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News Breaks
May 14, 2014
08:03 EDTMRKMerck announces presentation of MK-3475 new data
Merck announced that new data for the company’s investigational anti-PD-1 antibody, MK-3475, in advanced melanoma, non-small cell lung cancer, and head and neck cancer, are scheduled to be presented on May 30 – June 3. The first presentation of data for MK-3475 as initial treatment in advanced NSCLC, where chemotherapy is currently the standard of care, and for the treatment of advanced head and neck cancer will be part of oral sessions at ASCO 2014. The broad MK-3475 dataset to be highlighted across multiple tumors and lines of therapy comprises 16 abstracts, with half being oral presentations or poster discussions. On May 6, Merck announced that the Biologics License Application for MK-3475 has been accepted for priority review by the U.S. Food and Drug Administration fpr the treatment of patients with advanced melanoma previously-treated with ipilimumab, the PDUFA date is October 28. The company also announced plans to file a Marketing Authorization Application for MK-3475 for advanced melanoma in Europe by the end of FY14.
News For MRK From The Last 14 Days
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May 22, 2015
10:52 EDTMRKJPMorgan says Actavis shares cheap compared to peers
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07:22 EDTMRKMerck receives positive CHMP opinion for Pembrolizumab in advanced melanoma
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07:15 EDTMRKMerck receives positive CHMP opinion for KEYTRUDA in advanced melanoma
Merck announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency has adopted a positive opinion recommending approval of KEYTRUDA, the company’s anti-PD-1 therapy, for the treatment of advanced melanoma, as both first-line therapy and in previously treated patients. The CHMP positive opinion for KEYTRUDA, which is based on data in more than 1,500 adult patients with advanced melanoma, will now be reviewed by the European Commission for central marketing authorization in the European Union.
May 19, 2015
07:28 EDTMRKUBS to hold a conference
Global Healthcare Conference is being held in New York on May 18-20 with webcasted company presentations to begin on May 19 at 8 am; not all company presentations may be webcasted. Webcast Link
06:55 EDTMRKGenocea could be takeover target after data, says Piper Jaffray
Piper Jaffray analyst Edward Tenthoff expects Genocea Biosciences (GNCA) will report positive Phase II GEN-003 post-immunization results late in Q2. GEN-003 is a therapeutic vaccine for genital herpes targeting Herpes Simplex Virus Type 2. Positive GEN-003 data could position Genocea as a potential acquisition target by a larger vaccine player, Tenthoff tells investors today in a research note. Large vaccine makers include Sanofi (SNY), Merck (MRK), GlaxoSmithKline (GSK), Pfizer (PFE) and Novartis (NVS). The analyst reiterates an Overweight rating on Genocea with a $14 price target. Shares of the clinical-stage vaccine developer with a $227M market capitalization closed yesterday up 83c to $10.22.
May 14, 2015
09:22 EDTMRKLeerink pharma/biotech analysts hold an analyst/industry conference call
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May 13, 2015
18:33 EDTMRKMerck to present new Keytruda data on 10 types of cancer at 2015 ASCO meeting
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13:12 EDTMRKSen. Sanders urges VA to break patents on Gilead hepatitis C drugs
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May 12, 2015
13:13 EDTMRKExpert says Norway biosimilar case an 'outlier,' CT Financial News reports
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06:09 EDTMRKThreshold announces Merck receives FDA Fast Track designation for evofosfamide
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