FDA Approves Gilead HIV Pill Complera - Aug. 11, 2011

Having trouble viewing this email? View in Browser.

Thursday, August 11, 2011  |   |   |   |  CHI's Ninth International Discovery on Target November 2 - 4, 2011 - Boston, Massachusetts Event Website This fall Cambridge Healthtech Institute will host its Ninth International Discovery on Target event showcasing novel "hot" targets for the pharmaceutical industry November 2-4 in Boston, Massachusetts. Special Early Registration Discounts are available. Don't miss this opportunity to take advantage of reduced registration rates and save up to $350! This is a must attend event to keep up with current and upcoming developments in target discovery and to collaborate and connect with experienced scientists and high level decision makers. Join us for in-depth coverage of novel drug targets focused on HDAC, RNAi, the PI3K pathways, allosteric modulators, metabolic pathways in tumor cells, kinase inhibitors, GPCR and Diabetes. To register and for up-to-date information, visit: DiscoveryOnTarget.com. •  FDA Approves Gilead Sciences, Inc. (GILD) HIV Pill Complera More... More Drug Approval News •  Affymax, Inc. (AFFY) Announces Assignment of March 27, 2012 PDUFA Date for Peginesatide New Drug Application More... More PDUFA News •  FDA Sets Review Deadline For Amylin Pharmaceuticals, Inc. (AMLN) Diabetes Drug More... •  Neoprobe Corporation (NEOP) Submits New Drug Application for Lymphoseek More... •  Advaxis, Inc. Completes Pre-IND Meeting for ADXS-PSA More... More BLA/NDA/ANDA News More IND News More MAA News •  Bayer AG (BAY.F). Johnson & Johnson (JNJ) Anti-Clot Drug Gets Cautious Journal Welcome More... •  Lexicon Pharmaceuticals, Inc. (LXRX) Announces Publication of Results From the Phase 2 Trial of LX1031 in Patients With Irritable Bowel Syndrome in Journal of Gastroenterology More... •  Emergent BioSolutions (EBS) Release: New Tuberculosis Vaccine Enters Phase IIb Proof-of-Concept Trial in People Living with HIV in Senegal and South Africa More... •  Science Translational Medicine Publishes Breakthrough Finding From Cleveland Biolabs Inc. (CBLI) and Incuron on Identification of Target and Mechanism of Action of Novel Anticancer Agents Curaxins More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News Featured Free Magazine of the Week - Nature Methods Nature Methods provides techniques for life scientists and chemists. It is a print and online publication dedicated to publishing novel methods together with significant advances to tried and tested techniques allowing researchers to perform faster, better and more efficient experimental research. Request Now! •  Red Meat Linked to Increased Risk of Type 2 Diabetes, Harvard School of Public Health Study More... •  Leukemia Breakthrough - Serial Killer T Cells Wipe Out Tumors in Small Trial, University of Pennsylvania Study More... •  Breakthrough Multiple Sclerosis DNA Study Could Lead to New Treatments, University of Cambridge Study More... •  New Agent Prevents Stroke in Patients With Atrial Fibrillation, Duke Clinical Research Institute Study Suggests More... •  Drug Improves Some Cases of Chronic Constipation, Beth Israel Deaconess Medical Center 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 PDFhere. 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 • Pharm Country (Cranbury, New Jersey) On Assignment Clinical Research Clinical Project Manager Responsible for the operational oversight of our clinical development programs and management of our CRO. Providing input to our clinical development strategies. He/she is responsible for technical leadership and successful execution of projects involving clinical operations, etc. • 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. • 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 •  MAP Pharmaceuticals, Inc. (MAPP) Issued U.S. Patent for Methods of Achieving Rapid Relief of Migraine and Minimizing Side Effects Based Upon Pharmacokinetic Profile More... More Patent News •  Lannett Company, Inc. (LCI) Launches Morphine Sulfate Oral Solution More... More Drug Product News Hot Company Gentris Corporation 133 Southcenter Court, Suite 400 Morrisville, North Carolina 27560 U.S.A. Gentris Corporation, is a leading global provider of applied clinical pharmacogenomic services. As pioneers in the field of pharmacogenomics, Gentris assists pharmaceutical companies and clinical research organizations to effectively integrate pharmacogenomics into their drug development programs to deliver safer, more effective drugs to market more quickly. 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, 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.