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News Breaks
March 31, 2014
13:41 EDTNVS, MRKNovartis rises after committee recommends early closure of study
Shares of drug maker Novartis (NVS) are climbing after the Data Monitoring Committee of its PARADIGM-HF study, which tested LCZ696 in comparison to patients who received standard care with enalapril, unanimously recommended early closure of the trial due to the drug's efficacy. WHAT'S NEW: Novartis announced that the committee unanimously recommended early closure of the study, indicating patients with chronic heart failure with reduced ejection fraction who received LCZ696 lived longer without being hospitalized for heart failure than those who received standard care with ACE-inhibitor enalapril. Based on the compelling efficacy and primary endpoint having been met, the trial was closed early. This follows two previous interim analyses that showed the safety profile of LCZ696 was acceptable. One of the two principal investigators, Dr. Milton Packer, said, "The finding that treatment with LCZ696 was superior to currently recommended doses of enalapril has profound implications for the care of patients with chronic heart failure. We now have compelling evidence that supports LCZ696 as a new cornerstone in the management of chronic heart failure." The company said the results of PARADIGM-HF will be submitted to a major medical conference for presentation and Novartis will now initiate discussions with global health authorities regarding approval for marketing. WHAT'S NOTABLE: Novartis said that the PARADIGM-HF study was initiated in December 2009 and currently is the largest clinical trial in heart failure ever undertaken. LCZ696 is a medicine that acts in multiple ways on the neurohormonal systems of the heart, blocking receptors exerting harmful effects while simultaneously promoting protective mechanisms. LCZ696 is thought to reduce the strain on the failing heart, promoting the ability of the heart muscle to recover. LCZ696 is the second treatment being developed by Novartis for patients with heart failure, along with RLX030 for acute heart failure. The standard ACE-inhibitor enalapril has been marketed as VASOTEC in the U.S. by Merck (MRK). Several companies sell generic enalapril under the name enalapril maleate tablets. PRICE ACTION: During afternoon trading, shares of Novartis were up by $3.31 or 4%, to $84.90.
News For NVS;MRK From The Last 14 Days
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August 28, 2014
08:40 EDTNVSPositive data on Novartis LCZ696 could raise sales outlook, says Leerink
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August 27, 2014
09:53 EDTMRKOn The Fly: Analyst Initiation Summary
Bristol-Myers (BMY) initiated with a Hold at Deutsche Bank... ASML (ASML) initiated with a Hold at Stifel... Akamai (AKAM) initiated with an Outperform at RW Baird... Concur (CNQR) initiated with a Neutral at DA Davidson... CyrusOne (CONE) initiated with a Neutral at Citigroup... Eli Lilly (LLY) initiated with a Buy at Deutsche Bank... Garmin (GRMN) initiated with a Neutral at RW Baird... Merck (MRK) initiated with a Hold at Deutsche Bank... NetSuite (N) initiated with a Buy at DA Davidson... Oracle (ORCL) initiated with a Neutral at DA Davidson... Oxford Industries (OXM) initiated with a Buy at Wunderlich... Pfizer (PFE) initiated with a Buy at Deutsche Bank... ServiceNow (NOW) initiated with a Buy at DA Davidson... Workday (WDAY) initiated with a Neutral at DA Davidson... MannKind (MNKD) initiated with a Buy at Jefferies... STMicroelectronics (STM) initiated with an Underperform at Credit Suisse... Kirkland's (KIRK) initiated with an Outperform at Barrington.
06:42 EDTMRKMerck initiated with a Hold at Deutsche Bank
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August 26, 2014
08:01 EDTMRKPfizer, Merck to collaborate on study evaluating anti-cancer combination regimen
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August 25, 2014
16:13 EDTMRKOn The Fly: Closing Wrap
Stocks began the session in positive territory and proceeded to tack on gains throughout the morning. Despite a disappointing report on new home sales in July, the S&P surpassed the 2,000 level for the first time before noon. The market pared its gains shortly after the milestone was reached and drifted for the remainder of the session on light volume, as trading activity may be restrained all week ahead of the Labor Day weekend. ECONOMIC EVENTS: In the U.S., the Chicago Fed's National Activity index jumped to 0.39 in July from an upwardly revised 0.21 in June. Markit's preliminary August services PMI came in at 58.5, which was down from a prior reading of 60.8 but above the 58.0 consensus projection. New home sales dropped 2.4% to a 412K rate in July, missing expectations for them to have risen to a 430K annualized rate. COMPANY NEWS: Shares of InterMune (ITMN) surged $19.05, or 35.41%, to $72.85 after the company agreed to be acquired by Roche (RHHBY) for $74.00 per share in an all-cash transaction. The deal announcement comes less than two weeks after Bloomberg reported that Roche, along with big pharma peers Sanofi (SNY) and GlaxoSmithKline (GSK), had made takeover bids for the smaller drugmaker. A number of other biotech companies gained following the deal announcement, including bigger names like Gilead (GILD) and Celgene (CELG) and smaller ones such as Achillion Pharmaceuticals (ACHN) and Receptos (RCPT)... Burger King (BKW) shares rose $5.29, or 19.51%, to $32.40 after the company confirmed it is in talks regarding a potential strategic transaction with Canadian donut chain Tim Hortons (THI). Shares of Tim Horton's trading in New York also gained $11.88, or 18.91%, to $74.72 following the confirmation of news first reported by The Wall Street Journal. MAJOR MOVERS: Among the other notable gainers was Advaxis (ADXS), which advanced 75c, or 23.08%, to $4.00 after announcing it has entered into a clinical trial collaboration agreement with Merck (MRK). Also rising were shares of Comtech (CMTL), which jumped $1.70, or 4.84%, to $36.81 after Reuters said the company is working with Citigroup to explore a potential sale. Among the noteworthy losers was Chinese internet and software company Qihoo 360 Technology (QIHU), which fell $7.88, or 7.74%, to $93.87 despite reporting second quarter earnings and revenue that beat analysts' estimates. Also lower were shares of GrubHub (GRUB), which fell $3.60, or 8.42%, to $39.16 after filing to sell 10M shares of common stock. INDEXES: The Dow gained 75.65, or 0.44%, to 17,076.87, the Nasdaq rose 18.80, or 0.41%, to 4,557.35, and the S&P 500 advanced 9.54, or 0.48%, to 1,997.94.
09:11 EDTMRKOn The Fly: Pre-market Movers
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05:17 EDTMRKAdvaxis, Merck enter clinical trial collaboration agreement
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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
07:57 EDTMRKCambridge Healthtech Institute to hold a summit
6th Annual Bioprocessing Summit to be held in Boston on August 18-22.
07:35 EDTNVSApricus Biosciences launches topical ED treatment in Germany
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