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Stock Market & Financial Investment News

News Breaks
June 27, 2014
07:01 EDTBMYBristol-Myers receives positive CHMP opinion for Daklinza for treatment of HCV
Bristol-Myers Squibb Company announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending that Daklinza, an investigational, potent pan-genotypic NS5A complex inhibitor, be granted approval for use in combination with other medicinal products for the treatment of chronic hepatitis C virus infection in adults. This is the first positive opinion given by the CHMP for an NS5A complex inhibitor and will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union. Applications for Daklinza-based regimens are also pending in Japan and the U.S. A decision from Japan’s Pharmaceutical and Medical Devices Agency is expected soon, and the U.S. Food and Drug Administration has granted priority review status and set a target review date under the Prescription Drug User Fee Act of November 30.
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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