Genzyme Apologizes for Fabrazyme Screw Up - Sept. 8, 2011

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Thursday, September 08, 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 •  Genzyme Corporation (GENZ) Apologizes for Fabrazyme Screw Up More... •  Ranbaxy Laboratories (RANBAXY.BO) Climbs on Lipitor Launch Buzz More... More Drug Product News •  FDA Updates Boxed Warning for TNF-alpha Inhibitors More... More Discontinuations News More Recalls and Warning News •  Medicis (MRX) Announces FDA Clearance of LIPOSONIX(R) System More... More Drug Approval News •  Johnson & Johnson (JNJ) and Bayer HealthCare (BAY) Bloodthinner Faces FDA Panel Today More... •  NeurogesX, Inc. (NGSX) Submits Supplemental New Drug Application for Qutenza(R) (capsaicin) 8% Patch for HIV-Associated Peripheral Neuropathy (HIV-PN) More... More BLA/NDA/ANDA News More IND News More MAA News •  Pfizer Inc. (PFE)'s Arthritis Pill Tofacitinib Matches Abbott Laboratories (ABT)'s Humira in Final Studies More... •  Santen, Inc. Announces European Medicines Evaluation Agency Orphan Drug Status for Sirolimus (DE-109) More... •  Auxilium Pharmaceuticals (AUXL) Announces Additional Data from Three-Year XIAFLEX® Recurrence Study in Dupuytren's Contracture in E-poster at ASSH Meeting More... •  Interim Data from Low Dose Oral Proellex(R) Study Supports Repros Therapeutics Inc. (RPRX)' Belief of a Return to Phase III in 2012 More... •  Protalix Biotherapeutics, Inc. (PLX) Taliglucerase Alfa Phase III Results Published in Blood, the Journal of the American Society of Hematology More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News Nature Methods Nature Methods provides techniques for life scientists and chemists. It is a print and online publication dedicated to publishing novel methods together with significant advances to tried and tested techniques allowing researchers to perform faster, better and more efficient experimental research. Request Now! •  Potatoes Reduce Blood Pressure in People With Obesity and High Blood Pressure, University of Scranton Study More... •  Why Kidney Failure Risk 4x Higher for Blacks, Emory University Study More... •  BRCA1 Gene Mutation Associated With Neoadjuvant Chemotherapy, University of Texas Study More... •  Chondroitin Sulfate Improves Hand Function, Relieves Morning Stiffness Caused by Osteoarthritis, University Hospitals of Geneva Study More... •  Bilingual Brain May Start to Fade By Age 1, University of Washington Study More... More General Clinical Research News Biomarker Applications for Improved Clinical Trial Outcomes November 15 - 16, 2011 Hilton Boston Back Bay - 40 Dalton Street The only personalized medicine conference allowing you to make biomarkers and diagnostics available during every stage of clinical research, to stratify patients, prove clinical validity, and streamline the regulatory approval and reimbursement process. Featuring up-to-date analysis of new FDA legislation regulations and a special spotlight from Blue Cross Blue Shield. Please click here for more information . Biomarkers in Late Stage Clinical Trials • Quantify and analyze revenues of late stage biomarker technology and services in North America, Europe, Asia and the Rest of the World. • Identify the key market drivers and resistors of the biomarker market and evaluate the growth potential of emerging technologies. • Assess biomarker activity at leading companies, including Abbott, AZ, BMS, Eli Lilly, GSK, Merck & Co, Novartis, Pfizer, Roche and Sanofi-Aventis. Click Here for More Information. • Genetown and Bio NC (Billerica, Massachusetts and Durham, North Carolina) SPARKS Clinical Trial Specialists Act as an independent Coordinator on projects both locally and remotely. Apply knowledge across multiple projects. Contribute to the development and implementation of Study Start Up (SSU) related processes, tools, and training materials as well as provide training as needed. • Pharm Country (Horsham, Pennsylvania) On Assignment Clinical Research Clinical Biostatistician Work collegially and closely with clinical research staff to determine appropriate study designs, sample size estimates, and write appropriate sections of study protocols. The position is also responsible for writing statistical analysis plans, analyzing data, writing manuscripts, and writing sections of clinical study reports and registration documents. • Biotech Bay (Redwood City, California) Counsyl, Inc. Clinical Lab Scientist Perform one of the most innovative tests available today. Opportunities for qualitified applicants to take general supervisor responsibilities. Work alongside a team of scientists and engineers to help end preventable genetic disease. • BioCapital (Bethesda, Maryland) SAIC-Frederick, Inc. Clinical Research Associate II Directly supports that effort by providing quality assurance and quality control of NHLBI clinical trials, including, but not limited to: Good Clinical Practice (GCP) monitoring of non-IND protocols; IND and IDE clinical trial monitoring; and development and maintenance of a database to track and tabulate adverse events and unanticipated adverse events. • Southern Pharm (Nashville, Tennessee) Sarah Cannon Research Institute Clinical Project Lead Will work closely with Project Managers to facilitate collaboration between SCRI Services project teams, research sites and clinical trial sponsors to advance common interests and achieve mutual goals. Ensures that all clinical tasks meet client and SCRI expectations and are completed in accordance with the contract, protocol, ICH-GCP guidelines and applicable Standard Operating Procedures (SOPs). • Get Noticed! Add your resume to the BioSpace Career Center! • See more than 5,000 job postings in the BioSpace Career Center! Biotech Beach 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 Southern California 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. • 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 •  Following Biotage AB (BIOTa.ST)'s Request for Re-Examination US Patent and Trademark Office Has Rejected All Claims in US Patent 7,410,571 More... More Patent News Hot Company Coldstream Laboratories Inc. 1500 Bull Lea Road, Suite 250 Lexington, Kentucky 40511 U.S.A. Phone: 859-257-6600 Fax: 859-323-5985 At Coldstream Laboratories Inc., we're seasoned at turning pharmaceutical development ideas into safe, pure, and effective clinical pharmaceutical dosage forms. Since 1986, we have completed more than 200 formulation development projects that led to clinical trials providing us extensive clinical manufacturing experience with both commercial product development and grant-funded projects from such sources as the National Institutes of Health. More Company Profiles 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. Editor & Publisher: Rosemary Do Editorial & Production Staff: Lana Ho, Suvarna Sheth, Maysa Darwish, Tammy Liu ClinicaSpace.com - Clinical Trials. Clinical Research. Community. • ClinicaSpace is a registered trademark of BioSpace, Inc. • Please distribute this e-cast freely. • Credit any excerpts as follows: Copyright 2011 ClinicaSpace http://www.clinicaspace.com • While BioSpace and its agents used their best efforts in collecting and preparing the information published herein, we do not assume, and hereby disclaim, any liability for any loss or damage caused by errors or omissions, whether such errors or omissions resulted from negligence, accident or other causes. If someone forwarded this news to you and you'd like to receive your own copy FREE of charge, simply Subscribe here. Safely unsubscribe from ClinicaSpace.com e-mail at any time by managing your account here.