Bristol's Opdivo Suffers Rare, But Unsurprising, Rejection By FDA
This article was originally published in The Pink Sheet Daily
Executive Summary
Data were lacking for Bristol's PD-1 inhibitor as monotherapy in first-line BRAF-mutant melanoma, resulting in FDA complete response letter for expanded indication.
You may also be interested in...
New EU Filings
Obecabtagene autoleucel, Autolus Therapeutics’s investigational treatment for relapsed or refractory B cell precursor acute lymphoblastic leukemia, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
BMS Has A Strong Pipeline, But Access Challenges Remain
Bristol Myers Squibb’s head of major markets, Monica Shaw, wants to improve patients’ access to lifesaving therapies. And the group has several new products ready to roll.
Novartis Nominates Ex-BMS Chief As It Pursues US Growth Strategy
The Swiss pharma company is looking to tap into the experience of ex-BMS leader Giovanni Caforio to help further it US-first commercial strategy.