Panel Backs FDA Pulling Plug on Avastin - June 30, 2011

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Thursday, June 30, 2011  |   |   |  Reduce Risk and Maximize Potential in Ophthalmology Development: Ophthalmic study design and execution can be quite different than other therapeutic areas. Pharm-Olam's team has a proven track record of excellence in achieving trial objectives and can provide strategic, operational and consulting to sponsors for phase I to phase IV development. The majority of our clinical staff in emerging markets are MDs or PhDs, including Ophthalmologists in strategic areas for clinical trials. The incidence of disorders and standards of treatment can vary widely, so let Pharm-Olam conduct a complimentary feasibility study specific to your protocol and study budgets to use in your resource planning. Contact us at www.pharm-olam.com, info@pharm-olam.com, USA +1-713-559-7900, UK +44-0-1344-891121. •   Panel Backs FDA Pulling Plug on Avastin More... •  Doctors to FDA: Gilead Sciences, Inc. (GILD)'s "HIV Prevention Pill" Not Ready for Approval More... •  VIVUS, Inc. (VVUS) Submits New Drug Application for Avanafil for the Treatment of Erectile Dysfunction More... •  FDA Accepts Submission of New Drug Application for Corcept Therapeutics Inc. (CORT)'s CORLUX for Cushing's Syndrome More... •  Forest Laboratories, Inc. (FRX) and Almirall Announce Submission of New Drug Application for Aclidinium Bromide for the Treatment of Chronic Obstructive Pulmonary Disease (COPD) More... More BLA/NDA/ANDA News More IND News More MAA News •  Sagent Pharmaceuticals, Inc. Announces FDA Approval of Polymyxin B for Injection, USP More... More Drug Approval News •  Endo Pharmaceuticals (ENDP) 's Lower Back Pain Drug Fails Trial; Drug Did Not Meet Mid-stage Trial Goals More... •  Nuvo Research Inc. (NRI.TO) Announces Positive Top-Line Results for Pennsaid Viscous Solution Phase 2 Trial More... •  Medicago, Inc. Announces Positive Top-Line Results for Pennsaid Viscous Solution Phase 2 Trial More... •  Vectura Group plc Phase III Study Shows Once-Daily NVA237 is Superior to Placebo and Similar to Tiotropium in Improving Lung Function in COPD More... •  ACORN Research Reports Positive Findings of Phase 2b Metastatic Breast Cancer Trial at ASCO More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News •  Natural Gases as a Therapy for Heart Disease, University of Exeter and National University of Singapore (NUS) Study More... •  Blocking Molecular Target Could Make More Cancers Treatable With PARP Inhibitors, Dana-Farber Cancer Institute Study More... •  New Therapy for Childhood Neuroblastoma Proves Feasible and Safe, Study in The Journal of Nuclear Medicine Finds More... •  Possible Way to Make Bladder Cancer Cells More Susceptible to Chemotherapy, University of California, Davis (UCD) Study More... •  Inovio Pharmaceuticals (INO)' DNA Vaccine for Foot-and-Mouth Disease Generates Protective Neutralizing Antibodies in Second Large-Animal Study More... More General Clinical Research News Join us for the 40th Annual Meeting of the American College of Clinical Pharmacology, Sept. 11-13, 2011 at the Crowne Plaza Chicago O'Hare Hotel, Chicago (Rosemont), IL, covering a wide range of current, relevant topics as noted below. CME and CPE credits available for registered attendees. • Transdermal Delivery Systems • Opioids and Psychotropic Drugs • First-in-Human Clinical Trials • Model-based Drug Development • Biotherapeutic Dose Selection Strategies • Drug Safety vs. Disease Treatment • Quantitative Clinical Pharmacology in Inflammation & Immunology • Imaging Techniques in Drug Development • Bridging Clinical Trials • Innovations in Pharmacoepideomiology • Hormone Therapy in Menopausal Women Keynote speakers include: Francis S. Collins, MD, PhD, Director of the National Institutes of Health (NIH) on Sunday, Sept 11th and Anne Schuchat, MD, Director of the CDC's National Center for Immunization and Respiratory Diseases (NICRD) on Monday, Sept 12th. Additional information about the ACCP 40th Annual Meeting and the Preliminary Program are available online or contact TStevens@ACCP1.org. 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 • Biotech Beach (Irvine, California) Edwards Life Sciences Clinical Research Associate Oversight of all study documentation review (for completeness), filing and tracking activities to ensure compliance. This includes the Master files, Site file and Business files for THV each study. Etc. • Biotech Bay (Newark, California) Synarc, Inc. Clinical Data Manager Provides accurate, timely, and consistent clinical data to client organizations and internal staff to support business objectives. The Clinical Data Manager defines and directs the data management workflow. Etc. • Genetown (Rockville, Maryland) Novartis Institutes for BioMedical Research, Inc. BS/MS Level In Vivo Biologist: Oncology Research The successful candidate will join a dynamic, multi-disciplinary team of scientists in the In Vivo Pharmacology Oncology Department, playing a key role in the development of in vivo models of cancer and the use of those models for evaluating new drug candidates. • Pharm Country (Ridgefield, Connecticut) Kforce Clinical Research Clinical Research Associate To collaborate in the identification and drive the selection of investigator sites with input from other cross-functional groups. Also monitors investigator sites in compliance with company SOPs, ICH/GCP and local laws so that site performance targets are achieved. Etc. • BioMidwest (Deerfield, Illinois) Astellas Pharma US Associate Director, Clinical Studies Responsible for overseeing the management of multiple clinical development programs that typically involve multiple therapeutic areas or indications. Provides direction to Senior Managers and Study Managers and clinical teams. Etc. • 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 •  Forest Laboratories, Inc. (FRX) Announces Commercial Availability of VIIBRYD(TM) in Pharmacies More... •  Malaria Parasite and Mosquito Products and Assay Services Available for Sale by Sanaria Inc. More... More Drug Product News Hot Company Idenix Pharmaceuticals, Inc. 60 Hampshire Street Cambridge, Massachusetts 02139 U.S.A. Phone: 617-995-9800 Fax: 617-995-9801 Idenix Pharmaceuticals, Inc. is a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases. 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. 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