FDA Orders Hold on Idera Trial; Green Light for AZN Heart Drug - July 21, 2011

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Thursday, July 21, 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 Orders Hold on Idera Pharmaceuticals, Inc. (IDRA) Trial More... •  Manhattan Pharmaceuticals, Inc. (MHA) Reaches Agreement With the FDA on a Special Protocol Assessment for the Phase 3 Clinical Study of AST-726 More... •  Inotek Pharmaceuticals Corporation to Expand Phase 2 Clinical Trial in Glaucoma Based on Promising Preliminary Results More... •  Vical Incorporated (VICL) Reports Successful Nonclinical Results With Vaxfectin(R) Adjuvant More... •  Isis Pharmaceuticals, Inc. (ISIS) Initiates Phase 1 Study of ISIS-PTP1BRx to Treat Type 2 Diabetes More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News •  Green Light for AstraZeneca PLC (AZN) Heart Drug More... •  Perrigo Company (PRGO) Receives FDA Approval to Market Coated Cinnamon Nicotine Gum More... •  Lannett Company, Inc. (LCI) Receives FDA Approval for Phentermine HCl Capsules, 37.5 mg More... More Drug Approval News •  Defect in Sperm Cloaking Protein May Explain Puzzling Male Infertility, University of California, Davis (UCD) Study More... •  Progress is Seen on a Blood Test for Alzheimer's, Australian National Research Organization Reveals More... •  Aspirin Holiday is a Bad Idea, Spanish Center for Pharmacoepidemiologic Research Reveals More... •  Herpes Drug Slows HIV Progress, National Institute of Allergy And Infectious Diseases (NIAID) Study More... •  Walking Tops Weights for Metabolic Syndrome, Duke University Medical Center Study 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 • Biotech Beach (San Diego, California) Santarus Inc. Clinical Research Associate (Sr.) Assist in planning implementing, and managing clinical studies in accordance with FDA Regulations, Good Clinical Practices Guidelines (GCPs) and Santarus, Inc SOPs. Support Clinical Research project teams and provide backup for other activities and projects. Etc. • 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. • 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 •  Adamis Pharmaceuticals' Prostate Cancer Drug APC-100 Granted a Patent in US More... •  Intellect Neurosciences, Inc. Obtains Notice of Allowance for Alzheimer's Beta Amyloid Vaccine from the Japan Patent Office in Relation to the Company's RECALL-VAX(TM) Technology More... •  NeuralStem Inc. Receives Russian Patent for Stem Cell Transplantation to Treat Neurodegenerative Conditions More... More Patent News •  Actavis Launches Oxymorphone Hydrochloride Extended-Release Tablets, CII in the U.S. More... •  Cephalon, Inc. (CEPH) Receives FDA Approval for Risk Evaluation and Mitigation Strategy for FENTORA and ACTIQ 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. 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