Transcept Plunges as Insomnia Drug Hits FDA Hurdle - July 13, 2011

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Wednesday, July 13, 2011  |   |   |   |  At Aptuit's MHRA certified and FDA inspected multi-purpose manufacturing site in Oxford, England, we can produce highly potent compounds at commercial scale in accordance with the highest safety and quality standards. To learn more, visit www.aptuit.com/oxfordapi. •  Transcept Pharmaceuticals, Inc. (TSPT) Plunges as Insomnia Drug Hits FDA Hurdle; Shares Fall 3.46 (-40.28%) @ 1:05PM EDT More... •  Seattle Genetics, Inc. (SGEN) Lymphoma Drug Faces FDA Concern on Data to Weigh Benefit, Faces Panel on Thursday More... •  FDA Accepts SuperGen, Inc. (SUPG)'s DACOGEN(R) (Decitabine) sNDA Submission in Acute Myeloid Leukemia More... •  Newron Pharmaceuticals (NWRN) Submits US IND for NW-3509, a Potential Add-On Treatment for Patients with Schizophrenia More... More BLA/NDA/ANDA News More IND News More MAA News •  Dr. Reddy's Laboratories, Inc. (RDY)'s Announces the FDA Approval of Fondaparinux Sodium Injection More... More Drug Approval News •  Sanofi (France) (SASY.PA)/Regeneron Pharmaceuticals, Inc. (REGN)'s Sarilumab Shines for Rheumatoid Arthritis, Fails in Ankylosing Spondylitis in Phase 2b Trial More... •  Success for Eisai Inc. (ESALF.PK)'s Antiepileptic Zonegran as Monotherapy More... •  Two Key Validation Steps Achieved by BioAlliance Pharma More... •  Chimerix, Inc. Commences Phase 2 Clinical Study of CMX001 for Prevention of Adenovirus Disease in Pediatric and Adult Hematopoietic Stem Cell Transplant Patients More... •  Ohr Pharmaceutical (OHRP) Announces Positive Animal Studies for Novel Squalamine Eye Drop for Wet-AMD More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News •  New Study Suggests That a Breakfast Including Almonds May Help to Maintain Fullness Throughout the Day, Purdue University Study More... •  Indirubin, Component Of Chinese Herbal Remedy, Might Block Brain Tumor's Spread, Ohio State University Study Suggests More... •  Obstructive Sleep Apnea Linked To Blood Vessel Abnormalities, University of Birmingham Reveals More... •  Omega-3 Reduces Anxiety and Inflammation in Healthy Students, Ohio State University Study More... •  Single Drug and Soft Environment Can Increase Platelet Production: University of Pennsylvania Research More... More General Clinical Research News SafeBridge Consultants, Inc. Announces Two Potent Compound Safety Training Offerings (May be Taken Separately or Consecutively) The SafeBridge original Potent Compound Safety "Boot Camp"® (Boot Camp I) is a comprehensive two-day course in pharmaceutical potent compound safety focused on training EH&S and related professionals in critical technical concepts and proactive safety programs in pharmaceutical industrial hygiene, occupational and environmental toxicology, analytical chemistry, and risk communication. The SafeBridge new Advanced Concepts to Support Drug Development of Potent Compounds from R&D through Manufacturing - Potent Compound Safety "Boot Camp II" is a one-day advanced course focused on case studies and problem-solving to address potent compound safety issues in discovery, development, contract manufacturing and commercialization. COURSE SEATING IS LIMITED AND USUALLY SELLS OUT! New Brunswick, New Jersey Boot Camp I September 20-21, 2011 Boot Camp II September 22, 2011 Contact: Susan Custer: susan.custer@safebridge.com or 650-961-4820 x 231 or www.safebridge.com 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 • Genetown (Cambridge, Massachusetts) Novartis Institutes for BioMedical Research, Inc. Pharmacogenetics Lab Leader Lead and manage the Biomarker Development (BMD) Pharmacogenetics Laboratory in Cambridge. Design, direct, review, and supervise genotyping studies and reports. Etc. • BioCapital (Gaithersburg, Maryland) MedImmune, LLC Associate Director, Clinical Development Establish and approve scientific methods for design and implementation of applicable clinical protocols, data collection systems, and final reports. Medical Monitor in planning, conducting and evaluating clinical trials. Etc. • Southern Pharm (Memphis, Tennessee) St. Jude Children's Research Hospital Clinical Research Associate Performs data abstraction, collection, and entry to support clinical research. Prepares submission for all reportable events. Develops, maintains, and/or monitors case report forms. Etc. • Biotech Bay (Menlo Park, California) Auxogyn, Inc. Lead Scientist This position is responsible for the overall management and development of scientific research and development at Auxogyn. The Lead Scientist interfaces with engineering, clinical and marketing staff to provide technical lead in scientific projects that enhance the company's current or future products and promote their transition to the clinic. • Genetown (Cambridge, Massachusetts) AVEO Pharmaceuticals, Inc. Senior Clinical Research Scientist, Oncology The Senior Clinical Research Scientist will be expected to take a leadership role in overseeing the design, implementation, and conduct of oncology clinical trials to insure the quality and integrity of data and safe and proper management of study parameters. • 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 •  RXi Pharmaceuticals (RXII) Strengthens NeuVax(TM) (E75) Patent Portfolio More... More Patent News •  Fero Industries, Inc. Expands Sucanon® Distribution in Mexico More... More Drug Product News Hot Company InterMune, Inc. 3280 Bayshore Boulevard Brisbane, California 94005 U.S.A. Phone: 415-466-2200 Fax: 415-466-2329 InterMune, Inc. is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and hepatology. 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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