Insmed Slammed as FDA Puts Hold on CF Study - Aug. 2, 2011

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Tuesday, August 02, 2011  |   |   |   |  Pharm-Olam International Acquires StatWorks, Inc. With Pharm-Olam's acquisition of StatWorks we have expanded our team Data Management and Biostatistics experts for functional outsourcing and full service clinical trials. Our comprehensive biometric services include: • Integration of randomization into EDC systems, eliminating IVRS costs, with added benefit of full inventory control over supplies • Adaptive, Sequential, and Bayesian design methods • CDISC, SDTM and ADaM datasets • SAS programming, eCRF design, and medical coding in MedDRA/WHO Drug • Streamlining and reconciling across SAE, CTMS, and study DB • Health Outcomes Research and Patient Reported Outcomes • Protocol development, sample size, and randomization Contact us at www.pharm-olam.com, info@pharm-olam.com, USA +1-713-559-7900, UK +44-0-1344-891121. •  Insmed Incorporated (INSM) Slammed as FDA Puts Hold on CF Study; Shares Fall -5.37 (47.31%) @ 1:26PM EDT More... •  Arena Pharmaceuticals, Inc. (ARNA), Eisai Company, Ltd. (ESALY.PK) Weight-Loss Drug Unlikely to Cause Brain Tumors More... •  Swedish Orphan Biovitrum Release: First Patient Enrolled in the Kiobrina(R) Phase III Study More... •  Oasmia Release: Positive Phase III Result From the Interim Analysis of the Study in Ovarian Cancer With Paclical(R) More... •  Jennerex Reports Positive Mechanistic Proof-of-Concept Clinical Trial Results Using JX-594 to Treat Metastatic Melanoma More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News •  FDA Warns of Fluter Domull's Counterfeit "Morning-After" Pill More... More Discontinuations News More Recalls and Warning News •  AstraZeneca PLC (AZN) Nexium-Aspirin Combo Gets EU OK More... More Drug Approval News •  FDA Approves Supplemental New Drug Application for Novartis Pharmaceuticals Corporation (NVS) Therapy Gilenya(TM) to Include Data Showing Reduction in T1 Lesions in MS, a Marker of Disease Activity More... •  MAP Pharmaceuticals, Inc. (MAPP) Announces FDA Acceptance for Filing of NDA for LEVADEX® More... •  Teva Pharmaceutical Industries Limited (TEVA) Receives European Marketing Authorization for ZOELY(TM) Oral Contraceptive More... More BLA/NDA/ANDA News More IND News More MAA News Strategies for Entering Emerging Markets in Life Sciences Everyone knows Emerging Markets present big opportunities, but successfully capitalizing on them is hard. This survey provides insight into the strategies of medical device, pharma and healthcare services companies. Hear about past mistakes and future approaches in this report that you simply can't afford to miss. Download Your Copy Now! •  University of Minnesota Researchers Use Improved Brain Imaging Techniques; Discover a Better Approach to Diagnosing Epilepsy More... •  Colon Cleansing Has No Benefit but Many Side Effects Including Vomiting and Death, Georgetown University Medical Center Study More... •  Rise in Asthma Risk Linked to Exposure to Magnetic Fields During Pregnancy, Kaiser Permanente Study More... •  Smoking, Diabetes, Obesity May Shrink Your Brain, University of California, Davis (UCD) Study More... •  Agios Pharmaceuticals Founder and Advisor Publish in Nature Genetics on Further Links Between Serine Metabolic Pathway and Cancer More... More General Clinical Research News KELLOGG SCHOOL OF BUSINESS - NORTHWESTERN UNIVERSITY Sept 12-14, 2011 $3650 SCIENCE FOR MANAGERS, offered in association with Johns Hopkins Medical School is designed to provide executives and managers with a practical understanding of the scientific and development foundations in the life sciences. You will learn the science behind the industry and the breakthrough technologies so as to communicate and perform more effectively in this complex environment. Please click here for more information. 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 • BioTechxus (Houston, Texas) Allergan Inc. Sr. Clinical Research Associate To perform the activities associated with the site-level feasibility, evaluation, initiation, patient recruitment and retention, monitoring and collection of data, and closeout of clinical trial sites in the geographic area assigned. Etc. • Biotech Bay (Hayward, California) Anthera Pharmaceuticals, Inc. Director, Clinical Quality Assurance This position will be the lead and subject matter expert for GCP, playing a key role in ensuring GCP compliance at investigator sites and selected vendors, as well as reviewing clinical study reports, documents, and regulatory submissions for clarity and accuracy. • BioCapital (Germantown, Maryland) Intrexon Corporation Senior Research Scientist - DNA Vaccines The qualified candidate will work closely with a team of scientists in the Animal Sciences Division (ASD) to develop novel approaches to meet therapeutic needs of companion and farm animals. • Biotech Beach (San Diego, California) Ardea Biosciences, Inc. Clinical Program Manager The overall responsibility will be to manage one or more phase 2-3 studies for our lead development program in Gout. The successful candidate will manage CROs, clinical sites, liaise with Finance and Project Management. Etc. • BioCapital (Columbia, Maryland) Pfizer Inc. Director, Clinical Research and Development The purpose of the position is to provide medical and scientific expertise to design, plan and implement preclinical and clinical development programs for investigational and marketed drugs. 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 •  Femina Pharma Announces CALJ's Initial Determination Finding Certain Internet Pharmacies in Default in Patent Dispute Concerning NuvaRing® More... More Patent News •  Amneal Pharmaceuticals Announces Four New Generic Drugs More... More Drug Product News Hot Company OSI Pharmaceuticals, Inc. One Bioscience Park Drive Farmingdale, New York 11735 U.S.A. Phone: 631-962-2000 Fax: 631-752-3880 OSI Pharmaceuticals, Inc., acquired by Astellas Pharma Inc. in 2010, is a leading biotechnology company focused on the discovery and development of high-quality, next-generation oncology products to both extend and improve the lives of cancer patients worldwide. 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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