Amylin Soars as FDA Finally OKs Diabetes Drug - Jan. 30, 2012

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Monday, January 30, 2012  |   |   |   |  Get the specialized instruction you need to advance your career. UC Berkeley Extension offers targeted certificates and programs to provide essential 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 Spring courses are open for enrollment. Learn more. •  Amylin Pharmaceuticals, Inc. (AMLN) Soars as FDA Finally OKs Diabetes Drug More... •  FDA Approves Pfizer Inc. (PFE)'s INLYTA® (axitinib) for Patients With Previously Treated Advanced Renal Cell Carcinoma (RCC) More... •  FDA Approves Genentech (RHHBY)'s Erivedge (Vismodegib) Capsule, the First Medicine for Adults with Advanced Basal Cell Carcinoma More... •  Bayer AG (BAY.F) Gets EU Approval for Gadovist For Children Aged 2-6 Years More... •  Lannett Company, Inc. (LCI) Receives FDA Approval for Hydrochlorothiazide Capsules, 12.5 mg More... More Drug Approval News •  Teva Pharmaceutical Industries Limited (TEVA)'s Cephalon, Inc. (CEPH) Recalls Treanda Leukemia Drug Due to Glass Fragments More... More Discontinuations News More Recalls and Warning News •  Amsterdam Molecular Therapeutics (AMT) (RHP.DE) Announces European Commission (EC) Delays Decision on Glybera® Marketing Authorisation and Requests Further Information From the CHMP More... •  Cell Therapeutics, Inc. (CTIC) Withdraws New Drug Application for Pixuvri(TM) and Plans to Resubmit in 2012 More... More BLA/NDA/ANDA News More IND News More MAA News •  BTG plc (BGC.L)'s Varicose-vein Drug Succeeds in US Study More... •  AMAG Pharmaceuticals, Inc. (AMAG) Announces Completion of Enrollment in its Phase III Program Evaluating Feraheme for a Broader Iron Deficiency Anemia Indication More... •  Vical Incorporated (VICL) Presents Case Study on Successful Design of Allovectin(R) Phase 3 Melanoma Trial More... •  ZIOPHARM Oncology, Inc. (ZIOP.OB) Announces Recommendation by Independent Data Monitoring Committee to Continue Phase 3 Study of Palifosfamide in Metastatic Soft Tissue Sarcoma More... •  ISTA Pharmaceuticals, Inc. (ISTA) Completes Patient Enrollment in Phase 2 Clinical Study of BEPOSONE(TM) (Bepotastine Besilate - Steroid Combination Nasal Spray) for the Treatment of Symptoms Associated With Seasonal Allergic Rhinitis More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News Quantifying the Value of Pipeline Pilot, the Accelrys Scientific Enterprise Platform This white paper outlines the methodology, sources of value, and quantifiable results from bringing products to market faster, avoiding unproductive experiments, saving developer time, and more. Request Now! •  Body Clock Receptor Linked to Diabetes in New Genetic Study, Imperial College London Reveals More... •  For Diabetics Not on Insulin, Self-Monitoring Blood Sugar Has No Benefit, VU University Medical Center Study More... •  Swimming Lowers Older Adults' Blood Pressure, University of Texas Study More... •  Social Skills Suffer When Tweens Multitask, Stanford University Study More... •  A Glass of Milk a Day Could Benefit Your Brain, University of Maine Study More... More General Clinical Research News Cambridge Healthtech Institute's 19th Annual Molecular Medicine Tri-Conference February 19-23, 2012 | San Francisco, California www.TriConference.com CHI's flagship event The 2012 program will feature compelling talks from industry, academia, government, and healthcare organizations. Spanning five days this year, the event now includes more activities including: 2 partnering forums, 5 symposia, 18 short courses, and 12 core programs. Join over 3,000 attendees in interactive lectures, discussions, and various receptions as a way to facilitate networking opportunities and hearing differing views and perspectives on poignant issues facing you and our industry today. Emerging Clinical Trial Locations • Provides insight into the background to the clinical trials market in the emerging geographic regions including specific issues in each geography. • Reviews of the structure of the healthcare system in each of the emerging clinical trial markets. • Reviews the principal CROs in each emerging location covering domestic and international players. Click Here for More Information. • Genetown (Cambridge, Massachusetts) Vertex Clinical Safety Manager Responsible for providing daily support to the Clinical Study Teams in the management of all aspects of the safety letter distribution process. The Clinical Operations (CO) Safety Manager is responsible for centralization, distribution, tracking and quality control of the safety information which is submitted to investigational sites and Ethics Committees across all compounds. • Biotech Bay (Redwood City, California) Abbott Senior Section Manager, Clinical Data Management Responsible for a given compound(s) or therapeutic area. Ensures that: a) CRFs or eCRFs, clinical databases and clinical data management plans are prepared and approved within project timelines. • Biotech Bay (Mountain View, California) BN ImmunoTherapeutics Inc. Senior Director - Clinical Operations Will provide operational clinical, project management, and administrative leadership, direction, and oversight for all clinical operations programs in the company. Responsibilities include design of department objectives, selection of clinical investigation techniques and service providers, supervision of ethical and good clinical practices, supervision of clinical trials within the programs, development of clinical relationships with partners of the corporation, including interactions with corporate partners and physicians. • BioMidwest (Deerfield, Illinois) Baxter International, Inc. Project Leader, Clinical and Scientific Affairs Supports clinical trials utilizing stem cells in therapeutic areas of regenerative medicine. Specifically, the individual will support the manufacture of the biological components of the Isolex system used for the selection of CD34+ stem cells from mobilized apheresis products. • Biotech Beach (San Diego, California) Nexus Dx Clinical Research Associate Will initiate activities related to the conduct of clinical studies, oversee those activities during the study including adherence to Good Clinical Practices (GCPs). Represents Company in the research community and develops collaborative relationships with investigative sites and contract research organizations. • Get Noticed! Add your resume to the BioSpace Career Center! • See more than 5,000 job postings in the BioSpace Career Center! Genetown 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 Northeast 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. • Genetown Career Fair, Cambridge, MA February 21, 2012 • BioSpace Career Fair at CALBIO2012, San Francisco, CA March 7, 2012 • BioMidwest Career Fair, Bridgewater, NJ March 22, 2012 • Biotech Beach Career Fair, La Jolla, CA April 17, 2012 • BioCapital Career Fair, Bethesda, MD April 25, 2012 • Pharm Country Career Fair, King Of Prussia, PA May 1, 2012 • BioNC Career Fair, Durham, NC May 2, 2012 • Biotech Bay Career Fair, Burlingame, CA May 29, 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 •  Precision BioSciences Announces Allowance of Third U.S. Patent Related to Engineered Meganucleases More... •  Alnylam Pharmaceuticals (ALNY) Receives Notice of Allowance from United States Patent and Trademark Office (USPTO) for New Patent Broadly Covering Second Generation Lipid Nanoparticles (LNP) for Systemic Delivery of RNAi Therapeutics More... More Patent News Hot Company Nektar Therapeutics (AL) 490 Discovery Drive Huntsville, Alabama 35806 U.S.A. Phone: 256-533-4201 Fax: 256-533-4805 Nektar Therapeutics is a biopharmaceutical company developing novel therapeutics based on its proprietary polymer conjugation technology platform. Nektar has a robust R&D pipeline of potentially high-value therapeutics in oncology, pain and other areas. 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, Maysa Darwish, Tammy Liu, Michelle Wong ClinicaSpace.com - Clinical Trials. Clinical Research. 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