Merck: FDA Won't OK Its Combo Cholesterol Drug - Mar. 5, 2012

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Monday, March 05, 2012  |   |   |   |  Are you measuring multiple biomarkers in your late stage trial? The widespread adoption of biomarker pattern profiling has boosted efficiency in drug development beyond traditional single target methods. Increasingly, sponsorsneed to measure multiple biomarkers to capture the data necessary to accurately evaluate safety and efficacy in Phase II-III trials. Multiplexing quantifies all the targeted biomarkers in a single test to save money, conserve precious sample volume, and increase reproducibility. Contact us to learn more about how our services can benefit your late stage trial: www.myriadrbm.com/latestage/clinicaspace.   •  Merck & Co., Inc. (MRK): FDA Won't OK Its Combo Cholesterol Drug More... •  GlaxoSmithKline (GSK) to Hire Hundreds More Reps in China More... •  4s3 Bioscience, Inc. Lands $20 Million in Venture Funding More... •  H. Lundbeck A/S (LUN.CO)'s Selincro Cuts Alcohol Use by 66% in Clinical Trials More... •  Merck & Co., Inc. (MRK) Reveals Positive Results From Phase III Study of AIT for Ragweed Pollen More... •  Teva Pharmaceutical Industries Limited (TEVA) Reports Positive Phase III Findings From Late Stage Studies With QNASL Nasal Aerosol More... •  Eli Lilly and Company (LLY) and Its Big Bet on Alzheimer's Drug More... •  Five Reasons Illumina, Inc. (ILMN) Should Fight Roche (RHHBY)'s Insulting Low-Ball Bid More... More Top News PPD Central Labs Combine the expertise of a leading contract research organization (CRO) with global central laboratories that are among the world's largest dedicated exclusively to clinical trials. We offer: • Comprehensive range of central lab services • Extensive reach • High level of accuracy Please click here for more information. •  Sitting Around Ups Diabetes Risk in Women, University of Leicester Study More... •  Vitamin E "May Be Bad for Bones," Keio University Study More... •  University of Edinburgh Scientists Shed Light on How Liver Repairs Itself More... •  Kids' Snoring Linked to Behavioral Problems, Albert Einstein College of Medicine Study More... •  Cocoa May Enhance Skeletal Muscle Function, University of California, San Diego (UCSD) Study More... •  When Our Eyes Serve Our Stomach, University of Nice Sophia Antipolis Study More... •  New Pathway Found for Regulation of Blood Vessel Growth in Cancer, Winship Cancer Institute Study More... •  Smoking Linked to Higher Rate of Psoriasis, Harvard Medical School Study More...   More Featured News Cell Culture Technology Workshop A new, three-day, hands-on, laboratory training for bioscience professionals March 26-28, 2012 The University of Maryland, together with industry experts, is offering a new three-day workshop on cell culture technology. Geared toward bioscience industry professionals, this workshop combines eight lectures and eight lab exercises focusing on the theory and practical applications of cell culture technology. The lectures will cover principles, practices and case studies leading directly into laboratory exercises performed at the Biopharmaceutical Advancement Facility. The lab exercises will cover a broad range of topics: from inoculation of cultures, to aseptic sampling to the preparation, inoculation, and harvest of a bioreactor. The lectures and lab exercises will cover applications of both anchorage dependent and suspension adapted cell lines. This workshop is designed for industry professionals, including bench scientists, QA/QC, manufacturing, business development, and sales personnel seeking to advance their knowledge and experience in cell culture. For more information and to register, visit: http://www.mtech.umd.edu/biotech/workshops/cell_culture_technology/index.html The CMO Market Outlook to 2017 • Develop contract manufacturing strategies based on regional forecast performance and key industry trends. • Analyze the strengths and weaknesses of global players in the CMO market. • Evaluate the future outlook of clinical quantity manufacturing as against finished dose supply. Click Here for More Information. Building Novel Applications with Pipeline Pilot to Drive Next Generation Sequencing This case study shows how scientists are streamlining the process of analyses of DNA sequence information. Enabled by new DNA sequencing technologies, many more scientists and informaticians are interrogating larger and more complex data set. Request Now! • BioMidwest (Chicago, Illinois) Takeda Pharmaceuticals Senior Medical Director Pharmacovigilance Oversee the work of the Clinical Safety physicians who support each therapeutic area. This position will liaise with other TGRD departments (Clinical Research, Regulatory, Pharmaco-epidemiology) to ensure comprehensive product stewardship for developmental products. • Pharm Country (Lebanon, New Hampshire) Adimab LLC Scientist in Cell Culture Development Responsible for generating stable mammalian cell lines, selecting highly productive clones, and developing and optimizing in-house fermentation processes for rapid production of IgG antibodies at multi-liter scale. • Pharm Country (Lebanon, New Hampshire) Adimab LLC Scientist in Membrane Protein Biochemistry Will carry out purification, characterization, and formulation of integral membrane proteins and conduct antibody discovery and optimization research. • Pharm Country (Paramus, New Jersey) Mannkind Corporation Associate Director, Scientific Communications Responsible for writing MannKind documents; managing writing projects and timelines; managing and mentoring medical writing staff and external business consultants with a variety of writing responsibilities to achieve Mannkind's objectives and goals. • Biotech Bay (Novato, California) BioMarin Pharmaceutical Inc. Associate Medical Director, Clinical Science Will report to the Vice President of Clinical Science, needs to be proficient in clinical study, program design and execution. Experience and knowledge in interaction with clinical investigators, collaboration with regulatory affairs, and FDA interactions is required. Get Noticed! Add your resume to the BioSpace Career Center! See more than 5,000 job postings in the BioSpace Career Center! BioSpace Career Fair at CALBIO2012 Job seekers can spend a day with HR representatives and Hiring Managers from top biotech, pharma, medical device and diagnostics companies in the Bay Area. 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. • 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 Alkermes plc 852 Winter Street Waltham, Massachusetts 02451 U.S.A. Phone: 781-609-6000 Alkermes plc is a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to develop innovative medicines that improve patient outcomes. The company has a diversified portfolio of more than 20 commercial drug products and a substantial clinical pipeline of product candidates that address central nervous system (CNS) disorders such as addiction, schizophrenia and depression. More Company Profiles FREE Subscription to Pharmaceutical & Medical Packaging News Pharmaceutical & Medical Packaging News is a comprehensive resource for medical and pharmaceutical manufacturing professionals who need focused, reliable, and timely information to make intelligent packaging decisions. 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. Community. • BioSpace is a registered trademark of BioSpace, Inc. • Please distribute this e-cast freely. • Credit any excerpts as follows: Copyright 2012 BioSpace http://www.biospace.com • While BioSpace and its agents used their best efforts in collecting and preparing the information published herein, we do not assume, and hereby disclaim, any liability for any loss or damage caused by errors or omissions, whether such errors or omissions resulted from negligence, accident or other causes. If someone forwarded this news to you and you'd like to receive your own copy FREE of charge, simply Subscribe here. 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