Trius Skin-infection Tx Meets Ph3 Study Goals - Dec. 19, 2011

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Monday, December 19, 2011  |   |   |   |  Equipment Donations: Free eBook Have you considered donating your surplus laboratory equipment? The scientific community thrives on the open exchange of ideas and information. This eBook will help you design and run a successful equipment donation program. You will learn the best practices that have enabled leading organizations to create successful equipment donation programs that allow them to do well, while doing good. For more information, please visit: www.EquipNet.com/HowToDonate •  Trius Therapeutics (TSRX) Skin-infection Tx Meets Ph3 Study Goals More... •  Alkermes plc (ALKS) Initiates Phase 3 Clinical Study of ALKS 9070 for Treatment of Schizophrenia More... •  Ardea Biosciences, Inc. Initiates Phase 3 Clinical Development Program for Lesinurad More... •  Amicus Therapeutics, Inc. (FOLD) Completes Enrollment of 67 Patients in Phase 3 Study of Migalastat HCl for Fabry Disease More... •  Pacira Pharmaceuticals, Inc. Announces Results from EXPAREL(TM) Pivotal Trial Published in Diseases of the Colon & Rectum More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News •  Bayer HealthCare (BAY)'s Xarelto® (rivaroxaban) Becomes First Fixed Dose Once-Daily Anticoagulant Tablet Approved in the UK for Stroke Prevention in Non-valvular Atrial Fibrillation; and the First Single Drug Regimen for Deep Vein Thrombosis More... More Drug Approval 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! •  Cholesterol-Lowering Drugs May Reduce Mortality for Influenza Patients, Vanderbilt University Medical Center Study More... •  Wayne State University Study Finds Soybean Compounds Enhances Effects of Cancer Radiotherapy More... •  Stuttering Starts in the Brain, University of Illinois Study More... •  Low Iron Levels in Blood Raises Blood Clot Risk, Imperial College London Study More... •  Sun "Stops Chickenpox Spreading," University of London Study 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. Optimizing Clinical Trials Through IT • Examine the trends shaping clinical trials. • Learn how social media are being used in patient recruitment. • Analyse the potential of electronic health record data in clinical development. Click Here for More Information. • Biotech Bay (South San Francisco, CA) Crescendo Bioscience Senior Clinical Research Associate Will monitor progress and activities of clinical studies and sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. The CRA will be responsible for multiple projects and must work both independently and in a team environment. • BioCapital (Rockville, Maryland) Otsuka America Pharmaceutical, Inc. Manager Clinical Development TB Will provide leadership and management for the microbiology procedures for the TB program and ensure quality of the endpoint assessment at global trial sites. S/he will ensure cross-study consistency in protocol design, data analysis, and reporting. • Genetown (Cambridge, Massachusetts) Cubist Pharmaceuticals, Inc. In House Clinical Research Associate Managing clinical study documentation (e.g. documentation for study start-up and IRB submission) and Trial Master File component. Knowledge of the processes involved in clinical studies following Good Clinical Practice (GCP) and the Code of Federal Regulations is required. • 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. • 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 •  Pharmacyclics, Inc. (PCYC) Receives Issue Notice of Significant Bruton's Tyrosine Kinase (BTK) Patent More... More Patent News •  AstraZeneca PLC (AZN)'s Brilique is First Drug to Gain Post-AMNOG Decision in Germany More... •  GlaxoSmithKline (GSK), Pfizer Inc. (PFE) Extend Cut-price Pneumonia Vaccine Deal More... •  Mylan Inc. (MYL) Launches Generic Version of Toprol-XL(R) Tablets More... More Drug Product News Hot Company SGS Life Science Services 201 Route 17 North Rutherford, New Jersey 07070 U.S.A. Phone: 201-508-3000 SGS Life Science Services is a leading contract service organization providing clinical research, analytical development, biologics characterization, and quality control testing. SGS serves various life science companies, including pharmaceutical, biopharmaceutical, biotechnology, and medical-device manufacturers. 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. Community. • ClinicaSpace is a registered trademark of BioSpace, Inc. • Please distribute this e-cast freely. • Credit any excerpts as follows: Copyright 2011 ClinicaSpace http://www.clinicaspace.com • While BioSpace and its agents used their best efforts in collecting and preparing the information published herein, we do not assume, and hereby disclaim, any liability for any loss or damage caused by errors or omissions, whether such errors or omissions resulted from negligence, accident or other causes. If someone forwarded this news to you and you'd like to receive your own copy FREE of charge, simply Subscribe here. Safely unsubscribe from ClinicaSpace.com e-mail at any time by managing your account here.