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News Breaks
March 31, 2014
13:41 EDTMRK, NVSNovartis 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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March 26, 2015
10:18 EDTNVSHigh option volume stocks
High option volume stocks: BTX ALL FIVE SGYP SWFT RHT IDCC NVS WGO XBI
08:31 EDTMRKMerck announces collaboration with American Diabetes Association
Merck announced a collaboration with the American Diabetes Association. The collaboration aims to educate adults with diabetes about their increased risk for potentially serious health problems, including pneumococcal pneumonia, influenza and hepatitis B, making it important for people with Type 1 or Type 2 diabetes to talk to their health care professional about these diseases.
March 25, 2015
07:28 EDTMRKOptions expected to be active
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March 24, 2015
19:40 EDTMRKOn The Fly: After Hours Movers
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17:02 EDTMRKMerck announces new $10B share repurchase program
Merck announced that its board of directors has authorized additional purchases of up to $10B of Merck’s common stock for its treasury. The treasury stock purchase has no time limit and will be made over time in open-market transactions, block transactions on or off an exchange, or in privately negotiated transactions. With this announcement, the company’s total outstanding share repurchase authorization is now approximately $11.7B, which includes approximately $1.7B in authorized repurchases remaining under the program previously announced on May 1, 2013. Merck continues to expect average diluted shares outstanding will be approximately 2.86B in 2015.
17:00 EDTMRKMerck announces new $10B share repurchase program
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16:00 EDTMRKOptions Update; March 24, 2015
iPath S&P 500 VIX Short-Term Futures down 10c to 25.14 Option volume leaders: AAPL TSLA TWTR GILD FB AMAT GOOG C MRK GILD according to Track Data.
11:05 EDTNVSNovartis granted orphan status for medulloblastoma treatment
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08:31 EDTMRKMerck: Phase 3 KEYNOTE-006 study met co-primary endpoints, will be stopped early
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March 23, 2015
09:45 EDTNVS, MRKUBS to hold a field trip
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09:03 EDTNVSLeerink analysts hold a meeting with a conference call hookup
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07:17 EDTMRKAmerican Academy of Dermatology to hold annual meeting
73rd Annual Meeting of AAD is being held in San Francisco on March 20-24.
March 20, 2015
12:33 EDTNVSNovartis says CLEAR Phase IIb study met primary endpoint
Novartis announced results from the CLEAR study demonstrating that Cosentyx is significantly superior to Stelara, a widely used biologic, in achieving clear or almost clear skin for psoriasis patients. The detailed findings were presented in a late-breaking research session at the 73rd Annual Meeting of the American Academy of Dermatology in San Francisco, USA. Cosentyx -- at a dose of 300 mg -- is the first and only interleukin-17A inhibitor approved to treat adult patients with moderate-to-severe plaque psoriasis. In this Phase IIIb study, Cosentyx met the primary endpoint of showing superiority to Stelara as assessed by the Psoriasis Area Severity Index 90 response, known as clear to almost clear skin at Week 16. PASI 90 is considered an important measure of treatment success by the European Medicines Agency and an optimal treatment goal for patients. In addition, completely clear skin at Week 16 was achieved by significantly more patients treated with Cosentyx than those receiving Stelara. In addition, Cosentyx demonstrated rapid onset of action and greater efficacy at all time points in the study up to Week 16, with 50% of Cosentyx patients achieving PASI 75 as early as Week 4 compared to Stelara. The CLEAR study follows the pivotal Phase III FIXTURE study, which showed Cosentyx was superior to Enbrel.
07:41 EDTMRK, NVSAmerican Academy of Dermatology to hold annual meeting
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March 19, 2015
15:55 EDTNVSAmgen injunction bid for Neupogen biosimilar denied, Reuters reports
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15:13 EDTNVSAmgen denied preliminary injunction for biologics against Novartis, Reuters says
March 17, 2015
12:51 EDTNVSNovartis hit with $100M gender discrimination lawsuit, Reuters reports
A proposed class action lawsuit against Novartis claims the drug maker routinely denied female employees equal pay and promotional opportunities, reports Reuters. The $110M lawsuit filed on Tuesday says Novartis' Alcon Laboratories maintains a "boy's club atmosphere" that is hostile to women and bars them from leadership positions. Reference Link
05:32 EDTNVSIncyte announces Novartis receives EC approval for Jakavi
Incyte (INCY) announced that Novartis (NVS) received approval from the European Commission for Jakavi for the treatment of adult patients with polycythemia vera, or PV, who are resistant to or intolerant of hydroxyurea. Jakavi is the first targeted treatment approved by the European Commission for these patients. Under the Incyte-Novartis Collaboration and License Agreement signed in 2009, Novartis received exclusive development and commercialization rights to ruxolitinib outside of the United States for all hematologic and oncologic indications, and sells ruxolitinib under the name Jakavi. Ruxolitinib is marketed by Incyte in the United States as Jakafi. Jakafi is approved by the FDA for treatment of people with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea. Jakafi is also indicated for treatment of people with intermediate or high-risk myelofibrosis, or MF, including primary MF, post–polycythemia vera MF, and post–essential thrombocythemia MF.
05:30 EDTNVSNovartis receives EU approval for Jakavi in polycythemia vera
Novartis announced that the European Commission has approved Jakavi for the treatment of adult patients with polycythemia vera, or PV, who are resistant to or intolerant of hydroxyurea. Jakavi is the first targeted treatment approved by the European Commission for these patients. Jakavi is the only JAK 1/2 inhibitor available to treat PV and is also currently approved in more than 80 countries to treat myelofibrosis.
March 16, 2015
15:33 EDTMRKMerck says study shows VYTORIN reduced CV events more than simvastatin alone
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