Roche Boosted By Drug-Trial Data - Aug. 22, 2011

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Monday, August 22, 2011  |   |   |   |  UC Berkeley Extension Clinical and Regulatory Sciences Get the specialized instruction you need to advance your career. UC Berkeley Extension offers targeted certificates and programs to provide the skills to design and manage clinical trials, navigate compliance issues, and ensure new products and processes adhere to U.S. and international regulatory specifications. Choose from programs in: • Clinical Research Conduct and Management (available online) • Quality and Compliance for Biotechnology • Regulatory Affairs Fall courses are open for enrollment. Learn more. •  Roche (RHHBY) Boosted By Drug-Trial Data More... •  Data May Prove Bristol-Myers Squibb Company (BMY), Pfizer Inc. (PFE) Drug a Winner More... •  Immune Response BioPharma Reports NeuroVax MS Vaccine Increased Results with Women Taking Estrogen More... •  Living Cell Technologies Ltd. Implants First Patients in Argentina Trial More... •  Breast Cancer Study With Hemispherx Biopharma (HEB)'s Ampligen(R) Commences More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News •  FDA Approves Seattle Genetics, Inc. (SGEN) Cancer Drug Adcetris to Treat Two Types of Lymphoma More... •  Health Canada Approves Vertex Pharmaceuticals (MA) (VRTX)'s INCIVEK(TM) (telaprevir) for People With Hepatitis C More... More Drug Approval News •  No FDA Advisory Committee Meeting Planned in Connection With New Drug Application for Corcept Therapeutics Inc. (CORT)'s CORLUX for Cushing's Syndrome More... •  Amgen (AMGN) Announces PDUFA Date for XGEVA® Supplemental Biologics License Application 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! •  Heart Failure Drug Not as Effective on US Patients More... •  Moms' Depression Affects Kids' Brain Structure, Scans Show, University Of Montreal Study More... •  Women Who Take Vitamins Have Fewer Preemies, American Journal of Clinical Nutrition Reveals More... •  Stanford University Study Draws Connection Between Narcolepsy And Influenza More... •  New Way to Treat Common Hospital-Acquired Infection: Novel Approach May Offer Treatment for Other Bacterial Diseases, University of California, Los Angeles (UCLA) Study More... More General Clinical Research 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. 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 • 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. • Biotech Bay (Foster City, California) Gilead Sciences Senior Clinical Data Associate Works collaboratively with CRA, Statistical Programmer, Biostatistician and other Clinical, Global Drug Safety, Regulatory and Project Management staffs to meet project deliverables and timelines for non-routine clinical data acquisition, quality checking and reporting. • Biotech Beach (Westlake, California) Baxter International, Inc. Clinical Data Analyst II Responsible for supporting clinical data management (CDM) operational activities in one or more therapeutic areas. Support the creation, execution and maintenance of Data Management Plans in support of clinical study deliverables. • 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 •  Ohr Pharmaceutical (OHRP) Awarded Key U.S. Composition of Matter Patent for Squalamine More... More Patent News •  BioDelivery Sciences International (BDSI) Announces Commercial Launch of ONSOLIS in Canada More... •  AstraZeneca PLC (AZN) Release: BRILINTA (ticagrelor) Tablets Now Available in U.S. Pharmacies for Patients with Acute Coronary Syndrome More... More Drug Product News Hot Company Southeastern Research Group, Inc. 2000 Centre Pointe Boulevard Tallahassee, Florida 32308 U.S.A. Southeastern Research Group, Inc., is a clinical trials management organization. We represent an alliance of private practice physicians conducting trials in multiple specialties. We offer full-service clinical trials management providing high quality services across Phases II - IV drug and device trials. 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, Suvarna Sheth, Matt Thwin, Maysa Darwish ClinicaSpace.com - Clinical Trials. 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