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January 28, 2014
08:25 EDTMRK, MRKFDA Allergenic Products Advisory Committee to hold a meeting
The Committee discusses and makes recommendations on the safety and efficacy of Merck's (MRK) and its partner, ALK-Abello's (AKBLF) Ragwitek, a short ragweed pollen allergen extract tablet in a meeting being held at FDA Silver Spring, Maryland offices on January 28 at 8:30 am. Webcast Link
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 2P 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 2P 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 2P 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 2P 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 NGMs most recent financing. Merck will commit up to $250M to fund all of NGMs 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.
February 19, 2015
08:38 EDTMRKNewLink reports clinical development milestone achieved with Merck for rVSV-EBOV
NewLink Genetics (NLNK) announced that it had received notification from Merck (MRK) that the milestone event specified in the license and collaboration agreement between the two companies relating to the further development of the rVSV-EBOV, Ebola, vaccine candidate had been achieved. Under the terms of the agreement, NewLink Genetics will receive a payment of $20M in connection with the achievement of the milestone. The milestone pertains to the initiation of a key clinical trial for the vaccine.

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