Trophos ALS Drug Fails Ph3 Trial - Dec. 14, 2011

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Wednesday, December 14, 2011  |   |   |   |  Pharm-Olam International Acquires StatWorks, Inc. With Pharm-Olam's acquisition of StatWorks we have expanded our team Data Management and Biostatistics experts for functional outsourcing and full service clinical trials. Our comprehensive biometric services include: • Integration of randomization into EDC systems, eliminating IVRS costs, with added benefit of full inventory control over supplies • Adaptive, Sequential, and Bayesian design methods • CDISC, SDTM and ADaM datasets • SAS programming, eCRF design, and medical coding in MedDRA/WHO Drug • Streamlining and reconciling across SAE, CTMS, and study DB • Health Outcomes Research and Patient Reported Outcomes • Protocol development, sample size, and randomization Contact us for your resource planning atwww.pharm-olam.com, info@pharm-olam.com, USA 1-713-559-7900, UK 44-0-1344-891121. •  Trophos ALS Drug Fails Ph3 Trial More... •  Celgene International Sarl (CELG) Release: Phase III Study Evaluating REVLIMID® in Patients with High-Risk Smoldering Multiple Myeloma Presented at American Society of Hematology More... •  Amgen (AMGN) Presents Final Results from the Largest Phase 3 Open-Label Study Assessing the Safety and Efficacy of Nplate® (Romiplostim) More... •  Threshold Pharmaceuticals, Inc. (THLD) Announces Promising Phase 1 Clinical Trial Results in Patients With Advanced Leukemias More... •  Celgene International Sarl (CELG) Release: Final Phase II Data Evaluating REVLIMID® and Rituximab in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News •  VIVUS, Inc. (VVUS)' Experimental Diet Drug Keeps Weight Off for 2 Years More... •  Salix Pharmaceuticals, Ltd. (SLXP) Announces NDA Submission for Crofelemer for the Treatment of HIV-Associated Diarrhea More... •  ContraFect Corporation Completes Successful Pre-IND Meeting With FDA More... More BLA/NDA/ANDA News More IND News More MAA News Quantifying the Value of Pipeline Pilot, the Accelrys Scientific Enterprise Platform This white paper outlines the methodology, sources of value, and quantifiable results from bringing products to market faster, avoiding unproductive experiments, saving developer time, and more. Request Now! •  Merck & Co., Inc. (MRK) Chemists Use High-Tech Science to Combat Alzheimer's Disease Challenge More... •  Few Allergies in Unstressed Babies, Karolinska Institute Study More... •  Acupuncture Might Ease Chemotherapy Pain, Acupuncture in Medicine Reveals More... •  Most Common Causes, Risk Factors for Stillbirth, University of Utah Study More... •  Meta-analysis of Five Clinical Trials Including Columbia Laboratories, Inc. (CBRX)' PREGNANT Study Published in American Journal of Obstetrics and Gynecology More... More General Clinical Research News Eighth Annual PEGS the essential protein engineering summit April 30 - May 4, 2012 | Boston, MA www.PEGSummit.com Cambridge Healthtech Institute is proud to present the Eighth Annual PEGS, protein engineering summit. This comprehensive event encompasses 12 tracks, 15 short courses, and a pre-conference partnering forum for showcasing early stage companies. Topics span from early stage discovery of new methods for protein expression and antibody engineering, to improved analytical techniques, and clinical results in the most promising areas of biotechnology. There is tremendous momentum and investment in biologics, and the PEGS conference offers an unparalleled view of the field. Make plans to join us this April in Boston. Please click here for more information. Innovative Clinical Trial Design and Management • Use detailed case studies of recent adaptive trials featuring companies including Merck, Pfizer, Novartis, GSK, Eli Lilly, and AstraZeneca. • Measure the potential cost savings offered by the reduced development times and improved decision-making associated with adaptive trials. • Assess the logistics of adaptive trial implementations. Click Here for More Information. • Biotech Beach (Irvine, California) Allergan Inc. Clinical Study Manager Will ensure that clinical strategies are translated into operational plans and executed in line with clinical development plans. In particular they will align operational execution activities with agreed upon project priorities, timings and quality specifications and adhere to all relevant regulations including GCP, ICH and PhRMA guidelines, Regulatory requirements, and Allergan's SOPs and policies. • BioForest (Bothell, Washington) Seattle Genetics, Inc. Clinical Data Associate II/ Senior Clinical Data Associate Responsible for all aspects of the data management process throughout a clinical trial. Specific responsibilities will include: creating a Data Management Plan, designing online Case Report Forms for an EDC data management system, defining the edit checks required per study, coordinate medical coding, SAE reconciliation, and identifying and resolving data discrepancies. • Pharm Country (Bridgewater, New Jersey) Sanofi Senior Clinical Trial Manager Responsible for the overall operational planning and activities for the implementation and conduct of clinical exploratory pharmacology clinical trials in compliance with ICH, GCP's, SOPs, local requirements, internal/departmental guidelines, and established timelines. • Biotech Bay (Sunnyvale, California) Pharmacyclics, Inc. Clinical Trial Assistant Ensure studies are completed, on time, within budget and in compliance with SOPs, FDA regulations and ICH/GCP guidelines. Set up CTMS system, as appropriate. Assist in preparation of documents including regulatory document templates, study binders, study communications and presentations. • Genetown (Cambridge, Massachusetts) Millennium: The Takeda Oncology Company Global Medical Affairs (GMA) Clinical Research Manager I Lead provides oversight and management of Investigator Initiated Studies (IIS) for one or more molecule (s), either in development or post approval, within the IIS Program. The IIS Program includes studies submitted from US academic institutions, NCI CTEP/COOP, and Ex-US Investigators and/or COOPs. • Get Noticed! Add your resume to the BioSpace Career Center! • See more than 5,000 job postings in the BioSpace Career Center! BioSpace Life Science Career Fairs are the biotech industry's premier career events. Featuring well-respected employers from around the nation, our job fairs attract top candidates in the biotech, pharmaceutical, life science and medical device industries. With such a great number of recruiters and hiring managers from top biotech companies attending our career fairs, there are an abundance of opportunities available for job seekers. Many different disciplines within the industry are represented bringing a diversity of candidates to our job fairs. Companies seeking pharmaceutical sales representatives and marketing jobs regularly attend our job fairs. Engineering and technical jobs can be found, as well as regulatory jobs and positions in QA/QC. Individuals desiring a science job or a research job will find many opportunities at our job fairs. In addition, hiring managers seeking candidates for clinical research jobs also attend our events. More information about BioSpace's Career Fairs BioSpace White Paper Biotech Career Fairs For Job Seekers 101: Control Your Experience By June Salvati, BioSpace Director of Events and Corporate Services •  Kythera Biopharmaceuticals Receives Notice of Allowance for Additional U.S. Patent on ATX-101 (Formulations of Deoxycholic Acid and Salts) More... •  Immunomedics, Inc. (IMMU) Awarded New Patent for Improved Cell Lines for Protein Therapeutic Manufacturing More... •  Coronado Biosciences is Granted First Patent for CNDO-10 More... •  SRU Biosystems, Inc. Settles Patent Infringement Lawsuit with Resonant Biotechnologies, LLC More... More Patent News Hot Company Coldstream Laboratories Inc. 1500 Bull Lea Road, Suite 250 Lexington, Kentucky 40511 U.S.A. Phone: 859-257-6600 Fax: 859-323-5985 At Coldstream Laboratories Inc. (CLI), we're seasoned at turning pharmaceutical development ideas into safe, pure, and effective clinical pharmaceutical dosage forms. Since 1986, we have completed more than 200 formulation development projects that led to clinical trials providing us extensive clinical manufacturing experience with both commercial product development and grant-funded projects from such sources as the National Institutes of Health. More Company Profiles Post Your: News | Jobs | Company Profile | Event | Advertising / Sponsorship ClinicaSpace 6465 South Greenwood Plaza, Suite 400 Centennial, Colorado 80111 U.S.A. Phone: 877-277-7585 Fax: 800-595-2929 ClinicaSpace 90 New Montgomery Street, Suite 414 San Francisco, California 94105 U.S.A. Phone: 877-277-7585 Fax: 415-576-9217 Send questions and comments to the ClinicaSpace News Beat Team. Editor & Publisher: Rosemary Do Editorial & Production Staff: Lana Ho, Maysa Darwish, Tammy Liu, Michelle Wong ClinicaSpace.com - Clinical Trials. Clinical Research. 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