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News Breaks
March 3, 2013
13:38 EDTBMY, SHPG, BIIBUnclear if pipeline alone can restore Bristol's growth, WSJ says
With Bristol-Myers' (BMY) losing Plavix patent exclusivity, the company took a 17% hit in revenues in 2012, and is now counting on new drugs like Eliquis and late-stage drugs aiming to treat cancer, diabetes and hepatitis C to restore growth, says the Wall Street Journal. However, "it remains unclear whether new drugs alone will be enough to restore growth," says WSJ, adding that in recent months Bristol has studied the possibility of Biogen Idec (BIIB) Shire (SHPG) as possible acquisition targets. Reference Link
News For BMY;SHPG;BIIB From The Last 14 Days
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September 17, 2014
07:43 EDTSHPG, BMYBofA/Merrill to hold a conference
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September 16, 2014
11:51 EDTSHPGOECD looks to close tax loopholes with new proposals
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06:00 EDTBMYBristol-Myers announces Health Canada approval of Yervoy
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September 15, 2014
10:55 EDTSHPGRegulators to determine AbbVie, Shire deal by next month, Reuters says
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08:01 EDTSHPGShire announces FDA acceptance for filing of sNDA for Vyvanse
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08:01 EDTBIIBAlnylam names Karen Anderson as SVP, Chief Human Resources Officer
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September 12, 2014
07:32 EDTBIIBBiogen, AbbVie announce ZINBRYTA DECIDE Phase 3 study results
Biogen (BIIB) and AbbVie (ABBV) announced the full results from the Phase 3 DECIDE clinical trial, which show ZINBRYTA, dosed subcutaneously once a month, demonstrated a statistically significant improvement in reducing disease activity in people with relapsing-remitting multiple sclerosis compared to AVONEX. These results are being presented at the Sixth Triennial Joint Meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis and the European Committee for Treatment and Research in Multiple Sclerosis. Patients on ZINBRYTA demonstrated a statistically significant 45% reduction in annualized relapse rate compared to patients treated with AVONEX. Based on the efficacy and safety data from the ZINBRYTA clinical development program, Biogen Idec and AbbVie plan to file marketing applications for ZINBRYTA with regulatory authorities during 1H15.
September 11, 2014
07:31 EDTBIIBBiogen announces 5-year results from TECFIDERA ENDORSE Phase 3 study
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07:31 EDTBIIBBiogen announces new data from Plegridy Phase 3 ADVANCE trial
Biogen Idec announced new data from the second year of its Phase 3 ADVANCE clinical trial that show the positive treatment effects of PLEGRIDY were maintained in people with relapsing forms of multiple sclerosis beyond the first year of the study. These results were presented at the sixth Triennial Joint Meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis and the European Committee for Treatment and Research in Multiple Sclerosis in Boston. Post-hoc analyses from the two-year, Phase 3 ADVANCE clinical trial confirm that PLEGRIDYs positive effects on reducing disease activity and disability progression were maintained in year two of the study. A significantly higher proportion of patients taking PLEGRIDY during both years of the study experienced no evidence of disease activity defined as the absence of clinical and MRI disease activity over two years of treatment compared to those who switched to PLEGRIDY from placebo. Also, those treated with PLEGRIDY for both years of the study had significant reductions in the risk of 24-week confirmed disability progression compared to patients treated with placebo during the first year. In addition, new data from the second year of ADVANCE show that patients who took PLEGRIDY throughout the study experienced statistically significant improvements in clinical and MRI outcomes including annualized relapse rate, risk of relapse, risk of 24-week confirmed disability progression, and number of brain lesions when compared to those who switched to PLEGRIDY after taking placebo for the first year. This new data also showed that the safety profile of PLEGRIDY was consistent between years one and two of the study.
September 10, 2014
08:37 EDTSHPGMedgenics appoints Scott Applebaum as Chief Legal Officer
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07:06 EDTSHPGSangamo plans to submit IND application for hemophilia B in 2Q15
Sangamo BioSciences (SGMO) plans to submit an Investigational New Drug application for the treatment of hemophilia B in Q2 2015. This program, partnered with Shire (SHPG), is the first therapeutic application of Sangamo's zinc finger nuclease-mediated In Vivo Protein Replacement Platform. Sangamo is developing the IVPRP as a generally applicable strategy to provide a one-time, permanent genetic cure for monogenic diseases that are currently managed by protein replacement therapy, which involves costly repeat infusions over the lifetime of the patient.
September 8, 2014
09:27 EDTBIIBLeerink biotech analyst holds a luncheon meeting with a conference call
Biotech Analyst Schwartz provides an update on key trends and controversies for marketed MS therapies and discusses new data presented at ACTRIMS-ECTRIMS at a Luncheon Meeting with an Analyst/Industry conference call to be held in Boston on September 11 at 12:15 pm.
07:15 EDTBIIBIBC Life Sciences to hold a conference
10th Annual Cell Line Development & Engineering Conference to be held in Berkeley, California on September 8-10.

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