EU Beats FDA, Approves Lilly's Byuderon - June 21, 2011

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Tuesday, June 21, 2011  |   |   |  Discover why more and more biotech and pharmaceutical companies are turning to Aptuit: • Industry-leading consulting expertise • State of the art GMP/GLP facilities • Aptuit Laurus, India: world-class research center and large-scale drug substance manufacturer • Innovative technologies that streamline and expedite the process • Complete project management capabilities • Comprehensive regulatory compliance services Please click here for further information. •  EU Beats FDA, Approves Eli Lilly and Company (LLY)'s Weekly Diabetes Drug Bydureon More... •  12 Generics of Johnson & Johnson (JNJ)'s Antibiotic Levaquin are Approved by FDA More... •  Hi-Tech Pharmacal (HITK) Receives Final Approval for Levofloxacin Oral Solution More... More Drug Approval News •  FDA Lifts Hold on Senesco Technologies, Inc. (SNT)'s Lead Drug Candidate More... More BLA/NDA/ANDA News More IND News More MAA News •  LifeCycle Pharma Drug Works as Well as Rival at Lower Dose; Share Gains More... •  Pfizer Inc. (PFE)'s Lyrica Top-Line Results Positive In Global Phase 3 Study Of Central Neuropathic Pain Following Spinal Cord Injury More... •  Shire plc Drug for Rare Swelling Worked in Trial: FDA More... •  Medicis (MRX) Drugs Bests Botox In Tackling Crow's Feet In Study More... •  CEL-SCI (CVM) Announces Data Showing Cancer Drug Multikine Lowers Cholesterol in Clinical Studies More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News •  Leeds University Scientists Develop New Approach For Cancer Vaccine More... •  Could Bacterial Predator Be Harnessed to Mop Up Biofilms?, University of Nottingham Study More... •  Molecule May Revive Injured Nerve Cells, University of California, Davis (UCD) Study More... •  First Ever Drug to Treat "Celtic Gene" In Cystic Fibrosis Sufferers, Queens University's Study More... •  Blueberries Help Lab Rats Build Strong Bones, Study in Journal of Bone and Mineral Research More... More General Clinical Research News BioSurplus Announces ONE GIANT AUCTION BioSurplus will be hosting a large public auction: a campus-wide auction of a global biotech located in San Diego. Details of the auctions can be found atauctions.biosurplus.com Global Biotech - San Diego Campus Liquidation The San Diego campus liquidation will have over 1500 pristine laboratory equipment items. An open viewing will be held on June 22, 2011 from 10 am to 6 pm. Items are being added to the online auction site daily. Please click here for more information. 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 • BioCapital (Rockville, Maryland) Human Genome Sciences, Inc. Clinical Trial Manager Responsible for study start up activities, including assisting with investigator recruitment, site feasibility, vendor selection (CRO, Central Laboratory, etc.), CRF development, edit specifications, procurement of clinical trial insurance, collection of regulatory documents, etc. • Pharm Country (Ridgefield, Connecticut) Boehringer Ingelheim Pharmaceuticals, Inc. Director, Clinical Research (MD) - Diabetes You will ensure that goals and objectives for a drug development program are met. Provides medical/scientific and technical direction to the planning, implementation, conduct, completion, etc. • Biotech Beach (Irvine, California) Allergan Inc. Clinical Study Specialist Develops, evaluates, and executes all essential clinical trial documents and clinical trial agreements (CTAs). Aligns execution activities with agreed upon project priorities, timings and quality specifications. Etc. • BioMidwest (Indianapolis, Indiana) Eli Lilly and Company Principal Research Scientist, Immunologist - Autoimmune Disease Serve as a source of state-of-the-art scientific knowledge in the field of immuno-inflammation especially as this applies to autoimmune disease; exert influence on research direction and the choice of experimental approaches taken. Etc. • Biotech Bay (South San Francisco, California) Bayside Solutions, Inc. Pre-Clinical Research Associate, In Vivo Pharmacology We are currently seeking an experienced and motivated Research Associate with experience in Pre-Clinical in vivo pharmacology. Experiments will assess both the pharmacodynamic and pharmacokinetic nature of novel variants, utilizing various animal models of disease. • Get Noticed! Add your resume to the BioSpace Career Center! • See more than 5,000 job postings in the BioSpace Career Center! BIO 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 Washington, DC 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. • BIO Career Fair, Washington DC, June 27, 2011 • 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 •  Watson Pharmaceuticals, Inc. (WPI) Confirms AVODART(R) Patent Challenge More... •  Palatin Technologies (PTN) Issued U.S. Patent for Key Component in PL-3994 Drug Candidate More... •  ImmunoCellular Therapeutics, Ltd Cancer Vaccine Technology Issued Key Patent More... •  miRagen Therapeutics Receives Notice of Allowance for Intellectual Property for MicroRNAs that Modulate Smooth Muscle Proliferation and Differentiation More... •  U.S. Patents Issued for Akonni Biosystems's Thermal Cycling Technology More... More Patent News •  Spectrum Pharmaceuticals, Inc. (SPPI) Has Ample Supplies of FUSILEV(R) to Meet the Growing Demand of Colorectal Cancer Patients in the U.S. More... More Drug Product News Hot Company Accelovance 2275 Research Boulevard, Suite 700 Rockville, Maryland 20850 U.S.A. Phone: 240-238-4900 Fax: 240-238-4901 Accelovance, based in Rockville, MD, is a clinical services company specializing in high patient throughput from recruitment through study completion. 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. 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