Regeneron Wins FDA Approval for Blindness Drug Eyle - Nov. 21, 2011

Monday, November 21, 2011  |   |   |   |  Pharm-Olam International Acquires StatWorks, Inc. With Pharm-Olam's acquisition of StatWorks we have expanded our team Data Management and Biostatistics experts for functional outsourcing and full service clinical trials. Our comprehensive biometric services include: • Integration of randomization into EDC systems, eliminating IVRS costs, with added benefit of full inventory control over supplies • Adaptive, Sequential, and Bayesian design methods • CDISC, SDTM and ADaM datasets • SAS programming, eCRF design, and medical coding in MedDRA/WHO Drug • Streamlining and reconciling across SAE, CTMS, and study DB • Health Outcomes Research and Patient Reported Outcomes • Protocol development, sample size, and randomization Contact us for your resource planning at www.pharm-olam.com, info@pharm-olam.com, USA 1-713-559-7900, UK 44-0-1344-891121. •  Regeneron (REGN) Wins FDA Approval for Blindness Drug Eylea More... •  Spectrum Pharmaceuticals, Inc. (SPPI) Release: FDA Approves the Removal of the Bioscan Requirement for ZEVALIN® Treatment More... •  Celgene International Sárl (CELG)'s REVLIMID(R) Granted Swissmedic Approval for Treatment of Rare Blood Cancer More... More Drug Approval News •  IGI Laboratories, Inc. Announces the Submission of Two More ANDAs More... •  Pfizer Inc. (PFE) Announces European Medicines Evaluation Agency Acceptance of Regulatory Submission For Tofacitinib For the Treatment of Rheumatoid Arthritis More... More BLA/NDA/ANDA News More IND News More MAA News •  Celldex Therapeutics, Inc. (CLDX) Reports Positive Mature Survival Data from Rindopepimut Phase 2 Brain Cancer Study at SNO 2011 More... •  Starpharma Holdings Ltd Secures European Medicines Evaluation Agency Agreement on BV Treatment Phase 3 More... •  Exelixis, Inc. (EXEL) Announces Initiation of Phase 2 Investigator-Sponsored Trial of Cabozantinib in Women with Hormone Receptor-Positive Metastatic Breast Cancer and Bone Metastases More... •  Data from Phase 2 Study of Knopp Biosciences's Dexpramipexole in ALS Published in Nature Medicine More... •  Merrimack Pharmaceuticals Inc. Initiates Enrollment in Phase 2 Study of MM-121 in Combination with Erlotinib in Three Groups of Patients with Non-Small Cell Lung Cancer More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News Moving from Molecule to Clinical Trial- Overcoming Challenges in the Early Development of Small Molecules. Patheon is proud to bring together four scientific leaders who, in a complimentary half-day seminar, will help you navigate through regulatory obstacles, give you tips for getting your molecule to clinical trials more efficiently, and provide practical case studies that demonstrate how other molecules have successfully moved to clinic. Through this event, you will get the chance to network, meet with scientists, and learn from presentations with solutions to the challenges you currently or might face in the near future. As the global leader in Pharmaceutical Development Services, Patheon is committed to providing effective science-based learning opportunities for local professionals. Date: Tuesday, December 13, 2011 Time: 8:30am-2:00 pm Location: Hyatt Regency La Jolla, 3777 La Jolla Village Dr, San Diego, CA 92122 RSVP: events@patheon.com Please click here for more information. •  Healthy Male Diet May Boost IVF Success, Fertility-Assisted Fertilization Center Study More... •  Tender Breasts From Combo HRT Linked to Higher Cancer Risk, University of California, Los Angeles (UCLA) Study More... •  Words Recognized by Looks, Not Sounds, Georgetown University Medical Center Study More... •  Seniors' Memory Doesn't Seem to Improve With Sleep, University of Massachusetts - Amherst Study More... •  Florida Agricultural and Mechanical University Study Claims Senior Citizens Who Are More Intimate Are Happier More... More General Clinical Research News Emerging Clinical Trial Locations • Provides insight into the background to the clinical trials market in the emerging geographic regions including specific issues in each geography. • Reviews of the structure of the healthcare system in each of the emerging clinical trial markets. • Reviews the principal CROs in each emerging location covering domestic and international players. Click Here for More Information. • Bio NC (Durham, North Carolina) Cato Research Director, Clinical Trial Operations Manages overall operation of the entire clinical study including project planning, budget, resource management and contract research organization management. Manages clinical operational plan, and incorporates the study and scientific plan. • Biotech Beach (Santa Monica, California) Astellas Pharma US Clinical Research Specialist Responsible for preparation, processing, review and filing of study documents. Assists the study team and CRO in study start-up activities including system set-up and study tracking. Processes and tracks site and vendor payments. • Pharm Country (Princeton, New Jersey) Otsuka America Pharmaceutical, Inc. Associate Director, Clinical Outsourcing Responsible for supporting OPDC Clinical Regulatory Teams (CRT) in selecting, negotiating costs, contracting and providing business oversight of CROs and other ancillary vendors. The position provides leadership in developing internal processes and standards • Biotech Bay (San Francisco, California) Jennerex Clinical Research Associate/Senior Clinical Research Associate Oversees the conduct of assigned clinical studies including acting as liaison to clinical investigators & ensuring the quality and integrity of data. This position will independently perform clinical monitoring activities to ensure site compliance and adherence with study protocols, project plans, Jennerex SOPs, and FDA/ICH GCP regulations. • BioCapital (Bethesda, Maryland) Technical Resources International Clinical Information Specialist II Primary responsibilities include the receipt and abstraction of protocol and/or contact information into the appropriate databases for use by the client and their collaborators in support of clinical trials. • 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 •  IMPAX Laboratories, Inc. (IPXL) Confirms Patent Challenge Relating to Generic FENTORA® More... •  U.S. Patent Office Issues Notice of Allowance for Patent Application Related to Cell Therapeutics, Inc. (CTIC)'s GlycoPolymer Technology More... More Patent News •  Pierre Fabre Medicament is Granted Authorization in Australia to Market the Milnacipran JONCIA(R) to Treat Fibromyalgia More... More Drug Product 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! 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. 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