Genentech's Breast CA Drug Clears Huge Hurdle- Mar. 30, 2012

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Friday, March 30, 2012  |   |   |   |  Your goals. Our expertise. Norwich Clinical Services is a global contract research organization for the pharmaceutical and biotech industries. Dedicated Norwich program management will guide your program from the initial stages of development through study-end reconciliation with specific focus on budget efficiency and schedule adherence. Please click here for more information. •  Genentech (RHHBY) Breast Cancer Drug Clears Huge Hurdle More... •  Shire plc (SHPGY) Hit by Bowel Drug Study Failure More... •  Portola Pharmaceuticals, Inc. Initiates Global Pivotal Phase 3 Study of Factor Xa Inhibitor Betrixaban More... •  Shire plc (SHPGY) Release: One Year Data Provide Evidence of Effectiveness and Tolerability of REPLAGAL(R) (agalsidase alfa) in Fabry Patients More... •  Data From AVI BioPharma, Inc. (AVII)'s Infectious Disease Programs to be Presented at the 22nd European Congress of Clinical Microbiology and Infectious Diseases More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News •  Sun Pharmaceutical Industries Ltd Recalls 1,55,000 Eye Solution Bottles From US More... More Discontinuations News More Recalls and Warning News •  Genzyme Corporation (GENZ) Submits Drug for Rare Cholesterol Disorder to FDA More... More BLA/NDA/ANDA News More IND News More MAA 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! •  After Soccer, Testosterone Soars in Amazon Men, University of California, Santa Barbara Study More... •  Too Little Calcium, Water Linked to Kidney Stones, University of Washington Study More... •  Feeling Fat? Maybe Facebook is to Blame, The Center for Eating Disorder at Sheppard Pratt More... •  Myriad Genetics, Inc. (MYGN) Study Finds High Prevalence of Mutations in the PMS2 Gene More... •  Shire plc (SHPGY) Reaffirms Support of Patients Requiring Midodrine HCl; Advances FDA Agreed Upon Clinical Trials More... More General Clinical Research News Hurley Write has over 20 years designing and teaching customized online and onsite courses in technical, business, and scientific writing, including writing standard operating procedures (SOPs), proposals, and writing the scientific manuscript. We also offer specialty classes in writing clinical documentation; lab, deviation, and investigative reports; and other technical and scientific documents. 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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. • Rocky Bio (Tucson, Arizona) Ventana Medical Systems, Inc. Clinical Data Specialist Supervises data capture in clinical studies and implements tools to improve clinical data management, including quality initiatives to ensure that high quality clinical data sets are created to support US Food and Drug Administration (FDA) submissions for Ventana products. • Pharm Country (Bridgewater, New Jersey) Omega Management Group Clinical Quality Control Manager Will manage the QC department in regards to clinical and regulatory documentation QC. In addition s/he will be responsible for the managing of the clinical departments SOPs in accordance with GCP guidelines. This includes training of responsible individuals within and across departments. In addition s/he will maintain and support QC audits of clinical Trial Master Files. • BioCapital (Rockville, Maryland) Otsuka America Pharmaceutical, Inc. Manager, Clinical Programming Manages compound programming activities including the planning, coordination, and execution of the statistical programming functions in support of the clinical research project. • Biotech Beach (Irvine, California) Allergan Inc. Director, Clinical Development Leads, directs and coordinates team activities (development and/or clinical) to ensure completion of the clinical development of projects of major importance to the corporation's long term future that are difficult and complex in nature and require the expert application of advanced knowledge in a broad area of science/technology. • Biotech Bay (Novato, California) Ultragenyx Pharmaceutical Inc. Senior Manager, Clinical Operations Manages the operational aspects of clinical trials. Manages the study project plan, including timeline, budget, and resources. Participates in protocol, CRF and strategy development, Clinical Study Report preparation, NDA submission, as appropriate • 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 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. • Biotech Beach Career Fair, La Jolla, CA April 17, 2012 • BioCapital Career Fair, Bethesda, MD April 25, 2012 • Pharm Country Career Fair, King Of Prussia, PA May 1, 2012 • BioNC Career Fair, Durham, NC May 2, 2012 • 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 •  Islet Sciences Announces DiaKine Therapeutics, Inc.' Novel Diabetes, Atherosclerosis Drugs Receives European Patent Protection More... More Patent News •  New Doubts About Dendreon Corporation (DNDN)'s Provenge Arise More... •  National Institute for Clinical Excellence (NICE) Okays Bayer AG (BAY.F)'s Genentech Xarelto In Stroke Prevention More... •  Highland Pharmaceuticals Creates Meth-proof Drug More... •  Covis' Zantac® Injection Returns to the Market More... •  Teva Pharmaceutical Industries Limited (TEVA) Announces Launch of Authorized Generic of Provigil® More... More Drug Product News Hot Company SNBL Clinical Pharmacology Center 800 West Baltimore Street, 5th Floor Baltimore, Maryland 21201 U.S.A. Phone: 800-690-9110 Fax: 410-706-8963 SNBL-CPC partners with pharmaceutical companies, biotech firms and CROs to accelerate drug development utilizing our best-in-class facility, technology, operational excellence and strong affiliations with local academic medical institutions (University of Maryland and Johns Hopkins University). A US subidiary of one the largest Clinical Reserach Organizations in Japan, SNBL-CPC is a Phase I/IIa clinical pharmacology center with both inpatient (96 beds) and outpatient facilities. 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. 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