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News Breaks
July 10, 2014
12:43 EDTBMYBristol-Myers announces plans for Q3 submission of Opdivo BLA
Bristol-Myers Squibb announced earlier that, following discussions with the FDA, the company is planning a Q3 submission of a Biologics Licensing Application for Opdivo for previously treated advanced melanoma. This will mark the second tumor type for which Bristol-Myers Squibb has a regulatory submission underway for Opdivo in the U.S. “We continue to collaborate closely with the FDA on Opdivo and the planned submission in advanced melanoma represents an important step forward in our company’s commitment to deliver innovative treatment options for patients with cancer,” said Michael Giordano, MD, Head of Oncology Development, Bristol-Myers Squibb. The advanced melanoma BLA is based on data from Checkmate -037, a multinational, multicenter, randomized open-label Phase 3 trial evaluating Opdivo compared to dacarbazine or carboplatin/paclitaxel in patients with unresectable or metastatic melanoma who have been previously treated with Yervoy and, if BRAF-mutation positive, a BRAF inhibitor regimen. Bristol-Myers Squibb has proposed the name Opdivo, which, if approved by health authorities, will serve as the trade name for nivolumab.
News For BMY From The Last 14 Days
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March 26, 2015
07:30 EDTBMYDeutsche Bank to hold a conference
Pharma One-on-One Day is being held in Denver, Colorado on March 26.
March 24, 2015
08:02 EDTBMYBristol-Myers acquires exclusive license from Novo Nordisk for research program
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March 20, 2015
07:55 EDTBMYAstraZeneca seen as potential target again if oncology drugs lag, Bloomberg says
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March 12, 2015
15:02 EDTBMYBristol-Myers announces FDA acceptance of NDA for daclatasvir
Bristol-Myers Squibb Company announced that the resubmitted new drug application, or NDA, for daclatasvir, an investigational NS5A replication complex inhibitor, has been accepted for review by the FDA for use in combination with sofosbuvir for the treatment of chronic hepatitis C, or HCV, genotype 3. The original NDA has been amended to include data from the Phase III ALLY-3 trial, which showed high cure rates for the combination, with sustained virologic response 12 weeks after treatment in 90% of treatment-naïve and 86% of treatment-experienced genotype 3 HCV patients. SVR12 rates were higher in non-cirrhotic genotype 3 patients, regardless of treatment history. The FDA will now review the submission within a six-month timeframe.
12:49 EDTBMYWHO recommends tenofovir or entecavir for hepatitis B treatment
The World Health Organization issued its first-ever guidance for the treatment of chronic hepatitis B. Its recommended medicines consist of Gilead's (GILD) tenofovir or Bristol-Myers' (BMY) entecavir. Teva (TEVA) has FDA approval for generic entecavir.

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