Pfizer, Bristol Eliquis Gets FDA Priority Review - Nov. 29, 2011

Tuesday, November 29, 2011  |   |   |   |  Assay Depot has created the world's largest network of public and private cloud-based Research Exchanges: Life science researchers from 53 countries use our public Research Exchange to find, create and purchase research services and products and to communicate with 5000+ research vendors. Pharmaceutical companies, universities and non-profit organizations use a private Research Exchange to manage and strengthen internal and external research partnerships. Research vendors use public and private Research Exchanges to offer their services and products to the global research community. Researchers - Use our free public marketplace at assaydepot.com. Vendors - Get a free vendor account at http://backoffice.assaydepot.com/. •  Pfizer (PFE), Bristol-Myers Squibb (BMY) Eliquis Gets FDA Priority Review More... •  Onyx Pharmaceuticals, Inc. (ONXX) Announces FDA Acceptance of New Drug Application for Carfilzomib for the Treatment of Relapsed and Refractory Multiple Myeloma More... •  Horizon Pharma, Inc. Announces U.S. FDA Acceptance of LODOTRA(R) New Drug Application for Review for the Treatment of Rheumatoid Arthritis More... •  Alexion Pharmaceuticals Inc. (ALXN)'s Soliris(R) (eculizumab) Granted Marketing Authorization in Europe for Treatment of Patients with Atypical Hemolytic Uremic Syndrome (aHUS) More... More BLA/NDA/ANDA News More IND News More MAA News •  Watson Pharmaceuticals, Inc. (WPI)'s Generic Yaz(R) Receives FDA Approval More... •  Qualitest Pharmaceuticals Receives FDA Approval for Myzilra(TM) Tablets (Levonorgestrel and Ethinyl Estradiol Tablets, USP), 0.05 mg/0.03 mg, 0.075 mg/0.04 mg, 0.125 mg/0.03 mg (28 - Day TriPhasic Regimen) More... More Drug Approval News Better Antibodies Through Better Antigen Design Join SDIX at the Boston Cambridge Marriott on December 8th, 2011 for a symposium focused on next generation antibody development. At SDIX, a focus on the philosophy of better antigen design has resulted in dramatic improvements to the antibody production process. In a series of talks, our scientists and collaborators will discuss this antigen design philosophy and provide case studies to demonstrate the effectiveness of this methodology. In particular, these talks will focus on the use of SDIX's proprietary Genomic Antibody Technology™ and its ability to deliver antibodies that match end users' requirements. Please click here for more information. •  Omthera Pharmaceuticals, Inc. Completes Enrollment of Pivotal Phase III EVOLVE Trial for Epanova(TM) in Patients With Very High Triglycerides More... •  Cytokinetics, Inc. (CYTK) Announces Opening of Third Phase II Clinical Trial of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis More... •  Provectus Pharmaceuticals Inc. Reports on Third End-of-Phase 2 Meeting with U.S. FDA to Define Pathway to Approval of PV-10 for Metastatic Melanoma More... •  Alnylam Pharmaceuticals (ALNY) Completes Enrollment in Phase IIb Study of ALN-RSV01, an RNAi Therapeutic for the Treatment of Respiratory Syncytial Virus (RSV) Infection More... •  OncoVista Innovative Therapies, Inc. Engages Oncology Therapeutic Development to Initiate a Phase Ib Study of Cordycepin in Patients With Refractory TdT Positive Leukemia More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News •  BioSante Pharmaceuticals, Inc. (BPAX) Announces Issuance of New LibiGel(R) Method of Use Patent More... More Patent News •  Genentech (RHHBY)'s Avastin Ousted by FDA for Breast Cancer, Sunshine Biopharma, Inc. Gears-Up for Clinicals More... More Drug Product News •  Heading Soccer Balls Can Lead to Brain Damage, Albert Einstein College of Medicine Study More... •  Could Slow Eating Be Key to Staying Slim? University of Rhode Island Study More... •  Growth Hormone Increases Bone Formation in Obese Women, Harvard Medical School Study More... •  Aging Stem Cells May Explain Higher Prevalence of Leukemia, Infections Among Elderly, Stanford University Study More... •  Brain Pathways Seem Disrupted in Kids With ADHD, Albert Einstein College of Medicine Study More... More General Clinical Research News 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. • SuisseBio (Basel, Switzerland) Novartis Institutes for BioMedical Research, Inc. Senior Clinical Trial Leader Responsible for planning and implementing all operational aspects of early phase Translational Medicine Autoimmunity studies (e.g. highly complex patient / mechanistic studies) from synopsis to reporting according to timelines, budget, operational and quality standards (ICH/GCP/Novartis SOPs and procedures). • Pharm Country (Wayne, Pennsylvania) Octagon Research Solutions, Inc. Clinical Data Project Manager Provides project management expertise in the planning and execution of regulatory oversight, leadership and oversight of multi-functional task force teams. Reporting directly to the Director of Project Management within our Clinical Data Operations Department. • Biotech Bay (Redwood City, California) Abbott Senior Section Manager, Clinical Data Management Responsibilities may include interaction and coordination with staff across multiple Abbott sites. Represents Clinical Data Management function at internal and regulatory agency audits. • Genetown (Billerica, Massachusetts) PAREXEL International Biostatistician II, Clinical Trials Will work under the supervision of an experienced biostatistician in the production of statistical analysis plans and reports, and provide statistical advice to clients as a key contact with regard to statistical and contractual issues. • Bio NC (Durham, North Carolina) Cato Research Director, Clinical Trial Operations Manages overall operation of the entire clinical study including project planning, budget, resource management and contract research organization management. Manages clinical operational plan, and incorporates the study and scientific plan. • Get Noticed! Add your resume to the BioSpace Career Center! • See more than 5,000 job postings in the BioSpace Career Center! BioSpace Life Science Career Fairs are the biotech industry's premier career events. Featuring well-respected employers from around the nation, our job fairs attract top candidates in the biotech, pharmaceutical, life science and medical device industries. With such a great number of recruiters and hiring managers from top biotech companies attending our career fairs, there are an abundance of opportunities available for job seekers. Many different disciplines within the industry are represented bringing a diversity of candidates to our job fairs. Companies seeking pharmaceutical sales representatives and marketing jobs regularly attend our job fairs. Engineering and technical jobs can be found, as well as regulatory jobs and positions in QA/QC. Individuals desiring a science job or a research job will find many opportunities at our job fairs. In addition, hiring managers seeking candidates for clinical research jobs also attend our events. 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 Hot Company Accelovance 2275 Research Boulevard, Suite 700 Rockville, Maryland 20850 U.S.A. Phone: 240-238-4900 Fax: 240-238-4901 Accelovance, Inc., based in Rockville, MD, is a clinical services company specializing in high patient throughput from recruitment through study completion. Accelovance has developed a model to increase the reliability and productivity on Phase I (outpatient) and Phase II-IV trials. 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. 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