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February 1, 2013
07:05 EDTMRKMerck says now anticipates odanacatib filing in 2014
Merck reported it recently received and is reviewing safety and efficacy data from the pivotal Phase III trial of odanacatib, the company’s investigational medicine for osteoporosis. As previously indicated, the company has been conducting a blinded extension of the trial in approximately 8,200 women, which will provide additional safety and efficacy data. Merck now anticipates that it will file applications for approval of odanacatib in 2014 with additional data from the extension trial, rather than filing in the first half of 2013. The company continues to believe that odanacatib will have the potential to address unmet medical needs in patients with osteoporosis.
News For MRK From The Last 14 Days
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October 12, 2015
07:22 EDTMRKCardiovascular Research Foundation to hold a conference
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October 9, 2015
14:19 EDTMRKFDA expands approved use of Opdivo in advanced lung cancer
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08:33 EDTMRKAmerican Society for Bone & Mineral Research to hold annual meeting
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08:30 EDTMRKBioNJ to hold a summit
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07:02 EDTMRKNICE issues draft recommendation for Keytruda as first-line Melanoma treatment
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05:54 EDTMRKEli Lilly upgraded to Outperform from Neutral at Credit Suisse
Credit Suisse analyst Vamil Divan upgraded Eli Lilly (LLY) to Outperform after his survey of 51 physicians suggested increasing use of the company's diabetes drug Jardiance. Jardiance is likely to drive near-term upside to Lilly while the company's pipeline is being underappreciated at current share levels, Divan tells investors in a research note. He raised his price target for shares to $105 from $89. The pharmaceutical giant closed yesterday down 24c to $83.75. The analyst also raised his sales estimates for Merck (MRK) and Johnson & Johnson (JNJ) following his physician survey.
October 8, 2015
07:05 EDTMRKDynavax initiates combination trial of SD-101 with Keytruda from Merck
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October 6, 2015
13:32 EDTMRKBiotechs plummet with TPP seen as industry negative
Biotechs are falling intraday after reports that the Trans-Pacific Partnership, or TPP, has language that the exclusivity period for bioligics, or drugs derived from a biological sources, would be eight years, less than the twelve years it is currently in the United States. WHAT'S NOTABLE: In the U.S., biologics are protected from competition by follow-on products for twelve years from the time they are first granted marketing approval by the U.S. Food and Drug Administration, a protection that is distinct from patent protection. Recent reports on the TPP suggest that the protection will last five years with an additional safety monitoring period of up to three years before a biosimilar can be registered, which would effectively be an eight year exclusivity period. ANALYST REACTION: Piper Jaffray analyst Joshua Schimmer, however, said the development is a "step forward," especially since it does not overrule the 12 years' exclusivity for the drugs in the U.S. While the sector asked for twelve years' exclusivity to match the U.S., eight years is a "reasonable compromise," the analyst argued. His top picks were Alexion (ALXN), Celgene (CELG), and Amgen (AMGN) in the large-cap space, GW Pharmaceuticals (GWPH) and bluebird bio (BLUE) among mid-caps, and Flex Pharma (FLKS), Lion Biotechnologies (LBIO), Otonomy (OTIC), and Ignyta (RXDX) in the small-cap sector. Further, Schimmer stated that more names look "increasingly compelling" amid the selloff. NOTABLE DECLINERS: Alexion is lower by 2.53%, Celgene is down 4.32%, Amgen is declining 1.91%, Biogen (BIIB) is down 3.4%, and Gilead Sciences (GILD) is falling 2.22%. STOCKS TO WATCH: Other publicly traded companies in the pharmaceutical space include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY).
October 5, 2015
19:05 EDTMRKMerck announces publication of results from C-SURFER
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05:29 EDTMRKDako announces FDA approval of new companion diagnostic assay
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October 4, 2015
14:28 EDTMRKMerck to license Dificid in Taiwan for $3M plus milestone payments
OBI Pharma announced an agreement with Merck to transfer exclusive rights to develop and commercialize Dificid, or fidaxomicin, in Taiwan to Merck. OBI Pharma will receive an initial up-front payment of $3M and is eligible to receive royalties and payments associated with the completion of certain undisclosed milestones. Merck will be responsible for all future costs associated with commercialization, development, and manufacturing of Dificid in Taiwan.
October 2, 2015
15:43 EDTMRKQuest Diagnostics introduces Dako's PD-L1 companion diagnostic for KEYTRUDA
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15:25 EDTMRKAgilent's Dako confirms FDA approval of NSCLC diagnostic
Dako, an Agilent Technologies (A) company and a worldwide provider of cancer diagnostics, announced the FDA approval of a new companion diagnostic assay that can reveal whether a patient with advanced non-small cell lung cancer, or NSCLC, is likely to respond to a new form of treatment. The approval of PD-L1 IHC 22C3 pharmDx strengthens Dako's portfolio of companion diagnostics and the company's leadership position in developing and commercializing companion diagnostic products. Dako developed PD-L1 IHC 22C3 pharmDx in partnership with Merck (MRK), maker of the anti-PD-1 therapy Keytruda. The FDA approved PD-L1 IHC 22C3 pharmDx for use in the United States. Dako hopes to gain regulatory approval for the new diagnostic in Canada, Europe and other jurisdictions next year.
14:50 EDTMRKMerck confirms FDA approval of Keytruda
Merck announced that the FDA has approved Keytruda monotherapy, the company's anti-PD-1 therapy, at a dose of 2 mg/kg every three weeks, for the treatment of patients with metastatic non-small cell lung cancer whose tumors express PD-L1 as determined by an FDA-approved test and who have disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Keytruda. Under FDA's accelerated approval regulations, this indication for Keytruda is approved based on tumor response rate and durability of response. An improvement in survival or disease-related symptoms has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
13:51 EDTMRKFDA approves Merck's Keytruda for advanced non-small cell lung cancer
The U.S. Food and Drug Administration granted accelerated approval for Keytruda to treat patients with advanced non-small cell lung cancer whose disease has progressed after other treatments and with tumors that express a protein called PD-L1. Keytruda is approved for use with a companion diagnostic, the PD-L1 IHC 22C3 pharmDx test, the first test designed to detect PD-L1 expression in non-small cell lung tumors. In 2014, Keytruda was approved to treat patients with advanced melanoma following treatment with ipilimumab, a type of immunotherapy. Keytruda is marketed by Merck and the PD-L1 IHC 22C3 pharmDx diagnostic test is marketed by Dako North America.
13:43 EDTMRKFDA approves Merck lung cancer treatment Keytruda
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October 1, 2015
08:06 EDTMRKMerck, DNAtrix announce Phase 2 immuno-oncology collaboration
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07:23 EDTMRKNewLink Genetics awarded $18M contract option from BARDA
NewLink Genetics Corporation (NLNK) announced today that the Biomedical Advanced Research and Development Authority, or BARDA, of the United States Department of Health and Human Services, or HHS, has exercised an $18M option on NewLink Genetics' existing contract to support the scale-up of the manufacturing process relating to its investigational rVSV-ZEBOV GP vaccine candidate. BARDA made an initial $30M contract award to NewLink in late 2014 and is now providing additional funding to continue development of the Ebola vaccine candidate. Merck (MRK) has the license for research, development, manufacturing and commercialization of the rVSV-ZEBOV GP vaccine.
07:23 EDTMRKNewLink Genetics awarded $18M contract option from BARDA
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05:18 EDTMRKBioMarin to host a conference call
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