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News Breaks
March 21, 2014
08:10 EDTECYT, MRKMerck Endocyte announce 'positive opinions' for VYNFINIT, FOLCEPRI, NEOCEPRI
Merck (MRK) and Endocyte (ECYT) announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued "positive opinions" for the Conditional Marketing Authorisations of VYNFINIT and companion imaging components, imaging agent FOLCEPRI and NEOCEPRI for the treatment of adult patients with folate receptor-positive, platinum-resistant, ovarian cancer, in combination with pegylated liposomal doxorubicin. The applications for Conditional Marketing Authorization for vintafolide, etarfolatide and IV folic acid were submitted based on results in platinum-resistant ovarian cancer patients who express the folate receptor on all target lesions as evaluated in the PRECEDENT Phase 2 study. The CHMP positive opinions will be reviewed by the European Commission. If approved, the EC grants a centralized marketing authorization with unified labeling that is valid in the 28 countries that are members of the European Union, as well as European Economic Area members Iceland, Liechtenstein and Norway. The EC usually issues a final legally binding decision within three months of a CHMP opinion.
News For MRK;ECYT From The Last 14 Days
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November 21, 2014
07:51 EDTMRKBofA/Merrill biotech analysts hold analyst/industry conference call
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November 20, 2014
07:11 EDTMRKBofA/Merrill to hold a conference
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November 19, 2014
07:52 EDTMRKInforma Business Information to hold a conference
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November 18, 2014
06:39 EDTMRKAstraZeneca: 'Hard to comment' on whether Pfizer will come back, Reuters reports
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November 17, 2014
11:55 EDTMRKMerck says IMPROVE-IT study met all primary, secondary endpoints
Merck announced that the investigational IMPROVE-IT study met its primary and all secondary composite efficacy endpoints. In IMPROVE-IT, patients taking the LDL-cholesterol-lowering medicine VYTORIN – which combines simvastatin with the non-statin ZETIA -- experienced significantly fewer major cardiovascular events than patients treated with simvastatin alone. The results from this 18,144-patient study of high-risk patients presenting with acute coronary syndromes were presented today during the late-breaking clinical trials session at the American Heart Association 2014 Scientific Sessions. Merck plans to submit the data from IMPROVE-IT to the U.S. Food and Drug Administration in mid-2015 to support a new indication for reduction of major cardiovascular events for VYTORIN and ZETIA. VYTORIN and ZETIA are currently indicated for use along with a healthy diet to reduce elevated LDL cholesterol in patients with hyperlipidemia. The current U.S. Prescribing Information for both products states that the effect of ezetimibe on cardiovascular morbidity and mortality, alone or incremental to statin therapy, has not been determined.
08:34 EDTMRKMerck says IMPROVE-IT met primary endpoint
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November 16, 2014
13:26 EDTMRKMerck: KEYTRUDA showed superiority to chemotherapy for primary endpoint of PFS
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November 14, 2014
14:53 EDTMRKCVS Express Scripts implementing drug price controls, says Cleveland Research
Cleveland Research believes that CVS (CVS) and Express scripts are implementing rebates and price controls on drug. The firm expects the companies to increase their focus on controlling durg prices next year, and adds that they have already itnroduced prior authorization criteria for hepatitis drug. Publicly traded drug companies include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY). Makers of hepatits c drugs include AbbVie (ABBV) and Gilead (GILD),
11:46 EDTMRKMerck management to meet with SunTrust
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November 12, 2014
11:17 EDTMRKLeerink major pharma & biotech analysts hold analyst/industry conference call
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08:13 EDTMRKBoston Biotech to hold a conference
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November 11, 2014
16:01 EDTMRKOptions Update; November 11, 2014
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15:43 EDTMRKLeerink 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
15:53 EDTECYTCredit Suisse to hold a conference
Healthcare Conference is being held in Scottsdale, Arizona on November 10-13 with webcasted company presentations to begin on November 11 at 10:30 am; not all company presentations may be webcasted. Webcast Link
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.”

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