FDA Delays Ruling on Bristol, Astra Diabetes Drug - Oct. 27, 2011

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Thursday, October 27, 2011  |   |   |   |  Assay Depot has created the world's largest network of public and private cloud-based Research Exchanges: Life science researchers from 53 countries use our public Research Exchange to find, create and purchase research services and products and to communicate with 5000+ research vendors. Pharmaceutical companies, universities and non-profit organizations use a private Research Exchange to manage and strengthen internal and external research partnerships. Research vendors use public and private Research Exchanges to offer their services and products to the global research community. Researchers - Use our free public marketplace at assaydepot.com. Vendors - Get a free vendor account at http://backoffice.assaydepot.com/. •  FDA Delays Ruling on Bristol-Myers Squibb Company (BMY), AstraZeneca PLC (AZN) Diabetes Drug More... More PDUFA News •  Moberg Derma Discontinues Preclinical Development Program for A-Fizz More... More Discontinuations News More Recalls and Warning News •  European Commission (EC) Clears Pfizer Inc. (PFE)'s Pneumococcal Vaccine for Use in Individuals Over Age 50 More... •  Mylan Inc. (MYL) Receives Approval for Generic Version of MS Contin(R) Tablets More... More Drug Approval News •  FDA Schedules Delcath Systems, Inc. (DCTH) Pre-New Drug Application Meeting Date More... •  Alexza Pharmaceuticals, Inc. (ALXA) Announces Submission of European Marketing Authorization Application for Adasuve(R) (Staccato(R) Loxapine) More... More BLA/NDA/ANDA News More IND News More MAA News •  Sunovion Pharmaceuticals Inc.'s LATUDA(R) (lurasidone HCl) Shown to be Non-Inferior to SEROQUEL XR(R) (quetiapine fumarate XR) in Risk for Relapse in a 12-Month, Double-Blind Extension More... •  BioNovo, Inc. (BNVI) Initiates Menerba (MF101) Phase 3 Clinical Trial for Menopausal Hot Flashes More... •  Dynavax Technologies Corporation (DVAX) Phase 3 Data in Chronic Kidney Disease Demonstrates Superiority of HEPLISAV(TM) vs Engerix-B(R) More... •  Merck & Co., Inc. (MRK) Release: The New England Journal of Medicine Publishes Additional Efficacy and Safety Data for GARDASIL® in Males More... •  Activartis Develops Dendritic Cell-Based Therapeutic Cancer Vaccine in Phase II More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News Bioscience Technology This magazine provides information to life science/biotech researchers searching for technology, tools and techniques to conduct better, more cost-efficient and effective research. Request Now! •  Diet Failures Tied to Long-Lasting Hormones Driving Urge to Eat, University of California, Los Angeles (UCLA) Study More... •  Ovarian Cancer Risk Slashed by the Pill, Cancer Research UK Cambridge Research Institute Study More... •  Flu Shots Less Effective for Obese People, University of North Carolina Study More... •  Malaria Vaccine Aims to Target Multiple Disease Strains, Edinburgh University Study More... •  Mom's Antibody Attack Linked to Autism, University of California, Davis (UCD) Study More... More General Clinical Research News CHI's 11 Annual PepTalk: The Protein Science Week January 9-13, 2012 | Hotel Del Coronado | San Diego, CA www.www.chi-peptalk.com PepTalk 2012 continues the tradition of strong scientific programming centered around protein-based therapeutics. The four distinct protein pipelines focused on formulation, purification, biotherapeutics and expression range from applying protein discovery research, to developing downstream protein products that ultimately lead to clinical applications. Create your own agenda by moving between the tracks and choosing the sessions that best fit your research and networking needs. Please click here for more information. The Top 10 Contract Research Organizations • Learn from the strategies of the top 10 CRO companies to target future growth markets effectively, avoid their mistakes, replicate their successes. • Benchmark your performance against the leading CRO companies using market share data by company included in this report. • Predict the key growth areas across the various phases of the clinical research. Click Here for More Information. • Southern Pharm (Memphis, Tennessee) St. Jude Children's Research Hospital Clinical Research Associate-RN I Supporting the Neuro-Oncology Division in the Cancer Control Administration Department operates under general supervision. This position ensures compliance with eligibility, prescribed interventions and evaluations of the assigned protocol(s). Provides patient care, education, and management. Prepares submission for reportable events. • BioMidwest (Minneapolis, Minnesota) DaVita Clinical Research Senior Project Manager - Early Clinical Studies Lead an experienced and dedicated team in an early clinical research centered environment. This position will be part of our Senior Management Team, overseeing 3 Project Managers with a focus on ensuring that our clinical studies are conducted effectively and sponsor deliverables are met. From planning to implementation, this role will oversee and participate in all aspects of the project management lifecycle. • BioCapital (Gaithersburg, Maryland) MedImmune, LLC Director, Clinical Program Manager Responsible for technical leadership and successful execution of projects, facilitation of effective inter-and intra- departmental relationships, efficient functioning group, oversight of training, evaluation of new processes and methods, and achievement of departmental corporate goals and objectives on time and on budget. • Genetown(Cambridge, Massachusetts) AVEO Pharmaceuticals, Inc. Clinical Planning Manager Will serves as the point person to provide valuable analysis and clinical forecasts concerning the business needs within Clinical Development. Specific areas of expertise will include a strong business perspective, strategic planning, ability to develop and manage timelines, and present findings to related business partners. • Pharm Country (Nutley, New Jersey) Roche Associate Clinical Director Assists the Translational Medicine leader in all areas of project and study planning, evaluation, documentation including IND and annual report, clinical NDA preparation and protocol preparation. Is responsible for at least one study (in all aspects). • Get Noticed! Add your resume to the BioSpace Career Center! • See more than 5,000 job postings in the BioSpace Career Center! BioCapital 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 mid-atlantic 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. • BioCapital 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 •  NeuroNascent, Inc. Issued US Patent for Neurogenesis, Therapeutic Candidates More... •  TapImmune Inc. (TPIV) Announces Issuance of US Patent More... More Patent News Hot Company Coldstream Laboratories Inc. 1500 Bull Lea Road, Suite 250 Lexington, Kentucky 40511 U.S.A. Phone: 859-257-6600 Fax: 859-323-5985 At Coldstream Laboratories Inc. (CLI), we're seasoned at turning pharmaceutical development ideas into safe, pure, and effective clinical pharmaceutical dosage forms. Since 1986, we have completed more than 200 formulation development projects that led to clinical trials providing us extensive clinical manufacturing experience with both commercial product development and grant-funded projects from such sources as the National Institutes of Health. 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.