Vivus Resubmits FDA App for Obesity Drug - Oct. 17, 2011

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Monday, October 17, 2011  |   |   |   |  CHI's 11th Annual PepTalk: The Protein Science Week January 9-13, 2012 | Hotel Del Coronado | San Diego, CA 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 visit here for more information. •  VIVUS, Inc. (VVUS) Resubmits FDA App for Obesity Drug More... More BLA/NDA/ANDA News More IND News More MAA News •  FDA Approves ApoPharma's Deferiprone for Iron Overload More... More Drug Approval News •  Auris Medical AG Reporting Positive Results from Phase 2b Trial With AM-101 for the Treatment of Acute Inner Ear Tinnitus More... •  Multi-center Clinical Trial Shows ParaPRO LLC's Spinosad Eradicates Head Lice and Nits More... •  The Medicines Company (MDCO)'s MDCO-2010 Meets Clinical Trial Objectives in Patients Undergoing Open-Heart Surgery More... •  Lpath, Inc. Initiates Dosing of iSONEP in Second of Two Proof-of-Concept Trials More... •  Acasti Pharma Receives Health Canada Clearance for an Open-Label Phase II Hypertriglyceridemia Trial 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 sets and are expanding the range of problems that can be addressed through sequencing... Request Now! •  Men Who Have Never Married are More Likely to Die From Cancer, University of Oslo Study More... •  Low Birth Weight Babies Five Times More Likely to Be Autistic, University of Pennsylvania Study More... •  Smoking Linked to Earlier Menopause, University of Hong Kong Study More... •  Estrogen May Prevent Younger Menopausal Women from Strokes, Mayo Clinic Study More... •  Obesity More Harmful to Teen Girls Than Teen Boys, University of California at Merced Study More... More General Clinical Research News IBC's BioProcess International Conference & Exhibition October 31 - November 4, 2011 - Long Beach, California Event Website Download the 2011 BioProcess International brochure and see why this is YOUR must attend event for 2011. Download PDF file here. You will see the 2011 program, features a stellar line up keynote presentations including, the US FDA, EMA, Pfizer, Merck and more. Plus, there are over 50 presentations with new, previously unpublished data, and new topic coverage areas including antibody drug conjugates, viral clearance and managing global manufacturing facilities and partners. Exhibit hall & keynote passes are now available. Mention priority code B11171BSEODS2 and the fee will be waived. All passes subject to approval. Register here today or call 800-390-4078. Emerging Clinical Trial Locations • Provides insight into the background to the clinical trials market in the emerging geographic regions including specific issues in each geography • Reviews of the structure of the healthcare system in each of the emerging clinical trial markets. • Reviews the principal CROs in each emerging location covering domestic and international players. Click Here for More Information. • BioCapital (Frederick, Maryland) SAIC-Frederick, Inc. Clinical Research Associate II Provides clinical trials research monitoring for NIAID intramural research protocols at domestic and international sites and ensures clinical trials are conducted in a timely manner and in accordance with standard operating procedures (SOPs), Good Clinical Practices (GCPs), IND and IDE clinical trial monitoring and additional regulatory guidelines. • Genetown (Boston, Massachusetts) Vertex Clinical Trials Associate Assists the Clinical Project Managers in the conduct of trials and may be responsible for managing startup activities, vendor communication or other project activities as assigned. He/She performs work within established protocols under general supervision. • BioMidwest (Lake Forest, Illinois) Hospira, Inc. Clinical Product Safety Analyst Responsible for managing a Global Product Safety Complaint (GPSC) event through its entire life-cycle, from initial triage referral through regulatory reporting, sample retrieval, investigation, and ultimately to closure/reopening as needed. Analyst is also responsible for knowing when an event is sufficiently complex with significant consequences to escalate the event to the Team Lead. • Biotech Beach (San Diego, California) ClinDART Clinical Data Manager Responsible for supporting all activities associated with the data management process throughout a clinical trial and overall quality and integrity of data input and output. • Biotech Bay (San Francisco, California) FibroGen, Inc. Clinical Research Associate II (CRA II) Will assist with operational activities for two phase two trials in China. The therapeutic area is anemia. May monitor study sites for data collection, source data verification, review of regulatory documents/files and drug accountability. • Get Noticed! Add your resume to the BioSpace Career Center! • See more than 5,000 job postings in the BioSpace Career Center! Bio NC 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 south east 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. • 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 •  APP Pharmaceuticals Announces Increased Availability of APP Diprivan(R) and APP Propofol 1% More... More Drug Product 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 (CLI) 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. 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