Bayer, J&J's Xarelto Wins FDA Priority Review - July 9, 2012

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Monday, July 09, 2012  |   |   |   |  SECOND ASIA PACIFIC PHARMACEUTICAL COMPLIANCE CONGRESS A Hybrid Conference and Internet Event Sponsored by Pharmaceutical Compliance Forum and Asia Pacific Healthcare Industry Compliance Team Media Partners: Life Science Compliance and RX Compliance Report September 11 - 13, 2012 Intercontinental Shanghai Pudong Hotel Shanghai, China Please click here for more information. •  Bayer AG (BAY.F), Johnson & Johnson (JNJ)'s Xarelto Wins FDA Priority Review More... •  Acusphere Inc. (ACUS) Announces Completion of Marketing Authorisation Application for Imagify™ in Europe; Secures Additional Financing More... •  Capricor Announces FDA Approval to Initiate ALLSTAR Trial of Allogeneic Stem Cell Therapy in Patients Following Heart Attack More... More BLA/NDA/ANDA News More IND News More MAA News •  FDA Approves QIAGEN N.V. (QGEN) KRAS Test for Use With Eli Lilly and Company (LLY) and Bristol-Myers Squibb Company (BMY)'s Cancer Drug Erbitux More... •  Auxilium Pharmaceuticals (AUXL) and Actelion Pharmaceuticals US, Inc. (ATLN.VX) Announce Approval of XIAFLEX® In Canada More... •  Senomyx, Inc. (SNMX) Announces Regulatory Approvals for S6973, S2383, S6821, And S7958 In Many International Markets More... More Drug Approval News •  Isotechnika Pharma Inc. (ISA.TO)'s Partner Lux Biosciences Completes Enrollment in Phase 3 Uveitis Study More... •  FDA Accepts Repros Therapeutics Inc. (RPRX)' Phase 3 Efficacy Protocol for Androxal® Under a Special Protocol Assessment Agreement More... •  Bayer HealthCare (BAY) Initiates Phase II/III Trial of New Recombinant Factor VIII Compound for Treatment of Hemophilia A More... •  Inspiration Biopharmaceuticals Reports Positive Interim Results from the Accur8 Phase 2/3 Study of OBI-1 in Acquired Hemophilia A at World Federation of Hemophilia 2012 World Congress More... •  Verona Pharma Initiates Dosing in Clinical Trial to Investigate Anti-inflammatory Properties of RPL554 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 - 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. •  Sunburn May Help Rid Body of Radiation-Damaged Cells, University of California, San Diego (UCSD) Study More... •  Babies in Dog-Owning Families May Be Healthier, Kuopio University Hospital Study More... •  New Drug Offers New Hope for MS Patients, University Hospital in Basel Study More... •  Why Women Watch the Olympics, University of Tennessee Study More... •  Advanced Cell Technology Secures Approval to Proceed with Increased RPE Dosage for Patients in Clinical Trial for Dry AMD More... More General Clinical Research News • Bio NC (Durham, North Carolina) Sequenom Inc. Clinical Laboratory Supervisor Responsible for monitoring the production of medical diagnostic testing in the CLIA lab performed by assigned Medical Technologists. The supervisor will work closely with internal and external contacts including suppliers, physicians and other healthcare providers regarding clinical laboratory testing, operations and development of new tests. • Biotech Beach (Irvine, California) Allergan Inc. Principal Clinical Programmer - Business Objects Under the direction of management, the Principal Clinical Programmer, leads the design, development, validation, implementation, and provides ongoing support for reporting/business intelligence tools (e.g., Business Objects, Spotfire) and programs (e.g., PL/SQL) used in Clinical Research and Development studies. • BioMidwest (Indianapolis, Indiana) Eli Lilly and Company Data Management Associate Responsible for global consistency of medical data; structure, content and meaning, acquisition, storage, retrieval, interchange and representation. This requires an in depth understanding of data collection, data flow management, data quality, data technology, data archiving and data standards. • Genetown, (Cambridge, Massachusetts) Vertex Clinical Pharmacologist II Will perform highly scientific functions in support of the company's Clinical Pharmacology area with some guidance and mentoring on new and complex issues. He/She will complete assigned work in a resourceful, self-sufficient manner and will be able to create alternative approaches to achieve desired results if needed. • Biotech Bay (South San Francisco, California) Puma Biotechnology Clinical Trial Specialist/ Senior Clinical Trial Specialist Responsible for providing operational support for the day-to-day execution of clinical trials, follows established SOPs, GCP and other applicable regulatory requirements in the execution of all activities, proactively identifies and resolves operational project issues, and participates in process improvement initiatives as required. • 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 By June Salvati, BioSpace Director of Events and Corporate Services •  Novartis AG (NVS) India Patent Case Postponed to August 22 More... •  CytRx Corporation (CYTR) Announces Allowance of U.S. Patent Application for Tamibarotene Capsule More... •  Organovo Announces Two Issued Patents, First Company Patent and Key Founder Patent More... •  Chinese and Australian Patents Allowed for 22nd Century Group, Inc.'s NBB Nicotine Biosynthesis Gene More... •  AtheroNova Receives Notice of Allowance for Its US Patent Application 12/024,908 More... More Patent News •  Mobius Theraputics™ Commences First Shipments of New Glaucoma Drug More... •  Aceto Corporation Subsidiary, Rising Pharmaceuticals, Inc, Launches Generic Version of Soma® Compound With Aspirin Tablets and Sodium Bicarbonate Tablets More... •  Astellas Pharma Inc. (YPH.BE) and XenoPort, Inc. (XNPT) Announce the Launch of Regnite® Tablets for Restless Legs Syndrome in Japan 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 TransTech Pharma, Inc. 4170 Mendenhall Oaks Parkway High Point, North Carolina 27265 U.S.A. Phone: 336-841-0300 Fax: 336-841-0333 TransTech Pharma is a clinical-stage pharmaceutical company focused on the discovery and development of human therapeutics to fill unmet medical needs. Our mission is to utilize our innovative technology to rapidly translate the functional modulation of human proteins into safe and effective medicines. 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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