depth, data-driven analysis on biotech companies and markets.
Technical content, news, and opinions on the biotech industry.
Tutorials on biotech industry research methods and details about data sources and regulatory filings.
How to read SEC beneficial ownership and insider reporting filings such as Schedule 13D, 13G, Form 13F, and Form 4 and what they reveal when you layer them together for biotech companies.
A practical guide to tracking SEC Form D filings for biotech private capital. Covers the SEC quarterly data sets, schema design, and SQL queries for building your own monitoring database.
The drug development process consists of 5 distinct steps, and there are data sources available to learn more about each step. Here I will cover some of the most important for our work.
The FDA Orange Book, formally "Approved Drug Products with Therapeutic Equivalence Evaluations", is the authoritative reference for approved drug products, therapeutic equivalents, and the patent and exclusivity records that govern generic entry. Published since 1980, it is the primary source for understanding when brand-name drugs face generic competition.
Understand the various types of exclusivity and intellectual property protections surround pharmaceutical products in the United States
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