FDA Gives Another Chance to Vivus Obesity Drug - Nov. 4, 2011

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Friday, November 04, 2011  |   |   |   |  Assay Depot has created the world's largest network of public and private cloud-based Research Exchanges: Life science researchers from 53 countries use our public Research Exchange to find, create and purchase research services and products and to communicate with 5000+ research vendors. Pharmaceutical companies, universities and non-profit organizations use a private Research Exchange to manage and strengthen internal and external research partnerships. Research vendors use public and private Research Exchanges to offer their services and products to the global research community. Researchers - Use our free public marketplace atassaydepot.com. Vendors - Get a free vendor account at http://backoffice.assaydepot.com/. •   FDA Gives Another Chance to VIVUS, Inc. (VVUS) Obesity Drug More... More BLA/NDA/ANDA News More IND News More MAA News •  FDA Approves U.S. Market Return for Octapharma USA, Inc.'s Octagam(R) Following Octapharma's Implementation of Enhanced Safety Measures More... More Drug Approval News •  Rexahn Pharmaceuticals, Inc.'s Serdaxin(R) Disappoints in Phase II Trial for Major Depressive Disorder More... •  RegeneRx Biopharmaceuticals, Inc. (RGRX) Reports Positive Data with RGN-259 in Phase 2 Dry Eye Trial More... •  Presidio Pharmaceuticals, Inc. Announces Clinical Proof-of-Concept Data for its First HCV NS5A Inhibitor, PPI-461, and Initiation of Clinical Testing for its Second-Generation NS5A Inhibitor, PPI-668 More... •  Bristol-Myers Squibb Company (BMY) Release: New 12 Week, Interferon-Free Treatment Arms Added to All-Oral Combination Study of PSI-7977 and Daclatasvir (BMS-790052) for HCV Genotype 1 More... •  Galena Biopharma  (RXII) Presents Positive NeuVax(TM) Clinical Results at the 26th Annual Meeting of the Society for Immunotherapy of Cancer More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News Bioscience Technology This magazine provides information to life science/biotech researchers searching for technology, tools and techniques to conduct better, more cost-efficient and effective research. Request Now! •  Exercise Can Overpower the "Obesity Gene," Medical Research Council Epidemiology Unit Study More... •  Study Finds No Link Between Dyslexia and IQ, National Institutes of Health (NIH) Study More... •  Low Vitamin D Levels Do Not Increase the Risk of Chronic Obstructive Pulmonary Disease, Minneapolis Veterans Medical Center Study More... •  IVF Proven Unnecessary for Many Infertile Couples, Published in European Obstetrics and Gynaecology More... •  New Drug Targets Underlying Cause of Cystic Fibrosis, Seattle Children's Research Institute and University of Washington Study More... More General Clinical Research News CHI's 11 Annual PepTalk: The Protein Science Week January 9-13, 2012 | Hotel Del Coronado | San Diego, CA www.www.chi-peptalk.com PepTalk 2012 continues the tradition of strong scientific programming centered around protein-based therapeutics. The four distinct protein pipelines focused on formulation, purification, biotherapeutics and expression range from applying protein discovery research, to developing downstream protein products that ultimately lead to clinical applications. Create your own agenda by moving between the tracks and choosing the sessions that best fit your research and networking needs. Please click here for more information. 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. • Rocky Bio (Lakewood, Colorado) DaVita Clinical Research Medical Director Managing a team of Nurse Practitioners, Physicians Assistants and MD's, our Medical Director will play an integral role in defining our success. This highly visible position will be responsible for working collaboratively with a talented and experienced team to grow and develop this unit from both a medical and operational perspective. • BioCapital (Rockville, Maryland) Otsuka America Pharmaceutical, Inc. Senior Clinical Safety Specialist Enters data received from clinical trials (sites/filed) and immediate reportable adverse events coming from physicians into database. Provides support to Clinical Drug Safety Associates for project specific administrative tasks, including electronic and hard copy records management, data entry activities, and metrics collection. • Biotech Beach (San Diego, California) Amylin Pharmaceuticals, Inc. Manager, Clinical Outsourcing Manage contracts and provide vendor management that support clinical studies, primarily through the Clinical Operations department. Position will to source multiple vendors, develop accurate Requests for Proposal, and advise clinical teams through complex comparative analyses of information and proposal packages. • Pharm Country (Morris County, New Jersey) Omega Management Group VP Clinical R&D - Gastroenterology/GI Strategy: In partnership with Global Marketing, supports the development of a global strategic vision for the category. Determines critically important opportunities to drive growth. Encourages innovative thinking to create and develop long-term commercial value. Owns Category development strategy and project strategies within category. Collaborates across functions to build regulatory, clinical, development, sourcing, manufacturing, supply strategies. • Genetown (Lexington, Massachusetts) Cubist Pharmaceuticals, Inc. In House Clinical Research Associate The In-house CRA is a key participant in the start-up, implementation, management and close-out of clinical trials; preparation of clinical study protocols; clinical study reports. Additionally, the In-house CRA works closely and effectively with the Clinical Trial Manager (CTM) and Clinical Project Team to support various aspects of a Clinical Trial. • 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 November 7, 2011 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) (SASY.PA) Accelerates Development of New Lantus Formulation More... More Drug Product News Hot Company EMINENT Services Corporation 7495 New Technology Way Frederick, Maryland 21703-9401 U.S.A. Phone: 240-629-1972 Fax: 240-629-3298 EMINENT Services Corporation was founded in 1997 and is a privately owned company and is the pre-EMINENT provider of Pharmaceutical and Information Technology Services for pharmaceutical and biotech Industry and Research Organizations including Federal Government. EMINENT offers specialized regulatory guidance throughout the Drug Development Cycle, from bulk drug characterization to product launch and reimbursement support. 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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