FDA Approves Teva Copycat of Amgen Drug - Aug. 30, 2012

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Thursday, August 30, 2012  |   |   |   |  Free Webinar Access Bioprocess Technology & Innovation: Strategic Imperative for Challenging Times Check out this webinar by Timothy S. Charlebois, Ph.D., Vice President, Technology and Innovation Strategy, Pfizer in conjunction with IBC's BioProcess International Conference & Exhibition at: http://bit.ly/O2nH5N. IBC's BioProcess International Conference & Exhibition October 8 -12, 2012 - Rhode Island Convention Center, Providence, RI Download the Brochure: http://bit.ly/KPA7hp. Register today http://bit.ly/NXZkEe at or call 800-390-4078. Register with priority code BS12EOD. *Discounts are for new registrations only and cannot be used in conjunction with other offers. •  FDA Approves Teva Pharmaceutical Industries Limited (TEVA) Copycat of Amgen (AMGN) Drug More... •  FDA OKs Ironwood Pharmaceuticals's IBS Drug More... •  FDA OKs Novartis AG (NVS)'s Afinitor Disperz for Child Brain Tumors More... More Drug Approval News •  FDA Warns of Possible Cataract Link With Vertex Pharmaceuticals (MA) (VRTX)'s Kalydeco More... More Discontinuations News More Recalls and Warning News •  Johnson & Johnson (JNJ) Prostate Cancer Drug Gets FDA Priority Review Status More... •  Exelixis, Inc. (EXEL) Provides Update on ODAC Panel for Cabozantinib More... •  Bayer HealthCare Pharmaceuticals (BAYA.F) Submits New Drug Application for Regorafenib for the Treatment of Gastrointestinal Stromal Tumors (GIST) More... •  Ariad Pharmaceuticals, Inc. (ARIA) Announces Submission of Marketing Authorization Application for Ponatinib to the European Medicines Agency More... More BLA/NDA/ANDA News More IND News More MAA News •  Novartis AG (NVS) to Seek Lung Treatment Launch in Europe, Japan After Phase III Study Goals Were Met More... •  NeurogesX, Inc. (NGSX)' NGX-1998 Well-Tolerated Treatment Demonstrated Clear Dose-Response in Patients More... •  Elan Corporation PLC (ELN) Announces Dosing of First Patient in Phase 2 Trial of ELND005 (Scyllo-inositol) in Bipolar Disorder More... •  Transition Therapeutics Inc. (TTH.TO) Announces Dosing of First Patient in Phase 2 Clinical Study of ELND005 in Bipolar Disorder More... •  Pluristem Therapeutics (PSTI) Files for Orphan Drug Status With FDA for Use of PLX Cells in Treatment of Aplastic Anemia More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News •  Chocolate May Protect the Brain From Stroke, Karolinska Institute Study More... •  In New Gene Disorder, B12 Can't Get to Cells, McGill University Study More... •  New Cancer Drug Has 10x the Punch, University of Missouri Study More... •  Familiar Music Could Help People With Brain Damage, University of Lyon Study More... •  Chronic Stress Linked to High Risk of Stroke, Study Published in the Journal of Neurology Neurosurgery and Psychiatry Reveals More... More General Clinical Research News • BioForest (Seattle, Washington) Theraclone Sciences, Inc. Clinical Trial Manager Will be accountable for effective management of budgets, timelines and resources for assigned clinical studies and implementation of appropriate standards and processes to ensure clinical study quality. This position will also be responsible for effective training and management of interactions with study team, study sites and vendors for assigned clinical studies. • BioCapital (Gaitherburg, Maryland) MedImmune, LLC Associate Clinical Program Manager Supports the Clinical Program Manager (CPM) and Senior Clinical Program Manager (Sr CPM) with supervision from the Line Manager in the planning and management of overall clinical operations execution for assigned clinical trial(s) including timelines, budgets, resources, investigational sites, vendors and key project deliverables in compliance with SOPs, Regulatory requirements and ICH/GCP guidelines and in alignment with departmental strategies and goals. • Pharm Country (Summit, New Jersey) Celgene Lead Clinical Research Scientist Provide leadership and direction to the assigned Clinical Research Scientists. Review work and project responsibilities within the group and assign task to ensure equitable distribution of responsibilities as well as leadership and development opportunities. • Biotech Beach (Irvine, California) Lab Support, A Division Of On Assignment Clinical Lab Scientist Perform diagnostic laboratory activities on the basis of standard operating procedures. Contribute to writing and adjusting of Standard Operating Procedures (SOP's). Consults with the Senior CLS regarding the daily work flow of the clinical laboratory and troubleshooting. • Genetown (Cambridge, Massachusetts) Vertex Clinical Process Associate Responsible for managing the lifecycle of relevant policies, SOPs, work instructions and business documents by serving as a workflow coordinator for the functions he/she supports. The Associate is also responsible for managing the execution of the development and revision of process documents by training authors on document standards, criteria and adherence to timelines. • Get Noticed! Add your resume to the BioSpace Career Center! • See more than 5,000 job postings in the BioSpace Career Center! 2012 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 September 13, 2012 • Biotech Beach Career Fair, San Diego, CA September 20, 2012 • Biotech Bay Career Fair, Burlingame, CA October 3, 2012 • BioCapital Career Fair, Bethesda, MD October 9, 2012 • BioMidwest Career Fair, Lincolnshire, IL October 22, 2012 • Bio NC Career Fair, Durham, NC October 25, 2012 • Genetown Career Fair, Cambridge, MA November 5, 2012 More information about BioSpace's Career Fairs BioSpace White Paper Biotech Career Fairs For Job Seekers 101: Control Your Experience •  Quick-Med Technologies (QMDT) Announces Further Expansion of Its NIMBUS® Technology Global Patent Portfolio More... More Patent News The 6th Annual Pain Therapeutics October 3-4, 2012 San Francisco, CA Event Website ARROWHEAD'S ANNUAL PAIN THERAPEUTICS SUMMIT is the US's premier conference covering the field of pain management and therapeutics. Leaders from the pharmaceutical, biotech, device and medical communities attend this conference to learn about the latest advances in the treatment of various types of pain and to network with colleagues from industry, the non-profit sector, academia, the medical community, government and investors. This conference will provide attendees with thoughtful insight from key industry leaders and academic researchers concerning cutting edge drug discovery science, preclinical development trends, analysis of key clinical-stage pain therapies and newly marketed products. We will highlight the most important developments in recent years in the field, including new research in CGRP antagonists, NGF antagonists, Nav 1.7 antagonists, new research in biologic therapies and the genetic component of pain, abuse-resistant opioids, analysis of FDA's REMS program and a plethora of other topics. Please click here for more information. New Emerging R&D and Clinical Trial Locations • Compare 5 new emerging R&D locations in terms of population, economic activity, healthcare infrastructure, and current R&D activity. • Analyze how clinical trial numbers are changing in China, India, and Eastern Europe. • Develop strategies for geographic outsourcing. Click Here for More Information. Hot Company Purdue Pharma L.P. (Connecticut) Headquarters One Stamford Forum Stamford, Connecticut 06901-3431 U.S.A. Phone: 203-588-8000 Fax: 203-588-8850 Purdue Pharma L.P., headquartered in Stamford, CT, is a privately held pharmaceutical company founded by physicians and focused on meeting the needs of healthcare providers and the patients in their care. Together with its independent associated companies, Purdue is dedicated to finding, developing, and bringing to market new medicines and related products that improve health outcomes. 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