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FDA Accepts Supplemental Biologics License Application, Assigns Priority Review and Grants Breakthrough Therapy Designation to Mercks KEYTRUDA (pembrolizumab) for First-Line Treatment of Patients with Advanced Non-Small Cell Lung Cancer
2016-09-07 12:45:00| Merck.com - Product News
Dateline City: KENILWORTH, N.J. Merck Has Also Submitted a Marketing Authorization Application to the European Medicines Agency for KEYTRUDA in the Same Patient Population Submissions Based on Data from KEYNOTE-024 Trial Showing Superior Progression-Free and Overall Survival Compared to Chemotherapy in Patients Whose Tumors Express High Levels of PD-L1 KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for KEYTRUDA (pembrolizumab), the companys anti-PD-1 therapy, for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors express PD-L1, with a PDUFA, or target action, date of Dec. 24, 2016. Language: English Contact: MerckMedia:Pamela Eisele, 267-305-3558orCourtney Ronaldo, 908-236-1108orInvestors:Teri Loxam, 908-740-1986orAmy Klug, 908-740-1898 Ticker Slug: Ticker: MRK Exchange: NYSE read more
Tags: advanced
review
application
license
Bayer enters advanced negotiations with Monsanto over proposed acquisition
2016-09-07 01:00:00| Food Processing Technology
German pharmaceutical company Bayer has confirmed advanced negotiations with American multinational agrochemical and agricultural biotechnology firm Monsanto over the proposed $62bn acquisition.
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proposed
acquisition
negotiations
Robotic finishing sprayers offer advanced features
2016-09-07 00:45:22| Canadian Plastics Headlines
A range of robotic finishing sprayers are available from Exel North America, offering reliability, flexibility, increased productivity and more. The post Robotic finishing sprayers offer advanced features appeared first on Canadian Plastics.
Tags: advanced
features
offer
finishing
Brent Shows of Advanced Disposal Helps Improve Budgeting, Safety and Waste Diversion
2016-09-06 20:48:00| Waste Age
Waste360 recently spoke with Shows about his current role at Advanced Disposal, what the company is focusing on for the year and what he thinks is the biggest challenge in the industry right now.
Tags: advanced
shows
improve
safety
Estée Lauder Expands Advanced Night Repair Line
2016-09-06 08:59:00| Happi Breaking News
Adds Recovery Ampoules to the anti-aging arsenal.
Tags: advanced
line
night
este
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