FDA Puts Hold on Immunomedics Cancer Drug Trial - Sept. 23, 2011

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Friday, September 23, 2011  |   |   |   |  Ambion® Products...Superior Results Every Time Ambion® Products Represent Years of RNA Expertise. For over two decades, our scientists have developed high-quality, innovative RNA products that make your job easier with faster, more robust and more reliable results. Use the best and have confidence in your results...every time. Now, Ambion® products also include Invitrogen™ RNA products - all by Life Technologies. Please click here for more information. •  FDA Puts Hold on Immunomedics, Inc. (IMMU) Cancer Drug Trial More... •  GlaxoSmithKline (GSK)'s Alli Under Review Over Liver Failure Fears More... More Discontinuations News More Recalls and Warning News •  FDA Approves Alexion Pharmaceuticals Inc. (ALXN)'s Soliris for Rare Pediatric Blood Disorder More... More Drug Approval News •  European CHMP Adopts Positive Opinion for Gilead Sciences, Inc. (GILD)'s Eviplera(R), a Once-Daily Single-Tablet Regimen for the Treatment of HIV Infection More... •  Tibotec Pharmaceuticals Ltd's EDURANT(R) (rilpivirine) Receives Positive Opinion from CHMP for Use in Treatment-Naive Adults with HIV-1 More... •  Alexion Pharmaceuticals Inc. (ALXN) Receives CHMP Positive Opinion for Soliris(R) (eculizumab) in Patients with Atypical Hemolytic Uremic Syndrome (aHUS) in the European Union More... •  Bayer AG (BAY.F)'s Xarelto Wins EU Drug Panel Backing for Added Uses More... •  Optimer Pharmaceuticals, Inc. (OPTR) and Astellas Pharma Inc. (YPH.BE) Receive Positive Opinion from CHMP for European Approval of DIFICID(TM) More... More BLA/NDA/ANDA News More IND News More MAA News •  Helsinn Group and Eisai Inc. (ESALF.PK) Announce Start of Phase III Clinical Program of Oral Fixed-Dose Combination of Netupitant/Palonosetron (300 mg/0.50 mg) for Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) More... •  Novartis Pharmaceuticals Corporation (NVS) Drug Afinitor(R) Effective in Patients With Non-Cancerous Kidney Tumors Associated With TSC in Phase III Trial More... •  Purdue Pharma L.P. Release: Results of a Pivotal Phase 3 Efficacy and Safety Study for Butrans(R) (Buprenorphine) Transdermal System CIII Published in The Journal of Pain More... •  RegeneRx Biopharmaceuticals, Inc. (RGRX) Announces Completion of Patient Treatment in RGN-259 Phase 2 Dry Eye Trial More... •  MediStem, Inc. (Formerly known as Medistem Laboratories, Inc.) Receives FDA Approval to Begin Clinical Trial in USA With ERC Stem Cells More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News Drug Discovery & Development Drug Discovery & Development magazine delivers vital insight about the latest technologies and tools used to develop pharmaceutical products to key decision-makers Request Now! •  Calcium Raises Cancer Risk for Some Men, University of Southern California Study More... •  Vitamin D Deficiency Linked With Airway Changes in Children With Severe Asthma, Imperial College London and King's College London Study More... •  New Hope for Blind as Europe's First Embryonic Stem Cell Trial is Approved, Moorfields Eye Hospital Study More... •  Stratatech Initiates Second Clinical Trial of StrataGraft® Skin Substitute More... •  Cambridge Temperature Concepts Limited Release: IVF Proven Unnecessary for Many Infertile Couples, DuoFertility Study Shows More... More General Clinical Research News Social & Scientific Systems, Inc., and panel members, Eleanor Feingold, Gina D'Angelo, and Joan Bailey-Wilson, invite you to join us at a symposium to honor Brad Efron for his many contributions to theoretical and applied statistics. We will be discussing emerging statistical challenges in large-scale inference, with a focus on applications in genetics and biomedical imaging. The goal of the symposium is to stimulate discussion; it will include both formal and informal meeting and discussion time, in addition to the featured speakers. The symposium is limited to 200 people. Please RSVP to: LargeData@s-3.com. Please visit here for more information. Risk Sharing and Innovative Contracting with CROs • Identify the benefits and challenges of risk sharing & innovative contracting agreements and structure more successful deals. • Analyze compensation and pricing issues in risk sharing agreements, so that negotiations may be more fruitful. • Evaluate the different types of risk sharing and innovative contracting agreements. Click Here for More Information. • Pharm Country (Bridgewater, New Jersey) Aerie Pharmaceuticals Clinical Research Associate Travel to investigational sites to review CRF data for clinical studies. Assist with data query resolution.Perform study drug accountability. Maintain regulatory document files. Assist in development of: project plan, reference manual, study binder, CRF guidelines, transmittal/accountability forms. • Genetown (Lowell, Massachusetts) PAREXEL International Associate Director Clinical Applications Support EDC, CTMS, Drug Safety Responsible for the delivery of IT Application Support services for PAREXEL'S Clinical Systems application portfolio specializing in Electronic Data Capture ( EDC ), CTMS (Clinical Trial Management Systems), and Safety/Pharmacovigilance, Biostatistics Applications. Leads and manages global application support team to ensure consistent delivery of customer service excellence to all of PAREXEL'S Strategic Business Units. • BioMidwest (Chicago, Illinois) Takeda Pharmaceuticals Clinical Trial Manager / Sr. Clinical Trial Manager, Clinical Program Management Responsible for the execution of Phase II - IV and other approved US and ex-US clinical studies, according to ICH-GCP and required regional regulations as applicable in support of the clinical strategies defined in the Takeda Integrated Development Plan Responsible for the execution of Phase II-IV and other (IDP). • BioCapital (Gaithersbug, Maryland) MedImmune, LLC Associate Director, Clinical Development Create and maintain the CDP for assigned programs ensuring alignment with the Target Product Profile (TPP), accounting for feasibility and regional requirements, capturing health outcomes, epidemiology, and pharmacogenetic considerations. May have a leadership role on clinical teams for assigned programs/projects and may be a representative on the (PDT). Supervise/mentor/advise clinical project team and sub-team members in planning, conducting, data review and cleaning, and evaluating clinical trials. • SuisseBio (Basel, Switzerland) Novartis Institutes for BioMedical Research, Inc. MD Clinical Pharmacologist Autoimmunity Director (Snr TMEI Profiling) Develop strategies, design and execute clinical trials from Proof of Concept to Phase II/III, registration and beyond for new drugs. Represent and champion our compounds internally and with regulatory authorities. • Get Noticed! Add your resume to the BioSpace Career Center! • See more than 5,000 job postings in the BioSpace Career Center! BioMidwest 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 Midwest 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. • 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 •  Skinvisible, Inc. (SKVI) Receives European Patent Notice for Invisicare More... •  Isis Pharmaceuticals, Inc. (ISIS) Files Patent Infringement Suit Against Santaris Pharma A/S More... More Patent News Hot Company Purdue Pharma L.P. (Research & Development - New Jersey) 6 Cedar Brook Drive Cranbury, New Jersey 08512 U.S.A. Phone: 609-409-5123 Fax: 609-409-5799 Purdue Pharma is committed to developing safe and effective medicines to treat pain and other conditions. As a science-based company, we are discovering drugs with new mechanisms of action and exploring new techniques in drug delivery to enhance the effectiveness and safety of drug therapy. 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: Rosemary Do Editorial & Production Staff: Lana Ho, Suvarna Sheth, Maysa Darwish, Tammy Liu ClinicaSpace.com - Clinical Trials. Clinical Research. 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