Biogen Sends Potential MS Blockbuster to FDA - Feb. 28, 2012

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Tuesday, February 28, 2012  |   |   |   |  The Norwich Advantage. One comprehensive solution for all stages of the product lifecycle. Norwich is a recognized leader in full-service contract pharmaceutical development and manufacturing. As a single-source provider, Norwich offers customers greater flexibility, resources and speed that result in a streamlined progression from product development and clinical research to scale-up and through commercial manufacturing. Please click here for more information. •  Biogen Idec, Inc. (Massachusetts) (BIIB) Sends Potential MS Blockbuster to FDA More... •  Bayer HealthCare (BAY)'s Xarelto Granted Priority Review by FDA to Prevent Secondary Cardiovascular Events More... •  FDA Grants Repros Therapeutics Inc. (RPRX) Meeting to Discuss Androxal(R) Phase 3 Study Design and Required Drug Dossier for NDA More... More BLA/NDA/ANDA News More IND News More MAA News •  FDA Approves Biogen Idec, Inc. (Massachusetts) (BIIB)'s AVONEX® PEN#0153; and Dose Titration Regimen More... More Drug Approval News •  Forest Laboratories, Inc. (FRX), Gedeon Richter Ltd. Schizophrenia Drug Meet Phase III Trial Goals More... •  Ferring Pharmaceuticals, Inc. Release: FIRMAGON® (degarelix) Demonstrates Non-inferiority to goserelin with bicalutamide in Reducing Prostate Volume in Prostate Cancer Patients while Providing Better Relief from Lower Urinary Tract Symptoms More... •  Baxter International, Inc. (BAX) Initiates Phase III Adult Stem Cell Clinical Trial for Chronic Cardiac Condition More... •  Tranzyme Pharma and Norgine Complete Enrollment in ULISES 008, the Second of Two Phase 3 Pivotal Trials of Ulimorelin More... •  OncoSec Medical Inc. Doses First Patient in Phase II Clinical Trial for Metastatic Melanoma More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval 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 set. Request Now! •  Even Low Doses of Sleeping Pills Triple Death Risk, Scripps Health Study More... •  Hyperactivity in Brain May Explain Multiple Symptoms of Depression, University of California, Los Angeles (UCLA) Study More... •  Early Signs Vitamin D Might Ease Menstrual Cramps, Brigham and Women's Hospital Study More... •  Omega-3 Fatty Acids May Protect the Aging Brain, University of California, Los Angeles (UCLA) Study More... •  Wealthy More Likely to Lie, Cheat, University of California, Berkeley (CAL) Study More... More General Clinical Research News SDIX Presents: Better Antibodies Through Better Antigen Design Thursday, March 8th | Bethesda, MD (www.sdix.com/learn) Friday, March 9th | King of Prussia, PA (www.sdix.com/discover) Join SDIX on March 8th or March 9th for a series of talks focused on next generation antibody development. At SDIX, a focus on the philosophy of better antigen design has resulted in dramatic improvements to the antibody production process. In a series of talks, our scientists will discuss this antigen design philosophy and provide case studies to demonstrate the effectiveness of this methodology. In particular, these talks will focus on the use of SDIX's proprietary Genomic Antibody Technology™ and its ability to deliver antibodies that match end users' requirements. To register and for more information, visit: March 8th in Bethesda, MD:www.sdix.com/learn March 9th in King of Prussia, PA:www.sdix.com/discover New Emerging R&D and Clinical Trial Locations • Compare 5 new emerging R&D locations in terms of population, economic activity, healthcare infrastructure, and current R&D activity. • Analyze how clinical trial numbers are changing in China, India, and Eastern Europe. • Develop strategies for geographic outsourcing. Click Here for More Information. • BioTechxus (Austin, Texas) xBiotech USA, Inc. Clinical Research Associate Conducts site qualification, site initiation, interim monitoring visits and study close-out visits. Monitors progress of subject enrollment. Performs source document verification of electronic Case Report Forms (eCRFs). • Biotech Bay (South San Francisco, California) Threshold Pharmaceuticals, Inc. Clinical Research Associate II Contribute to the preparation of clinical protocols and amendments. Performs clinical study or clinical site feasibility. Assist in the activities associated with site start-up and management. Support the administration of study budgets. • Biotech Beach (Los Angeles, California) Puma Biotechnology Clinical Data Manager Identify external data issues and tracks resolutions. Reviews listings to identify data discrepancies and tracks resolutions. Performs database design and edit check specification testing. • Genetown (Cambridge, Massachusetts) Pfizer, Inc. Clinical Pharmacology Lead Apply Systems Pharmacology utilizing systems biology approaches, while combining experimental studies with model-based computational analyses to study drug activities, targets and effects. • Pharm Country (Princeton, New Jersey) Otsuka America Pharmaceutical, Inc. Associate Director Clinical Management Acts as the scientific lead for clinical program development activities within a product group or within a portfolio. Determines product and portfolio level standards for clinical development planning, scientific document content, data analysis and reporting ,and reporting to senior management, OPCJ and affiliates. • Get Noticed! Add your resume to the BioSpace Career Center! • See more than 5,000 job postings in the BioSpace Career Center! BioSpace Career Fair at CALBIO2012 Job seekers can spend a day with HR representatives and Hiring Managers from top biotech, pharma, medical device and diagnostics companies in the Bay Area. 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. • BioSpace Career Fair at CALBIO2012, San Francisco, CA March 7, 2012 • BioMidwest Career Fair, Bridgewater, NJ March 22, 2012 • Biotech Beach Career Fair, La Jolla, CA April 17, 2012 • BioCapital Career Fair, Bethesda, MD April 25, 2012 • Pharm Country Career Fair, King Of Prussia, PA May 1, 2012 • BioNC Career Fair, Durham, NC May 2, 2012 • Biotech Bay Career Fair, Burlingame, CA May 29, 2012 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 •  Fake Avastin Lacked Active Ingredient: Roche (RHHBY) More... More Drug Product News Hot Company Gallus Biopharmaceuticals, LLC 4766 LaGuardia Drive St. Louis, Missouri 63134 U.S.A. Phone: 314-426-5000 Fax: 314-426-1792 Gallus BioPharmaceuticals has recently emerged on the market as a premier cGMP biologics contract manufacturing organization based in St. Louis, MO USA. Gallus operates an FDA-approved, commercial facility formerly owned by Centocor Biologics. The plant has been approved by every major regulatory agency and currently manufactures two of Centocor Biologics™ leading products, Remicade® and Stelara™, which are distributed globally. The Gallus facility has capabilities for clinical and commercial mammalian cell culture in batch, fed-batch and perfusion as well as process development and analytical services. 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, Maysa Darwish, Tammy Liu, Michelle Wong 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 2012 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.