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News Breaks
June 1, 2014
14:05 EDTMRKMerck presents early findings from Phase 1b study for pembrolizumab
Merck announced the first presentation of early findings from a Phase 1b study evaluating pembrolizumab, MK-3475, Merck’s investigational anti-PD-1 antibody, as a single-agent, monotherapy, in patients with PD-L1 positive, advanced head and neck cancer. Early data showed a best overall response rate of 20% with 29% of patients having stable disease as measured by RECIST criteria . Similar overall response rates were observed in Human papillomavirus, HPV-positive and HPV-negative patients – HPV infection is a risk factor for some types of head and neck cancer. In the study, tumor shrinkage was demonstrated in 51% of evaluable patients who had measurable disease with one post baseline scan, per RECIST criteria. These early findings will be presented in an oral session by Dr. Tanguy Seiwert, associate director of the Head and Neck Cancer Program and assistant professor of medicine at The University of Chicago, at the 50th Annual Meeting of the American Society of Clinical Oncology. “Recurrent and metastatic head and neck cancer carries a very poor prognosis, and often is accompanied by poor quality of life and disfigurement. Additional treatment options are urgently needed,” said Dr. Seiwert. “These early response data with pembrolizumab as monotherapy provide an encouraging proof of concept and support further study of this novel investigational immunotherapy in this hard-to-treat cancer type.” “We continue to observe robust signals of anti-tumor activity in response to pembrolizumab monotherapy across multiple tumor types and lines of therapy, including these data in head and neck cancer,” said Dr. Roy Baynes, senior vice president, global clinical development, Merck Research Laboratories. “The breadth of data to be presented at ASCO underscores why Merck is advancing a broad development program for pembrolizumab across more than 30 tumor types, including late-stage studies in head and neck and other cancers.”
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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
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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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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