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FDA Accepts Supplemental Biologics License Application (sBLA) for KEYTRUDA (pembrolizumab), Mercks Anti-PD-1 Therapy, for First-Line Treatment of Advanced Melanoma, and Grants Priority Review

2015-08-18 14:00:00| Merck.com - Product News

Dateline City: KENILWORTH, N.J. Merck Provides Additional Update: FDA Extends Action Date for Additional sBLA in Ipilimumab-Refractory Advanced Melanoma KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for KEYTRUDA (pembrolizumab), Mercks anti-PD-1 therapy. Merck is seeking approval for KEYTRUDA, at the currently approved dose of 2 mg/kg every three weeks, for the first-line treatment of unresectable or metastatic melanoma patients. Language: English Contact: MerckMedia:Pamela Eisele, 267-305-3558orInvestors:Justin Holko, 908-740-1879An Phan, 908-255-6325 Ticker Slug: Ticker: MRK Exchange: NYSE read more

Tags: advanced review application license

 

Airgas Announces Acquisition of Weldinghouse, Inc. and the Nitrogen Services Business of Priority Energy Services

2015-07-24 12:31:06| Industrial Newsroom - All News for Today

RADNOR, PA  Airgas, Inc. (NYSE: ARG), one of the nation's leading suppliers of industrial, medical, and specialty gases, and related products, today announced that it has recently acquired the assets and operations of Weldinghouse, Inc. and its affiliates, effective July 17, 2015, and Priority Energy Services, LLC...

Tags: services business energy priority

 
 

Climate change is a security threat. Make it a foreign policy priority

2015-07-11 16:00:00| Climate Ark Climate Change & Global Warming Newsfeed

Grist: In March of this year, researchers at U.C. Santa Barbara and Columbia published a paper linking climate change and extreme drought to the Syrian Civil War. It wasnt the first time that scientists and economists had connected the dots between climate and violent conflict. It wasnt even the first time that scientists had connected the dots between climate and conflict in Syria. For Syria, wrote the authors, a country marked by poor governance and unsustainable agricultural and environmental policies,...

Tags: policy make change security

 

MM-398 Receiving The Priority Review Designation By US FDA For New Drug Application And The Acceptance Of Market Authorization Application By EMA In Post-Gemcitabine Metastatic Pancreatic Cancer

2015-07-01 08:52:42| drugdiscoveryonline Home Page

PharmaEngine, Inc. (TWO: 4162) announced that (1) its license partner, Merrimack Pharmaceuticals, Inc. (NASDAQ: MACK), has received the notification from the US Food and Drug Administration (FDA) for the acceptance and the grant of the priority review designation for their New Drug Application (NDA); and (2) its sublicense partner, Baxalta Incorporated, a wholly owned subsidiary of Baxter International Inc. (NYSE: BAX) has received the acceptance of Market Authorization Application (MAA) from the European Medicines Agency (EMA), of MM-398 (irinotecan liposome injection, also known as "nal-IRI,") in the treatment of patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy

Tags: review market application drug

 

Sustainability in Drinks - Sugar: A Shared Priority

2015-06-23 15:36:00| Daily beverage news and comment - from just-drinks.com

Within the sustainable sourcing challenge for food and drinks producers, the focus on sugarcane is set to increase substantially over the coming years. Not only does sugarcane present daunting sustainability challenges, Ben Cooper writes, but as a key ingredient shared by two of the major beverage sectors it could present opportunities for collective industry engagement.

Tags: shared priority sugar drinks

 

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