United's Ph3 Study Fails to Meet Primary Endpoint - Aug. 24, 2011

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Wednesday, August 24, 2011  |   |   |   |  CHI's 11 Annual PepTalk: The Protein Science WeeK January 9-13, 2012 | Hotel Del Coronado | San Diego, CA www.chi-peptalk.com REGISTER BY FRIDAY, AUGUST 26 and SAVE UP TO $400! 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. •  United Therapeutics Corporation (UTHR)'s Ph3 Study Fails to Meet Primary Endpoint More... •  Top-Line Results from Pivotal Trial of Shire plc's Dermagraft(R) for Venous Leg Ulcers More... •  Peregrine Pharmaceuticals, Inc. (PPHM) Reports Promising 20.7 Month Median Overall Survival From Phase II Advanced Breast Cancer Trial More... •  RegeneRx Biopharmaceuticals, Inc. (RGRX) Release: Patient Enrollment Completed in Phase 2 Trial with RGN-259 for the Treatment of Dry Eye More... •  Lightlake Therapeutics Inc. Set to Begin Phase II Clinical Trials of Binge Eating Disorder Treatment More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News •  Advocacy Group to FDA: Acid Reflux Drugs Should Have Black Box Warnings More... More Discontinuations News More Recalls and Warning News •  Pharmasset, Inc. (VRUS) Receives Fast Track Designation for Hep C Drug More... •  KFDA Grants D-Pharm Ltd. IND Approval for Phase III MACSI Study of DP-b99 in Korea More... More BLA/NDA/ANDA News More IND News More MAA News Nature Methods Nature Methods provides techniques for life scientists and chemists. It is a print and online publication dedicated to publishing novel methods together with significant advances to tried and tested techniques allowing researchers to perform faster, better and more efficient experimental research. Request Now! •  No Major Heart Risk Seen in New Psoriasis Drugs, Baylor Research Institute Study More... •  Diet Alone Helps Lower Bad Cholesterol, University of Toronto Study More... •  Faster Diagnosis With Less Radiation: New Heart Scan, Innsbruck Medical University Study More... •  "Targeted" Breast and Ovarian Cancer Drug Could Have Far Wider Application, Cancer Research UK Cambridge Research Institute Study More... •  Hypertension Study Prompts New Diagnosis Guidance, Leicester University Study More... More General Clinical Research News Advances in Drug-Diagnostic Co-Development • Understand the current regulatory environment for both diagnostics and drugs within the EU and the US and how these relate to their co-development. • Understand the biomarker discovery and validation process. • Using case studies discover how drugs and their companion diagnostics have already received approval in the US and EU. Click Here for More Information • Southern Pharm (Memphis, Tennessee) St. Jude Children's Research Hospital Clinical Research Associate-RN II Acts as site Study Coordinator. Serves as a preceptor/mentor to new clinical research staff. Performs data abstraction, collection, and entry to support clinical research. Prepares submission for all reportable events. Develops, maintains, and/or monitors case report forms. • Biotech Beach (Irvine, california) Allergan Inc. Principal Clinical Data Manager Working within clinical study teams as an extended team member. Defining project timelines and executing the clinical data management operations against them, and any other priorities. Using defined department metrics as a framework for timely and quality clinical data management deliverables. • Pharm Country (Princeton, New Jersey) DataFrenzy, LLC Regional CRA Developing and writing trial protocols (outlining the purpose and methodology of a trial). Presenting trial protocols to a steering committee. Designing data collection forms, known as case record forms (CRF s). Coordinating with the ethics committee, which safeguards the rights, safety and well being of all trial subjects. • Genetown (Cambridge, Massachusetts) Millennium: The Takeda Oncology Company Development Coordinator (Manager I), Drug Development Management Responsible for scheduling core team and clinical sub-team meetings. Provides meeting management support to various sub-teams. Assists in the planning and coordination of other large meetings. • BioMidwest (Cleveland, Ohio) Asahi Intecc USA, Inc. Sales/Clinical Rep in Midwest Area Responsible for the sales activities for cardiovascular and endovascular products in East coast area. Responsibilities will include, but not limited to: Market Development, Budget Planning and Management, Physician Relationship, Sales and Customer Support, etc. • Get Noticed! Add your resume to the BioSpace Career Center! • See more than 5,000 job postings in the BioSpace Career Center! Biotech Beach 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 Southern California 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. • Biotech Beach Career Fair, San Diego, CA September 22, 2011 • BioMidwest Career Fair, Chicago, IL October 4, 2011 • Pharm Country Career Fair, Bridgewater, NJ October 5, 2011 • Biotech Bay Career Fair, Burlingame, CA October 11, 2011 • Bio NC Career Fair, Durham, NC October 20, 2011 • BioCapital Beach Career Fair, Bethesda, MD November 1, 2011 • 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 •  U.S. Patent Office Awards Patent Protection to Microbix Biosystems Inc. (MBXBF)' Lumisort(TM) Livestock Semen Sexing Technology More... •  Cortex Pharmaceuticals, Inc. (COR) Receives U.S. Patent for the Use of Ampakine Molecules to Treat Respiratory Depression More... More Patent News •  Dey Pharma to Offer EpiPen 2-Pak® and EpiPen Jr 2-Pak® Exclusively More... More Drug Product News Biomarker Applications for Improved Clinical Trial Outcomes November 15 - 16, 2011 Hilton Boston Back Bay - 40 Dalton Street Event Website The only personalized medicine conference allowing you to make biomarkers and diagnostics available during every stage of clinical research, to stratify patients, prove clinical validity, and streamline the regulatory approval and reimbursement process. Featuring up-to-date analysis of new FDA legislation regulations and a special spotlight from Blue Cross Blue Shield. Please click here for more information. Hot Company SGS Life Science Services 201 Route 17 North Rutherford, New Jersey 07070 U.S.A. SGS Life Science Services, is a leading contract service organization providing clinical research, analytical development, biologics characterization, and quality control testing. 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