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Stock Market & Financial Investment News

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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October 1, 2014
08:14 EDTBMYPortola announces Phase 3 ANNEXA study met primary, secondary endpoints
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07:52 EDTBMYJ&J purchase of Alios an incremental negative for Achillion, says UBS
UBS views Johnson & Johnson's (JNJ) purchase of Alios as an incremental negative for Achillion (ACHN), as it implies there is now one less potential buyer of the company. However, the firm still thinks ACH-3422 will have considerable strategic value after data is reported and that other HCV players such as AbbVie (ABBV) and Bristol-Myers (BMY) are likely to be interested. UBS maintains its Buy rating and $15 price target on Achillion.
September 30, 2014
17:02 EDTBMYBristol-Myers to transfer $1.4B in U.S. pension obligations to Prudential
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16:39 EDTBMYCMS discloses drug makers' payments to doctors, WSJ says
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September 29, 2014
08:22 EDTBMYBristol-Myers says EMA validates MAA for Nivolumab in NSCLC
Bristol-Myers Squibb announced that the European Medicines Agency has validated for review the Marketing Authorization Application for nivolumab in non-small cell lung cancer– the first completed regulatory submission for a PD-1 immune checkpoint inhibitor in this tumor type. The MAA submitted to the EMA in lung cancer is based on data from the Phase 2 study of nivolumab in third-line pre-treated squamous cell NSCLC. In addition to the MAA for lung cancer in the E.U., the company previously announced that it has initiated a rolling submission with the FDA for Opdivo in third-line pre-treated squamous cell NSCLC and expects to complete the submission by year-end.
07:26 EDTBMYInforma Business Information to hold a conference
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05:32 EDTBMYBristol-Myers announces positive Phase 3 data for Opdivo
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September 26, 2014
16:20 EDTBMYBristol-Myers announces multiple regulatory milestones for Opdivo in U.S., EU
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September 23, 2014
12:10 EDTBMYBristol-Myers to build 650,000 square foot campus in Lawrenceville, NJ
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September 22, 2014
07:21 EDTBMYEBD Group to hold a conference
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September 17, 2014
07:43 EDTBMYBofA/Merrill to hold a conference
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