The biotechnology industry.
Biotech earnings season is the quarterly window, clustered in late January, April, July, and October, when listed companies report revenue, profit or loss, and pipeline progress for the closed quarter. Roche reported nine-month sales up 7% at constant exchange rates on October 23, 2025; Novartis…
A contract research organization is a company that performs research and development services for sponsors on a contractual basis, and its center of gravity is the clinical trial: site selection, monitoring, data management, statistics, and regulatory filings. The industry's rise was rapid, as a…
A biotech licensing deal is a risk-transfer contract built from four standard components: an upfront payment, milestone payments tied to development and sales events, tiered royalties on net sales, and sometimes equity. IMPACT Therapeutics licensed senaparib to Pharmanovia for up to 423.5…
Orphan drug designation is a formal FDA status for drugs and biologics intended for rare diseases, conferring three core incentives: tax credits for qualified clinical trials, exemption from user fees, and potential seven years of market exclusivity after approval, per the FDA's program page.…
A companion diagnostic is an in vitro diagnostic or imaging tool that "provides information that is essential for the safe and effective use of a corresponding therapeutic product," in FDA's definition. Biomarkers decide which patients get which therapy; the regulated test makes that decision…
The three main routes to market a medical device in the United States are the 510(k) premarket notification, the De Novo classification request, and premarket approval. Risk class and the existence of a legally marketed predicate decide which applies, per FDA's pathway pages. Most devices enter…