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Stock Market & Financial Investment News

News Breaks
April 7, 2014
04:55 EDTTLOG, TLOG, TLOG, TLOG, TLOG, AG, AG, AG, AG, AG, FMI, FMI, FMI, FMI, FMI, NLNK, NLNK, NLNK, NLNK, NLNK, TSRO, TSRO, TSRO, TSRO, TSRO, FPRX, FPRX, FPRX, FPRX, FPRX, SNSS, SNSS, SNSS, SNSS, SNSS, TROV, TROV, TROV, TROV, TROV, AZN, AZN, AZN, AZN, AZN, MRK, MRK, MRK, MRK, MRK, PFE, PFE, PFE, PFE, PFE, NVS, NVS, NVS, NVS, NVS, PPHM, PPHM, PPHM, PPHM, PPHMAmerican Association of Cancer Research to hold annual meeting
2014 Annual Meeting 2014 is being held in San Diego, California on April 5-9.
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August 13, 2014
16:52 EDTMRKMerck confirms FDA approval of BELSOMRA
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15:30 EDTMRKFDA approves Belsomra sleep drug
The Food and Drug Administration approved Belsomra tablets for use as needed to treat difficulty in falling and staying asleep. Belsomra is an orexin receptor antagonist and is the first approved drug of this type. Belsomra will be dispensed with an FDA-approved patient Medication Guide that provides instructions for its use and important safety information. Belsomra is a controlled substance because it can be abused or lead to dependence. Belsomra is made by Merck, Sharpe & Dohme.
13:27 EDTNLNKNewLink could start testing Ebola vaccine soon, Reuters reports
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13:20 EDTNLNKNewLink Genetics CEO says safety trial of Ebola vaccine could start 'in weeks'
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08:31 EDTAZNAstraZeneca says Phase 3 trials of lesinurad for gout met primary endpoints
AstraZeneca announced top-line results from CLEAR1, CLEAR2 and CRYSTAL, the pivotal Phase III clinical trials investigating the potential of lesinurad, a selective uric acid re-absorption inhibitor, as a combination therapy for the treatment of patients with symptomatic gout. Lesinurad is an investigational agent that inhibits the URAT1 transporter, increasing uric acid excretion and thereby lowering serum uric acid. In the CLEAR1 and CLEAR2 trials, both lesinurad 200mg and 400mg in combination with allopurinol met the primary endpoint, with a statistically significant higher proportion of patients reaching the target sUA goal of <6.0mg/dL at month 6 compared to allopurinol alone. In the CRYSTAL trial, lesinurad 400mg in combination with febuxostat met the primary endpoint, with a statistically significant higher proportion of patients reaching the target sUA goal of <5.0mg/dL at month 6 compared to febuxostat alone. Although lesinurad 200mg did not achieve statistical significance at month 6, this dose in combination with febuxostat, was superior to placebo plus febuxostat at all other time points. Results from these Phase III clinical trials will be submitted to a scientific meeting later in 2014. The company is proceeding with preparation of regulatory submissions for lesinurad 200mg combination therapy.
07:22 EDTAGFirst Majestic reports Q2 total production 3.86M silver equivalent ounces
The production growth was primarily due to higher throughput rates at Del Toro and San Martin following each of their respective expansions. Total ore processed during the second quarter amounted to 671,024 tonnes, representing a 5% increase compared to the previous quarter primarily driven by higher throughputs at Del Toro and San Martin.
07:22 EDTAGFirst Majestic reports Q2 adjusted EPS 2c, consensus 7c
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August 12, 2014
17:07 EDTPFEPfizer announces results from Lyrica studies conducted in China
Pfizer announced top-line results from two placebo-controlled studies conducted in China with Lyrica in patients with postherpetic neuralgia, pain after shingles or PHN, and painful diabetic peripheral neuropathy, pDPN, respectively.The PHN Phase 4 study, A0081276, met its primary endpoint by demonstrating a statistically significant reduction in pain when compared to placebo. Separately, the pDPN Phase 3 study, A0081265, did not meet its primary endpoint, a statistically significant change in endpoint mean pain score relative to placebo. The PHN study was an eight-week, randomized, double-blind, multi-center, placebo-controlled, post-marketing study evaluating the efficacy, safety and tolerability of pregabalin 300mg/day in the treatment of subjects with PHN. For the primary efficacy parameter, change from baseline in weekly mean pain scores, a significant treatment difference of -0.71 points for pregabalin relative to placebo was observed. The safety profile in this study was consistent with the known profile for Lyrica.
16:07 EDTFMIFoundation Medicine sees FY14 revenue $52M-$58M, consensus $58.01M
Sees Fy14 reported clinical tests in the range of 22,000-25,000.
16:06 EDTFMIFoundation Medicine reports Q2 EPS (49c), consensus (48c)
Reports Q2 revenue $14.5M, consensus $13.39M.
05:58 EDTAZNStocks with implied volatility movement; P AZN
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August 11, 2014
08:21 EDTPPHMPeregrine data shows statistically significant tumor growth suppression
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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
07:15 EDTTROVTrovagene price target lowered to $8 from $10 at Cantor
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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
06:39 EDTPFEPfizer faces torrent of Lipitor suits, Reuters says
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August 7, 2014
16:43 EDTTROVTrovagene reports Q2 EPS (6c), consensus (21c)
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08:38 EDTNVSEnanta's HCV NS5A inhibitor EDP-239 advances into combination studies
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08:12 EDTPFEPfizer says EMA accpets application seeking new indication for Prevenar 13
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06:13 EDTAZNDynavax says AZD1419 Phase 1 study met secondary endpoints
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