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News Breaks
March 29, 2012
13:55 EDTBAX, BAX, BAYRY, BAYRY, BIIB, BIIB, PBTH, PBTH, NVO, NVOLeerink's biotech analyst holds an analyst/industry conference call
Biotech Analyst Schimmer discusses the outlook for long-acting factor replacements in hemophilia on an Analyst/Industry conference call. Relevant covered companies BAX, BAYRY, BIIB, PBTH and NVO may be included on the Analyst/Industry conference call to be held on March 29 at 2 pm.
News For BAX;BAYRY;BIIB;PBTH;NVO From The Last 14 Days
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September 18, 2014
13:13 EDTNVONovo Nordisk Ryzodeg does not meet primary endpoint in phase 3b trial
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06:20 EDTBAYRYBayer to float MaterialScience as separate company
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September 17, 2014
17:44 EDTBAYRYBayer plans separation of MaterialsSciences unit, WSJ says
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08:44 EDTBAXJPMorgan biotech analysts hold an analyst/industry conference call
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September 16, 2014
07:31 EDTBAYRY, NVOEuropean Association for Study of Diabetes to hold annual meeting
50th Annual Meeting of EASD to be held in Vienna, Austria on September 15-19.
September 15, 2014
09:16 EDTBAXOn The Fly: Pre-market Movers
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09:01 EDTBAXBaxter announces FDA approval for RIXUBIS
(BAX) announced that the U.S. Food and Drug Administration has approved RIXUBIS for routine prophylactic treatment, control and prevention of bleeding episodes, and perioperative management in children with hemophilia B. RIXUBIS was the first recombinant factor IX approved for routine prophylaxis and control of bleeding episodes in the U.S. for adults living with this chronic condition. The approval is based on the results of a clinical trial investigating the efficacy and safety of RIXUBIS among 23 previously-treated male patients less than 12 years of age with severe or moderately severe hemophilia B. There were no reports of inhibitor development, no severe allergic reactions, and no thrombotic or treatment-related adverse events among the study participants. Baxter’s application for marketing approval for RIXUBIS for adults and pediatric patients is currently under review in the EU, with a regulatory decision expected later this year. The treatment also recently gained regulatory approval in Australia.
08:01 EDTBIIBAlnylam names Karen Anderson as SVP, Chief Human Resources Officer
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September 12, 2014
20:32 EDTBAXFDA approves Baxter's HYQVIA for treatment of primary immunodeficiency
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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
17:12 EDTNVONovo Nordisk Saxenda receives positive 14-1 vote in favor of approval from FDA
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08:15 EDTBAXBaxter says separation on track for mid-2015, new company to be called 'Baxalta'
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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 PLEGRIDY’s 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.
07:31 EDTNVOFDA Endocrinologic and Metabolic Drugs Advisory Committee to hold a meeting
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September 10, 2014
11:06 EDTNVOHigh option volume stocks
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September 9, 2014
12:46 EDTNVONovo Nordisk weight loss drug helped people get thinner, Bloomberg reports
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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 EDTBIIB, BAYRYIBC Life Sciences to hold a conference
10th Annual Cell Line Development & Engineering Conference to be held in Berkeley, California on September 8-10.
05:47 EDTBAXBaxter price target raised to $96 from $85 at Piper Jaffray
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