Amylin Soars as Diabetes Drug Gets FDA Nod - Oct. 20, 2011

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Thursday, October 20, 2011  |   |   |   |  Experience Scientific Excellence at Stand 2503 at the AAPS Annual Meeting and Exposition in Washington DC, October 23 - 27. Meet Aptuit scientific professionals and attend two informative Poster Sessions: • Monday, October 24, Poster #: M1082, Hall C, 1:00 PM to 5:00 PM, when Patricia Andres, Ph.D., Director, Drug Development, SSCI, a division of Aptuit, presents Crystallization Process Development of Cocrystals: Demystification, Scale-up and In-situ Raman Monitoring. • Wednesday, October 26, Poster #: W5260, Hall C, 1:00 PM to 4:30 PM, when Jon Selbo, Ph.D., Senior Research Investigator, SSCI, a division of Aptuit, presents Semi-Automated Preformulation Screening Using Carbamazepine For more information, please visit:http://www.aptuit.com/aaps. •   Amylin Pharmaceuticals, Inc. (AMLN) Soars as Diabetes Drug Gets FDA Nod More... •  Sagent Pharmaceuticals, Inc. Announces FDA Approval of Bupivacaine Hydrochloride Injection, USP More... More Drug Approval News •  Insight Pharmaceuticals Issues a Voluntary Nationwide Recall of "Nostrilla Nasal Decongestant" Due to Bacterial Contamination More... More Discontinuations News More Recalls and Warning News •  Biogen Idec, Inc. (Massachusetts) (BIIB) and Elan Corporation PLC (ELN) Receive Notification of PDUFA Date Extension More... More PDUFA News •  Gentium S.p.A. Provides Update on MAA Process for Defibrotide in Europe More... More BLA/NDA/ANDA News More IND News More MAA News •  Galderma Pharma S.A. Announces Positive Phase 2b Results for Investigational Compound Targeting Redness of Rosacea More... •  Pacira Pharmaceuticals, Inc. Announces New Data Demonstrating Longer Time to First Opioid Use and Reduction in Opioid-Related Adverse Events With EXPAREL(TM) Compared to Bupivacaine HCl More... •  Optimer Pharmaceuticals, Inc. (OPTR) Release: DIFICID(TM) Demonstrated Early Superiority in the First 12 Days Compared to Vancomycin in New Analysis of Phase 3 Study Results More... •  Galderma Pharma S.A. Announces Positive US Pivotal Interim 6-Month Results for EMERVEL Classic Lidocaine Compared to Juvederm Ultra More... •  Genentech (RHHBY)'s Phase II Study Showed Ocrelizumab Maintained Significant Reduction in Disease Activity for Multiple Sclerosis Patients for Almost Two Years More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval 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 sets and are expanding the range of problems that can be addressed through sequencing... Request Now! •  Cholesterol Drugs for Head Injury? Johns Hopkins University Study More... •  Viva Libido! Sexually Active Life Expectancy Just Keeps Rising, University of Chicago Study More... •  Sperm Moves Best for Moderate Exercisers: Yamaguchi University Study More... •  Fish Oil May Harm Lung Injury Patients, Vanderbilt University Study More... •  Exercise May Not Limit Pregnancy Weight Gain, Case Western Reserve University Study More... More General Clinical Research News IBC's BioProcess International Conference & Exhibition October 31 - November 4, 2011 - Long Beach, California Event Website Download the 2011 BioProcess International brochure and see why this is YOUR must attend event for 2011. Download PDF file here. You will see the 2011 program, features a stellar line up keynote presentations including, the US FDA, EMA, Pfizer, Merck and more. Plus, there are over 50 presentations with new, previously unpublished data, and new topic coverage areas including antibody drug conjugates, viral clearance and managing global manufacturing facilities and partners. Exhibit hall & keynote passes are now available. Mention priority code B11171BSEODS2 and the fee will be waived. All passes subject to approval. Register here today or call 800-390-4078. 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. • Southern Pharm (Memphis, Tennessee) St. Jude Children's Research Hospital Director-Clinical Trials Management Oversees clinical research activities for the Radiological Sciences Department, including interaction with researchers, clinicians, coordinators, clinical research associates, and administrators. Works with principal investigators to establish policies and procedures to ensure Best Clinical Practice Guidelines are followed. • Biotech Beach (Irvine, California) Allergan Inc. Senior Clinical Data Manager The Senior CDM (Clinical Data Manager) within Clinical Data Management will provide specialized knowledge and detailed attention to carry out data management data review activities in support of one or more clinical research studies. • Biotech Bay (San Carlos, California) Verinata Health, Inc. Clinical Laboratory Scientist Responsible for testing and reporting clinical laboratory results used to aide physicians in the diagnosis and treatment of patients. Selection, implementation, and evaluation of results for Quality Control materials used in statistical process control of laboratory assays. • BioCapital (Frederick, Maryland) SAIC-Frederick, Inc. Clinical Research Associate II Provides clinical trials research monitoring for NIAID intramural research protocols at domestic and international sites and ensures clinical trials are conducted in a timely manner and in accordance with standard operating procedures (SOPs), Good Clinical Practices (GCPs), IND and IDE clinical trial monitoring and additional regulatory guidelines. • Genetown (Boston, Massachusetts) Vertex Clinical Trials Associate Assists the Clinical Project Managers in the conduct of trials and may be responsible for managing startup activities, vendor communication or other project activities as assigned. He/She performs work within established protocols under general supervision. • Get Noticed! Add your resume to the BioSpace Career Center! • See more than 5,000 job postings in the BioSpace Career Center! Bio NC 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 south east 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. • 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 •  Mylan Inc. (MYL)'s Dey Pharma Successfully Obtains Patent Reexamination Certificates for Two Perforomist(R) Patents More... More Patent News Hot Company Gentris Corporation 133 Southcenter Court, Suite 400 Morrisville, North Carolina 27560 U.S.A. Phone: 919-465-0100 Fax: 919-465-0554 Gentris Corporation is a leading global provider of applied clinical pharmacogenomic services. As pioneers in the field of pharmacogenomics, Gentris assists pharmaceutical companies and clinical research organizations to effectively integrate pharmacogenomics into their drug development programs to deliver safer, more effective drugs to market more quickly. 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, Suvarna Sheth, Maysa Darwish, Tammy Liu ClinicaSpace.com - Clinical Trials. Clinical Research. 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