Shire Pulls BLA App for Rare-disease Drug - Mar. 15, 2012

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Thursday, March 15, 2012  |   |   |   |  Lab Equipment: Featuring Equipment from Par Pharmaceuticals & Other Leading Global Firms! Click here for more information and to view the catalog. •  Shire plc (SHPGY) Pulls BLA App for Rare-disease Drug More... More BLA/NDA/ANDA News More IND News More MAA News •  FDA Approves Bayer HealthCare Pharmaceuticals (BAYA.F) Oral Contraceptive Demonstrated to Treat Heavy Menstrual Bleeding (HMB) More... •  Teva Pharmaceutical Industries Limited (TEVA) Wins Approval for First Generic Lexapro for Depression; Awarded 180-Day Period of Marketing Exclusivity More... •  Alma Lasers New Nail Fungus Approach Receives FDA Clearance More... •  South Korea to Approve Pfizer Inc. (PFE)'s Viagra Generics More... More Drug Approval News •  Phase III Study of Teva Pharmaceutical Industries Limited (TEVA)'s Oral Laquinimod Published in The New England Journal of Medicine Demonstrates Clinical Benefits for Multiple Sclerosis Patients More... •  Foamix's Minocycline Foam - 100% Effective in Impetigo Phase II Clinical Trial With No Side Effects - 80% Improved Significantly After 3 Days of Treatment More... •  Novelos Therapeutics, Inc. (NVLT) Announces Enrollment of First Patient in Brain Cancer Trial with I-124-CLR1404 (LIGHT) Cancer-Targeted PET Imaging Agent at UW Carbone Cancer Center More... •  LEO Pharma Release: The New England Journal of Medicine Article Reviews the Benefits of Ingenol Mebutate in Field Treatment of Actinic Keratoses More... •  Abbott Laboratories (ABT) Announces Patient Enrollment in Two Phase 3 Studies of HUMIRA(R) (adalimumab) for Moderate to Severe Hidradenitis Suppurativa More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval 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! •  Diabetes Linked to Ulcer-Causing Bacteria, NYU Langone Medical Center Study More... •  Walking May Halve Genetic Influence On Obesity, Harvard School of Public Health Study More... •  Cadmium in Diet is Linked to Higher Breast Cancer Risk, Karolinska Institute Study More... •  Womb Environment Linked to Childhood Obesity, Newcastle University Study More... •  Eyesight "Clue" to Mental Decline, University of California, San Francisco (UCSF) Study More... More General Clinical Research News Value-driven Engineering: A National Conference on Medical Innovation and US Global Competitiveness April 22-24, 2012 John S.Knight Center 77 E. Mill Street, Akron, Ohio Event Website Join us April 22-24, 2012 for the Value-driven Engineering National Conference on Medical Innovation for U.S. Global Competitiveness. Value-driven Engineering is a national effort launched in 2011 that actively engages our nation's thought leaders in various sectors to explore the promise of maintaining our country's competitiveness through a medical device development strategy that focuses on product design based on patient need, resource optimization and efficiency. During the conference attendees from industry, academia, government, and public and private sectors will focus on developing the Value-driven Engineering equation, analyzing the components necessary for Value-driven Engineering, exploring real-world examples of Value-driven principles and promoting public-private engagement of the Value-driven Engineering strategy. A Call for Case Studies has been released. 3-5 case studies will be awarded $1,000 and an opportunity to present at the conference. One of the finalists will also be awarded a grand prize $2,500 at the conference. Learn more by visiting our website at www.abiakron.org/national-vde-conference-akron-ohio. 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. • Pharm Country (Hartford, Connecticut) Roche Diagnostics Clinical Specialist Support all aspects of clinically focused sales for Roche's ACCU-CHEK product line, which includes blood glucose meters, insulin delivery systems, diabetes information management solutions, diabetes programs and services, and co-promoted product solutions within an assigned territory. • Genetown (Billerica, Massachusetts) PAREXEL International Clinical Logistics Assistant / Clinical Logistics Specialist In this role you will perform sample tracking, support query processes, and various site distribution activities. Hired individuals will be responsible for keeping clinical trial material inventories updated daily, collection, tracking, and checking shipment forms and other shipment-related communications (paper based and/or electronically), as well as quality control. • 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. • 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 •  Watson Pharmaceuticals, Inc. (WPI) Confirms BYSTOLIC(R) Patent Challenge More... •  European Patent Issued for V&P Scientific, Inc.'s "Vortex Stirring of Vessels in a Two-Dimensional Array" More... •  Tekmira Pharmaceuticals Corporation Provides Update on Progress in USPTO Patent Interference Proceedings More... More Patent News •  Boehringer Ingelheim Corporation's Pradaxa Wins UK Agency's Backing in Stroke More... •  Amneal Pharmaceuticals Launches Escitalopram Oxalate Oral Solution More... •  InterMune, Inc. (ITMN) Release: Esbriet(R) (pirfenidone) Benefit Granted by German Federal Joint Committee (G-BA) More... More Drug Product News Hot Company Accelovance 2275 Research Boulevard, Suite 700 Rockville, Maryland 20850 U.S.A. Phone: 240-238-4900 Fax: 240-238-4901 Accelovance, Inc., based in Rockville, MD, is a clinical services company specializing in high patient throughput from recruitment through study completion. Accelovance has developed a model to increase the reliability and productivity on Phase I (outpatient) and Phase II-IV trials. 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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