FDA Staff Questions New Use for Amgen's Xgeva - Feb. 6, 2012

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Monday, February 06, 2012  |   |   |   |  Online Auction February 8 at 9 AM ET Featuring lab equipment from leading global firms! Lot catalog includes Lot catalog includes HP 1100 Series HPLC Components, Perkin Elmer HS40 Headspace Sampler, Gow-Mac 590-Series Gas Chromatograph, Beckman Coulter Laboratory Centrifuge Model GS-6KR and much more. Register and bid online! •  FDA Staff Questions New Use for Amgen (AMGN)'s Xgeva More... •  United Therapeutics Corporation (UTHR) to Fight Generic Copy of Lead Drug More... •  Santarus Inc. (SNTS) Begins Promoting Cholesterol-Lowering Product FENOGLIDE More... More Drug Product News •  Depomed, Inc. (DEPO) Announces FDA Approval of Merck & Co., Inc. (MRK)'s JANUMET(R) XR That Accesses Depomed Patents Licensed to Merck More... More Drug Approval News •  Clinuvel Files European Marketing Authorisation Application for SCENESSE® (afamelanotide) More... •  Orexigen Therapeutics, Inc. (OREX) Announces Agreement From the FDA on a Special Protocol Assessment for the Contrave(R) Outcomes Trial More... •  ZIOPHARM, Inc. Announces FDA Acceptance of IND for Oral Palifosfamide More... More BLA/NDA/ANDA News More IND News More MAA News •  Anacor Pharmaceuticals, Inc., GlaxoSmithKline (GSK) Suspends 4 Trials for Infection Drug More... •  Merck & Co., Inc. (MRK) Reports Postive Phase III Insomnia Results, to File NDA This Year More... •  Chimerix, Inc. Antiviral Compound, CMX001, Meets CMV Phase 2 Primary Endpoint in Allogeneic Hematopoietic Stem Cell Transplant Recipients More... •  Remedy Pharmaceuticals Release: Novel Drug Shows Significant Promise in Treating Severe Stroke Patients More... •  Argos Therapeutics, Inc. Announces New Data Demonstrating Prolonged Overall Survival in a Phase 2 Study of its Arcelis(TM) Immunotherapy AGS-003 in Combination with Sunitinib in Patients with Metastatic Renal Cell Carcinoma (mRCC) More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News Building Novel Applications with Pipeline Pilot to Drive Next Generation Sequencing This case study shows how scientists are streamlining the process of analyses of DNA sequence information. Enabled by new DNA sequencing technologies, many more scientists and informaticians are interrogating larger and more complex data set. Request Now! •  Green Tea Drinkers Show Less Disability With Age, Tohoku University Study More... •  Ulcer-Causing Bug Tied To Higher Diabetes Risk, University of Michigan Study More... •  Soy Supplements May Not Protect Against Breast Cancer, Northwestern University Study More... •  Diabetes Quadruples Birth Defects Risk, Newcastle Unversity Study More... •  Lower Levels of Sunlight Exposure Link to Allergy and Eczema in Children, European Centre for Enviroment and Human Health Study More... More General Clinical Research News Major 2 - Part Lab Equipment Auction: February 7 - 9 The Branford Group will auction surplus assets to the continuing operations of Stryker Corp., a major orthobiologic R & D laboratory located in Hopkinton, Mass. The first auction will take place on February 7, with bidding available online and in person. The facility's primary capital assets will be auctioned including a 2010 Thermo Fisher LTQ Orbitrap Velos ET9 Mass Spec and a 2010 Waters nanoAcquity UPLC, both brand New and still in their boxes. The second auction will take place electronically with bidding opening on February 8 and closing on February 9. Included in this sale are lab instruments and support equipment. Visit The Branford Group's website for more info. Register to Bid! The CRO Market Outlook to 2016 • Forecast the market size for contract research in the US, Eastern Europe, Western Europe, China, India, Other Asia, and Latin America. • Discover the opportunities presented by emerging CRO markets and optimize your research sourcing strategies. • Understand how CRO utilization is evolving, and what the future of the industry is. Click Here for More Information. • Genetown (Cambridge, Massachusetts) Pfizer, Inc. Clinical Pharmacology Lead Responsible for providing the clinical pharmacology components of Clinical Plans and provides clinical pharmacology expertise to the project team. Plans, designs and oversees clinical pharmacology studies as required throughout all stages of drug development with operational assistance from a Clinical Research Operations • Biotech Bay (San Francisco, California) Biotecher Senior Manager, Clinical Research Operations Support department head in oversight and management of US and ex-US clinical trials. Help ensure that US and ex-US clinical activities are GCP/FDA and/or ICH compliant and on track to meet deliverables. • Pharm Country (Bridgewater, New Jersey) Ipsen Clinical Project Assistant Ensures that the study master files are organised, maintained and complete, and Clinical Operations functions are supported in order to assist in the delivery of Clinical Development objectives and achieve clinical excellence. Assist the Clinical Operations staff in the financial follow up of the studies and assist the senior staff as needed. • Biotech Beach (Pasadena, California) Lotus Clinical Research, Inc. MD/Clinical Research Investigator Responsibilities include oversight and delivery of medical services to patients and study volunteers. This position requires leadership experience and the skills to manage a diverse team. The candidate will provide informed consent to potential study subjects and then determine their medical eligibility for trial participation based on clinical history, physical exam, lab results and other protocol-specific criteria. • BioCapital (Gaithersburg, Maryland) MedImmune, LLC Vice President, Clinical / R&D Quality Leads and directs the strategic direction of the Clinical/R & D Quality Operations organization and is accountable and responsible for the design, development, execution and administration of a GxP Quality System meeting all MedImmune and regulatory agency Good Laboratory Practices (GLP), Good Clinical Practice (GCP) and Pilot Plant Good Manufacturing Practices (GMP) compliance requirements. • Get Noticed! Add your resume to the BioSpace Career Center! • See more than 5,000 job postings in the BioSpace Career Center! Genetown 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 Northeast 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. • Genetown Career Fair, Cambridge, MA February 21, 2012 • BioSpace Career Fair at CALBIO2012, San Francisco, CA March 7, 2012 • BioMidwest Career Fair, Bridgewater, NJ March 22, 2012 • Biotech Beach Career Fair, La Jolla, CA April 17, 2012 • BioCapital Career Fair, Bethesda, MD April 25, 2012 • Pharm Country Career Fair, King Of Prussia, PA May 1, 2012 • BioNC Career Fair, Durham, NC May 2, 2012 • Biotech Bay Career Fair, Burlingame, CA May 29, 2012 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 •  Precision BioSciences Announces Allowances in Fifth and Sixth U.S. Patent Applications Related to Engineered Meganucleases More... More Patent News Hot Company SNBL Clinical Pharmacology Center 800 West Baltimore Street, 5th Floor Baltimore, Maryland 21201 U.S.A. Phone: 800-690-9110 Fax: 410-706-8963 SNBL-CPC partners with pharmaceutical companies, biotech firms and CROs to accelerate drug development utilizing our best-in-class facility, technology, operational excellence and strong affiliations with local academic medical institutions (University of Maryland and Johns Hopkins University). 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, Maysa Darwish, Tammy Liu, Michelle Wong ClinicaSpace.com - Clinical Trials. Clinical Research. 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