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News Breaks
March 5, 2014
10:33 EDTMRK, ABBV, GILD, OSUROraSure climbs after CMS proposes coverage of HCV tests
Shares of OraSure (OSUR), whose hepatitis C virus test has been approved by the FDA, are climbing after the Centers for Medicare & Medicaid Services yesterday proposed a rule that would enable Medicare and Medicaid to cover HCV tests in some circumstances. Orasure's OraQuick HCV test detects HCV antibodies in fingerstick and venipuncture whole blood. WHAT'S NEW: CMS proposed a rule under which the government would cover HCV tests that have been approved by the FDA. In order to be covered, the test must be ordered by beneficiaries' doctors, and performed by an eligible Medicare provider, CMS stated. Additionally, under the proposal the government would only cover tests for adult beneficiaries who are at high risk for HCV infection, and for those people born between 1945 and 1965. Individuals who have used illegal drugs or received blood transfusions before 1992 would be considered at risk individuals for the purposes of the rule, the agency stated. ANALYST REACTION: In a note to investors earlier today, Mizuho Securities analyst Peter Lawson wrote that the CMS' decision is positive for OraSure. The company has the largest exposure to HCV testing among publicly traded companies, the analyst indicated. The company could obtain over $1B of revenue by providing HCV tests for beneficiaries born between 1945 and 1965, the analyst estimated. Moreover, HCV drug developers will also use OraSure's test in the wake of CMS' decision, added Lawson, who reiterated a $9 price target and Outperform rating on the stock. PRICE ACTION: In early trading, OraSure climbed 11cv, or 1.5%, to $7.50. OTHERS TO WATCH: Companies developing HCV treatments include AbbVie (ABBV), Merck (MRK) and Gilead (GILD).
News For OSUR;ABBV;MRK;GILD From The Last 14 Days
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March 2, 2015
07:20 EDTOSURCowen to hold a conference
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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-naÔve 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 Gileadís 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 2ļP 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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11:19 EDTABBVEnanta announces JAMA publication of AbbVie VIEKIRA PAK study results
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11:04 EDTABBVAbbVie reports VIEKIRA PAK HPV/HIV co-infection study results published
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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 NGMís most recent financing. Merck will commit up to $250M to fund all of NGMís 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
10:33 EDTABBVBattleground update: AbbVie named top global pick at Jefferies
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07:23 EDTABBVAbbVie replaces Pfizer as top global pharma pick at Jefferies
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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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