Vertex Plunges on Bungled CF Data - May 29, 2012

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Tuesday, May 29, 2012  |   |   |   |  SECOND ASIA PACIFIC PHARMACEUTICAL COMPLIANCE CONGRESS A Hybrid Conference and Internet Event Sponsored by Pharmaceutical Compliance Forum and Asia Pacific Healthcare Industry Compliance Team Media Partners: Life Science Compliance and RX Compliance Report September 11 - 13, 2012 Intercontinental Shanghai Pudong Hotel Shanghai, China Please click here for more information. •  Vertex Pharmaceuticals Incorporated (VRTX) Plunges on Bungled CF Data More... •  Tranzyme Pharma (TZYM)/Norgine GI Drug Fails Second Late-stage Trial More... •  High Hopes for Sanofi (France) (SAN.PA)/Regeneron Pharmaceuticals, Inc. (REGN) Cholesterol Drug More... •  Lundbeck Inc. (LUN.CO) Says Alzheimer's Drug Effective in Trial More... •  Andromeda Announces FDA Orphan Drug Designation for DiaPep277 for the Treatment of Type 1 Diabetes With Residual Beta Cell Function More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News •  Ranbaxy Laboratories (RANBAXY.BO) Gets FDA OK for Acne Treatment Absorica More... More Drug Approval News •  Eisai Inc. (ESALF.PK) Receives Positive CHMP Opinion for Fycompa More... •  Genzyme Corporation (GENZ) and Isis Pharmaceuticals, Inc. (ISIS) Announce Filing of U.S. NDA for KYNAMRO™ (mipomersen sodium) in Homozygous Familial Hypercholesterolemia More... •  BioAlliance Pharma: Receivability of Sitavig® US Registration Dossier (NDA) for the Treatment of Recurrent Orofacial Herpes Validated by the FDA More... •  Janssen Therapeutics Release: FDA Issues Complete Response Letter for 800mg PREZISTA® (darunavir) Tablet More... More BLA/NDA/ANDA News More IND News More MAA News 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. DATES: Sept 19-21, 2012 For more information, please visit: http://www.mtech.umd.edu/biotech/workforce_training.html. •  Aspirin May Prevent Skin Cancer, Aarhus University Hospital Study More... •  Less Couch Time Equals Fewer Cookies, Northwestern University Feinberg School of Medicine Study More... •  Night Shift Might Boost Women's Breast Cancer Risk, Journal of Occupational and Environmental Medicine Reveals More... •  People Born With Certain "Personality Genes" May Live Longer, Albert Einstein College of Medicine Study More... •  Travel to High Altitudes Tied to Crohn's, Colitis Flare-Ups, Trieml Hospital Study More... More General Clinical Research News • Pharm Country (Pittsburgh, Pennsylvania) ZOLL LifeVest Clinical Research Associate Assist with site selection and site qualification visits. Develop and review clinical materials including informed consent forms, case report forms, study manuals, Standard Operating Procedures, and other clinical materials to ensure compliance with regulatory, IRB, and company policies. • Biotech Bay (Fremont, California) Zosano Pharma, Inc. Associate Director, Clinical Operatioins Will provide operational and implementation expertise to the product/project teams under the guidance of the Chief Medical Officer. He or she will be the primary contact for the contract research organizations (CROs), laboratory vendors and clinical sites involved in the clinical trials. • BioForest (Seattle, Washington) Amgen Director, Preclinical Will provide strategic vision and portfolio leadership in support of small and large molecule drug development, registration, and/or post-marketing activities. He/she will be responsible for portfolio-level strategic and resource planning, communication, scientific/technical deliverables, and issue resolution. • Southern Pharm (Memphis, Tennessee) GTx, Inc. Director, Clinical Development Will provide leadership in implementing the approved strategies to move drug product candidates effectively through, the clinical and regulatory process. This position will directly manage Phase I programs and facilitate the operations of Phase II and Phase III clinical trials. • Genetown (Billerica, Massachusetts) PAREXEL International Clinical Logistics Leader Ensures that clinical logistics projects are progressing and systems are set up and maintained according to quality standards, SOPs and applicable ICH-GxP* and other applicable industry guidelines. • Get Noticed! Add your resume to the BioSpace Career Center! • See more than 5,000 job postings in the BioSpace Career Center! Biotech Bay 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 Bay 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 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 •  Amarin Corporation PLC (AMRN) Announces U.S. Patent Issuance for AMR101 More... •  Oramed Pharmaceuticals Inc. (ORMP.OB) Granted Core Technology Patent in New Zealand More... More Patent News •  European Medicines Evaluation Agency Clears Roche (RHHBY) Cancer Drug MabThera More... •  Teva Pharmaceutical Industries Limited (TEVA) Decides Not to Launch Generic Lipitor 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, 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 Gentris Corporation 133 Southcenter Court, Suite 400 Morrisville, North Carolina 27560 U.S.A. Phone: 919-465-0100 Fax: 919-465-0554 Gentris Corporation is a leading global provider of applied clinical pharmacogenomic services. As pioneers in the field of pharmacogenomics, Gentris assists pharmaceutical companies and clinical research organizations to effectively integrate pharmacogenomics into their drug development programs to deliver safer, more effective drugs to market more quickly. 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: Lana Ho Editorial & Production Staff: Maysa Darwish, Tammy Liu ClinicaSpace.com - Clinical Trials. Clinical Research. 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