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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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November 12, 2014
08:18 EDTNVSUBS to hold a conference
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08:13 EDTMRKBoston Biotech to hold a conference
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07:58 EDTNVSGenVec expects 2014 cash burn between $6M-$7M from Novartis collaboration
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November 11, 2014
16:14 EDTNVSLeerink biotech analysts hold an analyst/industry conference call
Biotech Analysts provide a preview of items being discussed at the upcoming 56th Annual Meeting of ASH including JAK inhibitors, novel Jakafi combinations for Myelofibrosis and developing compounds on an Analyst/Industry conference call to be held on November 17 at 10 am.
16:01 EDTNVSQIAGEN enters master collaboration agreement with Novartis
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16:01 EDTMRKOptions Update; November 11, 2014
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15:43 EDTMRK, NVSLeerink major pharma & biotech analysts hold analyst/industry conference call
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09:37 EDTMRKActive equity options trading
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08:10 EDTMRKMerck reports results from Phase 2 study of Grazoprevir/Elbasvir
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November 10, 2014
16:07 EDTNVSUBS to hold a conference
UBS European Conference is being held in London, England on November 11-12.
15:57 EDTNVSWorldwide Business Research to hold a conference
ProcureCon for Digital & Marketing Services 2014 is being held in San Antonio on November 11-13.
09:20 EDTMRKOn The Fly: Pre-market Movers
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08:48 EDTMRKGilead rises after Merck presents data on HCV combo
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07:20 EDTMRKGilead overhang from Merck HCV combo removed, says Wells Fargo
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November 9, 2014
18:58 EDTMRKMerck presents interim data from C-SWIFT study
Merck announced the presentation of interim data from the C-SWIFT study exploring the potential of a candidate triple-therapy regimen consisting of the fixed-dose combination of grazoprevir/elbasvir , the company’s investigational NS3/4A protease inhibitor and NS5A inhibitor, in combination with sofosbuvir, a nucleotide inhibitor for the treatment of chronic hepatitis C virus, HCV, infection. Preliminary findings in treatment-naïve HCV genotype 1- infected non-cirrhotic patients, following six and four weeks of treatment, and patients with cirrhotic disease, following eight and six weeks of treatment, will be presented by Dr. Eric Lawitz, vice president, scientific and research development, The Texas Liver Institute, San Antonio, TX and C-SWIFT lead investigator. This poster presentation is part of a late-breaking abstract session at the 65th American Association for the Study of Liver Diseases, AASLD, Annual Meeting, also known as The Liver Meeting. “These interim data provide a compelling proof-of-concept for the potential of an eight- or six-week triple therapy course in treatment-naive patients with genotype 1 disease, including cirrhotic patients,” said Dr. Lawitz. “These findings will inform the design of larger studies aimed at understanding the potential of short-duration triple therapy across multiple patient types.”
November 6, 2014
15:13 EDTMRKAmerican Association for Study of Liver Diseases to hold a meeting
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12:48 EDTNVSNovartis: FDA Advisory Committee does not recommend LBH589
Novartis announced that the US FDA's Oncologic Drugs Advisory Committe did not recommend the investigational compound LBH589, a pan-deacetylase inhibitor, for patients with previously treated multiple myeloma when used in combination with bortezomib and dexamethasone. The Committee's vote will be considered by the FDA in its review of the LBH589 new drug application, but the FDA is not bound to follow the Committee's guidance. The final decision regarding US approval is made by the FDA. "We are disappointed by this voting outcome and believe the results from our clinical trials provide strong evidence to support LBH589 as a potential first- in-class treatment option for multiple myeloma, a cancer where an unmet patient need exists," said Bruno Strigini, President, Novartis Oncology. "We will continue to work with the FDA as it completes its review of the US application."
09:12 EDTMRKMerck to present KEYTRUDA data
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07:27 EDTMRKBIND announces agreement with Merck to develop Accurin nanomedicines
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07:16 EDTNVSFDA Oncologic Drugs Advisory Committee to hold a meeting
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