Pfizer's Xalkori Scores FDA Approval - Aug. 29, 2011

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Monday, August 29, 2011  |   |   |   |  UC Berkeley Extension Clinical and Regulatory Sciences Get the specialized instruction you need to advance your career. UC Berkeley Extension offers targeted certificates and programs to provide the skills to design and manage clinical trials, navigate compliance issues, and ensure new products and processes adhere to U.S. and international regulatory specifications. Choose from programs in: • Clinical Research Conduct and Management (available online) • Quality and Compliance for Biotechnology • Regulatory Affairs Fall courses are open for enrollment.Learn more. •   Pfizer Inc. (PFE)'s Xalkori Scores FDA Approval More... More Drug Approval News •  FDA Asks Novartis AG for More Data on Gout Drug More... •  AiCuris' HCMV Drug Letermovir (AIC246) Receives Fast Track from FDA, New Data to be Presented at 51st ICAAC More... •  Astellas Pharma Inc. (YPH.BE) Announcement of Regulatory Submission for Mirabegron (YM178), a Treatment for Overactive Bladder, in U.S. and Europe More... More BLA/NDA/ANDA News More IND News More MAA News •  Blood-Thinner From Bristol-Myers Squibb Company (BMY), Pfizer Inc. (PFE)'s Beats Warfarin More... •  Actelion Ltd. (ALIOF.PK)'s Macitentan Fails Phase 3 Study More... •  CureMark Reports Positive Results for Novel Compound CM-182 in Amphetamine Induced Hyperactivity More... •  Positive Avian Flu Trial Data Using Isconova's Matrix M(TM) Published More... •  Talon Therapeutics, Inc. (HNAB) Receives Special Protocol Assessment Agreement from the FDA for Its Phase 3 Confirmatory Study of Marqibo(R) in Newly Diagnosed Acute Lymphoblastic Leukemia More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News Nature Methods Nature Methods provides techniques for life scientists and chemists. It is a print and online publication dedicated to publishing novel methods together with significant advances to tried and tested techniques allowing researchers to perform faster, better and more efficient experimental research. Request Now! •  Chocolate Tied to Big Drop in Heart Disease Risk, University of Cambridge Study More... •  Overuse of Antibiotics May Harm Good Bacteria, Washington University Study More... •  Leucine May Help People Burn Fat During Periods Of Food Restriction, University of Utah Study More... •  Vitamin A Pills "Could Save Thousands Of Children," University of Oxford Study More... •  Starvation in Youth Linked to Heart Risk in Adulthood, University Medical Center Utrecht Study More... More General Clinical Research News Biomarker Applications for Improved Clinical Trial Outcomes November 15 - 16, 2011 Hilton Boston Back Bay - 40 Dalton Street The only personalized medicine conference allowing you to make biomarkers and diagnostics available during every stage of clinical research, to stratify patients, prove clinical validity, and streamline the regulatory approval and reimbursement process. Featuring up-to-date analysis of new FDA legislation regulations and a special spotlight from Blue Cross Blue Shield. Please click 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. • Genetown (Billerica, Massachusetts) SPARKS Clinical Trial Specialists Act as an independent Coordinator on projects both locally and remotely. Apply knowledge across multiple projects. Contribute to the development and implementation of Study Start Up (SSU) related processes, tools, and training materials as well as provide training as needed. • BioMidwest (Indianapolis, Indiana) Lundbeck Inc. (formerly Ovation Pharmaceuticals) Senior Director, Regional Clinical Quality Assurance-Americas Responsible for resourcing, budgeting and follow up for the region. Responsible for any outsourced CQA activities. Participate in the development of policies and procedures for Global CQA. • Biotech Bay (San Francisco, California) FibroGen, Inc. Manager/ Sr. Manager Clinical Supply Chain Interpretation of a protocol or study overview to calculate total demand and translation of total demand into a demand forecast over time Managing clinical labeling including label design and manufacturing. Preparation of a supply plan to support the demand forecast, including determination of supply overage amounts. • Southern Pharm (Memphis, Tennessee) St. Jude Children's Research Hospital Clinical Research Associate-RN II Acts as site Study Coordinator. Serves as a preceptor/mentor to new clinical research staff. Performs data abstraction, collection, and entry to support clinical research. Prepares submission for all reportable events. Develops, maintains, and/or monitors case report forms. • Biotech Beach (Irvine, California) Allergan Inc. Principal Clinical Data Manager Working within clinical study teams as an extended team member. Defining project timelines and executing the clinical data management operations against them, and any other priorities. Using defined department metrics as a framework for timely and quality clinical data management deliverables. • 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 •  Teva Pharmaceutical Industries Limited (TEVA) Announces Court Adopts All Relevant Teva Claim Construction Interpretations in Copaxone® Patent Infringement Case Against Sandoz, Inc./Momenta Pharmaceuticals, Inc. (MNTA) and Mylan Pharmaceuticals, Inc. (MYL)/Natco Pharma Limited; Court Denies Mylan’s Summary Judgment Motion of Invalidity More... More Patent News •  Reckitt Benckiser Plc (RB.L) Suspects Sabotage in Mix-up of Painkiller and Antipsychotic More... More Drug Product News Hot Company SNBL Clinical Pharmacology Center 800 West Baltimore Street, 5th Floor Baltimore, Maryland 21201 U.S.A. SNBL Clinical Pharmacology Center, partners with pharmaceutical companies, biotech firms and CROs to accelerate drug development utilizing our best-in-class facility, technology, operational excellence and strong affiliations with local academic medical institutions (University of Maryland and Johns Hopkins University). 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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