FDA, Roche Warns of Fake Avastin in the U.S. - Feb. 15, 2012

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Wednesday, February 15, 2012  |   |   |   |  Partnerships 2012: The Largest Yet Most Intimate Gathering of Clinical Decision Makers in the World The world has radically changed in just the last few years and the trend is likely to continue at an exponential rate. Partnerships in Clinical Trials is changing with it. Partnerships has always been where business gets done and strategic partnership deals are inked, but in 2012 it is where the industry moves forward with answers. We've taken your most pressing challenges and translated them into the most provocative meeting agenda the industry has ever seen. For more information, please visit the conference site: http://www.iirusa.com/cropartners/welcome-to-CROs.xml?registration=XP1700BSENL. •  FDA, Roche (RHHBY) Warns of Fake Avastin in the U.S. More... More Discontinuations News More Recalls and Warning News •  BioSante Pharmaceuticals, Inc. (BPAX), Teva Pharmaceutical Industries Limited (TEVA) Surge as FDA OKs Testosterone Gel More... More Drug Approval News •  FDA Accepts Pfizer Inc. (PFE)'s New Drug Application for Tafamidis Meglumine More... •  Santarus Inc. (SNTS) Announces FDA Acceptance of UCERIS New Drug Application for Induction of Remission of Active Ulcerative Colitis More... More BLA/NDA/ANDA News More IND News More MAA News •  Actelion Ltd. (ALIOF.PK) CEO Says 120 Patients Died in Lung Drug Study More... •  Biocryst Pharmaceuticals (BCRX) Announces Promising Results from Preclinical Studies of BCX5191 for Hepatitis C More... •  Nymox Pharmaceutical (NYMX) Announces Current Safety Monitoring Committee Results and Update for Phase 3 NX-1207 Trials More... •  Bionor Pharma ASA Release: With Final Review of Phase IIb Viral Load Data Completed, Researchers Confirm Statistically Significant Reduction of HIV Viral Load on Vacc-4x Compared to Placebo More... •  RegeneRx Biopharmaceuticals, Inc. (RGRX) Release: Researchers Show TB4 Provides Both Neuroprotection and Neurorestoration after Traumatic Brain Injury 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! •  Antibiotics No Help Against Most Sinus Infections, Washington University in St. Louis Study More... •  Lead, Cadmium Levels in Blood Linked to Reduced Fertility, National Institutes of Health (NIH) Study More... •  Sleeplessness Tied to Early Alzheimer's, Washington University School of Medicine Study More... •  Cold Baths May Help Ease Muscle Soreness After Workouts, University of Ulster Study More... •  No Cancer Benefit From Vitamin B, Omega-3 Supplements in Heart Patients, University of Paris Study More... More General Clinical Research News 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. • Genetown (Lexington, Massachusetts) Cubist Pharmaceuticals, Inc. Senior Manager/Manager, Clinical Risk Management Serves as Pharmacovigilance lead at cross-functional and/or external meetings including clinical trial team meetings and/or multidisciplinary product teams. Provides input to the product Clinical Development Team on program objectives and deliverables. • BioCapital (Wilmington, Delaware) AstraZeneca Pharmaceuticals LP Associate Director/Director Clinical Research Reports to the Group Director- Late Development and provides medical input to all aspects of product development. Serves as a source of medical expertise for Respiratory & Inflammation Therapy Area and product teams. Provides input to decisions of the that may have medical and scientific and marketing implications relative to his/her expertise. • Biotech Beach (Irvine, California) AcuFocus, Inc. Clinical Research Associate Assist in planning, executing and monitoring of multi-site clinical protocols in accordance with ICH and GCP guidelines. Maintain IRB/EC/IACUC submissions, track approvals and completion of periodic reports • Biotech Bay (Redwood City, California) Genomic Health, Inc. Clinical Laboratory Scientist I Responsible for performing high complexity laboratory testing on patient specimens, interpreting and reporting patient results, performing quality control and quality assurance procedures and complying with all applicable local, state and federal laboratory requirements. • Bio NC (Durham, North Carolina) PAREXEL International Clinical Monitoring Associate Perform remote clinical monitoring tasks and remote visits for designated projects in accordance with relevant SOPs, study specific procedures and regulations. Responsibilities include managing/coordinating/supporting clinical monitoring activities remotely, including issue resolution, patient enrollment management, handling protocol- and/or ICF- and/or contract amendments, drug / supply management and ensuring timely data entry at a site level. • Get Noticed! Add your resume to the BioSpace Career Center! • See more than 5,000 job postings in the BioSpace Career Center! Genetown 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 Northeast 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. • Genetown Career Fair, Cambridge, MA February 21, 2012 • 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 •  Ariad Pharmaceuticals, Inc. (ARIA) Announces Issuance of Key U.S. Patent on Ponatinib More... •  H. Lee Moffitt Cancer Center & Research Institute Release: New Patent Promises to Accelerate Cancer Trials More... •  Microbix Biosystems Inc. (MBXBF)' LumiSort® Patent Withstands Competitive Challenge More... •  Hatchtech Extends Patent Protection for DeOvo(TM) Head Lice Treatment More... More Patent 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 Hot Company LabConnect, LLC Corporate Office 2910 First Avenue South, Suite 200 Seattle, Washington 98134 U.S.A. Phone: 206-322-4680 Fax: 206-322-4682 LabConnect provides integrated, one-stop solutions for your laboratory service needs. Through the combined expertise of our worldwide network of leading laboratories, we provide customized laboratory service solutions designed to meet your unique requirements. 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. 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