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News Breaks
December 14, 2012
08:07 EDTMRK, ARIAEMA says Merck withdraws application for Jenzyl
The European Medicines Agency said on November 27 Merck Sharp & Dohme (MRK) officially notified the Committee for Medicinal Products for Human Use, or CHMP, that it wishes to withdraw its application for a marketing authorization for Jenzyl, for the maintenance treatment of patients with metastatic soft tissue sarcoma or bone sarcoma previously treated with chemotherapy. Jenzyl is the trade name for ridaforolimus, which is being co-developed by Merck and ARIAD Pharmaceuticals (ARIA). Jenzyl was expected to be used for the treatment of adults with soft tissue sarcoma, a type of cancer that affects the soft, supporting tissues of the body, or bone sarcoma that have spread to other parts of the body. The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated a list of questions. The company had not yet responded to the last round of questions at the time of the withdrawal. Based on the review of the data and the company’s response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Jenzyl could not have been approved for the treatment of patients with metastatic soft tissue sarcoma or bone sarcoma as maintenance therapy, the CHMP said.
News For ARIA;MRK 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.
07:36 EDTARIAARIAD, STA announce approval of Iclusig in Australia
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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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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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