FDA Panel Backs Pfizer's Kidney Cancer Drug - Dec. 07, 2011

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Wednesday, December 07, 2011  |   |   |   |  Eighth Annual PEGS the essential protein engineering summit April 30 - May 4, 2012 | Boston, MA www.PEGSummit.com Cambridge Healthtech Institute is proud to present the Eighth Annual PEGS, protein engineering summit. This comprehensive event encompasses 12 tracks, 15 short courses, and a pre-conference partnering forum for showcasing early stage companies. Topics span from early stage discovery of new methods for protein expression and antibody engineering, to improved analytical techniques, and clinical results in the most promising areas of biotechnology. There is tremendous momentum and investment in biologics, and the PEGS conference offers an unparalleled view of the field. Make plans to join us this April in Boston. Special Early Bird Rates are available until December 9 - Save up to $450! •  FDA Panel Backs Pfizer Inc. (PFE)'s Drug for Kidney Cancer More... More BLA/NDA/ANDA News More IND News More MAA News •  Theratechnologies Inc. (TH.TO) to Discontinue COPD Clinical Program and Accelerate Path to Profitability More... •  FDA: U.S. Marshals Seize Products Containing Banned Ephedrine for Dietary Supplements More... More Discontinuations News More Recalls and Warning News •  CureMark Reports Positive Phase III Results of CM-AT in Children With Autism More... •  CEL-SCI (CVM) Updates Phase III Clinical Activities for Investigational Cancer Therapy Multikine (Leukocyte Interleukin, Injection) More... •  Tranzyme Pharma and Norgine Complete Enrollment in First of Two Pivotal Phase 3 Trials of Ulimorelin More... •  Santarus Inc. (SNTS) and Pharming Group (PHGUF.PK) Announce Oral Presentations of Retrospective Analyses of Data From RHUCIN Clinical Program at World Allergy Congress More... •  VIVUS, Inc. (VVUS) Release: Weight Loss and Effects on Diabetes with Qnexa Treatment Results Presented at the World Diabetes Congress More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News Quantifying the Value of Pipeline Pilot, the Accelrys Scientific Enterprise Platform This white paper outlines the methodology, sources of value, and quantifiable results from bringing products to market faster, avoiding unproductive experiments, saving developer time, and more. Request Now! •  Women Who Mix Day And Night Shifts "Have a Greater Risk of Type 2 Diabetes," Harvard University Study More... •  Diabetes, Obesity After 60 May Drive Up Breast Cancer Risk, Lund University Study More... •  Prostate Cancer Hormonal Therapy Cuts Deaths, Dana-Farber Cancer Institute and Brigham and Women's Hospital Study More... •  Steroids May Boost Survival for Very Preemie Babies, University of Alabama at Birmingham Study More... •  Gene Mutation Helps Clear Fats From Blood, University Medical Center Groningen Study More... More General Clinical Research News Partnerships 2012: The Largest Yet Most Intimate Gathering of Clinical Decision Makers in the World The world has radically changed in just the last few years and the trend is likely to continue at an exponential rate. Partnerships in Clinical Trials is changing with it. Partnerships has always been where business gets done and strategic partnership deals are inked, but in 2012 it is where the industry moves forward with answers. We've taken your most pressing challenges and translated them into the most provocative meeting agenda the industry has ever seen. For more information, please visit the conference site: http://www.iirusa.com/cropartners/welcome-to-CROs.xml?registration=XP1700BSENL. Patient Recruitment and Retention in Clinical Trials • Understand the industry trends driving rising recruiting shortfalls. • Assess the applicability of different recruiting strategies to your clinical development programs. •Develop strategies to optimize recruiting program objectives. Click Here for More Information. • Biotech Beach (San Diego, California) Ardea Biosciences, Inc. Clinical Trials Assistant Will support the efforts of a Phase 1, 2 or 3 clinical operations team (special emphasis on Phase 1's). Responsibilities include, but are not limited to maintaining clinical master files, making investigator payments. • BioCapital (Bethesda, Maryland) Technical Resources International Attorney/Clinical Trials Agreement Advisor Will draft and negotiate Clinical Trial Agreements and other research agreements between the government client (National Institutes of Health) and industry collaborators (biologic and drug product manufacturers) and provide counsel on FDA laws and regulations, contracts, intellectual property, access to data, ownership of data and specimens, safety reporting, patient privacy, liability, indemnification, confidentiality, and human subject protection. • Pharm Country (Wayne, Pennsylvania) On Assignment Clinical Research Clinical SAS Programmer Provide statistical programming support and validation and help set specifications of anlysis datasets, pooled datasets, statistical tables, summaries, figures and listing for Phase II-IV clinical trials. Employ standardized programs where applicable. • Biotech Bay (Redwood City, California) On Assignment Clinical Research Senior Clinical Data Coordinator/Manager Acts as a core member of Study Management Teams and serves as the study data management contact at the study and/or program level, providing expert guidance to program teams. • Genetown (Cambridge, Massachusetts) Vertex Director, Clinical Operations Responsible for overseeing the conduct of global, pivotal, clinical trials and managing multiple trials over multiple indication programs and/or therapeutic areas in accordance with GCP regulatory requirements. • Get Noticed! Add your resume to the BioSpace Career Center! • See more than 5,000 job postings in the BioSpace Career Center! BioSpace Life Science Career Fairs are the biotech industry's premier career events. Featuring well-respected employers from around the nation, our job fairs attract top candidates in the biotech, pharmaceutical, life science and medical device industries. With such a great number of recruiters and hiring managers from top biotech companies attending our career fairs, there are an abundance of opportunities available for job seekers. Many different disciplines within the industry are represented bringing a diversity of candidates to our job fairs. Companies seeking pharmaceutical sales representatives and marketing jobs regularly attend our job fairs. Engineering and technical jobs can be found, as well as regulatory jobs and positions in QA/QC. Individuals desiring a science job or a research job will find many opportunities at our job fairs. In addition, hiring managers seeking candidates for clinical research jobs also attend our events. 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 •  ZIOPHARM, Inc. Granted European Patent Allowance for Palifosfamide More... •  Aradigm Corporation (ARDM) Selects Pulmaquin(TM) for Phase 3 Development and Announces Issuance of its First U.S. Patent Covering Inhaled Ciprofloxacin Formulations More... •  Silence Therapeutics plc Announces Positive Outcome From Oral Hearing at the European Patent Office More... •  Ampio Pharmaceuticals, Inc. (AMPE) Awarded European Patent that Strengthens Intellectual Property Protection for its Key Drug Ampion(TM) More... More Patent News •  Amgen (AMGN) and FDA Agree to Modify Nplate® (Romiplostim) Risk Evaluation and Mitigation Strategy More... More Drug Product News 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: Rosemary Do Editorial & Production Staff: Lana Ho, Maysa Darwish, Tammy Liu, Michelle Wong ClinicaSpace.com - Clinical Trials. Clinical Research. 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