Tag Archives: bmy

Bristol-Myers Pulls FDA Filing For 2-Drug Hep C Combo

Big pharma Bristol-Myers Squibb (BMY) said Monday that it’s dropping its effort to get its two-drug treatment for hepatitis C approved in the U.S., though it will continue pursuing other aspects of its hep C strategy. Bristol-Myers stock was down about 2% in morning trading on the stock market today. Bristol’s press release cited the “rapidly evolving hepatitis C treatment landscape” as the reason for withdrawing its FDA application for the

Bristol-Myers Hepatitis C Therapy Approved in EU

Bristol-Myers Squibb (BMY) won approval for its oral hepatitis C virus (HCV) drug Daklinza in the European Union Wednesday, as the company continued to carve out a niche in the increasingly competitive HCV space. The EU approved Daklinza with sofosbuvir, also known as Gilead Sciences ‘ (GILD) Sovaldi, for all genotypes of the disease. This combo performed outstandingly in clinical trials, achieving a 100% cure rate in some groups. But Gilead

Bristol-Myers Seeking Nivolumab Approval In Melanoma

Bristol-Myers Squibb (BMY) said Thursday that it will file for FDA approval of nivolumab for melanoma this quarter, earlier than some on the Street expected. Nivolumab, now branded Opdivo, is Bristol’s lead drug in the much-anticipated anti-PD-1 class of cancer fighters and has achieved outstanding results in clinical trials against melanoma when combined with Bristol’s already-launched drug Yervoy. Thursday’s announcement said the initial filing