Daiichi Unit Warned By FDA Over Manufacturing - Sept. 14, 2011

Having trouble viewing this email? View in Browser.

Wednesday, September 14, 2011  |   |   |   |  At Aptuit's MHRA certified and FDA inspected multi-purpose manufacturing site in Oxford, England, we can produce highly potent compounds at commercial scale in accordance with the highest safety and quality standards. Please click here for more information. •  Daiichi Sankyo, Inc. (D4S.F) Unit Warned by FDA Over Manufacturing More... More Discontinuations News More Recalls and Warning News •  Transcept Pharmaceuticals, Inc. (TSPT) Announces FDA Response to Proposal in Support of Intermezzo(R) New Drug Application More... •  AB Science (AB.PA) Announces That FDA Authorization (IND) Has Been Granted for the Initiation of Its Phase 3 Study in Severe Asthma. Patient Recruitment Commences in the US More... More BLA/NDA/ANDA News More IND News More MAA News •  AEterna Zentaris (AEZS) Presents Positive Final Phase 2 Efficacy and Safety Data for AEZS-108 in Advanced Endometrial Cancer at European Society of Gynecological Oncology Meeting in Milan, Italy More... •  PRANA Biotechnology (PRAN) Release: World Congress on Huntington's Learns About PBT2's Promise More... •  ViroPharma Incorporated (VPHM) and Halozyme Therapeutics, Inc. (HALO) Announce Initiation of Phase 2 Evaluation of Subcutaneous Delivery of Cinryze(R) (C1 Esterase Inhibitor [Human]) with Hyaluronidase (rHuPH20) More... •  Results From Phase IIB Placebo Controlled Study of Bionor Pharma's Vacc-4x Show Excellent Safety Profile, Statistically Significant Viral Load Reduction in Patients With HIV Who Suspend Antiretroviral Therapy More... •  Inovio Pharmaceuticals (INO) Completes PENNVAX(TM)-B HIV Vaccine Phase I Study, Demonstrates Best-in-Class T-Cell Immune Responses More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News Drug Discovery & Development Drug Discovery & Development magazine delivers vital insight about the latest technologies and tools used to develop pharmaceutical products to key decision-makers Request Now! •  Newly Found Gene Mutations May Aid Heart Treatments, Johns Hopkins University Study More... •  Potential To Diagnose, Prevent Osteoarthritis, Lund University Study More... •  Screening Lots of Lymph Nodes Little Help for Colon Cancer Patients, National Cancer Institute Study More... •  Cardiovascular Drug May Offer New Treatment for Some Difficult Types of Leukemia, Indiana University School of Medicine Study More... •  Intersect ENT Announces Positive Data from Pivotal Study of Propel Implant, Showing Significantly Improved Outcomes for Sinus Surgery 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. The Future of R&D Outsourcing • Understand the driving forces behind R&D outsourcing. • Learn how R&D outsourcing will evolve over the next several years and why. • Assess your competitive position vis-à-vis other drug makers and learn about R&D outsourcing best practices via detailed case studies. Click Here for More Information. • Biotech Bay (South San Francisco, California) Cytokinetics, Inc. Manager, Clinical Data Management Provides leadership and coordinates the activities of data management staff at the CROs. Review, and comment on CRFs, annotated CRFs, EDC supporting materials, and edit checks documents. Interacts with Statisticians, Clinical Trial Project Managers, and other personnel to provide support in the areas of data management, data validation, Data base lock, and metrics report generation. • Genetown (Boston, Massachusetts) PAREXEL International Associate Director, Early Phase Clinical Data Services General responsibilities include supervision and management of CDS Project Leads and staff, ensuring the group is trained, mentored and developed. Provide oversight of the execution and productivity of quality CDS Project Lead activities, ensuring adherence to regulatory and PAREXEL standards. Provide input to continuous productivity improvement. Ensure proactive planning takes place and provide issue resolution for the Group. • BioMidwest (Chicago, Illinois) Takeda Pharmaceuticals Medical Director/Senior Medical Director, Clinical Science - Metabolic Leads the development of the all components of the integrated development strategy and the resultant tactical clinical plan and study designs to support the global development of and establish the conditions essential for determining the safety, efficacy, medical usefulness, and marketability of multiple compounds. • Biotech Beach (Westlake Village, California) Baxter International, Inc. Sr Clinical Data Analyst Responsible for leading clinical data management (CDM) operational activities in one or more therapeutic areas. Manage the creation, execution and maintenance of Data Management Plans in support of clinical study deliverables. Lead the design, creation and lifecycle management of data collection, validation and reporting specifications and usage guidelines. • 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. • 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 •  Eisai Company, Ltd. (ESALY.PK) Says Aricept Patent is Upheld by Japan Court More... More Patent 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. Hot Company Bio-Rad Laboratories, Inc. 1000 Alfred Nobel Drive Hercules, California 94547 U.S.A. Phone: 510-724-7000 Fax: 510-741-5817 Bio-Rad Laboratories, Inc. has played a leading role in the advancement of scientific discovery for nearly 60 years by providing a broad range of innovative products and services to the life science research and clinical diagnostics markets. Founded in 1952, Bio-Rad has a global team of more than 6,800 employees and serves more than 85,000 research and industry customers worldwide through its global network of operations. 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.