"Female Viagra" Fails Ph3 Trails - Dec. 15, 2011

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Thursday, December 15, 2011  |   |   |   |  Equipment Donations: Free eBook Have you considered donating your surplus laboratory equipment? The scientific community thrives on the open exchange of ideas and information. This eBook will help you design and run a successful equipment donation program. You will learn the best practices that have enabled leading organizations to create successful equipment donation programs that allow them to do well, while doing good. For more information, please visit: www.EquipNet.com/HowToDonate. •  "Female Viagra" Fails Ph3 Trials More... •  Phase III Trial Confirms Safety Profile of Novartis AG (NVS) MS Pill More... •  Fat-Burning Roche (RHHBY) Drug Stops Diabetes in Mice, Researchers Say More... •  Successful Completion of Hatchtech's Phase 2b Clinical Trial in Head Lice More... •  Rib-X Pharmaceuticals, Inc. Reports Positive Top-Line Data from Phase 2b Study of Delafloxacin in Patients with Acute Bacterial Skin and Skin Structure Infections More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News •  Eisai Company, Ltd. (ESALY.PK) Announces Canadian Approval of its Anticancer Agent Halaven More... •  #1 Branded Topical Acne Product, Epiduo(R) Gel of Galderma Laboratories, Receives FDA Approval for a New Convenient Pump Dispenser More... More Drug Approval News •  ViroPharma Incorporated (VPHM) Announces Approval of Modernized Labeling for Vancocin(R) (Vancomycin Hydrochloride, USP) Capsules More... •  Vertex Pharmaceuticals Incorporated (VRTX) Release: FDA Grants Priority Review for KALYDECO(TM) (ivacaftor), the First Potential Medicine to Target the Underlying Cause of Cystic Fibrosis More... •  FDA Will Not Require a Risk Evaluation and Mitigation Strategy in Connection With Corcept Therapeutics Inc. (CORT)'s Proposed Distribution of Korlym(TM) for Cushing's Syndrome More... •  Isis Pharmaceuticals, Inc. (ISIS) Updates KYNAMRO Submission Timeline More... •  FDA Agrees With AtheroNova Inc. (AHRO.OB)'s Clinical Development Plan as Proposed 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! •  Heart Drug May Be Effective for Managing Certain Cancers, Queen's University Study More... •  Caffeine Study Shows Sport Performance Increase, Sheffield Hallam University Study More... •  AvidBiotics Release: DGR Technology Platform for Engineering Proteins Advanced in Publication by AvidBiotics Collaborators More... •  Amp Orthopedics, Inc. Expands Clinical Pipeline Initiating Two Trials For Post-Surgical Indications: Knee Replacement and Rotator Cuff Repair More... •  Mayo Clinic Study May Help Physicians Determine How Patients Will Respond to Multiple Myeloma Therapy 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. Innovative Clinical Trial Design and Management • Use detailed case studies of recent adaptive trials featuring companies including Merck, Pfizer, Novartis, GSK, Eli Lilly, and AstraZeneca. • Measure the potential cost savings offered by the reduced development times and improved decision-making associated with adaptive trials. • Assess the logistics of adaptive trial implementations. Click Here for More Information. • 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. • Biotech Bay (Sunnyvale, California) Pharmacyclics, Inc. Clinical Trial Assistant Ensure studies are completed, on time, within budget and in compliance with SOPs, FDA regulations and ICH/GCP guidelines. Set up CTMS system, as appropriate. Assist in preparation of documents including regulatory document templates, study binders, study communications and presentations. • 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 •  Ablynx Adds Another Key Patent to Its Expanding Patent Estate Around Half-Life Extension More... •  Chelsea Therapeutics, Inc. (CHTP) Receives Notice of Allowance of Key U.S. Patent for Novel, Controlled Release Formulation of Northera(TM) More... •  Intellect Neurosciences, Inc. Files Appeal in Europe in Response to Opposition Proceedings Instituted by Elan Pharmaceuticals (ELN) and Wyeth (WYE)/Pfizer Inc. (PFE) More... •  GeNO LLC Receives Two New Patents for Nitric Oxide Delivery Technology 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. If someone forwarded this news to you and you'd like to receive your own copy FREE of charge, simply Subscribe here. Safely unsubscribe from ClinicaSpace.com e-mail at any time by managing your account here.