FDA Panel Says No to Astra, Bristol Diabetes Pill - July 20, 2011

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Wednesday, July 20, 2011  |   |   |   |  The ADAPT 2011 Congress Features 5 tracks and 7 short courses exploring the relationship between biomarkers and the promise of personalized therapy, how circulating tumor cells (CTCs) could better track the progression of cancer, and adaptive trials that bring targeted therapies to market. Discount registration by July 22. To learn more, visit www.ADAPTcongress.com. •  FDA Panel Says No to AstraZeneca PLC (AZN), Bristol-Myers Squibb Company (BMY) Diabetes Pill More... More BLA/NDA/ANDA News More IND News More MAA News •  AstraZeneca PLC (AZN) Puts Heart Warning on Anti-Psychotic Seroquel More... More Discontinuations News More Recalls and Warning News •  Dynavax Technologies Corporation (DVAX) Phase 3 Demonstrates Superiority and Safety of HEPLISAV(TM) vs. Engerix-B(R) More... •  VIVUS, Inc. (VVUS) Release: Topiramate Exposure and Birth Defect Data to be Presented at the 29th International Epilepsy Congress More... •  Data on Bristol-Myers Squibb Company (BMY)'s Investigational Treatment for Alzheimer's Disease Demonstrate Potential Therapeutic Window at Doses Below 100 mg in Phase II Safety and Tolerability Study More... •  Gilead Sciences, Inc. (GILD)'s Investigational Antiretroviral Elvitegravir Once Daily Non-Inferior to Raltegravir Twice Daily at 48 Weeks More... •  D-Pharm Ltd. Receives Nod From DSMB to Continue the DP-b99 MACSI Phase III Study in Stroke Patients More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News •  Heartburn Treatment May Extend Survival in Idiopathic Pulmonary Fibrosis (IPF) Patients, University of California, San Francisco (UCSF) Study More... •  ICAD: Tracer Lights Up Alzheimer's Hot Spots in Brain, Duke University Study More... •  PrEP May Prevent HIV; University of Washington Study Surprises Researchers More... •  Alzheimer's Drug from Pfizer Inc. (PFE), Johnson & Johnson (JNJ) May Prove Safer More... •  Breast-Cancer Patients Under 40 May Keep Fertility With Drug, National Institute for Cancer Research Study Finds More... More General Clinical Research News SafeBridge Consultants, Inc. Announces Two Potent Compound Safety Training Offerings (May be Taken Separately or Consecutively) The SafeBridge original Potent Compound Safety "Boot Camp"® (Boot Camp I) is a comprehensive two-day course in pharmaceutical potent compound safety focused on training EH&S and related professionals in critical technical concepts and proactive safety programs in pharmaceutical industrial hygiene, occupational and environmental toxicology, analytical chemistry, and risk communication. The SafeBridge new Advanced Concepts to Support Drug Development of Potent Compounds from R&D through Manufacturing - Potent Compound Safety "Boot Camp II" is a one-day advanced course focused on case studies and problem-solving to address potent compound safety issues in discovery, development, contract manufacturing and commercialization. COURSE SEATING IS LIMITED AND USUALLY SELLS OUT! New Brunswick, New Jersey Boot Camp I September 20-21, 2011 Boot Camp II September 22, 2011 Contact: Susan Custer: susan.custer@safebridge.com or 650-961-4820 x 231 or www.safebridge.com Advances in Drug-Diagnostic Co-Development • Understand the current regulatory environment for both diagnostics and drugs within the EU and the US and how these relate to their co-development. • Understand the biomarker discovery and validation process. • Using case studies discover how drugs and their companion diagnostics have already received approval in the US and EU. Click Here for More Information • BioMidwest (Chicago, Illinois) Kforce Clinical Research Regional Clinical Research Associate The role is to collaborate in the identification and drive the selection of investigator sites with input from other cross-functional groups. Also monitors investigator sites in compliance with company SOPs, ICH/GCP and local laws so that site performance targets are achieved. Etc. • Southern Pharm (Memphis, Tennessee) St. Jude Children's Research Hospital Clinical Research Associate Performs data abstraction, collection, and entry to support clinical research. Prepares submission for all reportable events. Develops, maintains, and/or monitors case report forms. Etc. • Genetown (Weston, Massachusetts) Biogen Idec Sr Associate I, Clinical Trials Management Responsible for management of Biogen Idec's post marketing Investigator Initiated Trials (IITs) program. This position interacts with various institutions, vendors, departments, study coordinators, and investigators. Etc. • Biotech Bay (Menlo Park, California) Synarc, Inc. Clinical Project Manager Manages complex studies with multiple countries and modalities from start-up to close-out with minimal oversight. Manages all communications with the sponsor regarding timelines and study specific deliverables. • Pharm Country (Parsippany area, New Jersey) Omega Management Group Director Clinical Development-Cardiovascular For the assigned clinical trial(s) within program/brand, as a member of the Clinical Trial Team (CTT), provide medical scientific input to e.g,: All activities related to planning, execution and reporting of clinical trials. Etc. • Get Noticed! Add your resume to the BioSpace Career Center! • See more than 5,000 job postings in the BioSpace Career Center! Biotech Beach 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 Southern California 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. • Biotech Beach Career Fair, San Diego, CA September 22, 2011 • BioMidwest Career Fair, Chicago, IL October 4, 2011 • Pharm Country Career Fair, Bridgewater, NJ October 5, 2011 • Biotech Bay Career Fair, Burlingame, CA October 11, 2011 • Bio NC Career Fair, Durham, NC October 20, 2011 • BioCapital Beach 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 •  Mirna Therapeutics, Inc. Announces Allowance of Multiple Patents for Therapeutic Use of Tumor Suppressor miRNAs More... •  Avila Therapeutics is Granted its First U.S. Patent Covering a Class of Targeted Covalent Drugs More... More Patent News •  Eisai Company, Ltd. (ESALY.PK) Stunned By National Institute for Clinical Excellence (NICE) Rejection Of Breast Cancer Drug More... More Drug Product News Hot Company Human Genome Sciences, Inc. 14200 Shady Grove Road Rockville, Maryland 20850 U.S.A. Phone: 301-309-8504 Fax: 301-309-8512 Human Genome Sciences, Inc. is located in the Washington, DC metro area, and was founded in 1992 with the goal of creating a global biopharmaceutical company to discover, develop, manufacture, and market gene-based drugs to address unmet medical needs. 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, Suvarna Sheth, Matt Thwin, Maysa Darwish 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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