SGEN's New Drug Price: $108K Per Pt. - Aug. 23, 2011

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Tuesday, August 23, 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. •  Seattle Genetics, Inc. (SGEN)'s New Drug Price: $108K Per Pt. More... •  UK's National Institute for Clinical Excellence (NICE) Nixes AstraZeneca PLC (AZN) Breast Cancer Drug More... More Drug Product News •  Apricus Biosciences (APRI) Announces FDA Clearance for Its Second OTC Anti-Itch Drug (Hydrocortisone-D(TM)) Containing NexACT(R) Technology More... More Drug Approval News •  Amgen (AMGN): FDA to Decide on New Xgeva Use by April More... More PDUFA News •  FDA Speeds Review of Bayer AG (BAY.F), Algeta's Prostate Cancer Drug More... •  Cell Therapeutics, Inc. (CTIC) Submits Day 120 Response for Pixantrone Marketing Authorization Application to European Medicines Evaluation Agency; Potential Q1 2012 Opinion on Approval More... More BLA/NDA/ANDA News More IND News More MAA News •  GlaxoSmithKline (GSK) HPV Vaccine Protects Women From Anal Cancer More... •  Symphogen A/S Announces Initiation of Phase 2 Trial of Sym004 EGFR Antibody Mixture in Patients with Squamous Cell Carcinoma of Head and Neck Cancer More... •  Seattle Genetics, Inc. (SGEN) Announces Initiation of a Phase II Clinical Trial of ADCETRIS in CD30-Positive Non-Hodgkin Lymphoma More... •  Apceth Starts First Phase I/II Clinical Study on Somatic Cell Therapy for Peripheral Arterial Occlusive Disease (pAOD) More... •  Metabolon Study Provides Insight Into Acrolein-Induced Lung Injury More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval 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! •  Too Much Salt May Harm Mental Health, Baycrest, Institut Universitaire de Geriatrie de Montreal, McGill University and the Universite de Sherbrooke Study More... •  Bone Drug Tied to Lower Colon Cancer Risk, University of Manitoba Study More... •  Swine Flu, Not Vaccine, May Trigger Narcolepsy, Beijing University People's Hospital Study More... •  Infections Among Those With Heart Devices Has Doubled, Thomas Jefferson University Study More... •  Fewer Infant Colds When Moms Take DHA, Emory University 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 • 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. • 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. • 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 •  Angle PLC Release: Parsortix, Inc. Granted US Patent More... More Patent News 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. SGS serves various life science companies, including pharmaceutical, biopharmaceutical, biotechnology, and medical-device manufacturers. 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. Clinical Research. 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