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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

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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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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.

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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.

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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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