BioLineRx Announces In-licensing of Novel Treatment for Liver Failure Conditions Under Strategic Collaboration

TEL AVIV, Israel, September 23, 2016 -- BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, announced today that it has signed an exclusive, worldwide agreement with BGN Technologies, the Technology Transfer Company of Ben-Gurion University, and Hadasit, the Technology Transfer Company of Hadassah Medical Organization, for the in-licensing of a novel treatment for various liver failure conditions such as end-stage liver disease (ESLD) and for conditions potentially leading to liver failure such as non-alcoholic steatohepatitis (NASH). This novel treatment, to be named BL-1220, is the second project in-licensed under the framework of the Company's strategic collaboration with Novartis Pharma AG for the screening and development of novel drug candidates.  
Published: 23 September 2016
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Anavex Life Sciences’ Drug Shows Efficacy to Support Potential Disease Modification in Parkinson’s Disease

NEW YORK, Sept. 22, 2016 -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (AVXL) today presented preclinical data demonstrating that ANAVEX 2-73, a sigma-1 receptor agonist, restores function in a classic animal model of Parkinson’s disease. Significant improvements were seen on all measures: behavioral, histopathological, and neuroinflammatory endpoints.
 
Veronica Francardo, PhD, and Angela Cenci, PhD, main authors of the study at Lund University, Sweden, commented: “We are in the fortunate situation that safety and tolerability of this compound have already been proven in human subjects, and that preliminary indications of a cognitive benefit have been obtained in a Phase 2a clinical trial for Alzheimer’s disease.”
Published: 22 September 2016
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Puma Biotechnology Announces U.S. FDA Acceptance of New Drug Application for PB272 (Neratinib) for Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer

Puma Biotechnology, Inc. (PBYI), a biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for its lead product candidate PB272 (neratinib) for the extended adjuvant treatment of patients with early stage HER2-overexpressed/amplified breast cancer who have received prior adjuvant trastuzumab (Herceptin®)-based therapy.
 
“The FDA acceptance of our NDA is an important regulatory milestone,” said Alan H. Auerbach, Chief Executive Officer and President of Puma. “Although the use of trastuzumab in the adjuvant setting has led to a reduction in disease recurrence in patients with early stage HER2-positive breast cancer, there remains an unmet clinical need to further reduce the risk of recurrence and improve outcome following trastuzumab therapy. We believe that neratinib may be able to provide this type of improvement to further help patients with this disease. We look forward to working with the FDA during their review of this submission.”
Published: 20 September 2016
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Can-Fite Reports New Data on CF102's Liver Protective & Regenerative Properties Published in Scientific Journal

PETACH TIKVA, Israel, Sept. 20, 2016  -- Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs being developed to treat inflammatory diseases, cancer and sexual dysfunction, today announced the peer reviewed scientific journal Molecular Medicine Report has published an article titled, "A3 adenosine receptor agonist, CF102, protects against hepatic ischemia/reperfusion injury following partial hepatectomy." The article reports the results of preclinical studies conducted by Can-Fite, showing the Company's liver cancer drug candidate CF102 protects the liver from ischemia/reperfusion injury and regenerates liver cells following partial hepatectomy.
 
Liver surgery, liver transplantation, and toxic liver conditions such as non-alcoholic steatohepatitis (NASH) can lead to injury of the liver characterized by inflammatory conditions and liver cell death. The studies showed that CF102 protected the liver against ischemic reperfusion manifested by a statistically significant (p<0.05) reduction in key liver enzymes, SGOT and SGPT. In addition, in studies where partial liver hepatectomy was conducted, a 45% increase in the regeneration rate of the remaining liver was observed after CF102 treatment, compared to placebo which regenerated only by 24%.
Published: 20 September 2016
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Windtree Therapeutics Announces FDA Fast Track Designation for AEROSURF®

WARRINGTON, Pa., Sept. 19, 2016 -- Windtree Therapeutics, Inc. (WINT), a biotechnology company focused on developing aerosolized KL4 surfactant therapies for respiratory diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for AEROSURF® (lucinactant for inhalation) for the treatment of premature infants with respiratory distress syndrome (RDS). AEROSURF is a novel, investigational combination drug/device product that is being developed to deliver aerosolized KL4 surfactant to premature infants with RDS, potentially reducing the need for invasive endotracheal intubation and mechanical ventilation to administer surfactant therapy.
 
"This Fast Track designation for AEROSURF underscores the significant need to reduce the use of invasive intubation and mechanical ventilation, which are required to administer surfactant therapy, but may result in serious complications and increase the risk for other respiratory conditions," commented Craig Fraser, President and Chief Executive Officer. 
Published: 20 September 2016
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