News Breaks |
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| January 7, 2013 |
| 08:04 EDT |  | MRK | Merck announces FDA acceptance of resubmission of NDA for Sugammadex
Merck announced that the resubmission of the New Drug Application for sugammadex sodium injection has been accepted for review by the U.S. Food and Drug Administration. Merck expects the FDA’s review to be completed in the first half of 2013. In 2008, the FDA did not approve the original NDA for sugammadex sodium injection, requesting additional data related to hypersensitivity reactions and coagulation events. Merck submitted this requested data within the NDA resubmission, which the FDA has now deemed complete for review. |
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News For MRK From The Last 14 Days Check below for free stories on MRK the last two weeks. |
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| May 20, 2013 |
| 07:32 EDT |  | MRK | Society for Information Display / IHS to host a conference
Display Week 2013 is being held in Vancouver, British Columbia on May 19-24. |
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| May 16, 2013 |
| 08:55 EDT | | MRK | BofA/Merrill's pharmaceuticals analysts hold analyst/industry conference call
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| May 14, 2013 |
| 17:39 EDT | | MRK | Moody's lowers Merck's guaranteed debt to A1 from Aa3; stable outlook
Moody's Investors Service lowered the long-term ratings of Merck by one notch, including the guaranteed senior unsecured rating to A1 from Aa3 and the non-guaranteed senior unsecured rating to A2 from A1. This action concludes a review for downgrade initiated on May 1, 2013. At the same time, Moody's affirmed Merck's Prime-1 commercial paper rating. The rating outlook is stable. |
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| May 10, 2013 |
| 11:48 EDT |  | MRK | Drugmakers to face pressure on U.S. prices, Reuters says
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| 06:53 EDT | | MRK | GlaxoSmithKline, Merck to discount cancer vaccine in poor nations, NY Times says
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| May 9, 2013 |
| 07:22 EDT | | MRK | Merck awarded significant portion of UNICEF HPV vaccine tender
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| May 8, 2013 |
| 08:32 EDT | | MRK | Merck says FDA accepts biologics license application for allergy tablet
Merck announced that the Biologics License Application for its investigational ragweed pollen sublingual allergy immunotherapy tablet has been accepted for review by the U.S. Food and Drug Administration. The BLA for Merck’s investigational ragweed pollen sublingual allergy immunotherapy tablet is supported by five studies evaluating the efficacy and safety of the tablet in adults, 18 years of age or older, with ragweed induced allergic rhinitis. On March 27, Merck announced that the FDA had also accepted the BLA for its investigational Timothy grass pollen sublingual allergy immunotherapy tablet. Merck expects the FDA’s review for both to be completed in the first half of 2014. |
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| May 6, 2013 |
| 08:53 EDT | | MRK | BofA/Merrill's major pharma analysts hold an analyst/industry conference call
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| 07:18 EDT | | MRK | American Congress of Obstetrics and Gynecology to hold annual meeting
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