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News Breaks
December 14, 2012
08:07 EDTARIA, MRKEMA 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 The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated a list of questions.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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April 20, 2015
08:05 EDTMRKTetraLogic, Merck enter into oncology clinical study collaboration
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07:20 EDTMRK, ARIAAmerican Association for Cancer Research to hold annual meeting
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April 19, 2015
19:35 EDTMRKMerck to swiftly repay $5B loan, explore acquisitions by late 2017, Reuters says
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15:21 EDTMRKMerck announces new data from Keytruda study
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14:59 EDTMRKMerck's Keytruda 'superior' to ipilimumab for PFS in patients with melanoma
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14:47 EDTMRKMerck submits supplemental biologics license for Keytruda in lung cancer
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14:31 EDTMRKMerck reports 28% Keytruda response rate in 25 pleural mesothelioma patients
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April 17, 2015
07:36 EDTARIAARIAD presents updated clinical data on Brigatinib
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April 15, 2015
08:33 EDTMRKFDA panel results positive for Merck, says SunTrust
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April 14, 2015
13:32 EDTMRKMerck, NewLink Genetics confirm initiation of Phase 3 trial of Ebola vaccine
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April 13, 2015
14:20 EDTARIANHS Scotland accepts ARIAD's Iclusig for use
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08:58 EDTMRKMerck may have positive read through from briefing docs, says SunTrust
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April 9, 2015
09:25 EDTMRKPiper Jaffray pharmaceuticals analysts hold an analyst/industry conference call
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April 8, 2015
07:33 EDTMRKAdvaxis, Merck begin enrollment in Phase 1/2 of ADJX-PSA with Keytruda
Advaxis (ADXS) and Merck (MRK) announced that enrollment has initiated in the Phase 1/2 clinical trial evaluating the combination of ADXS-PSA, an investigational Lm-LLO immunotherapy, and Keytruda, the first anti-PD-1 therapy approved in the United States, in patients with previously treated, metastatic castration-resistant prostate cancer, or mCRPC. The clinical trial, KEYNOTE-046, is the first-in-human study of Advaxis's lead Lm-LLO immunotherapy candidate for prostate cancer. It is the second study initiated to evaluate the use of KEYTRUDA in the treatment of advanced prostate cancer. ADXS-PSA and KEYTRUDA are members of a class of cancer treatments known as immuno-oncology therapies. Data from preclinical studies suggest that Advaxis Lm-LLO immunotherapies in combination with a PD-1 antibody may lead to an enhanced anti-tumor immune response. The results from KEYNOTE-046 will determine the future clinical development program for the combination.
07:04 EDTMRKMerck's investigational Hep C therapy granted breakthrough therapy designations
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April 7, 2015
07:14 EDTMRKEyeforpharma to hold a summit
Philadelphia 2015 Commercial Pharma Summit is being held in Philadelphia on April 7-8.
April 6, 2015
09:22 EDTARIAOn The Fly: Pre-market Movers
HIGHER: Uniqure (QURE), up 44.2% following strategic collaboration with Bristol-Myers (BMY)... Cytori Therapeutics (CYTX), up 22.4% after Lorem Vascular receives regulatory clearance in China... Curis (CRIS), up 8.5% after FDA grants orphan drug designation to CUDC-907 for the treatment of Diffuse Large B-Cell Lymphoma... Capnia (CAPN), up 5.9% after being awarded a $220,000 NIH grant... Tesla (TSLA), up 3.8% after reporting first quarter deliveries up 55% to 10,030 cars... Ariad (ARIA), up 3.4% following approval of Iclusig in Canada... Lumber Liquidators (LL), up 3.1% after being upgraded to Outperform from Market Perform at Raymond James. LOWER: Magnum Hunter (MHR), down 8.9% after being downgraded to Hold from Buy at Wunderlich... Herbalife (HLF), down following CNBC report that federal law enforcement agencies contacted the company regarding its business practices... Qualcomm (QCOM), down 2.2% following a Wall Street Journal report that the Samsung (SSNLF) Galaxy S6 did not have a Qualcomm LTE modem... Skyworks (SWKS), down 2.1% after being downgraded to Equal Weight from Overweight at Stephens.
07:36 EDTARIAARIAD announces approval of Iclusig in Canada
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