FDA Suspends Ipsen's Ph3 Hemophilia Drug Study - July 11, 2012

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Wednesday, July 11, 2012  |   |   |   |  Aptuit is a pharmaceutical services company that delivers early to mid-phase drug development solutions by applying scientific excellence, outstanding service and the industry's best team of people. For more information, visit: http://www.aptuit.com/headforscience/. •  FDA Suspends Ipsen (IPN.PA)'s Ph3 Hemophilia Drug Study More... •  Eli Lilly and Company (LLY) Schizophrenia Drug Fails Late-stage Trial More... •  Blow for BioInvent (BOVNF) as Vascular Treatment Fails More... •  Eisai Inc. (ESALF.PK)'s Halavan Misses Endpoints in Phase III Trial More... •  GlaxoSmithKline (GSK), Shionogi & Co., Ltd. Say HIV Drug Beats Gilead Sciences, Inc. (GILD) Atripla in Test More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News •  Links Medical Receives Both FDA & EU Market Clearance for Advance Wound Care Products With Medical-Grade Manuka Honey More... More Drug Approval News •  Hemispherx Biopharma (HEB) and the FDA Reach Agreement on Filing Requirements for the Company's Complete Response in Support of Ampligen® New Drug Application for Chronic Fatigue Syndrome Treatment More... More BLA/NDA/ANDA News More IND News More MAA News Cambridge Healthtech Institute is proud to announce the production of two sequencing conferences in one convenient location. Join us this summer (August 13-15) in Providence, Rhode Island for in-depth presentations, interactive discussion groups, short courses, and networking opportunities. Registration grants you access to both meetings, allowing you to create an agenda that best fits your research needs. Register today for CHI's Seventh Annual NGx: Applying Next-Generation Sequencing (www.healthtech.com/sqe) and the Fifth Annual Next-Generation Sequencing Data Analysis (www.healthtech.com/sda) conference. For more information and details, visit www.healthtech.com/sequencing. ADVANCE REGISTRATION DISCOUNTS EXPIRE JULY 13! •  3 Drinks a Week Found to Cut Arthritis Risk by Half, Karolinska Institute Study More... •  U.S. Patients Get More Cancer Drugs Access, But Pay for Privilege, Tufts Center for the Study of Drug Development Study More... •  Food in Smaller Pieces May Help Control Weight, Arizona State University Study More... •  Quitting Smoking Packs on More Pounds Than Thought, University of Paris Study More... •  Early-Life Exposure to PCE, Chemical in Drinking Water, May Affect Vision, Boston University School of Public Health Study More... More General Clinical Research News • BioCapital (Bethesday, Maryland) Technical Resources International Senior Clinical Research Associate Will manage one or more projects, with multiple active protocols, in a fast-paced environment with a focus on quality, milestones, and budget. The position involves overseeing the planning and execution of the regulatory document collection and reporting processes. • Biotech Bay (Sunnyvale, California) Pharmacyclics, Inc. Clinical Trial Manager Leads activities associated with the evaluation, initiation and management of clinical studies to ensure compliance with SOPs, FDA regulations and ICH/GCP guidelines. Leads study management team, including oversight of CRO and Vendors. Coordinates the training of staff involved in clinical trial management. Provides training to clinical operations staff and performs performance appraisals of direct reports. • Bio NC (Durham, North Carolina) Sequenom Inc. Clinical Laboratory Supervisor Responsible for monitoring the production of medical diagnostic testing in the CLIA lab performed by assigned Medical Technologists. The supervisor will work closely with internal and external contacts including suppliers, physicians and other healthcare providers regarding clinical laboratory testing, operations and development of new tests. • Biotech Beach (Irvine, California) Allergan Inc. Principal Clinical Programmer - Business Objects Under the direction of management, the Principal Clinical Programmer, leads the design, development, validation, implementation, and provides ongoing support for reporting/business intelligence tools (e.g., Business Objects, Spotfire) and programs (e.g., PL/SQL) used in Clinical Research and Development studies. • BioMidwest (Indianapolis, Indiana) Eli Lilly and Company Data Management Associate Responsible for global consistency of medical data; structure, content and meaning, acquisition, storage, retrieval, interchange and representation. This requires an in depth understanding of data collection, data flow management, data quality, data technology, data archiving and data standards. • Get Noticed! Add your resume to the BioSpace Career Center! • See more than 5,000 job postings in the BioSpace Career Center! 2012 Pharm Country 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 tri-state area. 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. • Pharm Country Career Fair, Bridgewater, NJ September 13, 2012 • Biotech Beach Career Fair, San Diego, CA September 20, 2012 • Biotech Bay Career Fair, Burlingame, CA October 3, 2012 • BioCapital Career Fair, Bethesda, MD October 9, 2012 • BioMidwest Career Fair, Lincolnshire, IL October 22, 2012 • Bio NC Career Fair, Durham, NC October 25, 2012 • Genetown Career Fair, Cambridge, MA November 5, 2012 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 •  Oramed Pharmaceuticals Inc. (ORMP.OB) Granted 2nd Patent in New Zealand; 3rd Patent for Core Technology on Oral Delivery of Proteins More... •  NuPathe Inc. (PATH) Announces Allowance of Additional U.S. Patent Application for NP202 More... •  SCOLR Pharma, Inc. (DDD) Announces Issuance of European Patent for CDT® Ibuprofen More... •  Star Scientific , Inc. Announces Allowance of Patent Claims Covering Products for Weight Loss and Reduction in Tobacco Use More... More Patent News •  U.S. Government Expands Population Eligible to Receive Bavarian Nordic (BAVA.CO)'s Smallpox Vaccine in an Emergency More... More Drug Product News Building Novel Applications with Pipeline Pilot to Drive Next Generation Sequencing This case study shows how scientists are streamlining the process of analyses of DNA sequence information. Enabled by new DNA sequencing technologies, many more scientists and informaticians are interrogating larger and more complex data set. Request Now! Biomarkers in Late Stage Clinical Trials • Quantify and analyze revenues of late stage biomarker technology and services in North America, Europe, Asia and the Rest of the World. • Identify the key market drivers and resistors of the biomarker market and evaluate the growth potential of emerging technologies. • Assess biomarker activity at leading companies, including Abbott, AZ, BMS, Eli Lilly, GSK, Merck & Co, Novartis, Pfizer, Roche and Sanofi-Aventis. Click Here for More Information. Hot Company Alder Biopharmaceuticals Inc. Corporate Headquarters 11804 North Creek Parkway South Bothell, Washington 98011 U.S.A. Phone: 425-205-2900 Fax: 425-205-2901 Alder is revolutionizing the way antibody therapies are identified, selected, developed and produced. Our proprietary technologies make great strides possible in the field of antibody therapeutics, dramatically accelerating the way pharmaceutical and biotechnology companies bring new therapies to market. 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