FDA Rejects Regeneron's Arcalyst for Gout - July 31, 2012

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Tuesday, July 31, 2012  |   |   |   |  Increase the odds of identifying a functional biomarker pattern using our comprehensive protein biomarker services. Please click here for more information. •  FDA Rejects Regeneron Pharmaceuticals, Inc. (REGN)'s Arcalyst for Gout More... •  Arena Pharmaceuticals, Inc. (ARNA) Transfers Diet Pill Application to Eisai Company, Ltd. (ESALY.PK) More... •  FDA Accepts NuPathe Inc. (PATH)'s Migraine Patch NDA Resubmission for Filing More... •  Ariad Pharmaceuticals, Inc. (ARIA) Announces Submission of New Drug Application for Ponatinib to the FDA More... More BLA/NDA/ANDA News More IND News More MAA News •  Vertex Pharmaceuticals Incorporated (VRTX) Lowers Incivek View; New Drug Data Lifts Shares More... •  Nymox Pharmaceutical (NYMX) Reports Positive Results From Combined Statistical Analysis of Long Term Follow-Up Studies of BPH Drug More... •  Rockwell Medical Technologies (RMTI) Completes Patient Enrollment in Phase III Clinical Trials for SFP Iron-Delivery in Hemodialysis Patients More... •  Pfizer Inc. (PFE) Announces Positive Top-Line Results From the ORAL Start Phase 3 Study of Tofacitinib in Rheumatoid Arthritis More... •  FDA Requests Teleconference to Discuss Repros Therapeutics Inc. (RPRX) Phase 2 Protocol for Proellex® in the Treatment of Endometriosis Last Week of August More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News •  Mindreading Hormone? A Better Judge of Character With Nasal Spray? University of Oslo Study More... •  Rejected Alzheimer's Drug Shows New Potential, Mount Sinai School of Medicine Study More... •  Brains are Different in People With Highly Superior Autobiographical Memory, University of California, Irvine Study More... •  Computer Scientists Present Smile Database, University of Amsterdam Study More... •  Brain Development Delayed in ADHD, National Institutes of Health (NIH) Study More... More General Clinical Research News The 6th Annual Pain Therapeutics October 3 - 4, 2012 San Francisco, CA Event Website ARROWHEAD'S ANNUAL PAIN THERAPEUTICS SUMMIT is the US's premier conference covering the field of pain management and therapeutics. Leaders from the pharmaceutical, biotech, device and medical communities attend this conference to learn about the latest advances in the treatment of various types of pain and to network with colleagues from industry, the non-profit sector, academia, the medical community, government and investors. This conference will provide attendees with thoughtful insight from key industry leaders and academic researchers concerning cutting edge drug discovery science, preclinical development trends, analysis of key clinical-stage pain therapies and newly marketed products. We will highlight the most important developments in recent years in the field, including new research in CGRP antagonists, NGF antagonists, Nav 1.7 antagonists, new research in biologic therapies and the genetic component of pain, abuse-resistant opioids, analysis of FDA's REMS program and a plethora of other topics. Please click here for more information. • BioMidwest (Northbrook, Illinois) Astellas Pharma US Associate Clinical Program Director Provide strategic input into clinical development plans, GMAP and other key global project team deliverables through participation on global project team. Deliver and manage the operational plan including budget, resources and timelines to global project team. • BioForest (Lake Oswego, Oregon) Galena Biopharma Global Clinical Project Manager Responsible for the planning, development, implementation and ongoing management of all of the operational aspects of clinical trials including protocol development, defining scope of work, resource planning and allocation, recruitment of clinical investigators, training, planning and execution of investigator meetings, establishment and adherence to timelines, ensuring compliance with protocols and clinical/corporate objectives, adherence to regulations and company Standard Operating Procedures (SOPs), and clinical supply management. • Biotech Bay (Foster City, California) Gilead Sciences Associate Director, Clinical Research Will primarily support the GS-7340 project, a new nucleotide reverse transcriptase inhibitor in development for the treatment of HIV, though work on other HIV development projects may also be required. • Pharm Country (Bedminster, New Jersey) Allergan Inc. Manager, Clinical Data Quality Manages a team of professionals responsible for supporting independent Data Management and Programming quality activities including database, documentation and data trend assessments. Responsible for hiring and managing the performance of these professionals. • Genetown (Boston, Massachusetts) Sterling-Hoffman Executive Search Director of Clinical Research Act as a key member of the early development team, providing a leadership role on the team with regard to design and execution of pre-clinical development strategy. Take responsibility to author initial program clinical plans and early development plan. • Get Noticed! Add your resume to the BioSpace Career Center! • See more than 5,000 job postings in the BioSpace Career Center! 2012 Pharm Country 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 tri-state 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. • Pharm Country Career Fair, Bridgewater, NJ September 13, 2012 • Biotech Beach Career Fair, San Diego, CA September 20, 2012 • Biotech Bay Career Fair, Burlingame, CA October 3, 2012 • BioCapital Career Fair, Bethesda, MD October 9, 2012 • BioMidwest Career Fair, Lincolnshire, IL October 22, 2012 • Bio NC Career Fair, Durham, NC October 25, 2012 • Genetown Career Fair, Cambridge, MA November 5, 2012 More information about BioSpace's Career Fairs BioSpace White Paper Biotech Career Fairs For Job Seekers 101: Control Your Experience •  StemCells Inc. (STEM) Broadens HuCNS-SC® Patent Portfolio With Key Patent in Japan More... •  GeNO LLC Receives Two Additional Patents For Inhaled Nitric Oxide Drug Delivery More... •  Abon Announces CLOLAR® Patent Challenge More... More Patent News •  GlaxoSmithKline (GSK) Shipping U.S. Flu Vaccine With New Strain Coverage Recommended for 2012-2013 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, Asia and the Rest of the World. • 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 Coldstream Laboratories Inc. 1500 Bull Lea Road, Suite 250 Lexington, Kentucky 40511 U.S.A. Phone: 859-257-6600 Fax: 859-323-5985 At Coldstream Laboratories Inc. (CLI), we're seasoned at turning pharmaceutical development ideas into safe, pure, and effective clinical pharmaceutical dosage forms. Since 1986, we have completed more than 200 formulation development projects that led to clinical trials providing us extensive clinical manufacturing experience with both commercial product development and grant-funded projects from such sources as the National Institutes of Health. 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. 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