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Don't Lose Track: Review And Approval News On Opdivo, Kalydeco And More

Executive Summary

US FDA had a busy week. Here's some bullet points of product development events you may have missed.

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Heplisav Postmarketing Worries Push PDUFA Date Back; FDA Seeks More Details

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.

BMS' Opdivo Approval In CRC Overshadowed By Keytruda Dominance

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.

Celltrion's Herceptin Biosimilar One Step Closer To US FDA Approval

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.

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