The biotechnology industry.
Biologics manufacturing is the production of medicines made by living cells rather than by chemical synthesis: master cell bank, large-scale culture, multi-step purification, sterile filling. Monoclonal antibody production in Chinese hamster ovary cells is described in the literature as a…
A platform technology designation is an FDA program, created by section 506K of the Federal Food, Drug, and Cosmetic Act, that lets a sponsor leverage prior data across applications for different drugs built on the same platform. The agency issued draft guidance in May 2024; the program is open…
Biotech financing is staged risk transfer: venture rounds fund value-creating milestones until a listing or sale clears at a higher price, and each stage re-prices the company against evidence rather than revenue. The machinery is standard — preferred stock, tranches, lock-ups — and it is…
Moderna has dosed the first patient in a Phase 1/2 study of mRNA-2808, an investigational mRNA therapy encoding three T-cell engagers, in relapsed or refractory multiple myeloma, per the company's November 3, 2025 announcement. The open-label, multicenter trial, registered on ClinicalTrials.gov…
The FDA has issued a complete response letter for Alvotech's Biologics License Application for AVT05, the company's proposed biosimilar to Simponi and Simponi Aria (golimumab), per a November 2, 2025 company announcement. The letter cites deficiencies tied to the FDA's pre-license inspection of…