Bristol-Myers' Melanoma Combo Opdivo/Yervoy Gets FDA Nod Print E-mail
By Zacks Equity Research   
Friday, 02 October 2015 19:45
Bristol-Myers Squibb Company BMY announced that the combination of two of its immuno-oncology drugs, Opdivo and Yervoy, has been cleared by the FDA for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma.
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U.S. FDA Approves Bayer's Electronic Autoinjector for MS Therapy Print E-mail
By Natalie Grover, Pharmacy Learning Network   
Monday, 28 September 2015 23:01
The first electronic automatic injector to deliver a drug for the most common form of multiple sclerosis received approval from the U.S. Food and Drug Administration on Friday.
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AAA Announces Positive Results from Phase 3 Study NETTER-1 Evaluating Lutathera in Patients with Advanced Midgut Neuroendocrine Tumors Print E-mail
By Staff and Wire Reports   
Monday, 28 September 2015 12:36
Advanced Accelerator Applications S.A., an international specialist in Molecular Nuclear Medicine (MNM), announced today that the pivotal Phase 3 NETTER-1 study for Lutathera (177Lu-DOTATATE) met its primary endpoint of assessing progression-free survival (PFS), demonstrating that Lutathera significantly improved PFS when compared with Sandostatin LAR 60mg (Octreotide LAR) in patients with advanced midgut neuroendocrine tumors (NETs).
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U.S. Stocks Ring Up Weekly Loss; Biotech Sector Routed Print E-mail
By Mark DeCambre - MarketWatch's Markets Editor   
Saturday, 26 September 2015 20:40
U.S. stocks ended the week with a whimper, turning big opening gains in the S&P 500 and Nasdaq Composite into losses by the conclusion of Friday’s session.    
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FDA approves Novo Nordisk's long-awaited diabetes drug Print E-mail
By Staff and Wire Reports   
Saturday, 26 September 2015 10:42
The U.S. Food and Drug Administration on Friday approved Danish drugmaker Novo Nordisk's diabetes drug Tresiba, two years after rejecting the long-acting form of insulin.
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Advaxis’ Cervical Cancer Treatment Trial Shows Progress in Survival Rate Print E-mail
By FDAnews Drug Daily Bulletin   
Saturday, 26 September 2015 00:57
A trial of a cervical cancer treatment by New Jersey biotech company Advaxis demonstrated it could extend life further than existing treatments in women with persistent, advanced forms of the disease.
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Oramed Patent Allowed in the US for Oral Administration of Proteins Print E-mail
By Staff and Wire Reports   
Thursday, 24 September 2015 10:04
Oramed Pharmaceuticals Inc., a developer of oral drug delivery systems, announced today that the Company's patent for its invention, titled "Methods and Compositions for Oral Administrations of Proteins" has been allowed by the United States Patent and Trademark Office.  
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Q&A with LabStyle Innovations Exec VP, Todd Durniak Print E-mail
By Staff and Wire Reports   
Thursday, 24 September 2015 05:01
icon_Q&AexclusiveRecently, LabStyle Innovations Corp. (OTCQB: DRIO), developer of the Dario™ Diabetes Management Solution, announced it had closed a round of funding totaling approximately $2.5 million. According to management, the monies will be used to support the global rollout and initial U.S. commercial launch of their flagship product Dario™ for working capital purposes.
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Scientists May Have Finally Discovered a Cure for Blindness Print E-mail
By Trace William Cowen -   
Tuesday, 22 September 2015 18:49
When Wayne State University researcher Dr. Zhou-Hua Pan placed a light-sensitive green algae protein into blind mice in 2006, he was amazed to find that it restored the subjects' vision almost immediately.
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Pluristem and NIAID Met With U.S. FDA and Agreed on Development Plan for Initiation of Pivotal Study of PLX-R18 in the Treatment of Acute Radiation Syndrome Print E-mail
By Staff and Wire Reports   
Monday, 21 September 2015 11:02
Pluristem Therapeutics Inc. (PSTI.TA) (PSTI.TA), a leading developer of placenta-based cell therapy products, announced today that Pluristem and the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health (NIH), completed a successful meeting with the U.S. Food and Drug Administration (FDA) regarding the development program for PLX-R18 cells in the treatment of Acute Radiation Syndrome (ARS).
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