FDA Accepts NDA Review of Pfizer RA Drug - Dec. 21, 2011

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Wednesday, December 21, 2011  |   |   |   |  Online Auction January 11 at 9 AM ET Featuring lab equipment from Elan and other leading global firms! Register and bid online. •  FDA Accepts NDA Review of Pfizer Inc. (PFE) RA Drug More... •  Repligen Corporation (RGEN) Announces Submission of New Drug Application for SecreFlo(TM) for Improved Pancreatic Imaging In Patients with Pancreatitis More... •  BioTie Therapies Corp.'s Partner Lundbeck Inc. Submits European Marketing Authorization Application for Selincro(TM) (nalmefene) More... •  Gilead Sciences, Inc. (GILD) Files European Marketing Application for the Quad, a Once-Daily Single-Tablet Regimen for the Treatment of HIV Infection More... •  Phage Pharmaceuticals (Formerly Known as Phage Biotechnology Corp.) to File Investigational New Drug (IND) Application Using Its Lead Drug Candidate, FGF-1, for a First-in-Class Indication to Repair Tympanic Membrane Perforations More... More BLA/NDA/ANDA News More IND News More MAA News •  FDA Approves Takeda Pharmaceutical Co. Ltd. (TKDG.DE)'s EDARBYCLOR (azilsartan medoxomil and chlorthalidone) for the Treatment of Hypertension More... More Drug Approval News •  Radius Announces Topline Results of Successful Phase 1b Clinical Trial of BA058 Microneedle Patch for the Transdermal Treatment of Osteoporosis More... •  Marinus Pharmaceuticals Experimental Epilepsy Treatment Shows Promise in Open-Label Extension Study More... •  Raptor Pharmaceutical Inc. (RPTP) Provides Program Update on RP103 (DR Cysteamine) for Nephropathic Cystinosis More... •  OphthaliX Inc. Release: Denali Concrete Management Inc. Announces the Commencement of Patient Enrollment for the Phase 3 Dry Eye Syndrome Study More... •  Celldex Therapeutics, Inc. (CLDX) Completes Accrual of CDX-011 Phase 2b "EMERGE" Study in Advanced Breast Cancer 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! •  Could Cod Liver Oil Help Combat Tuberculosis? Royal Brompton Hospital Study More... •  Treating High Blood Pressure May Add Years to Life, Robert Wood Johnson Medical School Study More... •  Mediterranean Diet Gives Longer Life, University of Gothenburg Study More... •  Increase in Resting Heart Rate Over 10-Year Period Linked With Increased Risk of Heart Disease Death, Norwegian University of Science and Technology Study More... •  Synesthesia Linked to a Hyper-Excitable Brain, Oxford University Study More... More General Clinical Research News The University of Florida's enrollment deadline for its online graduate program in Pharmaceutical Chemistry is January 9. Sign up now to begin work towards your MS, PSM or graduate certificate. These prestigious programs allow working professionals to expand their expertise and improve their credentials in medicinal chemistry, drug pharmacology, structural elucidation, metabolism, and more - all from the comfort of home, when it's convenient for them. Enroll today in a course or two; decide later if you want to continue on to earn a full master's degree or certificate. UF is the fourth largest academic institution in the United States, and is accredited by the Southern Association of Colleges and Schools (SACS) and the Association of American Universities (AAU). For more information, please visit the University of Florida's graduate program. 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 (Los Angeles, California) CytRx Corporation Clinical Study Manager Assessing global vendor requirements and liaising with appropriate departments on vendor selection followed by continued global vendor management. Site startup and management activities, including budgeting and contract negotiations. • BioForest (Woodinville, Washington) Bio-Rad Laboratories, Inc. Clinical Diagnostics Group RA/QA/QC Supervisor II Supervise and coordinate quality control activities for the BioPlex 2200 QC team in the Woodinville facility including raw materials QC, coupled antigens or antibodies to magnetic particles, conjugated antibodies with fluorescent tags, and critical component manufacturing. • Biotech Bay (South San Francisco, CA) Crescendo Bioscience Senior Clinical Research Associate Will monitor progress and activities of clinical studies and sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. The CRA will be responsible for multiple projects and must work both independently and in a team environment. • BioCapital (Rockville, Maryland) Otsuka America Pharmaceutical, Inc. Manager Clinical Development TB Will provide leadership and management for the microbiology procedures for the TB program and ensure quality of the endpoint assessment at global trial sites. S/he will ensure cross-study consistency in protocol design, data analysis, and reporting. • Genetown (Cambridge, Massachusetts) Cubist Pharmaceuticals, Inc. In House Clinical Research Associate Managing clinical study documentation (e.g. documentation for study start-up and IRB submission) and Trial Master File component. Knowledge of the processes involved in clinical studies following Good Clinical Practice (GCP) and the Code of Federal Regulations is required. • 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 Hot Company Accelovance 2275 Research Boulevard, Suite 700 Rockville, Maryland 20850 U.S.A. Phone: 240-238-4900 Fax: 240-238-4901 Accelovance, Inc., based in Rockville, MD, is a clinical services company specializing in high patient throughput from recruitment through study completion. Accelovance has developed a model to increase the reliability and productivity on Phase I (outpatient) and Phase II-IV trials. Accelovance enhances this offering with flexible CRO services to meet a Sponsor's specific trial needs. 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. 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