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News Breaks
February 8, 2013
10:12 EDTBMY, MDCOThe Medicines Co. and Bristol-Myers' Recothrom collaboration becomes effective
The Medicines Company (MDCO) announced that the global license and two-year collaboration for Recothrom, a recombinant thrombin approved by the FDA for use as a topical hemostat to control non-arterial bleeding during surgical procedures, established with Bristol-Myers Squibb Company (BMY), has become effective. The agreement was first announced in December 2012. The companies have satisfied all required regulatory and closing conditions.
News For MDCO;BMY From The Last 14 Days
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November 26, 2014
13:25 EDTBMYAchillion to benefit from Bristol-Myers CRL, says FBR Capital
FBR Capital expects Achillion (ACHN) to benefit from the complete response letter that the FDA sent to Bristol-Myers (BMY) on its daclatasvir HCV drug. The firm thunks the letter increases the value of GT-3 HCV patients for Achillion. FBR says that GT-3 patients constitute 5% of HCV patients in the U.S. and significantly higher in Europe. It keeps an Outperform rating on Achillion.
11:38 EDTBMYBristol-Myers receives CRL from FDA for daclatasvir
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11:36 EDTBMYBristol-Myers receives CRL from FDA for daclatasvir
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November 24, 2014
09:00 EDTBMYBristol-Myers, Five Prime announce clinical collaboration for Opdivo, FPA008
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November 20, 2014
10:02 EDTMDCOOn The Fly: Analyst Upgrade Summary
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07:41 EDTMDCOThe Medicines Co. upgraded at Credit Suisse
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06:06 EDTMDCOThe Medicines Co. upgraded to Outperform from Neutral at Credit Suisse
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November 19, 2014
07:52 EDTBMYInforma Business Information to hold a conference
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06:07 EDTBMYBristol-Myers' Opdivo for melanoma shows positive Phase 3 results
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November 17, 2014
11:06 EDTBMYLeerink biotech analysts hold an analyst/industry conference call
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08:13 EDTBMYPortola, Bristol-Myers, Pfizer announce results from Phase 3 ANNEXA-A studies
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08:10 EDTBMYBristol-Myers presents results from Phase IIIb AVERT trial at ACR
Bristol-Myers Squibb Company announced results of several new sub-analyses of the Phase IIIb AVERT trial that investigated the use of Orencia plus methotrexate in biologic and MTX-naïve citrullinated protein-positive early moderate to severe rheumatoid arthritis patients. These data were presented this week at the American College of Rheumatology 2014 annual meeting. Orencia is currently indicated in adults for moderate to severe RA. Orencia should not be administered with tumor necrosis factor antagonists and should not be used with other biologic RA drugs. One of the analyses looked at anti-CCP antibodies, which are a marker of RA and may contribute to disease progression. The analysis assessed the development of anti-CCP antibodies in patients with early rapidly progressing RA by measuring isotypes and the number of epitopes recognized after treatment with Orencia plus MTX, Orencia alone, or MTX alone. Results demonstrated Orencia plus MTX numerically reduced the concentrations of all CCP isotypes and the average number of epitopes recognized over one year of treatment more than Orencia alone or MTX alone. Over 12 months of treatment, 6.7 percent, 12.1 percent, and 7.8 percent of patients on Orencia plus MTX, Orencia alone, and MTX alone, respectively, experienced a serious adverse event and 1.7 percent, 4.3 percent and 2.6 percent led to discontinuation. Serious infections were observed in 0.8 percent of patients in the combination arm and 3.4 percent in the Orencia monotherapy arm. None of the patients in the MTX alone arm experienced a serious infection. Malignancies were reported in 0.8 percent, 1.7 percent, and 0 percent of patients in the Orencia + MTX, Orencia, and MTX arms, respectively. Additionally at ACR, investigators presented 12-month efficacy data from AVERT, including new results assessing the effect of Orencia on more clinically stringent remission criteria than DAS-defined remission, as well as new MRI data. Significantly more patients on Orencia plus MTX achieved the stringent clinical endpoint of Boolean-defined remission at 12 months.
November 16, 2014
13:41 EDTMDCOThe Medicines Co. presents findings from MDCO-216 study
The Medicines Company presented findings from a new Phase 1 study showing that a single infusion of MDCO-216, an investigational lipid-modifying agent, in both healthy and CAD patients, modified key lipid parameters including ApoA-1, phospholipids, HDL, pre-beta 1 HDL and Apo E, markedly increased ABCA1 mediated efflux, a potential marker of reverse cholesterol transport and was well tolerated. The study was presented today as part of a poster session at The American Heart Association’s Annual Scientific Sessions in Chicago. Clinical findings have shown that human carriers of the ApoA-1 Milano variant have a reduced incidence of cardiovascular disease. MDCO-216, currently under development by The Medicines Company, is a complex of recombinant human Apo A1 with phospholipids to emulate an HDL particle. MDCO-216 has the potential to modify atherosclerotic disease by promoting reverse cholesterol transport, and its potential impact on reducing cardiovascular events in acute coronary syndrome, ACS, patients. “This study provides a signal that MDCO-216 is able to modulate lipid parameters consistent with those humans with the ApoA-1 variant, had an important effect on markers of reverse cholesterol transport such as pre-beta1 HDL and ABCA1 mediated efflux, and importantly was well-tolerated,” commented David Kallend, MBBS, Vice President and Global Medical Director for the Lipid Programs at The Medicine Company. “These findings support the continued development of MDCO-216 as a potential treatment to help address a currently unmet need in coronary artery disease patients."
13:07 EDTBMYBristol-Myers announces results from CheckMate -066 study
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