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June 17, 2014
10:32 EDTGILD, IDIX, MRKGilead says Merck, Idenix acquistion 'makes sense'
Gilead (GILD) says it expects to see more advancement in the Hepititus C field. In terms of Merck's (MRK) recent acquisition of Idenix (IDIX), Gilead says the acquisition "makes sense" to them. Says this puts Gilead in a "strong position" and expects to see other company consolidations to catch up to where the company is. Says fully anticipates more competitors in the future with regiments and says the firm cannot predict who those future rivals will be at this time. Comments made at the Wells Fargo Healthcare conference.
News For GILD;MRK;IDIX 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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11:09 EDTGILDSanofi, Novartis, Shire may be weighing Genfit acquisition, Bloomberg says
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March 3, 2015
07:08 EDTGILDAmerican Society for Clinical Pharmacology and Therapeutics holds meeting
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March 2, 2015
09:34 EDTGILDActive equity options trading on open
Active equity options trading on open according to Track Data: AAPL MNTA CELG TSLA MCD ARUN GILD KO TWTR NFLX
February 27, 2015
07:37 EDTGILDGilead removed from the short-term buy list at Deutsche Bank
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February 26, 2015
19:09 EDTGILDGilead announces Phase 3 results for once-daily single tablet HIV regimen
Gilead Sciences announced detailed 48-week results from two Phase 3 studies, Studies 104 and 111, evaluating its investigational once-daily single tablet regimen containing tenofovir alafenamide, or TAF, for the treatment of HIV-1 infection in treatment-nave adults. A regimen of elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and TAF 10 mg was found to be statistically non-inferior to Gileads Stribild, containing elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg, based on percentages of patients with HIV-1 RNA levels less than 50 copies/mL. A second analysis found that patients receiving the TAF regimen also had significantly better renal and bone laboratory parameters than those treated with Stribild. The data were presented in two late-breaker presentations at the 22nd Conference on Retroviruses and Opportunistic Infections in Seattle.
15:25 EDTGILDGilead announces 96% SVR12 rate in Phase 3 study of Harvoni
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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
15:30 EDTGILDGilead announces preclincal data on investigational TLR7 agonist
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08:08 EDTMRKMerck to present new data from IMPROVE-IT, TRA 2P studies
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February 24, 2015
09:35 EDTGILDActive equity options trading on open
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05:17 EDTMRKMerck collaborates with Medicines Patent Pool to expand Raltegravir access
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February 23, 2015
16:00 EDTGILDOptions Update; February 23, 2015
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09:39 EDTGILDActive equity options trading on open
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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
07:16 EDTGILDMylan signs exclusive agreement with Gilead to distribute Solvaldi, Harvoni
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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.
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