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News Breaks
June 30, 2014
06:00 EDTMRKMerck's pembrolizumab under regulatory review in Europe
Merck announced the European Medicines Agency has accepted for review a Marketing Authorization Application for pembrolizumab, the company’s investigational anti-PD-1 antibody, for the treatment of advanced melanoma. If approved by the European Commission, pembrolizumab has the potential to be the first anti-PD-1 therapy in Europe. Additional regulatory filings in other countries outside of Europe are planned by the end of 2014.
News For MRK From The Last 14 Days
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March 5, 2015
08:15 EDTMRKMerck announces results of post-hoc analyses of TIMI 50 study
Merck, known as MSD outside the United States and Canada, announced results from post-hoc analyses of the TRA 2°P TIMI 50 -- Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events -- trial of ZONTIVITY, vorapaxar. Among the 3,787 patients whose qualifying diagnosis for the TRA 2°P TIMI 50 trial was symptomatic PAD including 514 patients with a history of stroke or TIA in whom use of ZONTIVITY is contraindicated, a total of 109 ALI events occurred during the trial. In this post-hoc subgroup analysis, researchers found that in patients with symptomatic PAD, adding ZONTIVITY to standard care which included aspirin and/or clopidogrel yielded a 42% relative risk reduction in the incidence of ALI versus aspirin and/or clopidogrel alone. In another post-hoc subgroup analysis of 5,845 patients in TRA 2ºP with a history of PAD regardless of primary enrollment stratum, ZONTIVITY vs. placebo, added to aspirin and/or clopidogrel, showed a consistent pattern of reduction in the need for peripheral revascularization among the various indications for PR captured by the analysis. Adding ZONTIVITY also reduced the rate of surgical PR procedures. Approximately 20% of the 5,845 patients included in this analysis had a history of stroke or TIA, which are contraindications to use of ZONTIVITY. In another post-hoc subgroup analysis of 2,942 post-MI or PAD patients with no history of stroke or TIA who had undergone coronary artery bypass grafting prior to the trial, adding ZONTIVITY to aspirin and/or clopidogrel reduced the risk of CV death, myocardial infarction or stroke; event rate 11.9% for ZONTIVITY vs. 15.6% for placebo. In these patients, ZONTIVITY increased the risk of GUSTO moderate or severe bleeding. In another subgroup analysis, among 319 post-MI or PAD patients with no history of stroke or TIA who underwent a new CABG during the trial, the rates of TIMI major bleeding within 30 days of surgery were 6% for ZONTIVITY and 4.2% for placebo.
March 4, 2015
18:34 EDTMRKMerck, Eisai enter clinical trial collaboration to test safety of KEYTRUDA
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February 26, 2015
15:20 EDTMRKMerck says GARDASIL 9 recommended by CDC advisory committee
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09:41 EDTMRKHospira launches generic Remicade, WSJ says
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February 25, 2015
08:08 EDTMRKMerck to present new data from IMPROVE-IT, TRA 2ºP studies
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February 24, 2015
05:17 EDTMRKMerck collaborates with Medicines Patent Pool to expand Raltegravir access
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February 23, 2015
08:27 EDTMRKNGM Biopharmaceuticals to hold a teleconference
NGM Biopharm discusses the strategic collaboration with Merck to discover, develop and commercialize novel biologic therapeutics on a teleconference to be held on February 23 at 9:30 am. Webcast Link
07:04 EDTMRKMerck, NGM Biopharmaceuticals announce multi-year collaboration
NGM Biopharmaceuticals and Merck announced they have entered into a multi-year collaboration to research, discover, develop and commercialize novel biologic therapies across a wide range of therapeutic areas. This agreement will become effective upon the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act. The collaboration includes multiple drug candidates currently in preclinical development at NGM, including NP201, which is being evaluated for the treatment of diabetes, obesity and nonalcoholic steatohepatitis. NGM will lead the research and development of the existing preclinical candidates and have the autonomy to identify and pursue other discovery stage programs at its discretion. Merck will have the option to license all resulting NGM programs following human proof of concept trials. If Merck exercises this option, Merck will lead global product development and commercialization for the resulting products, if approved. Under the terms of the agreement, Merck will make an upfront payment to NGM of $94M and will purchase a 15 percent equity stake in NGM for $106M at a price per share that represents a 20% premium to NGM’s most recent financing. Merck will commit up to $250M to fund all of NGM’s efforts under the initial five-year term of the collaboration, with the potential for additional funding if certain conditions are met. Prior to Merck initiating a Phase 3 study for a licensed program, NGM may elect to either receive milestone and royalty payments or, in certain cases, to co-fund development and participate in a global cost and revenue share arrangement of up to 50%. The agreement also provides NGM with the option to participate in the co-promotion of any co-funded program in the United States. Merck will have the option to extend the research agreement for two additional two-year terms.
February 20, 2015
07:08 EDTMRKAmerican Academy of Allergy, Asthma and Immunology to hold annual meeting
2015 Annual Meeting of AAAAI is being held in Houston, Texas on February 20-24.

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