Vertex Surges as CF Combo Improves Breathing - May 7, 2012

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Monday, May 07, 2012  |   |   |   |  UC Berkeley Extension Clinical and Regulatory Management Get the specialized instruction you need to advance your career. UC Berkeley Extension offers targeted certificates and programs to provide the skills to design and manage clinical trials, navigate compliance issues and ensure new products and processes adhere to U.S. and international regulatory specifications. Choose from programs in: • Clinical Research Conduct and Management (available online) • Quality and Compliance for Biotechnology • Regulatory Affairs Summer courses are open for enrollment. Learn more. •  Vertex Pharmaceuticals (MA) (VRTX) Surges as CF Combo Improves Breathing More... •  Roche (RHHBY) Abandons Cholesterol Drug Trial on Poor Results More... •  FDA Lifts Second Hold on Trials of Insmed Incorporated (INSM) Lung Drug More... •  Pfizer Inc. (PFE)'s Pristiq Shows Positive Results in Long-Term Study More... •  Kythera Biopharmaceuticals Announces Presentation of Positive Results from First of Two ATX-101 European Phase III Trials for Reduction of Submental Fat More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News •  Talon Therapeutics, Inc. (HNAB) Receives Notification of Three Month PDUFA Date Extension for Marqibo® More... More PDUFA News •  Pfizer Inc. (PFE) Arthritis Pill Raises Safety Concerns, FDA Staff Says More... •  Curis, Inc. (CRIS) Announces Collaborator Roche (RHHBY)'s Submission of Erivedge™ for Registration With Australian Regulatory Authority More... •  Nuvo Research Inc. (NRI.TO)'s Pliaglis Receives Positive Opinion from the BfArM in the E.U. More... •  Health Canada Grants Apricus Biosciences (APRI) Pre-NDS Meeting for Femprox for Female Sexual Arousal Disorder More... •  pSivida Corp (PSDV) Announces United Kingdom Grants ILUVIEN® Marketing Authorization for the Treatment of Chronic Diabetic Macular Edema More... More BLA/NDA/ANDA News More IND News More MAA News •  Eye Color May Indicate Risk for Serious Skin Conditions, University of Colorado Study More... •  Curry's Ability to Fight Cancer Put to the Test, Leicester Royal Infirmary and Leicester General Hospital Study More... •  Range of Brain Diseases Could Be Treated by Single Drug, University of Leicester Study More... •  Massive Rise in Asian Eye Damage, Australian National University Study More... •  Kids With Cerebral Palsy May Benefit from Video Game Play, University of Toronto Study More... More General Clinical Research News JAX® Patient-derived xenograft resource The enormous cost, and high failure rate, of cancer drug development have highlighted the need for new preclinical strategies and resources. To this end, a library of more diverse and representative patient-derived tumor xenograft (PDX) models has been created at The Jackson Laboratory. We utilize NOD scid IL2 receptor gamma chain knockout mice (NSG), constructed by JAX Professor Lenny Shultz, as the mouse host. This PDX resource (which includes tumor gene expression and copy number variation data), developed in collaboration with renowned medical centers throughout the United States, supports large-scale basic and preclinical cancer research and is both affordable and amenable to high throughput studies. For more information, please visit The Jackson Laboratory. • Genetown (Cambridge, Massachusetts) Millennium: The Takeda Oncology Company Clinical Quality Auditor Responsible for ensuring that audit plans are developed through discussion with the clinical project teams and then manage the outsourcing of clinical audits of all types. These will include audits of investigator sites, vendors, commercial IRBs, Clinical Study Reports, database, pharmacovigilance, Phase 1 units and other types. • Biotech Bay (Sunnyvale, California) Pharmacyclics, Inc. Clinical Research Associate/Senior Clinical Research Associate Responsible for driving and executing day-to-day activities during the conduct of clinical studies, according to the protocol, ICH/GCP, and applicable regulatory requirements. • BioMidwest (Chicago, Illinois) Takeda Pharmaceuticals Medical Director / Senior Medical Director, Clinical Science Leads the development of the all components of the integrated development strategy and the resultant tactical clinical plan and study designs to support the global development of and establish the conditions essential for determining the safety, efficacy, medical usefulness, and marketability of multiple compounds. • Southern Pharm (Memphis, Tennessee) GTx, Inc. Director, Clinical Development & Drug Safety Responsible for managing the design and production of clinical protocols. Responsible for the development, implementation and execution of clinical development strategic plans that meet GCP, FDA, and other regulations or standards, and that are consistent with GTx business and function objectives • Biotech Beach (Inglewood, California) ImaginAb, Inc. Clinical Development Director Supervise clinical research staff such as Clinical Study Managers (CSM), Assistant CSMs, and Data Managers. Will oversee all outsourced clinical research activities. • Get Noticed! Add your resume to the BioSpace Career Center! • See more than 5,000 job postings in the BioSpace Career Center! Biotech Bay 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 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. • 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 •  Sunovion Pharmaceuticals Inc.'s Latuda® (lurasidone HCl) Label Updated With Expanded Dosing Range Providing Added Flexibility for the Treatment of Patients With Schizophrenia More... •  Sunovion Pharmaceuticals Inc. Announces Upcoming Availability of ZETONNA™ (ciclesonide) Nasal Aerosol, a Non-Aqueous, Dry Nasal Aerosol Spray for Allergic Rhinitis 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! Optimizing Clinical Trials Through IT • Examine the trends shaping clinical trials. • Learn how social media are being used in patient recruitment. • Analyse the potential of electronic health record data in clinical development. Click Here for More Information. Hot Company Accelovance 201 College Road East Princeton, New Jersey 08540 U.S.A. Phone: 609-919-3400 Fax: 609-520-3963 Accelovance Inc., based in Rockville, MD, is a clinical services company specializing in high patient throughput from recruitment through study completion. Accelovance has developed a model to increase the reliability and productivity on Phase I (outpatient) and Phase II-IV trials. 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, Maysa Darwish, Tammy Liu, Michelle Wong ClinicaSpace.com - Clinical Trials. Clinical Research. 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