Gilead Eyes Earlier Approval for QUAD Drug - Sept. 20, 2011

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Tuesday, September 20, 2011  |   |   |   |  UC Berkeley Extension Clinical and Regulatory Sciences Get the specialized instruction you need to advance your career. UC Berkeley Extension offers targeted certificates and programs to provide the skills to design and manage clinical trials, navigate compliance issues, and ensure new products and processes adhere to U.S. and international regulatory specifications. Choose from programs in: • Clinical Research Conduct and Management (available online) • Quality and Compliance for Biotechnology • Regulatory Affairs Fall courses are open for enrollment. Learn more. •  Gilead Sciences, Inc. (GILD) Eyes Earlier Approval for QUAD Drug More... •  Santarus Inc. (SNTS) Announces Supportive Top-Line Results from Budesonide MMX Extended Use Study More... •  Niiki Pharma Announces Positive Interim Data from Ongoing Clinical Trial of Novel Anti-Cancer Agent NKP-1339 More... •  Active Biotech AB (BTPC)'s Prostate Cancer Project TASQ Featured in Journal of Clinical Oncology More... •  New Data on Odanacatib, Merck & Co., Inc. (MRK)'s Phase III Investigational Cat-K Inhibitor for Osteoporosis, Presented at the Annual Meeting of American Society for Bone and Mineral Research More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News •  Vaccine Maker CSL Limited (CMXHF.PK) Downplays Link to Side Effects More... More Discontinuations News More Recalls and Warning News •  Watson Pharmaceuticals, Inc. (WPI) Announces Approval of Amphastar Pharmaceuticals, Inc.'s Generic LOVENOX(R) More... More Drug Approval News •  Mylan Inc. (MYL)'s Matrix Laboratories Limited (MAXL.BO) Gets Tentative FDA Approval for AIDS Drug More... More BLA/NDA/ANDA News More IND News More MAA 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! •  Diabetes May Significantly Increase Your Risk of Dementia Kyushu University Study More... •  More Than a Sign of Sleepiness, Yawning May Cool the Brain, Princeton University Study More... •  One Size Doesn't Fit All for Vitamin D And Men, Northwestern University Feinberg School of Medicine Study More... •  NexBio, Inc. Anti-Flu Drug Reduces Virus in Trial to Seek New Therapy More... •  BG Medicine Release: Study Shows Association of Galectin-3 Levels With Near-Term Rehospitalization in Heart Failure Patients - Results Presented at Heart Failure Society of America 15th Annual Meeting 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. 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Represent and champion our compounds internally and with regulatory authorities. • 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. • 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 •  Rock Creek Pharmaceuticals Discloses Further Anatabine Patent Filing More... More Patent News •  HRA Pharma and Hyundai Pharm First Launch of ellaOne(R) in Asia More... More Drug Product News Hot Company Dyax Corp. 300 Technology Square Cambridge, Massachusetts 02139 U.S.A. Phone: 617-225-2500 Fax: 617-225-2501 Dyax Corp. is a biotechnology company focused on advancing novel biotherapeutics for unmet medical needs, with an emphasis on oncology and inflammatory indications. The Company utilizes its proprietary drug discovery technology, phage display, to identify antibody, small protein and peptide compounds for clinical development. 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, Maysa Darwish, Tammy Liu ClinicaSpace.com - Clinical Trials. Clinical Research. 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