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February 14, 2013
07:06 EDTINCY, NVS, LLYIncyte sees FY13 Jakafi net product revenue $210M-$225M
This range excludes any product royalty revenues received from Novartis (NVS) on sales of Jakavi. The Company expects to receive a $60M milestone payment under its collaboration with Novartis when European Union pricing approval for Jakavi in specific countries is received. Excluding any other potential milestones received under collaborations, the Company expects revenues of $66M from the amortization of the upfront payments received under the Novartis and Lilly (LLY) collaborative agreements. Sees FY interest expense $47M.
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August 21, 2014
07:12 EDTLLYEli Lilly announces results from pivotal UNCOVER studies for ixekizumab
Eli Lilly announces that its investigational medicine ixekizumab was statistically superior to etanercept and placebo on all skin clearance measures in Phase 3 studies. Patients treated with both dosing regimens of ixekizumab had significantly greater levels of skin clearance compared to placebo and to etanercept at the 12-week endpoint. Skin clearance was measured by standard primary endpoints for psoriasis studies: the Psoriasis Area and Severity Index and the Static Physician Global Assessment. For patients treated with ixekizumab either every four weeks or every two weeks, between 78 to 90 percent of patients achieved at least a 75 percent reduction in PASI score at 12 weeks. Additionally, 31 to 41 percent of these patients achieved PASI 100, or clear skin, at week 12. For comparison, between 5 to 7 percent of patients treated with etanercept in the UNCOVER-2 and 3 studies achieved PASI 100. Adverse events were comparable for patients receiving ixekizumab in the 12-week, randomized control portion across all three studies.
August 20, 2014
12:06 EDTNVSNovartis treatment for pigmented villonodular synovitis gets orphan designation
According to a post on the FDA's website, Novartis' recombinant human monoclonal antibody of the IgG1 kappa class against human macrophage colony-stimulating factor received orphan designation. Reference Link
05:17 EDTNVSNovartis provides drug candidate compounds to TB Alliance
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August 19, 2014
05:11 EDTNVSGamida Cell announces investment, option agreement with Novartis
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August 18, 2014
17:37 EDTLLYFDA grants tentative approval for Lilly, Boehringer Basaglar insulin
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11:41 EDTLLYCubist rises after report sparks takeover interest speculation
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07:35 EDTNVSApricus Biosciences launches topical ED treatment in Germany
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August 11, 2014
11:58 EDTLLYMannKind rallies after inking licensing agreement with Sanofi
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05:18 EDTNVSNovartis reports LCZ696 significantly reduced cardiovascular deaths
New data revealing the reduction in cardiovascular, or CV, deaths with Novartis' LCZ696 in patients with heart failure with reduced ejection fraction, or HF-REF, will be presented at the European Society of Cardiology, or ESC, Congress 2014. The 8,442 patient study, PARADIGM-HF, was specifically designed to see if LCZ696 could increase survival over and above what can be achieved with ACE-inhibitor enalapril in addition to current best treatment in HF-REF patients. In March the Data Monitoring Committee overseeing the study confirmed those given LCZ696 were significantly less likely to die from CV causes, leading to the trial being closed early. LCZ696 significantly reduced cardiovascular deaths in head to head study against enalapril, in addition to current best treatment, in patients with HF-REF. PARADIGM-HF is the largest heart failure study ever conducted and was stopped early in March due to compelling efficacy. LCZ696 was recently granted FDA Fast Track status and rolling submission expected to be complete by end of year.
August 8, 2014
06:51 EDTNVSJudge rules DOJ can pursue Novartis kickback suit, Reuters says
U.S. District Judge Colleen McMahon ruled that the U.S. Department of Justice is allowed to continue its False Claims Act lawsuit versus Novartis regarding allegations that the company used kickbacks to increase sales of medications covered by Medicare and Medicaid, according to Reuters, citing comments from McMahon. Reference Link

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