Drug shortages, stable prices and a demand recovery in the US helped drive Aurobindo’s growth in Q4. Meanwhile, the company is developing a biosimilar to Roche/Novartis’s multi-billion product Xolair, as predicted by Scrip earlier. Use of decentralized mode for its Phase III trials is a notable aspect

The CEO of Korean bioventure Kanaph Therapeutics, Byoung Chul Lee, talks to Scrip about the difficulties such companies are going through amid generally weak investor sentiment, as well as the company's own financing and R&D plans.

Oncology's surprisingly low numbers this year are among the latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

Rather than conduct most analytical characterization and non-clinical studies first, the hallmark of the US FDA approach, biosimilar sponsors are often initiating clinical trials about the same time.