GSK to Seek OK for Diabetes Drug as Data Impresses - Apr. 3, 2012

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Tuesday, April 03, 2012  |   |   |   |  Lab Equipment: Featuring Equipment from Bayer Healthcare & Other Leading Global Firms! Please click here for information. •  GlaxoSmithKline (GSK) to Seek OK for Diabetes Drug as Data Impresses More... •  Bayer AG (BAY.F) Gastrointestinal Cancer Drug Meets Phase 3 Trial Goal More... •  Johnson & Johnson (JNJ) Alzheimer's Med Cut Chemical Tied to Brain Tangles More... •  Astex Pharmaceuticals (ASTX) Announces Subcutaneous SGI-110 Interim Phase 1/2 MDS and AML Data Presentation at American Association for Cancer Research More... •  Stemedica Cell Technologies, Inc. Ischemic Tolerant Stem Cells Produce Significant Improvement in Cardiac Function After Heart Attack More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News •  American Regent, Inc. Initiates Nationwide Voluntary Recall of Cyanocobalamin Injection, USP, 1000 mcg/mL, 1mL Vial Lot #s 1662, 1679, 1683 Due to Cracks in the Vials More... More Discontinuations News More Recalls and Warning News •  UCB, Inc. (UCBJF.PK)'s Neupro® Approved by FDA for Parkinson's Disease and Restless Legs Syndrome More... More Drug Approval News •  Navidea Biopharmaceuticals (NEOP) Release: FDA Extends PDUFA Date for Lymphoseek® by Three More... More PDUFA News •  Astellas Pharma Inc. (YPH.BE) Overactive Bladder Drug Raises Blood Pressure Dangers, FDA Says More... •  Amylin Pharmaceuticals, Inc. (AMLN) Completes Biologics License Application for Metreleptin to Treat Diabetes and/or Hypertriglyceridemia in Patients With Rare Forms of Lipodystrophy 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! •  Why Stress Might Make You Sick, Carnegie Mellon University Study More... •  Osteoporosis Drugs May Lead to Eye Trouble, University of British Columbia Study More... •  Improvements in Autism Symptoms Vary Kid By Kid, Columbia University Study More... •  Smelly Urine a Red Flag for Kids' UTI, University Of Montreal Study More... •  ApoCell, Inc.'s Circulating Tumor Cell (CTC) Capture Technology First to Reliably Detect and Recover Deadly Liver Cancer Cells 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. Our online courses feature voiced lectures, downloadable supplements that include additional explanation and resources, knowledge checks, writing aids, writing options on which participants receive professional written feedback, and a certificate of completion. Our customized onsite courses are developed after careful analysis of your organization's unique writing needs. These onsite workshops are offered in one-, two-, three-, or four-day options and feature pre-class writing assessments, interactive discussion, in-class exercises, breakout sessions, coaching, and post-class assessment to ensure a relevant workshop that provides long-term results. Whether you need training for one or two individuals, a group, or an organization, Hurley Write is your solutions provider for all of your writing training needs. For more information, please visit: http://www.hurleywrite.com/. 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. • Biotech Beach (San Diego, California) Ceregene, Inc. Clinical Operations Associate Responsible for various in-house activities related to clinical data managed by a contract research organization (CRO). Initiates manual queries of CRO and Ceregene databases and reviews for correct data values. Investigates and resolves incorrect data values with CRO contact. • Biotech Bay (Santa Rosa, California) On Assignment Clinical Research Clinical Research Specialist Works closely with the study manager to satisfy applicable clinical and regulatory requirements and internal requirements for clinical studies. This role focuses on assigned areas of clinical study management and provides support for clinical deliverables required in the Product Commercialization Process This role may perform some site training and co-monitoring. • 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. • 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 •  U.S. Granted Patent 8,088,385 B2 Strengthens Advanced Cardiac Therapeutics' Anti-Cancer Product Portfolio More... •  Cytochroma Inc. Receives Notice of Allowance for US Patent Covering CTAP101 Capsules More... •  Watson Pharmaceuticals, Inc. (WPI) Confirms LUMIGAN® and LATISSE® Patent Challenges More... More Patent News •  Eisai Company, Ltd. (ESALY.PK)'s Halaven Breast-Cancer Drug Rejected by National Institute of Clinical Research More... •  FDA OKs Pregnancy Use of Novo Nordisk A/S (NVO) Diabetes Therapy Levemir More... •  Latitude Pharmaceuticals Inc. Develops a Stable Liquid Glucagon Formulation More... •  Prasco Laboratories Launches Authorized Generic Nisoldipine Extended Release Tablets More... •  Mylan Inc. (MYL) Launches Generic Version of Mesnex Injection® More... More Drug Product News Hot Company Eli Lilly and Company Lilly Corporate Center Indianapolis, Indiana 46285 U.S.A. Phone: 317-276-2000 Lilly makes medicines that help people live longer, healthier, more active lives. We were founded by Eli Lilly in 1876, and are now the 10th largest pharmaceutical company in the world. We have steadfastly remained independent, but not isolated. Across the globe, Lilly has developed productive alliances and partnerships that advance our capacity to develop innovative medicines at lower costs. 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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