FDA: Chelsea's BP Drug Should Not be Approved - Feb. 22, 2012

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Wednesday, February 22, 2012  |   |   |   |  The Norwich Advantage. One comprehensive solution for all stages of the product lifecycle. Norwich is a recognized leader in full-service contract pharmaceutical development and manufacturing. As a single-source provider, Norwich offers customers greater flexibility, resources and speed that result in a streamlined progression from product development and clinical research to scale-up and through commercial manufacturing Please click here for more information. •  FDA: Chelsea Therapeutics, Inc. (CHTP)'s Blood Pressure Drug Should Not be Approved More... More BLA/NDA/ANDA News More IND News More MAA News •  APP Pharmaceuticals Announces Approval of Preservative-Free Methotrexate Injection, USP More... More Drug Approval News •  Inspiration Biopharmaceuticals Highlights Positive Data on its Recombinant Factor IX for People With Hemophilia B Who Have Undergone Major Surgical Procedures More... •  UCB, Inc. (UCBJF.PK) Announces Start of C-EARLY(TM) Study More... •  SK Bio-Pharmaceuticals to Initiate Phase 2 Trials in US More... •  PhaseBio Pharmaceuticals, Inc. Launches Clinical Program to Evaluate Novel VPAC2 Agonist for Cardiovascular Disease More... •  Novelos Therapeutics, Inc. (NVLT) Announces Enrollment of First Patient in Lung Cancer Trial With I-124-CLR1404 (Light) Cancer-Targeted PET Imaging Agent at UW Carbone Cancer Center 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 set. Request Now! •  Heart Attack With No Chest Pain More Likely in Women, Imperial College Healthcare NHS Trust Study More... •  Environmental Pollutant Linked With Overweight, Norwegian Institute of Public Health Study More... •  Brain Makes Call on Which Ear is Used for Cell Phone, Henry Ford Hospital Study More... •  Cleveland Clinic Study Says Overweight Americans May Risk Kidney Damage When Attempting Weight Loss More... •  Does Depression Contribute to the Aging Process? Biological Psychiatry Reveals More... More General Clinical Research News SDIX Presents: Better Antibodies Through Better Antigen Design Thursday, March 8th | Bethesda, MD (www.sdix.com/learn) Friday, March 9th | King of Prussia, PA (www.sdix.com/discover) Join SDIX on March 8th or March 9th for a series of talks focused on next generation antibody development. At SDIX, a focus on the philosophy of better antigen design has resulted in dramatic improvements to the antibody production process. In a series of talks, our scientists will discuss this antigen design philosophy and provide case studies to demonstrate the effectiveness of this methodology. In particular, these talks will focus on the use of SDIX's proprietary Genomic Antibody Technology™ and its ability to deliver antibodies that match end users' requirements. To register and for more information, visit: March 8th in Bethesda, MD: www.sdix.com/learn March 9th in King of Prussia, PA: www.sdix.com/discover Innovative Clinical Trial Design and Management • Use detailed case studies of recent adaptive trials featuring companies including Merck, Pfizer, Novartis, GSK, Eli Lilly, and AstraZeneca. • Measure the potential cost savings offered by the reduced development times and improved decision-making associated with adaptive trials. • Assess the logistics of adaptive trial implementations. Click Here for More Information. • Pharm Country (Princeton, New Jersey) Otsuka America Pharmaceutical, Inc. Associate Director Clinical Management Acts as the scientific lead for clinical program development activities within a product group or within a portfolio. Determines product and portfolio level standards for clinical development planning, scientific document content, data analysis and reporting ,and reporting to senior management, OPCJ and affiliates. • Biotech Beach (San Diego, California) Lab Support, A Division Of On Assignment Clinical Lab Scientist Determine the acceptability of specimens for testing according to established criteria. Calculate results using testing data with both manual and computerized procedures. Accurately enter results of testing. Review reports to ensure accurate test result reporting. • Biotech Bay (Palo Alto, California) Theranos, Inc. Clinical Laboratory Scientist Under the direction of Technical and General Supervisors, perform laboratory procedures across a broad range of assays and in accordance with standards established in the Clinical Laboratory Improvement Amendments (CLIA). • Bio NC (Durham, North Carolina) PAREXEL International Manager, Clinical Data Analysts Recruit, develop and retain an experienced and motivated team of Clinical Data Analysts in order to optimally resource projects with suitably experienced staff. In this role, you will have the opportunity to promote new business by participating in project bids and client presentations as appropriate. • Genetown (Lexington, Massachusetts) Cubist Pharmaceuticals, Inc. Senior Manager/Manager, Clinical Risk Management Serves as Pharmacovigilance lead at cross-functional and/or external meetings including clinical trial team meetings and/or multidisciplinary product teams. Provides input to the product Clinical Development Team on program objectives and deliverables. • Get Noticed! Add your resume to the BioSpace Career Center! • See more than 5,000 job postings in the BioSpace Career Center! BioSpace Career Fair at CALBIO2012 Job seekers can spend a day with HR representatives and Hiring Managers from top biotech, pharma, medical device and diagnostics companies in the Bay 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. • BioSpace Career Fair at CALBIO2012, San Francisco, CA March 7, 2012 • BioMidwest Career Fair, Bridgewater, NJ March 22, 2012 • Biotech Beach Career Fair, La Jolla, CA April 17, 2012 • BioCapital Career Fair, Bethesda, MD April 25, 2012 • Pharm Country Career Fair, King Of Prussia, PA May 1, 2012 • BioNC Career Fair, Durham, NC May 2, 2012 • Biotech Bay Career Fair, Burlingame, CA May 29, 2012 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 •  Marina Biotech, Inc. (Formerly Known as MDRNA, Inc.) Receives Notice of Allowance for U.S. Patent Related to Its Lipid Based Nucleic Acid Drug Delivery Platform More... •  OphthaliX Announces Issuance of Chinese Patent for the Treatment of Dry Eye Disorders More... •  BioDelivery Sciences International (BDSI) Release: US Patent Office Rejects All Claims in Second MonoSol Patent More... More Patent News •  National Institute for Clinical Excellence (NICE) Backs Earlier Use of Roche (RHHBY)'s Arthritis Therapy RoActemra More... •  Mylan Inc. (MYL) to Launch Generic Copaxone in H2 2013 More... •  Shire plc (SHPGY) Announces European Approval of Manufacturing Facility for VPRIV(R) (velaglucerase alfa) 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 is a leading contract service organization providing clinical research, analytical development, biologics characterization, and quality control testing. 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