ISTA Eye Drug Trials Show Mixed Results - Oct. 13, 2011

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Tuesday, October 11, 2011  |   |   |   |  Pharm-Olam International Acquires StatWorks, Inc. With Pharm-Olam's acquisition of StatWorks we have expanded our team Data Management and Biostatistics experts for functional outsourcing and full service clinical trials. Our comprehensive biometric services include: • Integration of randomization into EDC systems, eliminating IVRS costs, with added benefit of full inventory control over supplies • Adaptive, Sequential, and Bayesian design methods • CDISC, SDTM and ADaM datasets • SAS programming, eCRF design, and medical coding in MedDRA/WHO Drug • Streamlining and reconciling across SAE, CTMS, and study DB • Health Outcomes Research and Patient Reported Outcomes • Protocol development, sample size, and randomization Contact us for your resource planning at www.pharm-olam.com, info@pharm-olam.com, USA 1-713-559-7900, UK 44-0-1344-891121. •  ISTA Eye Drug Trials Show Mixed Results ISTA said its experimental cataract drug met the main goal of two late-stage trials, but its other drug for dry eye failed to meet the main goal of a second late-stage trial. Read press releases below. •  ISTA Pharmaceuticals, Inc. (ISTA)'s REMURA Was Not Statistically Significantly Better Than Placebo More... •  ISTA Pharmaceuticals, Inc. (ISTA) Announces Statistically Significant Phase 3 Results for PROLENSA(TM); NDA Planned in Q1 2012 More... •  Anadys Pharmaceuticals, Inc. (ANDS) Announces Positive 12-Week Data for Setrobuvir in Phase 2b Hepatitis C Study More... •  Pozen, Inc. (POZN) Reports Top-Line Data from Long-Term Safety Study of PA32540 More... •  Merck & Co., Inc. (MRK)'s ISENTRESS(R) (raltegravir) in Combination Therapy Shows Benefits Over Efavirenz More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News •  Helix Biopharma (CC:HBP) Files IND Clinical Hold Response With FDA for Its Planned Topical Interferon Alpha-2b Phase II/III Efficacy Trial More... More BLA/NDA/ANDA News More IND News More MAA News CHI's Ninth International Discovery on Target November 2-4, 2011 | Boston, MA www.DiscoveryOnTarget.com This fall Cambridge Healthtech Institute will host its Ninth International Discovery on Target event showcasing novel "hot" targets for the pharmaceutical industry November 2-4 in Boston, Massachusetts. This is a must attend event to keep up with current and upcoming developments in target discovery and to collaborate and connect with experienced scientists and high level decision makers. Join us for in-depth coverage of novel drug targets focused on HDAC, RNAi, the PI3K pathways, allosteric modulators, metabolic pathways in tumor cells, kinase inhibitors, GPCR and Diabetes. To register and for up-to-date information, visit www.DiscoveryOnTarget.com. •  Oral Bacteria Might Signal Early Pancreatic Cancer, University of California, Los Angeles (UCLA) Study More... •  Regular Exercise Seems to Guard Against Migraine, North Shore-Long Island Jewish Health System Study More... •  Preemies With Faster Brain Growth May End Up Smarter, Massachusetts General Hospital Study More... •  Kids With Blocked Tear Ducts at Higher Risk for "Lazy Eye," Family Eye Group Study More... •  Smoking Cigarettes Simulates Cystic Fibrosis, University of North Carolina Study More... More General Clinical Research News • Pharm Country (Radnor, Pennsylvania) PolyMedix, Inc. Clinical Trial Operations Manager/Director Experience in execution of Phase II Phase II pivotal studies, Phase III and small Phase I studies and larger, multi-center trial management. Experience in infectious diseases and/or cardio vascular. Well versed in GCP and applicable FDA/EMEA regulations required. Ability to prepare and present clinical trial updates to senior management. • 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. • Genetown (Boston, Massachusetts) On Assignment Clinical Research Clinical Contract Manager Responsible for overseeing large complex contract negotiation and management for CRO and other vendor agreements providing expert consultancy and assisting with difficult negotiations and developing innovative strategies and solutions. • 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 •  Horizon Pharma, Inc. Receives U.S. Patent Allowance for DUEXIS(R) in the United States More... •  Allenex AB: XM-ONE Receives US Patent Protection More... •  Critical Outcome Technologies Inc. Receives U.S. Patent for Promising Oncology Compound COTI-2 More... More Patent News •  Ferrer Therapeutics Release: Introducing CerAxon(R), the First & Only Oral Solution Medical Food for Dietary Management of Brain Ischemia in Patients With Partially Impaired Swallowing More... More Drug Product 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! 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. 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