Dynavax: FDA Agrees With HEPLISAV Findings - July 28, 2011

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Thursday, July 28, 2011  |   |   |   |  FIRST ASIA PACIFIC PHARMACEUTICAL COMPLIANCE CONGRESS September 13 - 15, 2011 The Ritz-Carlton, Millenia Singapore Sponsored by Pharmaceutical Compliance Forum and Asia Pacific Healthcare Industry Compliance Team Please click here for more information. •  Dynavax Technologies Corporation (DVAX): FDA Agrees With HEPLISAV(TM) Findings More... •  Histogenics Corporation Reports Positive Phase 2 Data for NeoCart Autologous Cartilage Tissue Implant for the Treatment of Knee Cartilage Injury More... •  Entest Biomedical, Inc. Announces Promising Results From ImenVax(TM) Canine Cancer Vaccine Safety Study More... •  RegeneRx Biopharmaceuticals, Inc. (RGRX) Set to Begin Enrolling Phase 2 Dry Eye Trial More... •  Inspiration Biopharmaceuticals Announces Data from OBI-1 Pivotal-Stage Program in Hemophilia at 23rd ISTH Congress More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News •  Amylin Pharmaceuticals, Inc. (AMLN), Eli Lilly and Company (LLY) and Alkermes (ALKS)'s BYDUREON Reply Submitted to FDA More... More PDUFA News •  Yaupon Therapeutics Inc. Submits New Drug Application for Proprietary Gel Formulation of Mechlorethamine Hydrochloride More... •  Genzyme Corporation (GENZ) and Isis Pharmaceuticals, Inc. (ISIS) Announce Submission of European Marketing Authorization Application for Mipomersen (Kynamro(R)) More... More BLA/NDA/ANDA News More IND News More MAA News •  Fructose Consumption Increases Risk Factors for Heart Disease, University of California, Davis (UCD) Study More... •  Increased Muscle Mass May Lower Risk of Pre-Diabetes, University of California, Los Angeles (UCLA) Study More... •  Yale University Researchers Show How Memory is Lost -- and Found More... •  Coronary Calcium Linked to Maintenance Warfarin, Maastricht University Medical Center Study More... •  Metabolic Syndrome Increases Risk of Both Major Types of Primary Liver Cancer, National Cancer Institute Study More... More General Clinical Research News 3rd Annual Partnerships in Clinical Trials Asia October 12-14, 2011 Grand Hyatt Shanghai The largest concentration of clinical decision makers specializing in clinical development, operations and outsourcing meet to provide you the opportunity to establish benchmarks, standards and next practices in the development and commercialization of products in a global marketplace. The agenda is filled with in-depth case studies on strategic partnering and effective outsourcing to ensure quality, control costs and accelerate cures to market. 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 • Biotech Beach (San Diego, California) Ardea Biosciences, Inc. Clinical Program Manager The overall responsibility will be to manage one or more phase 2-3 studies for our lead development program in Gout. The successful candidate will manage CROs, clinical sites, liaise with Finance and Project Management. Etc. • BioCapital (Columbia, Maryland) Pfizer Inc. Director, Clinical Research and Development The purpose of the position is to provide medical and scientific expertise to design, plan and implement preclinical and clinical development programs for investigational and marketed drugs. Etc. • BioMidwest (Lake Forest, Illinois) Hospira, Inc. Associate Director/Director Biologics Drug Product Formulation and Process Development Will be responsible for identifying and developing suitable Drug Product formulations and manufacturing processes for Hospira's growing portfolio of Global Biologics compounds. Etc. • Genetown (Cambridge, Massachusetts) Biogen Idec Associate Medical Director Fampridine Will lead the Global Medical Affairs Team activities associated with product life cycle management. The position is responsible for the support and execution of the Life Cycle Management plan as it pertains to Global Medical Affairs activities, etc. • Biotech Bay (San Francisco, California) Johnson & Johnson Family of Companies Senior Clinical Science Liaison- Oncology A field based role that provides scientific and research support to opinion leaders and other healthcare providers, supports the Clinical Research Program, and is involved in key internal scientific initiatives. • 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 •  Is AstraZeneca PLC (AZN) Overcharging for its Bloodthinner? More... •  National Institute for Clinical Excellence (NICE) OKs Celgene (CELG)'s Thalidomide for Multiple Myeloma More... More Drug Product News Hot Company Nektar Therapeutics 490 Discovery Drive Huntsville, Alabama 35806 U.S.A. Phone: 256-533-4201 Fax: 256-533-4805 Nektar Therapeutics is a biopharmaceutical company developing novel therapeutics based on its proprietary polymer conjugation technology platform. 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. Clinical Research. 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