Exelixis Shares Tank as FDA Rejects Proposal - Nov. 1, 2011

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Tuesday, November 01, 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 atassaydepot.com. Vendors - Get a free vendor account at http://backoffice.assaydepot.com/.   •  Exelixis, Inc. (EXEL) Shares Tank as FDA Rejects Proposal More... •  NPS Pharmaceuticals, Inc. (NPSP) Reports Two Patient Deaths in Study of Bowel Drug Gattex More... •  Group: Johnson & Johnson (JNJ)'s Baby Shampoo a Cancer Risk More... •  PathoGenetix Raises $7.5 Million in Second Closing of Series B Financing for Rapid Bacterial Identification System More... •  Boehringer Ingelheim Corporation's Pradaxa Wins UK Backing for Stroke Prevention More... •  Takeda Global Research & Development Center, Inc. Announces PDUFA Action Date for Investigational Type 2 Diabetes Therapies Alogliptin and the Fixed-Dose Combination Alogliptin/Pioglitazone More... •  GlaxoSmithKline (GSK) Taps Alnylam Pharmaceuticals (ALNY)'s RNAi Technology for Vaccine Production More... •  H3 Biomedicine Names Markus Warmuth Chief Executive Officer More... More Top News Download PPD's new white paper, Drug-Induced Liver Injury, to gain an understanding of DILI and how to recognize it early during drug development. These regulatory actions include: • Failure to obtain approval for marketing • Restrictions on how and to whom the drug may be prescribed • Removal from the market Download the white paper to gain insight on drug-induced liver injury and how to identify it early in your clinical trials. •  Why Steve Jobs' Magic Doesn't Work in Medicine More... •  Past Trauma May Contribute to Bowel Disorder, Mayo Clinic Study More... •  Watermelon Reduces Atherosclerosis, University of Kentucky Study More... •  Brain-Training Games Stop Depression Before It Starts, Stanford University Study More... •  Vibrating Gel Offers Hope on Throat-Cancer, Massachusetts Institute of Technology (MIT) Study More... •  Scientists Identify Protein Form Linked to Huntington's Disease, Gladstone Institute Study More... •  Oxitec Release: Mosquito Bred to Fight Dengue Fever Shows Promise in Study More... •  Live Longer With Fewer Calories? Key Enzyme Involved in Aging Process Found, University of Gothenburg Study More...   More Featured News Acceleration 2011: Nutter Early Stage Life Sciences Conference Thursday, November 17, 2011 Nutter Conference Center, Seaport West 155 Seaport Boulevard, 5th Floor Boston, Massachusetts This free event is by invitation only. To request an invitation, please visit: www.acceleration.nutter.com/2011. An outstanding line-up of speakers is being assembled for this conference including representatives of Atlas Venture, GlaxoSmithKline (GSK), Novartis, Smith and Nephew, Longwood Founders Fund, and Pfizer. Two panel discussions will examine issues and trends in early-stage development among life science companies. Panel I will seek to answer the question "How Lean is Too Lean?" and will consider some of the pitfalls and challenges faced by development stage life science companies as they execute on a lean business model from raw technology through the clinical and operational phases of development and finally to commercial launch. Panel II asks "Are Big Pharma and Big Device the New Development Accelerators?" and will examine how large companies are deploying new external investment and development models to optimize their "buy" and "build" pipelines. The program will be followed by cocktails, hors d'oeuvres and networking To request an invitation, please visit www.acceleration.nutter.com/2011. 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Director, Manufacturing Technical Support / Process Development Seeking a highly qualified individual who will be responsible for overseeing the transfer and implementation of process development modifications and improvements into commercial manufacturing operations. This hands-on position will include designing and executing specific studies to evaluate process modifications, optimization and validation of manufacturing processes, training of manufacturing operators, and review of impact of process changes on product quality and yields. • BioForest (Bainbridge Island, Washington) Emerald BioSystems Technical Support Representative The Technical Support Rep. handles customer sales and support activities for technical instrumentation; the position can be located in the Seattle or Boston areas. Key responsibilities include: installation, maintenance and technical support of instrumentation. • Biotech Bay (San Francisco, California) Medivation, Inc. Director, Clinical Quality Assurance Provides oversight of clinical research and development activities to ensure that these are conducted in accordance with applicable regulatory requirements, guidelines, laws and Medivations established standards and practices. This position will be the lead and subject matter expert on FDA GCP regulations, guidance documents and ICH GCP. • BioMidwest (Schaumburg, Illinois) APP Pharmaceuticals Sr. Quality Assurance Auditor Responsible for scheduling and leading domestic and international Corporate Compliance Audits, including internal audits of APP facilities and external audits of APP suppliers in accordance with APP policies and procedures. • Rocky Bio (Lakewood, Colorado) DaVita Clinical Research Medical Director Managing a team of Nurse Practitioners, Physicians Assistants and MD's, our Medical Director will play an integral role in defining our success. This highly visible position will be responsible for working collaboratively with a talented and experienced team to grow and develop this unit from both a medical and operational perspective. Get Noticed! Add your resume to the BioSpace Career Center! See more than 5,000 job postings in the BioSpace Career Center! BioCapital 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 mid-atlantic 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. • BioCapital 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 LabConnect, LLC 2910 First Avenue South, Suite 200 Seattle, Washington 98134 U.S.A. Phone: 206-322-4680 Fax: 206-322-4682 LabConnect provides integrated, one-stop solutions for your laboratory service needs. Through the combined expertise of our worldwide network of leading laboratories, we provide customized laboratory service solutions designed to meet your unique requirements. Our "open platform" approach enables us to combine our scientific expertise with unparalleled project management and client service tools to ensure the success of your trial. More Company Profiles FREE Subscription to Genetic Engineering & Biotechnology News Published 21 times a year Genetic Engineering & Biotechnology News (GEN)'s unique news and technology content focus includes the entire bioproduct life cycle from early-stage R&D to applied research and bioprocess through to commercialization. Post Your: News | Jobs | Company Profile | Event | Advertising / Sponsorship BioSpace Inc. 6465 South Greenwood Plaza, Suite 400 Centennial, Colorado 80111 U.S.A. Phone: 877-277-7585 Fax: 800-595-2929 BioSpace Inc. 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 BioSpace News Beat Team. Editor & Publisher: Rosemary Do Editorial & Production Staff: Lana Ho, Maysa Darwish, Tammy Liu, Michelle Wong BioSpace.com - Life. Science. 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