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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

 

Gore-Tex fabric made under license for first time in Taiwan

2016-09-06 12:35:00| Daily apparel & textile news and comment - from just-style.com

Outdoor materials specialist WL Gore & Associates is outsourcing production of its Gore-Tex fabric for the first time, as part of an extended agreement with Taiwan's Formosa Taffeta Company.

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LORD to Divest and License Coatings to SOCOMORE

2016-09-01 15:00:00| Coatings World Breaking News

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Duke Energy secures operating license for Keowee-Toxaway Hydroelectric project in US

2016-08-18 01:00:00| Power Technology

Duke Energy has secured a 30-year operating license from the US Federal Energy Regulatory Commission (FERC) for Keowee-Toxaway Hydroelectric project.

Tags: us project license energy

 

Johnson Matthey and 3M complete NMC patent license agreement for automotive Li-ion batteries

2016-08-08 15:55:57| Green Car Congress

Tags: complete agreement license automotive

 

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