Oncolytics Biotech® Inc. Announces Receipt of Orphan Drug Designation from the U.S. FDA for Primary Peritoneal Cancer

CALGARY, March 3, 2015  - Oncolytics Biotech® Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY), a clinical-stage biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for its lead product candidate, REOLYSIN®, for the treatment of primary peritoneal cancers. The designation was granted on the basis of the Company's December 2014 application for an Orphan Drug Designation encompassing ovarian, fallopian tube and primary peritoneal cancers which are generally treated as one indication.  On February 11, 2015, the Company announced that it had received Orphan Drug Designation for ovarian cancer and for cancers of the fallopian tube on March 2, 2015.

Published: 03 March 2015
Written by Editor
Nasdaq   FDA HC Decision   Up on News  
Read more: Oncolytics Biotech Inc ( ONC / ONCY )

Oncolytics Biotech® Inc. Announces Receipt of Orphan Drug Designation from the U.S. FDA for Cancer of the Fallopian Tube

CALGARY, March 2, 2015- Oncolytics Biotech® Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY), a clinical-stage biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for its lead product candidate, REOLYSIN®, for the treatment of cancer of the fallopian tube. The designation was granted on the basis of the Company's December 2014 application for an Orphan Drug Designation encompassing ovarian, fallopian tube and primary peritoneal cancers which are generally treated as one indication.  On February 11, 2015, the Company announced that it had received Orphan Drug Designation for ovarian cancer.

Published: 02 March 2015
Written by Editor
TSX   Nasdaq   FDA HC Decision   Up on News  
Read more: Oncolytics Biotech Inc ( ONC / ONCY )

Athersys and Chugai Enter License Agreement and Collaboration to Develop MultiStem(R) Cell Therapy for Ischemic Stroke in Japan

Regenerative Medicine Partnership Focused on Development of Novel Stem Cell Therapy

CLEVELAND and TOKYO, March 2, 2015 -- Athersys, Inc. (ATHX) and Chugai Pharmaceutical Co., Ltd. (Tokyo Stock Exchange:4519) have announced a partnership and license agreement to exclusively develop and commercialize MultiStem(R) cell therapy for ischemic stroke in Japan. Ischemic stroke represents a priority disease area in Japan, given the high healthcare burden of the condition and the expected increase in incidence associated with Japan's aging population.

Athersys' proprietary cell therapy product, MultiStem, is currently being evaluated in a Phase 2 clinical study for ischemic stroke in the United States and Europe, and Athersys has begun preparations for clinical development in Japan, including engagement with the Japanese Health Authority. Chugai is a leading research-based pharmaceutical company with strengths in biotechnology products, and brings to the collaboration substantial expertise and experience in late-stage development and commercialization in Japan.

Published: 02 March 2015
Written by Editor
Nasdaq   Up on News   Project Update  
Read more: Athersys Inc ( ATHX )

Ohr Pharmaceutical Announces Additional Positive Anatomic Data From the OHR-102 IMPACT Study Interim Analysis Presented at Annual Macula Society Meeting

Rapid Resolution in SHRM Correlates With Early Improvements in Visual Acuity Observed in Phase II IMPACT Study in Wet AMD
NEW YORK, March 2, 2015  -- Ohr Pharmaceutical, Inc. (OHRP), an ophthalmology research and development company, today announced the presentation of new data from the IMPACT study interim analysis at the 38th Annual Macula Society Meeting which took place February 25-28th, in Scottsdale, Arizona. The new data show an early regression of subretinal hyper-reflective material (SHRM), an anatomic biomarker for the wet form of age-related macular degeneration (wet-AMD), which is consistent with the early gains in visual acuity previously reported from this study. The data were presented by Jason S. Slakter, MD, Chief Medical Officer at Ohr and Clinical Professor of Ophthalmology, NYU School of Medicine.

Published: 02 March 2015
Written by Editor
Nasdaq   Up on News   Project Update  
Read more: Ohr Pharmaceutical Inc ( OHRP )

Taglich Brothers Initiates Coverage on Apricus Biosciences, Inc.

NEW YORK, NY--(Marketwired - Feb 23, 2015) - Taglich Brothers, Inc. announces it initiated coverage of Apricus Biosciences, Inc.

Apricus Biosciences, Inc., (NASDAQ: APRI) headquartered in San Diego, California, manufactures a treatment for erectile dysfunction and is developing pharmaceuticals to treat urological and rheumatoid disorders, and women's sexual disorders. The company's lead product, Vitaros, is a topical treatment for erectile dysfunction (ED), delivery of which is based on a proprietary permeation enhancer technology (NexACT®) which facilitates the delivery of the drug into the blood stream.

Vitaros is aimed at patients who have not responded satisfactorily to oral ED medications and prefer a treatment that is less invasive or easier to use than other alternatives. Vitaros is cleared for marketing in a number of European countries and in Canada.

Published: 24 February 2015
Written by Editor
Up on News   opinion  
Read more: Apricus Biosciences Inc ( APRI )
  1. Celldex Therapeutics Inc ( CLDX )
  2. Rigel Pharmaceuticals Inc ( RIGL )
  3. Oncolytics Biotech Inc ( ONC / ONCY )
  4. Capnia Inc ( CAPN )
  5. Oncolytics Biotech Inc ( ONC / ONCY )