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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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September 16, 2014
06:00 EDTBMYBristol-Myers announces Health Canada approval of Yervoy
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September 5, 2014
16:45 EDTBMYMarket ends week little changed after mixed economic data
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11:17 EDTBMYBristol-Myers files patent infringement suit against Merck
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September 4, 2014
08:02 EDTBMYTeva launches generic Baraclude in U.S.
Teva (TEVA) announces the launch of the generic equivalent to Baraclude tablets in the U.S. Teva was first to file, making the product eligible for 180 days of marketing exclusivity. Baraclude is marketed by Bristol-Myers Squibb (BMY).

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