FDA Panel Rejects Wider Use of Amgen's Xgeva - Feb. 9, 2012

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Thursday, February 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 Panel Rejects Wider Use of Amgen (AMGN)'s Xgeva More... •  Ironwood Pharmaceuticals Announces FDA Advisory Committee Meeting Will Not be Scheduled in Connection with New Drug Application for Linaclotide More... •  Cubist Pharmaceuticals, Inc. (CBST) Receives CUBICIN Paragraph IV Notice Letter More... More BLA/NDA/ANDA News More IND News More MAA News •  FDA Warning: Stomach Acid Drugs Including AstraZeneca PLC (AZN)'s Nexium and Santarus Inc. (SNTS)'s Zegerid, Increase Risk of Bacterial Infections More... More Discontinuations News More Recalls and Warning News •  Mylan Inc. (MYL) Receives Final FDA Approval for First Generic Version of Doryx(R) Tablets, 150 mg More... More Drug Approval News •  BioSante Pharmaceuticals, Inc. (BPAX) Reports Positive LibiGel® Safety Data Review for Phase III Program More... •  Protalix Biotherapeutics, Inc. (PLX) Announces New Clinical Data on Taliglucerase Alfa to be Presented at the WORLD Lysosomal Disease Network Symposium More... •  Rock Creek Pharmaceuticals Announces Initiation of Second Multi-Site Clinical Trial; Protocol to Study an Anatabloc(TM) Formulation and Thyroid Health More... •  Results From Phase I Clinical Trials Demonstrate Positive Safety Data of AVI BioPharma, Inc. (AVII)'s RNA-Based Therapeutics for Treatment of Ebola and Marburg Viruses More... •  Titan Pharmaceuticals (TTP) Announces Positive Results of Six-Month Open-Label Safety Retreatment Study of Probuphine More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval 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! •  Fish Oil May Prevent Psychiatric Disorders, Zucker Hillside Hospital Study More... •  Gene Therapy Helps People With Inherited Blindness See, University of Pennsylvania Study More... •  Heart Disease May Be a Risk Factor for Prostate Cancer, Duke Cancer Institute Study More... •  Stimulant Treatment for ADHD Not Associated With Increased Risk of Cardiac Events in Youth, New York State Psychiatric Institute and Columbia University Study More... •  Tai Chi May Help Parkinson's Patients, Oregon Research Institute Study More... More General Clinical Research News CHI's 8th Annual PEGS: The Protein Engineering Summit April 30- May 4 | Boston, MA www.PEGSummit.com Early Registration Deadline is Friday, February 10 Register now and save over $350! 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. To register and for more information, visit www.PEGSummit.com. The CRO Market Outlook to 2016 • Forecast the market size for contract research in the US, Eastern Europe, Western Europe, China, India, Other Asia, and Latin America. • Discover the opportunities presented by emerging CRO markets and optimize your research sourcing strategies. • Understand how CRO utilization is evolving, and what the future of the industry is. Click Here for More Information. • Biotech Bay (Redwood City, California) Genomic Health, Inc. Clinical Laboratory Scientist I Responsible for performing high complexity laboratory testing on patient specimens, interpreting and reporting patient results, performing quality control and quality assurance procedures and complying with all applicable local, state and federal laboratory requirements. • Bio NC (Durham, North Carolina) PAREXEL International Clinical Monitoring Associate Perform remote clinical monitoring tasks and remote visits for designated projects in accordance with relevant SOPs, study specific procedures and regulations. Responsibilities include managing/coordinating/supporting clinical monitoring activities remotely, including issue resolution, patient enrollment management, handling protocol- and/or ICF- and/or contract amendments, drug / supply management and ensuring timely data entry at a site level. • Genetown (Cambridge, Massachusetts) Pfizer, Inc. Clinical Pharmacology Lead Responsible for providing the clinical pharmacology components of Clinical Plans and provides clinical pharmacology expertise to the project team. Plans, designs and oversees clinical pharmacology studies as required throughout all stages of drug development with operational assistance from a Clinical Research Operations • Biotech Bay (San Francisco, California) Biotecher Senior Manager, Clinical Research Operations Support department head in oversight and management of US and ex-US clinical trials. Help ensure that US and ex-US clinical activities are GCP/FDA and/or ICH compliant and on track to meet deliverables. • Pharm Country (Bridgewater, New Jersey) Ipsen Clinical Project Assistant Ensures that the study master files are organised, maintained and complete, and Clinical Operations functions are supported in order to assist in the delivery of Clinical Development objectives and achieve clinical excellence. Assist the Clinical Operations staff in the financial follow up of the studies and assist the senior staff as needed. • Get Noticed! Add your resume to the BioSpace Career Center! • See more than 5,000 job postings in the BioSpace Career Center! Genetown 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 Northeast region. 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. • Genetown Career Fair, Cambridge, MA February 21, 2012 • BioSpace Career Fair at CALBIO2012, San Francisco, CA March 7, 2012 • BioMidwest Career Fair, Bridgewater, NJ March 22, 2012 • 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 •  Sanofi (France) (SAN.PA), Bristol-Myers Squibb Company (BMY) Receive Nearly $445 Million From Apotex Inc. Over Generic Plavix More... •  Cumberland Pharmaceuticals (CPIX) Receives Acetadote(R) Patent Notice of Allowance More... •  Catalyst Pharmaceutical Partners, Inc. Files U.S. Provisional Patent Application for GABA Aminotransferase Inhibitor Use in Treatment of Tourette Syndrome More... •  Tekmira Pharmaceuticals Corporation Announces USPTO Issuance of Key Patents Broadly Covering LNP Formulations and Mitigation of Immune Stimulation More... More Patent News •  Nouveau Life Pharmaceuticals, Inc. Release: HRID Announces Product Distribution Update and Additional Marketing Strategy for Azul Instant(TM) - "Be Ready in an Instant" 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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