FDA OKs First Generic Copies of Merck's Singulair - Aug. 6, 2012

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Monday, August 06, 2012  |   |   |   |  Planning allergy studies can be very challenging because of variable weather, pollen variance among site locations, indoor/outdoor lifestyle of patients, study medication compliance, and limited enrollment periods. Pharm-Olam has offices worldwide, including South America and South Africa to conduct a variety of seasonal studies year round. Our locations in North America and Europe provide opportunities for seasonal studies in key markets. We also have experience with Environmental Exposure Units (EEU) which can help sponsors address study variables through strictly controlled conditions. This includes variables for air quality, temperature, humidity, and precise maintenance of allergen concentration. Let Pharm-Olam conduct a complimentary feasibility study specific to your protocol and study budgets to use in your resource planning. Contact us at www.pharm-olam.com, info@pharm-olam.com, USA 1-713-559-7900, UK 44-0-1344-891121. •  FDA OKs First Generic Copies of Merck & Co., Inc. (MRK)'s Singulair More... More Drug Approval News •  Medivation, Inc. (MDVN) and Astellas Pharma Inc. (YPH.BE) Get PDUFA Date for Prostate Cancer Drug More... More PDUFA News •  OXiGENE (OXGN) Announces Phase 2 Ovarian Cancer Trial of ZYBRESTAT® Plus Bevacizumab Achieves Important Interim Safety Objective More... •  TWi Pharmaceuticals, Inc. Announces Positive Phase IIb Clinical Trial Results of AC-201 in Patients With Type 2 Diabetes. More... •  Cellceutix (CTIX) Reports Its Very Novel Anti-Cancer Agent, Kevetrin, at Dana-Farber Cancer Institute for Start of Clinical Trials More... •  Alnylam Pharmaceuticals (ALNY) Presents New Data From Its Conjugate Delivery Platform, Enabling Subcutaneous Administration of RNAi Therapeutics With Wide Therapeutic Index More... •  Rexahn Pharmaceuticals, Inc. Completes Exploratory Phase I Clinical Study of RX-3117 More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News 8th Annual Bioassays and Bioanalytical Method Development October 1 - 3, 2012 Event Website IIR's 8th Annual Bioassays and Bioanalytical Method Development event (formerly Cell Based Assays and BAMD) gives you access to the know how of the pharmaceutical scientists with the most experience in cell-based and ligand binding assays and bio analytical method development. For more information, please visit: www.bioassaysevent.com. •  The Way Your Pupils Dilate May Show Sexual Preference, Cornell University Study More... •  Carbon Monoxide's Damaging Role in Heart Rhythm Found, Leeds University Study More... •  Memory Improves for Older Adults Using Computerized Brain Fitness Program, University of California, Los Angeles (UCLA) Study More... •  Bilingualism "Can Increase Mental Agility," University of Strathclyde Study More... •  Honey May Ease Nighttime Coughing in Kids, Tel Aviv University Study More... More General Clinical Research News • Biotech Bay (Mountain View, California) VIVUS, Inc. Senior Director, Clinical Statistics and Data Management Responsible for proper experimental design and valid statistical analysis of clinical trials in all phases. Provide statistical direction for complex projects. Provides strategic input into development programs including filing strategies worldwide, study design, analytic methods, endpoints that meet both regulatory and scientific requirements. • BioCapital (Gaithersburg, Maryland) MedImmune, LLC Senior Director, Clinical Development Reports to the Vice President and Therapeutic Area Head of Oncology. The Director/Senior Director will have full responsibility for the planning, implementation and daily operation of a drug development project (s) • Pharm Country (Princeton, New Jersey) Otsuka America Pharmaceutical, Inc. Associate Director Clinical Management Acts as the scientific lead for clinical program development activities within a product group or within a portfolio. Determines product and portfolio level standards for clinical development planning, scientific document content, data analysis and reporting, and reporting to senior management, OPCJ and affiliates. • Southern Pharm (Miami, Florida) Cubist Pharmaceuticals, Inc. Clinical Business Manager Responsible for achieving and maximizing territory and account sales goals through account management, high level clinical proficiency and effective selling. The CBM will be the primary point of contact for Cubist with key hospital influencers and decision makers across key functional areas including but not limited to physicians, pharmacists and formulary committee members. • BioMidwest (Northbrook, Illinois) Astellas Pharma US Associate Clinical Program Director Provide strategic input into clinical development plans, GMAP and other key global project team deliverables through participation on global project team. Deliver and manage the operational plan including budget, resources and timelines to global project team. • Get Noticed! Add your resume to the BioSpace Career Center! • See more than 5,000 job postings in the BioSpace Career Center! 2012 Pharm Country 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 tri-state 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. • Pharm Country Career Fair, Bridgewater, NJ September 13, 2012 • Biotech Beach Career Fair, San Diego, CA September 20, 2012 • Biotech Bay Career Fair, Burlingame, CA October 3, 2012 • BioCapital Career Fair, Bethesda, MD October 9, 2012 • BioMidwest Career Fair, Lincolnshire, IL October 22, 2012 • Bio NC Career Fair, Durham, NC October 25, 2012 • Genetown Career Fair, Cambridge, MA November 5, 2012 More information about BioSpace's Career Fairs BioSpace White Paper Biotech Career Fairs For Job Seekers 101: Control Your Experience •  Biostar Pharmaceuticals, Inc. (BSPM) Receives Approval From Xianyang SFDA to Restart Sales of Its Gel Capsule Drugs More... •  Mylan Inc. (MYL) Launches Generic Version of Amidate® Injection More... •  Qualitest Pharmaceuticals Launches Generic Singulair® More... More Drug Product News 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! New Emerging R&D and Clinical Trial Locations • Compare 5 new emerging R&D locations in terms of population, economic activity, healthcare infrastructure, and current R&D activity. • Analyze how clinical trial numbers are changing in China, India, and Eastern Europe. • Develop strategies for geographic outsourcing. Click Here for More Information. Hot Company Dynavax Technologies Corporation 2929 Seventh Street, Suite 100 Berkeley, California 94710 U.S.A. Phone: 510-848-5100 Fax: 510-848-1379 Dynavax Technologies Corporation is a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious and inflammatory diseases. 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: Lana Ho Editorial & Production Staff: Maysa Darwish, Tammy Liu ClinicaSpace.com - Clinical Trials. Clinical Research. 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