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...
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...
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...
WINSTON-SALEM, N.C. -- Targacept, Inc. (NASDAQ: TRGT), a clinical-stage biopharmaceutical company developing a new class of drugs known as NNR Therapeutics TM, today announced the initiation of a Phase 2 clinical trial of AZD3480 (TC-1734) in adults with Attention Deficit/Hyperactivity Disorder, or ADHD.
SANTA ROSA, Calif. -- Medtronic, Inc. (NYSE:MDT) today announced that enrollment has begun in its ENDEAVOR IV Clinical Trial, the final phase of its ENDEAVOR Clinical Program to be used in support of U.S. Pre-Market Approval PMA approval. The first patient implant in the trial was performed yesterday by Charles...
EMERYVILLE, Calif. & BERKELEY, Calif. -- Chiron Corporation (Nasdaq:CHIR) and XOMA Ltd. (Nasdaq:XOMA) today announced the initiation of a second clinical trial of CHIR-12.12, a novel, fully human, antagonist antibody that targets the CD40 antigen. The Phase I trial is for patients with multiple myeloma, a type of cancer that...
Ash Access Technology, Inc., a privately held specialty pharmaceutical and medical device company, announced that patient enrollment had been initiated this August for the pivotal clinical trial of its flagship antimicrobial / antithrombotic therapy, Zuragen TM. The clinical trial is a multi-centered study evaluating the efficacy and...
CARLSBAD, Calif.--BUSINESS WIRE--June 16, 1998--Cypros Pharmaceutical Corporation (AMEX:CYP) announced today that it has begun recruiting clinical trial sites and chosen a contract research organization to both conduct and manage the Company's first multi-center phase III clinical trial of its Cordox drug in treating the painful vaso-occlusive episode VOE of sickle...
SAN DIEGO -- Somaxon Pharmaceuticals, Inc., a specialty pharmaceutical company focused on in-licensing, developing and commercializing proprietary product candidates for the treatment of diseases and disorders in the fields of psychiatry and neurology, today announced that enrollment has begun in the second Phase III clinical trial of SILENORTM doxepin hydrochloride...
PALO ALTO, Calif. -- StemCells, Inc. (NASDAQ:STEM) today announced that the first patient to receive a transplant of HuCNS-SC([R]) cells purified human neural stem cells in the Company's Phase I clinical trial has completed the trial. The patient, who was transplanted in November 2006, has finished the twelve-month period of...
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