Adventrx Stock Plunges on FDA NDA Rejection - Aug. 10, 2011

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Wednesday, August 10, 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 athttp://www.pharm-olam.com, info@pharm-olam.com, USA +1-713-559-7900, UK +44-0-1344-891121 •  ADVENTRX Pharmaceuticals Inc. (ANX) Stock Plunges on FDA NDA Rejection More... •  FDA Approval of Roche (RHHBY) Melanoma Drug May Come Early, According to Sources More... •  GlaxoSmithKline (GSK) Wants OK to Market Horizant for Shingles Pain More... •  Ironwood Pharmaceuticals Seeks FDA Approval for its First Drug More... More BLA/NDA/ANDA News More IND News More MAA News •  Nutra Pharma Corp. (NPHC) Receives Regulatory Approval to Market Nyloxin in India More... •  Watson Pharmaceuticals, Inc. (WPI)'s Rosuvastatin Zinc Tablets Receive Tentative FDA Approval More... More Drug Approval News •  Roche (RHHBY)'s Herceptin Has Higher Heart Risk for Older Women More... •  Adolor Corporation (ADLR) Announces Positive Results from Phase 2 Program in OIC More... •  Amarin Corporation PLC (AMRN) Announces Agreement From FDA on Special Protocol Assessment for AMR101 Outcomes Study More... •  Immune Network Ltd. (IMMFF) to Start Clinical Trial of Oral Mycobacterium Vaccae in Tuberculosis Patients More... •  Glenmark Pharmaceuticals Initiates Phase IIb Human Trials Globally for its Novel Molecule 'Revamilast' More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News Strategies for Entering Emerging Markets in Life Sciences Everyone knows Emerging Markets present big opportunities, but successfully capitalizing on them is hard. This survey provides insight into the strategies of medical device, pharma and healthcare services companies. Hear about past mistakes and future approaches in this report that you simply can't afford to miss. Download Your Copy Now! •  Maternal Blood Test Can Tell Parents Fetus's Sex After 7 Weeks, National Institutes of Health (NIH) Study More... •  Mothers of Twins "Have Heavier Single Babies", University of Sheffield Study More... •  Baylor University Study Finds Popular Muscle-Boosting Supplement Does Not Increase Blood Flow More... •  Fading Ability to Taste Iron Raises Health Concerns gor People Over Age 50, Virginia Tech Study More... •  Sleep Apnea Linked To Memory Decline, Dementia, University of California, San Francisco (UCSF) Study More... More General Clinical Research News IBC's BioProcess International Conference & Exhibition October 31-November 4, 2011-Long Beach, California Event Website Download the 2011 BioProcess International brochure and see why this is YOUR must attend event for 2011, Download your PDF here. BioProcess International is your one stop industry resource for driving down costs, improving quality, achieving rapid, robust and resilient process development and manufacturing. 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. Register by August 12 and you will save $300 off the standard conference rates with priority code B11171BSEODA. Register here today 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 • BioForest (Bothell, Washington) AVI BioPharma Sr. Director, Clinical Operations, Infectious Diseases Responsible for overseeing the anti-viral programs for Ebola, Marburg and H1N1. This person will manage the CROs in the trials and work with Program Management to ensure that timelines and budgets are adhered to. Etc. • Biotech Bay (San Francisco, California) Johnson & Johnson Family of Companies Manager, Clinical Data Management - Janssen AI, LLC Manages one or more clinical studies in a predominantly outsourced Data Management model and manages all aspects of study conduct in relation to data management: vendor oversight, study timelines, data quality and database lock deliverables. Etc. • BioMidwest (Chicago, Illinois) Hospira, Inc. Medical Science Liaison - Biologics The Medical Science Liaison provides clinical and scientific expertise to enable health care professionals to uinderstand biosimilar concepts and safely and effectively use these products. Etc. • BioTechxus (Dallas, Texas) DAVA Oncology, LP Medical Director, Accrual Enhancement Support Seeking a MD/DO who is a budding drug development entrepreneur with experience in the design and conduct of phase I-III clinical trials including some knowledge of site selection and accrual acceleration strategies. • Genetown (Cambridge, Massachusetts) Pfizer Inc. Clinician The non-physician Clinician is responsible for working collaboratively with the clinical leader, physicians and members of the development team to establish the clinical development plan(s) for one or more compounds from lead development in discovery to Phase I-II clinical trials. • 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 •  Agennix AG Announces Issuance of European Patent Covering Use of Talactoferrin to Treat Cancer More... •  Acorda Therapeutics (ACOR) Announces Allowance of Second U.S. Patent Application for AMPYRA(R) Covering Methods of Use for Improving Walking in Multiple Sclerosis More... More Patent News •  Northwest Biotherapeutics (NWBT) Highlights Cost Effectiveness of DCVax® in View of Recent Immunotherapy Pricing Concerns More... More Drug Product News Hot Company Amylin Ohio LLC 8814 Trade Port Drive Hamilton Ohio 45011 U.S.A. Amylin Pharmaceuticals, Inc.,is a biopharmaceutical company dedicated to improving lives of patients through the discovery, development and commercialization of innovative medicines. Amylin has developed and gained approval for two first-in-class medicines for diabetes, SYMLIN® (pramlintide acetate) injection and BYETTA® (exenatide) injection. 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. 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.