FDA OKs Amgen Bone Drug for Cancer Patients - Sept. 19, 2011

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Monday, September 19, 2011  |   |   |   |  Pharm-Olam International Acquires StatWorks, Inc. With Pharm-Olam's acquisition of StatWorks we have expanded our team Data Management and Biostatistics experts for functional outsourcing and full service clinical trials. Our comprehensive biometric services include: • Integration of randomization into EDC systems, eliminating IVRS costs, with added benefit of full inventory control over supplies • Adaptive, Sequential, and Bayesian design methods • CDISC, SDTM and ADaM datasets • SAS programming, eCRF design, and medical coding in MedDRA/WHO Drug • Streamlining and reconciling across SAE, CTMS, and study DB • Health Outcomes Research and Patient Reported Outcomes • Protocol development, sample size, and randomization Contact us for your resource planning at www.pharm-olam.com, info@pharm-olam.com, USA 1-713-559-7900, UK 44-0-1344-891121 •  FDA OKs Amgen (AMGN) Bone Drug for Cancer Patients More... More Drug Approval News •  Sangamo BioSciences, Inc. (SGMO)'s Blood-Cell Gene Therapy Fights HIV Without Drugs More... •  Merck & Co., Inc. (MRK) HIV Treatment Effective In Combination Study More... •  Bristol-Myers Squibb Company (BMY)'s Once-Daily Hepatitis C Drug Works in Phase II Study More... •  Amgen (AMGN)'s Prolia(R) (Denosumab) Phase 2 Extension Study Showed Continued Increase in Bone Mineral Density Over Eight Years of Treatment More... •  Tarsa Therapeutics Presents Positive Efficacy and Safety Data Comparing its Oral Calcitonin to Nasal Calcitonin and Placebo in Phase 3 Osteoporosis Treatment Trial More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News Drug Discovery & Development Drug Discovery & Development magazine delivers vital insight about the latest technologies and tools used to develop pharmaceutical products to key decision-makers Request Now! •  Surgeons Make Cancer Cells Fluoresce for Removal, University of Groningen Study More... •  Possible Link Between Two Type 2 Diabetes Drugs and Pancreatic Cancer, University of California, Los Angeles (UCLA) Study More... •  Schizophrenia and Epilepsy Have "Strong Link," China Medical University Hospital Study More... •  Gene Variant May Raise Death Risk After Heart Bypass, Duke University Medical Center Study More... •  NanoInk, Inc. Platform Proven to Reproducibly Detect Protein Biomarkers From Dried Blood Spot Samples More... More General Clinical Research News Social & Scientific Systems, Inc., and panel members, Eleanor Feingold, Gina D'Angelo, and Joan Bailey-Wilson, invite you to join us at a symposium to honor Brad Efron for his many contributions to theoretical and applied statistics. We will be discussing emerging statistical challenges in large-scale inference, with a focus on applications in genetics and biomedical imaging. The goal of the symposium is to stimulate discussion; it will include both formal and informal meeting and discussion time, in addition to the featured speakers. The symposium is limited to 200 people. Please RSVP to: LargeData@s-3.com. Please visit here for more information. Market and Product Forecasts: Depression - Pipeline set to rejuvenate saturated market • Access Datamonitor's patient-based depression market forecast in the seven major markets, with transparent methodology and clear assumptions. • Evaluate a highly granular forecast with sales value and volume projections to 2020 at the country, class, product, and regimen level. • Understand depression market dynamics, and which factors will lead to commercial success. Click Here for More Information. • Pharm Country (Bridgewater, New Jersey) Aerie Pharmaceuticals Clinical Research Associate Travel to investigational sites to review CRF data for clinical studies. Assist with data query resolution.Perform study drug accountability. Maintain regulatory document files. Assist in development of: project plan, reference manual, study binder, CRF guidelines, transmittal/accountability forms. • Biotech Beach (Westlake Village, California) Baxter International, Inc. Senior Clinical Project Coordinator Assist Management (i.e., Clinical Project Managers, Managers of Clinical Operations) of Clinical Operations with the day-to-day activities that support clinical trials conducted for new product license applications, for line extensions of existing products, and for post-marketing commitments to Regulatory Authorities. • Rocky Bio (Phoenix, Arizona) Cubist Pharmaceuticals, Inc. Clinical Business Manager - Phoenix West Responsible for achieving and maximizing territory and account sales goals through account management, high level clinical proficiency and effective selling. The CBM will be the primary point of contact for Cubist with key hospital influencers and decision makers across key functional areas including but not limited to physicians, pharmacists and formulary committee members. • Biotech Bay (South San Francisco, California) Cytokinetics, Inc. Manager, Clinical Data Management Provides leadership and coordinates the activities of data management staff at the CROs. Review, and comment on CRFs, annotated CRFs, EDC supporting materials, and edit checks documents. Interacts with Statisticians, Clinical Trial Project Managers, and other personnel to provide support in the areas of data management, data validation, Data base lock, and metrics report generation. • Genetown (Boston, Massachusetts) PAREXEL International Associate Director, Early Phase Clinical Data Services General responsibilities include supervision and management of CDS Project Leads and staff, ensuring the group is trained, mentored and developed. Provide oversight of the execution and productivity of quality CDS Project Lead activities, ensuring adherence to regulatory and PAREXEL standards. Provide input to continuous productivity improvement. Ensure proactive planning takes place and provide issue resolution for the Group. • 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 •  Sanofi (France) (SASY.PA) Wins U.S. Cancer Drug Patent Ruling More... •  Vical Incorporated (VICL) Announces Key International Patents for Vaxfectin(R) Adjuvant More... More Patent News •  Roche (RHHBY) Keeps Drugs From Strapped Greek Hospitals, May Do the Same for Spain More... •  Generic Felbamate Now Available from Amneal Pharmaceuticals More... •  The Flu Season is Coming, but Where is Johnson & Johnson (JNJ)'s Tylenol? More... More Drug Product News Hot Company Synteract, Inc. (San Diego) Global Headquarters 5759 Fleet Street, Suite 100 Carlsbad, California 92008 U.S.A. Phone: 760-268-8200 Fax: 760-929-1419 Established in 1995, Synteract is a full-service Contract Research Organization, dedicated to meeting the clinical development needs of the biotechnology, medical device, and pharmaceutical companies. We have earned a reputation for responsiveness and reliability - ask for references, our clients will attest to this! We have accomplished this by focusing on the unique needs of each client and tailoring our services to meet those needs, while maintaining the highest standards and meeting all requirements for superior quality. 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