Roche Drug Rejected by NICE Triples Survival Time - July 25, 2011

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Monday, July 25, 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 at www.pharm-olam.com, info@pharm-olam.com, USA +1-713-559-7900, UK +44-0-1344-891121. •  Roche (RHHBY) Drug Rejected by National Institute for Clinical Excellence (NICE) Triples Survival Time More... •  Raptor Pharmaceutical Inc. (RPTP) Cystinosis Drug Meets Late-Stage Trial Goal More... •  Bayer AG (BAY.F)'s Xarelto Blood Thinner Matched Warfarin in Japanese Safety Study More... •  BioDelivery Sciences International (BDSI) Announces Completion of BEMA Buprenorphine Phase 3 Chronic Pain Study More... •  The Lancet Publishes Clinical Trial Data That Demonstrate Statistically Significant and Dose-Dependent Expression of Dystrophin in Duchenne Muscular Dystrophy Patients Treated With Lancet's Eteplirsen More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News •  Biogen Idec, Inc. (Massachusetts) (BIIB) Receives Conditional Approval in the European Union for FAMPYRA(R) to Improve Walking in Adults with Multiple Sclerosis More... •  Valeant Pharmaceuticals International (VRX) Announces Approval of Sublinox(R) in Canada More... •  Baxter International, Inc. (BAX) Announces FDA Approval of Subcutaneous Route of Administration for GAMMAGARD LIQUID for Patients with Primary Immunodeficiency More... •  Pharmalucence, Inc. Announces FDA Approval for Use of Sulfur Colloid Injection to Locate Lymph Nodes in Breast Cancer Patients More... More Drug Approval News •  FDA Rejects New Use for Johnson & Johnson (JNJ) Immune Disorder Drug More... More BLA/NDA/ANDA News More IND News More MAA News Lower R&D IT Support Costs with Improved Scientific Data Integration and Management. A must-read for IT departments in today's science-driven industries whose R&D departments are looking to them to meet demanding innovation schedules. Learn how can easily deploy a Scientific Informatics Platform that will dramatically improve R&D productivity, reduce R&D support costs through improved scientific data integration and management, and enable R&D to quickly access, analyze & report on data, regardless of location or format. Download Your Copy Now! •  Weight Has Strongest Influence on Breast Cancer Hormones in Post Menopausal Women, Oxford University Study More... •  ADHD Kids at Increased Risk When Crossing the Street, University of Alabama at Birmingham Study More... •  Childhood Pets Linked to Lower Allergy Risk, University of Melbourne Study More... •  Alnylam Pharmaceuticals (ALNY) and Massachusetts Institute of Technology (MIT) Collaborators Discover Novel "Core-Shell" Nanoparticles for Systemic Delivery of RNAi Therapeutics More... •  Adaptimmune Ltd. Announces Opening of Pilot Clinical Trial in Synovial Sarcoma More... More General Clinical Research News KELLOGG SCHOOL OF BUSINESS - NORTHWESTERN UNIVERSITY Sept 12-14, 2011 $3650 SCIENCE FOR MANAGERS, offered in association with Johns Hopkins Medical School is designed to provide executives and managers with a practical understanding of the scientific and development foundations in the life sciences. You will learn the science behind the industry and the breakthrough technologies so as to communicate and perform more effectively in this complex environment. Please click here for more information. Lower R&D IT Support Costs with Improved Scientific Data Integration and Management. A must-read for IT departments in today's science-driven industries whose R&D departments are looking to them to meet demanding innovation schedules. Learn how can easily deploy a Scientific Informatics Platform that will dramatically improve R&D productivity, reduce R&D support costs through improved scientific data integration and management, and enable R&D to quickly access, analyze & report on data, regardless of location or format. Download Your Copy Now! Advances in Drug-Diagnostic Co-Development • Understand the current regulatory environment for both diagnostics and drugs within the EU and the US and how these relate to their co-development. • Understand the biomarker discovery and validation process. • Using case studies discover how drugs and their companion diagnostics have already received approval in the US and EU. Click Here for More Information • Genetown (Cambridge, Massachusetts) Biogen Idec Associate Medical Director Fampridine Will lead the Global Medical Affairs Team activities associated with product life cycle management. The position is responsible for the support and execution of the Life Cycle Management plan as it pertains to Global Medical Affairs activities, etc. • Biotech Bay (San Francisco, California) Johnson & Johnson Family of Companies Senior Clinical Science Liaison- Oncology A field based role that provides scientific and research support to opinion leaders and other healthcare providers, supports the Clinical Research Program, and is involved in key internal scientific initiatives. • Biotech Beach (San Diego, California) Santarus Inc. Clinical Research Associate (Sr.) Assist in planning implementing, and managing clinical studies in accordance with FDA Regulations, Good Clinical Practices Guidelines (GCPs) and Santarus, Inc SOPs. Support Clinical Research project teams and provide backup for other activities and projects. Etc. • BioMidwest (Chicago, Illinois) Kforce Clinical Research Regional Clinical Research Associate The role is to collaborate in the identification and drive the selection of investigator sites with input from other cross-functional groups. Also monitors investigator sites in compliance with company SOPs, ICH/GCP and local laws so that site performance targets are achieved. Etc. • Southern Pharm (Memphis, Tennessee) St. Jude Children's Research Hospital Clinical Research Associate Performs data abstraction, collection, and entry to support clinical research. Prepares submission for all reportable events. Develops, maintains, and/or monitors case report forms. Etc. • 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 •  Watson Pharmaceuticals, Inc. (WPI) Confirms JALYN(TM) Patent Challenge More... More Patent News •  Ranbaxy Laboratories (RANBAXY.BO) Launches Letrozole Tablets on Day-1 in UK, Romania, France More... More Drug Product News Hot Company Human Genome Sciences, Inc. 14200 Shady Grove Road Rockville, Maryland 20850 U.S.A. Phone: 301-309-8504 Fax: 301-309-8512 Human Genome Sciences, Inc. is located in the Washington, DC metro area, and was founded in 1992 with the goal of creating a global biopharmaceutical company to discover, develop, manufacture, and market gene-based drugs to address unmet medical needs. 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, Suvarna Sheth, Matt Thwin, Maysa Darwish ClinicaSpace.com - Clinical Trials. Clinical Research. 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