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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 25, 2014
13:00 EDTMRKMerck raises quarterly dividend to 45c from 44c per share
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November 24, 2014
08:02 EDTMRKMerck submits NDA to Japanese PMDA for Omarigliptin
Merck announced that the company has submitted a new drug application for omarigliptin, its investigational once-weekly DPP-4 inhibitor for the treatment of type 2 diabetes, to the Japanese Pharmaceuticals and Medical Devices Agency. The new drug application for omarigliptin is based on a comprehensive clinical development program in Japan. The results from the first Phase 3 study of omarigliptin, conducted in Japan, were presented recently at the 50th European Association for the Study of Diabetes Annual Meeting. Japan is the first country with a regulatory filing for omarigliptin. Worldwide, Merck is supporting omarigliptin with a clinical development program that includes nine Phase 3 clinical trials involving approximately 7,500 patients with type 2 diabetes in support of planned regulatory filings.
07:33 EDTMRKMerck, NewLink enter licensing, collaboration agreement for Ebola vaccine
Merck (MRK) and NewLink Genetics (NLNK) announced that they have entered into an exclusive worldwide license agreement to research, develop, manufacture, and distribute NewLink's investigational rVSV-EBOV vaccine candidate. Under the terms of the agreement, Merck will be granted the exclusive rights to the rVSV-EBOV vaccine candidate as well as any follow-on products. The vaccine candidate is under an exclusive licensing arrangement with a wholly-owned subsidiary of NewLink Genetics. Under these license arrangements, the PHAC retains non-commercial rights pertaining to the vaccine candidate. Phase I clinical trials of the rVSV-EBOV vaccine are now underway at the Walter Reed Army Institute of Research and the NIAID at the NIH. Additional Phase I studies are underway or planned to begin in the near future at clinical research centers in Switzerland, Germany, Kenya, and Gabon in a World Health Organization-coordinated effort, and in Canada by the Canadian Immunization Research Network.
07:31 EDTMRKMerck, NewLink Genetics enter into agreement for investigational Ebola vaccine
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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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