FDA Rejects J&J HIV Pill; BMY Drug Helps Body Attack Lung CA - May 30, 2012

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Wednesday, May 30, 2012  |   |   |   |  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. •  FDA Rejects Johnson & Johnson (JNJ) HIV Pill More... •  FDA Seeks Safety Report on Repros Therapeutics Inc. (RPRX) Tumor Drug More... •  Genzyme Corporation (GENZ) Rare-disease Drug Denied Accelerated Decision by FDA More... •  Exelixis, Inc. (EXEL) Completes Submission of New Drug Application for Cabozantinib for the Treatment of Medullary Thyroid Cancer More... •  Ligand Pharmaceuticals Inc. (LGND) Partner GlaxoSmithKline (GSK) Submits US and European Regulatory Applications for use of PROMACTA/REVOLADE to Increase Platelet Counts in Patients with Hepatitis C More... More BLA/NDA/ANDA News More IND News More MAA News •  Bristol-Myers Squibb Company (BMY) Drug Helps Body Attack Lung Cancer More... •  Antioxidant May Help Children With Autism, Stanford University Study More... •  Bananas Are as Beneficial as Sports Drinks, Appalachian State University Study More... •  PCB Exposure Linked to Increased Abdominal Fat, Uppsala Universitet Study More... •  21st Century Bloodletting Reduces Cardiovascular Risk, Charite-University Medical Centre Study More... More General Clinical Research News •  FDA Warns Johnson & Johnson (JNJ) Over Vaginal Products More... •  FDA Warns Consumers About Fake Versions of Teva Pharmaceutical Industries Limited (TEVA)'s Adderall More... More Discontinuations News More Recalls and Warning News •  Perrigo Company (PRGO) Announces Tris Pharma, Inc. Final Approval of Tris Pharma, Inc.'s Dextromethorphan Polistirex Extended-Release Oral Suspension More... More Drug Approval News •  Alnylam Pharmaceuticals (ALNY) Lung Drug Fails Mid-stage Trial More... •  Flexion Therapeutics Reports Positive Data for Osteoarthritis Drug More... •  Celsion Corporation (CLN) Announces Completion of Enrollment in Its Pivotal Phase III HEAT Study of ThermoDox(R) in Primary Liver Cancer More... •  Exelixis, Inc. (EXEL) Initiates COMET-1 Pivotal Trial Focused on Overall Survival in Men With Advanced Prostate Cancer More... •  Bionor Pharma ASA Release: First Human Clinical Study of HIV Vaccine Vacc-C5 Approved to Begin More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News 8th Annual Bioassays and Bioanalytical Method Development October 1, 2012 - October 3, 2012 Event Website IIR's 8th Annual Bioassays and Bioanalytical Method Development event (formerly Cell Based Assays and BAMD) gives you access to the know how of the pharmaceutical scientists with the most experience in cell-based and ligand binding assays and bio analytical method development. For more information, please visit: www.bioassaysevent.com. • Biotech Beach (Carlsbad, California) Genoptix, Inc. Associate Director, Clinical Trial Support Oversee and provide day-to-day scientific expertise and guidance for clinical trial testing projects. Ensure all aspects of departmental activities meet established quality and technical standards, including CLIA and/or GCLP. • Pharm Country (Pittsburgh, Pennsylvania) ZOLL LifeVest Clinical Research Associate Assist with site selection and site qualification visits. Develop and review clinical materials including informed consent forms, case report forms, study manuals, Standard Operating Procedures, and other clinical materials to ensure compliance with regulatory, IRB, and company policies. • Biotech Bay (Fremont, California) Zosano Pharma, Inc. Associate Director, Clinical Operatioins Will provide operational and implementation expertise to the product/project teams under the guidance of the Chief Medical Officer. He or she will be the primary contact for the contract research organizations (CROs), laboratory vendors and clinical sites involved in the clinical trials. • BioForest (Seattle, Washington) Amgen Director, Preclinical Will provide strategic vision and portfolio leadership in support of small and large molecule drug development, registration, and/or post-marketing activities. He/she will be responsible for portfolio-level strategic and resource planning, communication, scientific/technical deliverables, and issue resolution. • Southern Pharm (Memphis, Tennessee) GTx, Inc. Director, Clinical Development Will provide leadership in implementing the approved strategies to move drug product candidates effectively through, the clinical and regulatory process. This position will directly manage Phase I programs and facilitate the operations of Phase II and Phase III clinical trials. • Get Noticed! Add your resume to the BioSpace Career Center! • See more than 5,000 job postings in the BioSpace Career Center! 2012 BIO 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 Massachusetts 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. • 2012 BIO Career Fair, Boston, MA June 18, 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 •  Cytune Pharma is Granted an EU Patent for Its Potent Immunotherapy CYP0150: an Optimized Recombinant Il-15 Fusion Protein and Will Attend BIO 2012 After a Year of Achievements More... More Patent News •  Cytori Therapeutics, Inc. (CYTX) Obtains Celution(R) Approval in Russia; to Launch Product Line for Plastic Surgery and Select Soft Tissue Therapies More... •  MD Bioproducts Releases HLA-B27 Subtype Specific Antibody. More... More Drug Product 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! Biomarkers in Late Stage Clinical Trials • Quantify and analyze revenues of late stage biomarker technology and services in North America, Europe, Identify the key market drivers and resistors of the biomarker market and evaluate the growth potential of emerging technologies. • Assess biomarker activity at leading companies, including Abbott, AZ, BMS, Eli Lilly, GSK, Merck & Co, Novartis, Pfizer, Roche and Sanofi-Aventis. Click Here for More Information. Hot Company Gentris Corporation 133 Southcenter Court, Suite 400 Morrisville, North Carolina 27560 U.S.A. Phone: 919-465-0100 Fax: 919-465-0554 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: Lana Ho Editorial & Production Staff: Maysa Darwish, Tammy Liu ClinicaSpace.com - Clinical Trials. Clinical Research. 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