The oncology field pioneered adaptive trial designs through efforts such as I-SPY 2 (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis 2), Puma Biotechnology Inc.’s phase II study of the pan-HER tyrosine kinase inhibitor neratinib (Nerlynx) as neoadjuvant therapy in metastatic breast cancer, and the ongoing multidrug, biomarker-driven
non-small-cell lung cancer trial known as Lung-MAP. Read More
Centogene BV filed to sell 4 million common shares on Nasdaq for between $14 and $16 in an IPO expected to raise $60 million at the midpoint. Read More
The FDA’s Janet Woodcock, director of the Center for Drug Evaluation and Research, testified before a House subcommittee on the national security risk raised by U.S. reliance on China exports of active pharmaceutical ingredients (API). Read More