Musty Odor Causes Another J&J Recall - June 29, 2011

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Wednesday, June 29, 2011  |   |   |  The Bioprocessing Summit August 22-23, 2011 Boston, Massachusetts www.BioprocessingSummit.com CHI's annual "The Bioprocessing Summit" is specially 'formulated' to focus on the most pressing challenges of bioproduction. From cell line selection and transfection, to biopreservation, scale-up and bioreactor design, this event explores the bioprocesses that continually consume time and resources. The six meetings comprising the Summit provide a close-up look at the current strategies and innovations for optimizing bioprocesses while mitigating risk and ensuring bottom-line quality. To view complete details, visit To view complete details, visitwww.BioprocessingSummit.com. •  Musty Odor Causes Another Johnson & Johnson (JNJ) Recall More... More Discontinuations News More Recalls and Warning News •  Pfizer Inc. (PFE) Submits Axitinib for Advanced RCC to FDA More... •  Regeneron Pharmaceuticals, Inc. (REGN) and Bayer HealthCare (BAY) Release: EYLEA(TM) (aflibercept injection) Submitted in Japan for Marketing Authorization for the Treatment of Wet Age-Related Macular Degeneration More... •  Immune Response BioPharma Sends Open Letter To FDA Seeks Emergency NDA Approval Of Remune HIV/AIDS Vaccine More... •  Nuvo Research Inc. (NRI.TO) Receives IND Clearance From FDA to Begin Clinical Testing of Lidocaine Spray More... More BLA/NDA/ANDA News More IND News More MAA News •  AstraZeneca PLC (AZN)'s Brilinta Worse With High-Dose Aspirin in Analysis More... •  Amsterdam Molecular Therapeutics (AMT) (RHP.DE)' Glybera(R) Significantly Reduces the Risk of Pancreatitis in LPLD Patients More... •  QRxPharma Pty Ltd. Releases Additional Data on Phase 3 Comparative Safety Study for MoxDuo® IR More... •  Inovio Pharmaceuticals (INO)' Prostate Cancer DNA Vaccine Demonstrates Strong T Cell Responses in Monkeys; Company on Track for Phase I Clinical Trial More... •  Omeros Corporation (OMER) Announces Publication of Phase 2 Clinical Results for OMS103HP in Arthroscopy: The Journal of Arthroscopic and Related Surgery More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News •  Old Osteoporosis Drug May Help In Killing Flu Viruses, University of Hong Kong Study More... •  Kids Who Survive Cancer More Often Get New Tumors, St. Jude Children's Research Hospital Study More... •  Chemical Produced in Pancreas Prevented and Reversed Diabetes in Mice, St. Michael's Hospital Study More... •  Mystery Ingredient in Coffee Boosts Protection Against Alzheimer's Disease, University of South Florida Study Finds More... •  Children's Hay Fever Relieved by Cellulose Powder Without Adverse Effects, Queen Silvia Children's Hospital Study Suggests More... More General Clinical Research News Just Released: IBC's BioProcess International Conference Brochure Download your copy today at: www.ibclifesciences.com/bpi/brochure.xml BioProcess International Conference & Exhibition October 31 - November 4, 2011: Long Beach, California This conference is where challenges are explored, solutions are uncovered and opportunities are developed, making it the largest and most highly respected event solely dedicated to biopharmaceutical manufacturing. BioProcess International is your one stop industry resource for driving down costs, improving quality, achieving rapid, robust and resilient process development and manufacturing. Register today at www.IBCLifeSciences.com/BPI/register.xml or call 800-390-4078. 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 • Biotech Bay (Newark, California) Synarc, Inc. Clinical Data Manager Provides accurate, timely, and consistent clinical data to client organizations and internal staff to support business objectives. The Clinical Data Manager defines and directs the data management workflow. Etc. • Genetown (Rockville, Maryland) Novartis Institutes for BioMedical Research, Inc. BS/MS Level In Vivo Biologist: Oncology Research The successful candidate will join a dynamic, multi-disciplinary team of scientists in the In Vivo Pharmacology Oncology Department, playing a key role in the development of in vivo models of cancer and the use of those models for evaluating new drug candidates. • Pharm Country (Ridgefield, Connecticut) Kforce Clinical Research Clinical Research Associate To collaborate in the identification and drive the selection of investigator sites with input from other cross-functional groups. Also monitors investigator sites in compliance with company SOPs, ICH/GCP and local laws so that site performance targets are achieved. Etc. • BioMidwest (Deerfield, Illinois) Astellas Pharma US Associate Director, Clinical Studies Responsible for overseeing the management of multiple clinical development programs that typically involve multiple therapeutic areas or indications. Provides direction to Senior Managers and Study Managers and clinical teams. Etc. • BioForest (Bothell, Washington) OncoGenex Technologies Inc. Clinical Research Associate II Monitor clinical trials or co-monitor with internal and external (e.g. CRO or contractor) staff. Contribute to protocol and case report form development. Ensure appropriate regulatory documents and agreements from investigational sites are obtained and materials are filed in the Clinical Trial Master File. Etc. • 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 •  zuChem Receives Patent for Fermentative Production of Xylitol More... More Patent News •  PharmStar Pharmaceuticals, Inc. Announces New Product Line Extension More... More Drug Product News Hot Company Idenix Pharmaceuticals, Inc. 60 Hampshire Street Cambridge, Massachusetts 02139 U.S.A. Phone: 617-995-9800 Fax: 617-995-9801 Idenix Pharmaceuticals, Inc. is a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases. 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, Matt Thwin, Maysa Darwish ClinicaSpace.com - Clinical Trials. Clinical Research. 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