Transcept to Resubmit Rejected Sleep Drug to FDA - Sept. 15, 2011

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Thursday, September 15, 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 at www.pharm-olam.com, info@pharm-olam.com, USA 1-713-559-7900, UK 44-0-1344 891121 •  Transcept Pharmaceuticals, Inc. (TSPT) to Resubmit Rejected Sleep Drug to FDA More... •  Astellas Pharma Inc. (YPH.BE) and Theravance, Inc. (THRX) Announce European Marketing Authorization for VIBATIV(R) for Nosocomial Pneumonia Caused by MRSA More... •  VIVUS, Inc. (VVUS) Provides Regulatory Update on QNEXA More... More BLA/NDA/ANDA News More IND News More MAA News •  Soligenix (SNGX.OB) Stops Phase 3 orBec(R) Study; Stock Falls - 0.2120 (80.00%) @ 12:55AM EDT More... •  The New England Journal of Medicine Publishes Data from Vertex Pharmaceuticals (MA) (VRTX)'s Phase 3 ILLUMINATE Study of INCIVEK(TM) (telaprevir) in Hepatitis C More... •  Alexion Pharmaceuticals Inc. (ALXN)'s Phase 2 Study of Eculizumab (Soliris(R)) in Patients with Severe and Refractory Generalized Myasthenia Gravis Presented at MGFA Annual Meeting More... •  Cempra Pharmaceuticals, Inc. Announces Comparable Efficacy of Oral Solithromycin (CEM-101) Compared with Levofloxacin in Phase II Clinical Trial in Patients with Community-Acquired Bacterial Pneumonia (CABP) More... •  ChemoCentryx, Inc. Reports CCX140-B Meets Primary Endpoint and Demonstrates Clinical Efficacy in Phase II Study in Type 2 Diabetes More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News Drug Discovery & Development Drug Discovery & Development magazine delivers vital insight about the latest technologies and tools used to develop pharmaceutical products to key decision-makers Request Now! •  Breakthrough Opens New Avenues for Hep C Vaccine, University of New South Wales Study More... •  Feared Spinal X-Ray Found to Be Safe, Study Shows; Spinal Angiography Also Rules out Misdiagnosis of Inflammation, Transverse Myelitis, Johns Hopkins University School of Medicine Study More... •  Sickle Cell Trait is Not Risk Factor for Kidney Disease: Study Contradicts Earlier Findings, Wake Forest University Baptist Medical Center Study More... •  Longer Supply May Help Women Stick With the Pill, Tufts University School of Medicine and Baystate Medical Center Study More... •  Older Musicians Experience Less Age-Related Decline in Hearing Abilities Than Non-Musicians, Baycreast's Rotman Research Institute Study More... More General Clinical Research News Biomarker Applications for Improved Clinical Trial Outcomes November 15 - 16, 2011 Hilton Boston Back Bay - 40 Dalton Street The only personalized medicine conference allowing you to make biomarkers and diagnostics available during every stage of clinical research, to stratify patients, prove clinical validity, and streamline the regulatory approval and reimbursement process. Featuring up-to-date analysis of new FDA legislation regulations and a special spotlight from Blue Cross Blue Shield. Please click here for more information. The Future of R&D Outsourcing • Understand the driving forces behind R&D outsourcing. • Learn how R&D outsourcing will evolve over the next several years and why. • Assess your competitive position vis-a-vis other drug makers and learn about R&D outsourcing best practices via detailed case studies. Click Here for More Information. • Rocky Bio (Phoenix, Arizona) Cubist Pharmaceuticals, Inc. Clinical Business Manager - Phoenix West Responsible for achieving and maximizing territory and account sales goals through account management, high level clinical proficiency and effective selling. The CBM will be the primary point of contact for Cubist with key hospital influencers and decision makers across key functional areas including but not limited to physicians, pharmacists and formulary committee members. • Biotech Bay (South San Francisco, California) Cytokinetics, Inc. Manager, Clinical Data Management Provides leadership and coordinates the activities of data management staff at the CROs. Review, and comment on CRFs, annotated CRFs, EDC supporting materials, and edit checks documents. Interacts with Statisticians, Clinical Trial Project Managers, and other personnel to provide support in the areas of data management, data validation, Data base lock, and metrics report generation. • Genetown (Boston, Massachusetts) PAREXEL International Associate Director, Early Phase Clinical Data Services General responsibilities include supervision and management of CDS Project Leads and staff, ensuring the group is trained, mentored and developed. Provide oversight of the execution and productivity of quality CDS Project Lead activities, ensuring adherence to regulatory and PAREXEL standards. Provide input to continuous productivity improvement. Ensure proactive planning takes place and provide issue resolution for the Group. • BioMidwest (Chicago, Illinois) Takeda Pharmaceuticals Medical Director/Senior Medical Director, Clinical Science - Metabolic Leads the development of the all components of the integrated development strategy and the resultant tactical clinical plan and study designs to support the global development of and establish the conditions essential for determining the safety, efficacy, medical usefulness, and marketability of multiple compounds. • Biotech Beach (Westlake Village, California) Baxter International, Inc. Sr Clinical Data Analyst Responsible for leading clinical data management (CDM) operational activities in one or more therapeutic areas. Manage the creation, execution and maintenance of Data Management Plans in support of clinical study deliverables. Lead the design, creation and lifecycle management of data collection, validation and reporting specifications and usage guidelines. • Get Noticed! Add your resume to the BioSpace Career Center! • See more than 5,000 job postings in the BioSpace Career Center! Biotech Beach Career Fair Job seekers can spend a day with HR representatives and Hiring Managers from top biotech, pharma, medical device and diagnostics companies in the Southern California region. Candidates with a 4-year degree in the life sciences and a minimum of 2-years of industry related experience are invited to attend. (Equivalent work experience may be considered in lieu of a four-year college degree. PhD and Postdoc candidates welcome.) Exhibiting companies are recruiting for positions in areas such as: QA/QC, clinical research, engineering, manufacturing, biostatistics, clinical data management, chemistry, regulatory affairs, and research. Job seekers may register here. • Biotech Beach Career Fair, San Diego, CA September 22, 2011 • BioMidwest Career Fair, Chicago, IL October 4, 2011 • Pharm Country Career Fair, Bridgewater, NJ October 5, 2011 • Biotech Bay Career Fair, Burlingame, CA October 11, 2011 • Bio NC Career Fair, Durham, NC October 20, 2011 • BioCapital Beach Career Fair, Bethesda, MD November 1, 2011 • Genetown Career Fair, Cambridge, MA November 7, 2011 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 •  Actavis Launches Generic Keppra XR(R) Tablets in the U.S. More... More Drug Product News Hot Company Synteract, Inc. (San Diego) Global Headquarters 5759 Fleet Street, Suite 100 Carlsbad, California 92008 U.S.A. Phone: 760-268-8200 Fax: 760-929-1419 Established in 1995, Synteract is a full-service Contract Research Organization, dedicated to meeting the clinical development needs of the biotechnology, medical device, and pharmaceutical companies. We have earned a reputation for responsiveness and reliability - ask for references, our clients will attest to this! We have accomplished this by focusing on the unique needs of each client and tailoring our services to meet those needs, while maintaining the highest standards and meeting all requirements for superior quality. 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. 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