InterMune Falls as German Body Questions Lung Drug - Dec. 16, 2011

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Friday, December 16, 2011  |   |   |   |  Online Auction January 11 at 9 AM ET Featuring lab equipment from Elan and other leading global firms! Register and bid online. •  InterMune, Inc. (ITMN) Falls as German Body Questions Lung Drug More... •  Pharmasset, Inc. (VRUS) to Change Design of Hepatitis C Treatment Study, Says Trial Change Won't Affect Gilead Sciences, Inc. (GILD) Takeover More... •  Pfizer Inc. (PFE)'s Lyrica Helps in Phase III Restless Legs Syndrome Study More... •  SYGNIS Pharma AG Says Stroke Drug AX200 Failed to Meet Study Goal More... •  Valeant Pharmaceuticals International (VRX) Announces Successful Results From Phase III Onychomycosis Trials More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News •  Roche (RHHBY) Melanoma Drug Wins European Green Light More... •  FDA Approves Baxter International, Inc. (BAX)'s ADVATE as the Only FVIII for Routine Prophylaxis in Both Adults and Children with Hemophilia A More... More Drug Approval News •  Gilead Sciences Ltd. (GILD) Seeks First-ever Approval for Drug to Prevent HIV More... •  NeurogesX, Inc. (NGSX) Confirms FDA Advisory Committee to Review sNDA for Qutenza(R) (capsaicin) 8% Patch for HIV-Associated Peripheral Neuropathy (HIV-PN) More... More BLA/NDA/ANDA News More IND News More MAA News Quantifying the Value of Pipeline Pilot, the Accelrys Scientific Enterprise Platform This white paper outlines the methodology, sources of value, and quantifiable results from bringing products to market faster, avoiding unproductive experiments, saving developer time, and more. Request Now! •  Teaching Children With Autism to Imitate Others May Improve Social Skills, University of Michigan Study More... •  Medical College of Wisconsin Study Suggests Early ART in Recently HIV-Infected Patients Preferable to Delayed Treatment More... •  Williams College and University of Texas Study Finds Unattractive Men Most Likely to Incorrectly Think Women Really Dig 'em More... •  Malaria During Pregnancy: New Study Assesses Risks During First Trimester Shoklo Malaria Research Unit Reveals More... •  "Ecstasy" May Cause Long-Term Changes in Brain Chemistry, Vanderbilt University Medical Center Study More... More General Clinical Research News Third Annual X-Gen Congress & Expo Marhc 5-8, 2012 | San Diego, California www.XGenCongress.com Join us March 5-8, 2012 in San Diego, California to apply both established and emerging genomic technologies and discover why data is the driving force that enables these genomic discoveries. Leveraging these discoveries continues to impact the prevention, detection, and treatment of disease. Programs are organized and designed for you to attend sessions relevant to your unique research needs. 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. • BioCapital (Rockville, Maryland) Otsuka America Pharmaceutical, Inc. Manager Clinical Development TB Will provide leadership and management for the microbiology procedures for the TB program and ensure quality of the endpoint assessment at global trial sites. S/he will ensure cross-study consistency in protocol design, data analysis, and reporting. • Genetown (Cambridge, Massachusetts) Cubist Pharmaceuticals, Inc. In House Clinical Research Associate Managing clinical study documentation (e.g. documentation for study start-up and IRB submission) and Trial Master File component. Knowledge of the processes involved in clinical studies following Good Clinical Practice (GCP) and the Code of Federal Regulations is required. • Biotech Beach (Irvine, California) Allergan Inc. Clinical Study Manager Will ensure that clinical strategies are translated into operational plans and executed in line with clinical development plans. In particular they will align operational execution activities with agreed upon project priorities, timings and quality specifications and adhere to all relevant regulations including GCP, ICH and PhRMA guidelines, Regulatory requirements, and Allergan's SOPs and policies. • BioForest (Bothell, Washington) Seattle Genetics, Inc. Clinical Data Associate II/ Senior Clinical Data Associate Responsible for all aspects of the data management process throughout a clinical trial. Specific responsibilities will include: creating a Data Management Plan, designing online Case Report Forms for an EDC data management system, defining the edit checks required per study, coordinate medical coding, SAE reconciliation, and identifying and resolving data discrepancies. • Pharm Country (Bridgewater, New Jersey) Sanofi Senior Clinical Trial Manager Responsible for the overall operational planning and activities for the implementation and conduct of clinical exploratory pharmacology clinical trials in compliance with ICH, GCP's, SOPs, local requirements, internal/departmental guidelines, and established timelines. • Get Noticed! Add your resume to the BioSpace Career Center! • See more than 5,000 job postings in the BioSpace Career Center! BioSpace Life Science Career Fairs are the biotech industry's premier career events. Featuring well-respected employers from around the nation, our job fairs attract top candidates in the biotech, pharmaceutical, life science and medical device industries. With such a great number of recruiters and hiring managers from top biotech companies attending our career fairs, there are an abundance of opportunities available for job seekers. Many different disciplines within the industry are represented bringing a diversity of candidates to our job fairs. Companies seeking pharmaceutical sales representatives and marketing jobs regularly attend our job fairs. Engineering and technical jobs can be found, as well as regulatory jobs and positions in QA/QC. Individuals desiring a science job or a research job will find many opportunities at our job fairs. In addition, hiring managers seeking candidates for clinical research jobs also attend our events. 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 •  SpinalCyte, LLC Receives Notice Of Acceptance on Australian Patent for Spinal Disc Tissue Engineering More... More Patent News Hot Company SGS Life Science Services 201 Route 17 North 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 2011 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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