Don't Lose Track: Review And Approval News On Opdivo, Kalydeco And More
US FDA had a busy week. Here's some bullet points of product development events you may have missed.
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Dynavax's final pivotal trial for hepatitis B candidate was missing data from 150 patients, making its causality of myocardial infarctions unclear; the question now is whether the postmarketing trial can answer the question.
The US FDA has approved BMS' Opdivo for previously treated patients with some forms of colorectal cancer, however direct competition from Merck's Keytruda may limit its success.
Following Oncologic Drugs Advisory Committee's recommendation for Mylan and Biocon's trastuzumab biosimilar, Celltrion and Teva's CT-P6 appear to be one of the next one in, but given the expiry of Herceptin patent in the US and other late stage trastuzumab biosimilar candidates, it could be anybody's game to launch their products first.