FDA Advisers Reject Regeneron's Arcalyst - May 9, 2012

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Wednesday, May 09, 2012  |   |   |   |  Crown Bioscience Inc. leads the field in providing unique translational platforms and cost effective drug discovery solutions for its biotech and pharmaceutical partners in dedicated therapeutic areas: Oncology and Metabolic Disease. Our multi-disciplinary team of experts, headquartered in the heart of Silicon Valley, with wholly own research facilities in Kanapolis, Beijing (China), and Taicang (China)., provides an integrated service solution from your idea to an enabling IND, including: preclinical, translational and clinical capabilities. CrownBio offers a truly integrated approach to undertaking complete drug discovery programs as well as hit identification, hit-to-lead, and lead optimization projects. To learn more about our unique portfolio and breadth of services, visit www.crownbio.com or call us at 603-686-9330. •  FDA Advisers Reject Regeneron Pharmaceuticals, Inc. (REGN)'s Arcalyst More... •  FDA Staff Focus on Safety of Arena Pharmaceuticals, Inc. (ARNA) Obesity Pill More... More BLA/NDA/ANDA News More IND News More MAA News •  Merck KGaA (MKGAF.PK)'s Erbitux Fails in Colon Cancer Study More... •  Gilead Sciences, Inc. (GILD)'s Quad Pill Raises Kidney Questions, FDA Says More... •  Shanghai Generon Initiates a Phase II Trial for Breast Cancer in the US More... •  DARA BioSciences, Inc. Announces New Analysis of Patient Self-Reported Diary Results in a Phase 2a Clinical Trial of KRN5500 in Patients With Cancer and Neuropathic Pain More... •  Auxilium Pharmaceuticals (AUXL) Announces XIAFLEX(R) Peyronie's Phase IIb Study Published in the Journal of Urology More... 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Manages and directs the design, implementation and monitoring of clinical trials. • Pharm Country (Bedminster, New Jersey) Allergan Inc. Manager, Clinical Data Management Will direct internal and/or outsourced data management activities in support of multiple clinical research projects. Manages the safety data management deliverables (e.g. SAE reconciliation, IND Updates/DSURs, etc.) against defined project timelines and priorities. • Genetown (Cambridge, Massachusetts) Millennium: The Takeda Oncology Company Clinical Quality Auditor Responsible for ensuring that audit plans are developed through discussion with the clinical project teams and then manage the outsourcing of clinical audits of all types. These will include audits of investigator sites, vendors, commercial IRBs, Clinical Study Reports, database, pharmacovigilance, Phase 1 units and other types. • Biotech Bay (Sunnyvale, California) Pharmacyclics, Inc. Clinical Research Associate/Senior Clinical Research Associate Responsible for driving and executing day-to-day activities during the conduct of clinical studies, according to the protocol, ICH/GCP, and applicable regulatory requirements. • BioMidwest (Chicago, Illinois) Takeda Pharmaceuticals Medical Director / Senior Medical Director, Clinical Science 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. • Get Noticed! Add your resume to the BioSpace Career Center! • See more than 5,000 job postings in the BioSpace Career Center! 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. 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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 Bay Career Fair, Burlingame, CA May 29, 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 JAX® Patient-derived xenograft resource The enormous cost, and high failure rate, of cancer drug development have highlighted the need for new preclinical strategies and resources. To this end, a library of more diverse and representative patient-derived tumor xenograft (PDX) models has been created at The Jackson Laboratory. We utilize NOD scid IL2 receptor gamma chain knockout mice (NSG), constructed by JAX Professor Lenny Shultz, as the mouse host. 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