FDA Panel Backs Seattle Genetics Lymphoma Drug - July 14, 2011

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Thursday, July 14, 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. •  FDA Panel Backs Seattle Genetics, Inc. (SGEN) Lymphoma Drug More... More BLA/NDA/ANDA News More IND News More MAA News •  Bristol-Myers Squibb Company (BMY) Melanoma Drug Yervoy Gets EU Approval More... •  GlaxoSmithKline (GSK) and Human Genome Sciences, Inc. (HGSI) Receive European Authorization for BENLYSTA(R) (Belimumab) More... More Drug Approval News •  Inovio Pharmaceuticals (INO) Demonstrates Positive Immune Responses in Phase I Clinical Trial of SynCon(TM) H5N1 Influenza Vaccine and Launches Multi-Subtype Influenza Vaccine Phase I More... •  Advanced Cell Technology Announces First Patients Undergo Embryonic Stem Cell Transplantation Treatment for Stargardt's Disease and Macular Degeneration at University of California, Los Angeles (UCLA)'s Jules Stein Eye Institute More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News •  "Swine Flu" Shot May Be Cleared of Guillain-Barre Charges, a Study in the British Medical Journal More... •  Oxygen in Eyes May Raise Glaucoma Risk, Washington University Study More... •  Small Health Woes Increase Dementia Risk, Dalhousie University Study More... •  Drugs from Abbott Laboratories (ABT)'s Lupron and AstraZeneca PLC (AZN)'s Zoladex May Boost Life Expectancy for Prostate Cancer Patients More... •  St. Jude Children's Research Hospital Release: Bone Marrow Transplant Survival More Than Doubles for Young High-Risk Leukemia Patients More... More General Clinical Research News SafeBridge Consultants, Inc. Announces Two Potent Compound Safety Training Offerings (May be Taken Separately or Consecutively) The SafeBridge original Potent Compound Safety "Boot Camp"® (Boot Camp I) is a comprehensive two-day course in pharmaceutical potent compound safety focused on training EH&S and related professionals in critical technical concepts and proactive safety programs in pharmaceutical industrial hygiene, occupational and environmental toxicology, analytical chemistry, and risk communication. The SafeBridge new Advanced Concepts to Support Drug Development of Potent Compounds from R&D through Manufacturing - Potent Compound Safety "Boot Camp II" is a one-day advanced course focused on case studies and problem-solving to address potent compound safety issues in discovery, development, contract manufacturing and commercialization. COURSE SEATING IS LIMITED AND USUALLY SELLS OUT! New Brunswick, New Jersey Boot Camp I September 20-21, 2011 Boot Camp II September 22, 2011 Contact: Susan Custer: susan.custer@safebridge.com or 650-961-4820 x 231 or www.safebridge.com 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 (Parsippany area, New Jersey) Omega Management Group For the assigned clinical trial(s) within program/brand, as a member of the Clinical Trial Team (CTT), provide medical scientific input to e.g,: All activities related to planning, execution and reporting of clinical trials. Etc. • Genetown (Cambridge, Massachusetts) Novartis Institutes for BioMedical Research, Inc. Pharmacogenetics Lab Leader Lead and manage the Biomarker Development (BMD) Pharmacogenetics Laboratory in Cambridge. Design, direct, review, and supervise genotyping studies and reports. Etc. • BioCapital (Gaithersburg, Maryland) MedImmune, LLC Associate Director, Clinical Development Establish and approve scientific methods for design and implementation of applicable clinical protocols, data collection systems, and final reports. Medical Monitor in planning, conducting and evaluating clinical trials. Etc. • Southern Pharm (Memphis, Tennessee) St. Jude Children's Research Hospital Clinical Research Associate Performs data abstraction, collection, and entry to support clinical research. Prepares submission for all reportable events. Develops, maintains, and/or monitors case report forms. Etc. • Biotech Bay (Menlo Park, California) Auxogyn, Inc. Lead Scientist This position is responsible for the overall management and development of scientific research and development at Auxogyn. The Lead Scientist interfaces with engineering, clinical and marketing staff to provide technical lead in scientific projects that enhance the company's current or future products and promote their transition to the clinic. • 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 •  NeuralStem Inc. Announces Notice of Allowance for Two Additional Neurogenic Compound Patents More... More Patent News Hot Company InterMune, Inc. 3280 Bayshore Boulevard Brisbane, California 94005 U.S.A. Phone: 415-466-2200 Fax: 415-466-2329 InterMune, Inc. is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and hepatology. 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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