The process of developing and testing a new drug is lengthy, risky and costly. With the 20-year patent clock ticking from the time the Investigational New Drug application IND is submitted, over half of the patent-protected life is consumed developing, testing and seeking FDA approval. The paper highlights the clinical...
DUBLIN, Ireland -- Research and Markets (http://www.researchandmarkets.com/reports/c90962) has announced the addition of the Frost & Sullivan report "U.S. Clinical Trial Management Systems Markets" to their offering. This research service provides an in-depth analysis of the U.S. clinical trial management systems market. The research service includes revenue forecasts, data management...
Business Editors FRANKLIN LAKES, N.J.--BUSINESS WIRE--Nov. 20, 2002 ReGen Biologics, Inc. (OTC: RGBI), today announced that all surgeries have been completed for the required enrollment in its U.S. clinical trial for the Collagen Meniscus Implant ("CMI"), the largest-ever U.S. based multicenter clinical trial involving the meniscus of the...
PISCATAWAY, N.J. -- The Clinical Trial Solution Suite Uses Microsoft Office Systems to Increase Accuracy, Version Control, Collaboration and Speed to Market in the Clinical Trial Process
CAMBRIDGE, Mass. -- Curis, Inc. (NASDAQ: CRIS), a therapeutic drug development company, today provided an update on a Phase I clinical trial for the treatment of basal cell carcinoma. This Phase I clinical trial is being conducted by Genentech (NYSE: DNA) and Curis, and is expected to be completed in...
ST. PAUL, Minn. -- St. Jude Medical, Inc. (NYSE:STJ) today announced the clinical trial results, receipt of European CE Mark approval and European market launch of its QuickOptTM Timing Cycle Optimization. The trial results were presented by James G. Porterfield, M.D., principal investigator in the trial conducted under a U.S....
NEW HOPE, Pa. -- Protalex, Inc. (OTCBB:PRTX) today announced the initiation of the Phase I clinical trial of its lead compound PRTX-100. This clinical trial is designed to assess the safety and tolerability of PRTX-100 in healthy volunteers as a step towards demonstrating efficacy in autoimmune diseases beginning in mid-2006.
Despite decades of congressionally-- backed questing, the single clinical trial that is a sufficient basis for new drug approval remains the exception rather than the rule at the FDA - and this isn't likely to change soon, according to FDA presenters at a Georgetown University Center for Drug Development Science...
ALAMEDA, California, March 24 /PRNewswire/ -- AngioScore, Inc., a developer of novel angioplasty tools for interventional cardiologists and radiologists, announced today the completion of the US clinical trial for it's flagship AngioSculpt Scoring Balloon Catheter in coronary lesions and the conclusion of...
MONTREAL, QUEBEC, Feb 2, 2006 CCNMatthews via COMTEX -- Ecopia BioSciences (TSX:EIA) announced today that it has received a No Objection Letter from the Therapeutics Products Directorate of Health Canada for the commencement of a Phase I clinical trial relating to the Company's anticancer agent, ECO-4601....
MONTREAL -- Ecopia BioSciences (TSX:EIA) announced today that it has received a No Objection Letter from the Therapeutics Products Directorate of Health Canada for the commencement of a Phase I clinical trial relating to the Company's anticancer agent, ECO-4601. Ecopia is proposing to conduct a Phase...
BOSTON -- GlycoGenesys, Inc., (NASDAQ: GLGS), a biotechnology company focused on carbohydrate-based drug development, announced a new indication, chronic lymphocytic leukemia CLL, for its cancer clinical trial program for GCS-100LE. The addition of CLL to its clinical trial program positions GlycoGenesys to pursue approval in two indications for unmet medical...
CAMBRIDGE, Mass.--BUSINESS WIRE--March 28, 1996--Alkermes, Inc. (Nasdaq: ALKS) today announced the initiation of a multi-center Phase II clinical trial of RMP-7Tm and the chemotherapeutic agent carboplatin administered intra-arterially in patients with recurrent, malignant brain tumors. The Phase II study is being initiated following the successful completion of a first...
LONDON -- Considerable opportunities exist for e-clinical trial solutions. However, pharmaceutical companies should be convinced about the need for these solutions and the benefits of investing in them, as the entire industry is in a cost-cutting phase. E-clinical technology vendors, with highly scalable and cost-effective services and solutions, are well...
- Stem cell therapy trial proceeds to next stage and opens in two new clinical centers - HACKENSACK, N.J. -- Amorcyte, Inc. Amorcyte, a privately funded biotechnology company developing cell therapy products to treat cardiovascular disease, announced today that its phase I clinical trial is now open in two...
