FDA Panel Gives Nod for More Pain Drug Testing - Mar. 13, 2012

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Tuesday, March 13, 2012  |   |   |   |  Your goals. Our expertise. Norwich Clinical Services is a global contract research organization for the pharmaceutical and biotech industries. Dedicated Norwich program management will guide your program from the initial stages of development through study-end reconciliation with specific focus on budget efficiency and schedule adherence. Please click here for more information. •   FDA Panel Gives Nod for More Pain Drug Testing More... •  Omeros Corporation (OMER)' Eye Drug OMS302 Meets Phase 3 Clinical Trial Goal; Stock Rises +1.47(19.21%) @ 1:16PM EDT More... •  NicOx SA (COX.PA) Shares Gain on Glaucoma Drug Study Results; Earns $10 Million Milestone Under Bausch & Lomb Accord More... •  Dynavax Technologies Corporation (DVAX) Release: Phase 3 Data on HEPLISAV(TM) in Adults Aged 40-70 Published in VACCINE More... •  Medivir AB (MVIRb.F) Announces New Studies in Phase III Program for TMC435 More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News •  FDA Issues Warning Letter to Warner Chilcott, PLC (WCRX) Suggesting Subpotent Birth Control Pills Problem More... More Discontinuations News More Recalls and Warning News •  Enzo Biochem (ENZ)'s Clinical Laboratory Applies for NY State Health Department Approval for First Assay Based on its AmpiProbe™ Amplification Platform More... •  Cornerstone Therapeutics Inc. Receives FDA Acceptance for CRTX 080 NDA for Treatment of Hyponatremia More... More BLA/NDA/ANDA News More IND News More MAA 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! •  Red Meat Linked to Premature Death, Harvard School of Public Health Study More... •  Statins May Cut Parkinson's Disease Risk, Harvard School of Public Health Study More... •  Sugar-Sweetened Drinks Linked to Increased Risk of Heart Disease in Men, Harvard School of Public Health Study More... •  Tweens Just Say "Maybe" to Cigarettes and Alcohol, Concordia University Study More... •  Narcissism Impairs Ethical Judgment Even Among the Highly Religious, Baylor University Study More... More General Clinical Research News Cell Culture Technology Workshop A new, three-day, hands-on, laboratory training for bioscience professionals March 26-28, 2012 The University of Maryland, together with industry experts, is offering a new three-day workshop on cell culture technology. Geared toward bioscience industry professionals, this workshop combines eight lectures and eight lab exercises focusing on the theory and practical applications of cell culture technology. The lectures will cover principles, practices and case studies leading directly into laboratory exercises performed at the Biopharmaceutical Advancement Facility. The lab exercises will cover a broad range of topics: from inoculation of cultures, to aseptic sampling to the preparation, inoculation, and harvest of a bioreactor. The lectures and lab exercises will cover applications of both anchorage dependent and suspension adapted cell lines. This workshop is designed for industry professionals, including bench scientists, QA/QC, manufacturing, business development, and sales personnel seeking to advance their knowledge and experience in cell culture. For more information and to register, visit: http://www.mtech.umd.edu/biotech/workshops/cell_culture_technology/index.html. Optimizing Clinical Trials Through IT • Examine the trends shaping clinical trials. • Learn how social media are being used in patient recruitment. • Analyse the potential of electronic health record data in clinical development. Click Here for More Information. • BioMidwest (Lake Forest, Illinois) Hospira, Inc. Senior Clinical Quality Compliance Auditor Perform effective audits for Hospira Global Clinical Quality Compliance to ensure compliance and conformance with global GCP regulations and guidance. Work closely with Global Clinical Operations, the various clinical trail sites, and the corporate leadership team to drive a proactive culture of quality and compliance for clinical trial processes. • Biotech Bay (Sunnyvale, California) Pharmacyclics, Inc. Clinical Trial Manager/Senior Clinical Trial Manager Leads Clinical Research Associates and/or Clinical Trial Assistants for the implementation and management of clinical trials. Plans and manages clinical development trials to ensure studies are completed, on time, within budget, and in compliance with SOPs, FDA regulations and ICH/GCP guidelines. • BioForest (Pacific NorthWest, Washington) Biotecher Senior Director Clinical Development Directs and oversees GCP and/or ICH global clinical team activities to ensure that clinical department deliverables are met. Lead clinical design, planning, execution, and development. • Pharm Country (Morris County, New Jersey) Omega Management Group Associate Director/Director Clinical Development Serve as disease area scientific and medical expert for internal (e.g., CTT, International Clinical Team, Scientific Review Committee, Franchise Boards, internal local medical organizations and other line functions) and external customers (e.g., Health Authorities, Key Opinion Leaders (KOLs)). Provide support for medical marketing activities (e.g., speaker training, advocacy, KOL management, advisory boards, launch support, promotional material). • Biotech Beach (Irvine, California) Allergan Inc. Senior Manager, Clinical Business Operations Oversees and ensures the successful execution many central business processes which enable the execution of clinical studies. The CS Manager may be responsible for contracting, vendor management, Beacon system support, Impact system support, metrics reporting, and/or budget & forecast development and support. • Get Noticed! Add your resume to the BioSpace Career Center! • See more than 5,000 job postings in the BioSpace Career Center! Pharm Country 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 tri-state area. 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. • Pharm Country 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 •  Cortex Pharmaceuticals, Inc. (COR) Reports Issuance of Next Generation of AMPAKINE® Patents More... •  Gevo, Inc. Granted Key Patent Covering Critical Technology to Enable Commercially Viable Yields of Isobutanol Production from Yeast More... More Patent News •  Pharma Industry Split Over Nod to Natco Pharma Limited to Sell Bayer AG (BAY.F)'s Cancer Drug; Verdict Opens Door for Cheaper Drugs More... •  Elite Pharmaceuticals, Inc. (ELI) Announces First Shipment of Generic Hydromorphone Product More... More Drug Product News Hot Company SGS Life Science Services 201 Route 17 North 11804 North Creek Parkway South Rutherford, New Jersey 07070 U.S.A. Phone: 201-508-3000 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, Maysa Darwish, Tammy Liu, Michelle Wong ClinicaSpace.com - Clinical Trials. Clinical Research. Community. • ClinicaSpace is a registered trademark of BioSpace, Inc. • Please distribute this e-cast freely. • Credit any excerpts as follows: Copyright 2012 ClinicaSpace http://www.clinicaspace.com • While BioSpace and its agents used their best efforts in collecting and preparing the information published herein, we do not assume, and hereby disclaim, any liability for any loss or damage caused by errors or omissions, whether such errors or omissions resulted from negligence, accident or other causes. 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