Vivus Surges After FDA Panel Backs Diet Drug - Feb. 23, 2012

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Thursday, February 23, 2012  |   |   |   |  Are you measuring multiple biomarkers in your late stage trial? The widespread adoption of biomarker pattern profiling has boosted efficiency in drug development beyond traditional single target methods. Increasingly, sponsorsneed to measure multiple biomarkers to capture the data necessary to accurately evaluate safety and efficacy in Phase II-III trials. Multiplexing quantifies all the targeted biomarkers in a single test to save money, conserve precious sample volume, and increase reproducibility. Contact us to learn more about how our services can benefit your late stage trial: www.myriadrbm.com/latestage/clinicaspace. •  VIVUS, Inc. (VVUS) Surges After FDA Panel Backs Diet Drug More... •  Pfizer Inc. (PFE)'s Prevnar 13® for Use in Adults Faces Setback, FDA Panel May Not Vote on Drug Until 2013 More... •  Mylan Laboratories Inc. (MYL)'s Combination Drug Gets Tentative FDA Approval Under PEPFAR More... •  Paladin Labs Inc. (CC:PLB) and Somaxon Pharmaceuticals, Inc. (SOMX) Announce Filing of New Drug Submission for Silenor® More... •  FDA Accepts Impax Pharmaceuticals NDA Filing for IPX066 for the Treatment of Idiopathic Parkinson's Disease More... More BLA/NDA/ANDA News More IND News More MAA News •  FDA Issues Import Alerts for Baxter International, Inc. (BAX)'s 22 Chinese Heparin Suppliers More... •  American Regent, Inc. Initiates Nationwide Voluntary Recall of Phenylephrine HCl Injection, USP, 1%, 5 mL Vial, Lot# 0693, Due to Visible Particles More... More Discontinuations News More Recalls and Warning News •  ULURU Inc. Announces Approval to Market Altrazeal(R) in Australia More... More Drug Approval News •  Roche (RHHBY)'s Zelboraf May Double Survival for Some Melanoma Patients More... •  Oragenics, Inc. (ONI) Announces Positive Clinical Results for its Proprietary Oral Care Probiotics Product, EvoraKids® More... •  Onyx Pharmaceuticals, Inc. (ONXX) Completes Enrollment in ASPIRE Phase 3 Carfilzomib Combination Trial for the Potential Treatment of Relapsed Multiple Myeloma More... •  Vertex Pharmaceuticals Incorporated (VRTX) Announces 12-Week On-Treatment Data and SVR4 From Phase 2 Study of Interferon-Free (All-Oral) Treatment Regimen of INCIVEK®, VX-222 and Ribavirin in People with Genotype 1 Hepatitis C More... •  Nuvilex Reports Encapsulated Living Cells Technology for Pancreatic Cancer Treatment Showcased in Shanghai 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! •  Migraines Linked to Depression in Women, Brigham and Women's Hospital Study More... •  Mixing Grapefruit Juice and Medicine Heightens Risk of Toxic Overdose, FDA Reveals More... •  Researchers Spot New Gene Mutation Linked to Breast Cancer, University of Pennsylvania Study More... •  Are Women Turned Off By Stressed-Out Men? University of Aberdeen Study More... •  Complete Genomics, Inc. Co-Authors Paper Demonstrating Impact of Hepatitis B Virus on Liver Cancer Genomes More... More General Clinical Research News 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. Innovative Clinical Trial Design and Management • Use detailed case studies of recent adaptive trials featuring companies including Merck, Pfizer, Novartis, GSK, Eli Lilly, and AstraZeneca. • Measure the potential cost savings offered by the reduced development times and improved decision-making associated with adaptive trials. • Assess the logistics of adaptive trial implementations. Click Here for More Information. • 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. • Biotech Beach (San Diego, California) Lab Support, A Division Of On Assignment Clinical Lab Scientist Determine the acceptability of specimens for testing according to established criteria. Calculate results using testing data with both manual and computerized procedures. Accurately enter results of testing. Review reports to ensure accurate test result reporting. • Biotech Bay (Palo Alto, California) Theranos, Inc. Clinical Laboratory Scientist Under the direction of Technical and General Supervisors, perform laboratory procedures across a broad range of assays and in accordance with standards established in the Clinical Laboratory Improvement Amendments (CLIA). • Bio NC (Durham, North Carolina) PAREXEL International Manager, Clinical Data Analysts Recruit, develop and retain an experienced and motivated team of Clinical Data Analysts in order to optimally resource projects with suitably experienced staff. In this role, you will have the opportunity to promote new business by participating in project bids and client presentations as appropriate. • 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 •  Precision BioSciences Announces Allowance of Five Additional U.S. Patent Applications Related to Engineered Meganucleases More... •  GENFIT Corp. (ALGFT) Release: GFT505: New Patents Granted in Major Countries More... •  MAP Pharmaceuticals, Inc. (MAPP) Issued Additional U.S. Patent for Methods of Achieving Rapid Treatment of Migraine Based Upon Pharmacokinetic Profile More... More Patent News Hot Company SNBL Clinical Pharmacology Center 800 West Baltimore Street, 5th Floor Baltimore, Maryland 21201 U.S.A. Phone: 800-690-9110 Fax: 410-706-8963 SNBL-CPC partners with pharmaceutical companies, biotech firms and CROs to accelerate drug development utilizing our best-in-class facility, technology, operational excellence and strong affiliations with local academic medical institutions (University of Maryland and Johns Hopkins University). 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.