Genentech Drug Impresses in Ph3 Trial - July 15, 2011

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Friday, July 15, 2011  |   |   |   |  FIRST ASIA PACIFIC PHARMACEUTICAL COMPLIANCE CONGRESS September 13 - 15, 2011 The Ritz-Carlton, Millenia Singapore Sponsored by Pharmaceutical Compliance Forum and Asia Pacific Healthcare Industry Compliance Team Please click here for more information. •  Genentech (RHHBY) Drug Impresses in Phase III Trial; to Seek Approval by Year End More... •  BioMarin Pharmaceutical Inc. (BMRN) Initiates Phase 1 Trial for BMN 673 in Patients With Advanced Hematological Malignancies More... •  Inovio Pharmaceuticals (INO) Demonstrates T Cell Immune Response Durability with Fourth Dose of Therapeutic Cervical Dysplasia and Cancer DNA Vaccine More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News •  AstraZeneca PLC (AZN), Bristol-Myers Squibb Company (BMY) Diabetes Pill Has Risks - FDA More... More Discontinuations News More Recalls and Warning News •  Aptalis Pharmaceutical Technologies (EURX) Announces FDA Approval of 25,000 Lipase-Unit Strength of ZENPEP(R) More... More Drug Approval News •  FDA Issues Transcept Pharmaceuticals, Inc. (TSPT) with Second CRL for Sleep-Aid Drug Intermezzo More... •  Novartis AG Eye Drug Rejected for Diabetic Use in UK More... •  Amgen (AMGN) Release: XGEVA® (Denosumab) Granted Marketing Authorization in the European Union More... More BLA/NDA/ANDA News More IND News More MAA News •  Natural Chemical Found in Grapes May Protect Against Alzheimer's Disease, Mount Sinai School of Medicine Study More... •  Novel Combined Therapy Extends Life, Diminishes Pain in Brain Cancer Patients, University of California, San Diego (UCSD) Study More... •  Ellipse Technologies, Inc. Announces Breakthrough for Correcting Spinal Deformities in Children; MAGEC(TM) Remote-Controlled Device Approved for Marketing in Europe More... •  Vitamin A May Not Prevent Asthma: Johns Hopkins University Study More... •  The Future of Cancer Clinical Trials Holds Promise Thanks to Oncolytics Biotech Inc. (ONC.TO)' REOLYSIN More... More General Clinical Research News Join us for the 40th Annual Meeting of the American College of Clinical Pharmacology, Sept. 11-13, 2011 at the Crowne Plaza Chicago O'Hare Hotel, Chicago (Rosemont), IL, covering a wide range of current, relevant topics as noted below. CME and CPE credits available for registered attendees. • Transdermal Delivery Systems • Opioids and Psychotropic Drugs • First-in-Human Clinical Trials • Model-based Drug Development • Biotherapeutic Dose Selection Strategies • Drug Safety vs. Disease Treatment • Quantitative Clinical Pharmacology in Inflammation & Immunology • Imaging Techniques in Drug Development • Bridging Clinical Trials • Innovations in Pharmacoepideomiology • Hormone Therapy in Menopausal Women Keynote speakers include: Francis S. Collins, MD, PhD, Director of the National Institutes of Health (NIH) on Sunday, Sept 11th and Anne Schuchat, MD, Director of the CDC's National Center for Immunization and Respiratory Diseases (NICRD) on Monday, Sept 12th. Additional information about the ACCP 40th Annual Meeting and the Preliminary Program are available online or contact TStevens@ACCP1.org. Advances in Drug-Diagnostic Co-Development • Understand the current regulatory environment for both diagnostics and drugs within the EU and the US and how these relate to their co-development. • Understand the biomarker discovery and validation process. • Using case studies discover how drugs and their companion diagnostics have already received approval in the US and EU. Click Here for More Information • Biotech Bay (Menlo Park, California) Synarc, Inc. Clinical Project Manager Manages complex studies with multiple countries and modalities from start-up to close-out with minimal oversight. Manages all communications with the sponsor regarding timelines and study specific deliverables. • Pharm Country (Parsippany area, New Jersey) Omega Management Group Director Clinical Development-Cardiovascular For the assigned clinical trial(s) within program/brand, as a member of the Clinical Trial Team (CTT), provide medical scientific input to e.g,: All activities related to planning, execution and reporting of clinical trials. Etc. • Genetown (Cambridge, Massachusetts) Novartis Institutes for BioMedical Research, Inc. Pharmacogenetics Lab Leader Lead and manage the Biomarker Development (BMD) Pharmacogenetics Laboratory in Cambridge. Design, direct, review, and supervise genotyping studies and reports. Etc. • BioCapital (Gaithersburg, Maryland) MedImmune, LLC Associate Director, Clinical Development Establish and approve scientific methods for design and implementation of applicable clinical protocols, data collection systems, and final reports. Medical Monitor in planning, conducting and evaluating clinical trials. Etc. • Southern Pharm (Memphis, Tennessee) St. Jude Children's Research Hospital Clinical Research Associate Performs data abstraction, collection, and entry to support clinical research. Prepares submission for all reportable events. Develops, maintains, and/or monitors case report forms. Etc. • 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 Hot Company InterMune, Inc. 3280 Bayshore Boulevard Brisbane, California 94005 U.S.A. Phone: 415-466-2200 Fax: 415-466-2329 InterMune, Inc. is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and hepatology. 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, Matt Thwin, Maysa Darwish ClinicaSpace.com - Clinical Trials. Clinical Research. 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