FDA Green-Lights Roche's Skin Cancer Drug - Aug. 17, 2011

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Wednesday, August 17, 2011  |   |   |   |  Gibco® Cell Culture The Difference Between Breakthrough and Try Again Your research will only be as accurate and efficient as yourcell culture. That's why groundbreaking researchers settle for nothing less than Gibco®. It could be the difference between publishing your results and reading someone else's. See all the Gibco® offers for mammalian cell culture or select from various products via this link. •  FDA Green-Lights Roche (RHHBY)'s Skin Cancer Drug More... More Drug Approval News •  Regeneron Pharmaceuticals, Inc. (REGN) Falls on FDA Delay of Eye Drug More... •  Protalix Biotherapeutics, Inc. (PLX) Announces FDA Accepts for Review Complete Response Resubmission for Taliglucerase Alfa and Assigns PDUFA Date More... •  Immune Response BioPharma Requests Meeting with FDA, Sees Approval of REMUNE the Best Outcome for HIV/AIDS Patients More... More BLA/NDA/ANDA News More IND News More MAA News •  Zogenix, Inc. Reports Positive Phase 3 Results for Zohydro - Meets Primary Efficacy Endpoint More... •  Patrys Limited (PATZF.PK) Anti-Cancer Product Shows Promise in Multiple Myeloma More... •  Celsion Corporation (CLN) Announces Publication of Clinical and Scientific Review of ThermoDox(R) as Treatment for Primary Liver Cancer More... •  Allos Therapeutics, Inc. (ALTH) Initiates Phase 3 Registration Trial of FOLOTYN(R) in Newly Diagnosed Patients with Peripheral T-Cell Lymphoma Following Treatment with a CHOP-based Regimen More... •  August 16 Safety Monitoring Committee Meeting for Nymox Pharmaceutical (NYMX) Pivotal Phase 3 NX-1207 Trials Indicates Favorable Safety Profile More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News Nature Methods Nature Methods provides techniques for life scientists and chemists. It is a print and online publication dedicated to publishing novel methods together with significant advances to tried and tested techniques allowing researchers to perform faster, better and more efficient experimental research. Request Now! •  New Drug May Relieve Severe, Tough-to-Treat Gout, University of Chicago Study More... •  Central Catheters May Raise Risk of Blood Clots After Surgery, University of California, Irvine Study More... •  Blood Injections May Help Chronic "Tennis Elbow", Henry Dunant Hospital Study More... •  Radioactive Iodine Risks May Outweigh Benefit for Some Tumors, University of Michigan Study More... •  Bladder Cancer Risk Even Higher for Smokers Than Thought, National Cancer Institute Study More... More General Clinical Research News Biomarker Applications for Improved Clinical Trial Outcomes November 15 - 16, 2011 Hilton Boston Back Bay - 40 Dalton Street Event Website The only personalized medicine conference allowing you to make biomarkers and diagnostics available during every stage of clinical research, to stratify patients, prove clinical validity, and streamline the regulatory approval and reimbursement process. Featuring up-to-date analysis of new FDA legislation regulations and a special spotlight from Blue Cross Blue Shield. Please click here for more information. Advancing Molecular Diagnostics to Personalize Cancer Therapy • Identify key innovations in molecular diagnostics for oncology that may compete with those in development at your company. • Understand the regulatory challenges facing the developers of molecular diagnostics for cancer. • Understand the challenges that surround successfully commercializing a combined drug-diagnostic product and learn how to overcome them. Click Here for More Information • Biotech Bay (Foster City, California) Gilead Sciences Senior Clinical Data Associate Works collaboratively with CRA, Statistical Programmer, Biostatistician and other Clinical, Global Drug Safety, Regulatory and Project Management staffs to meet project deliverables and timelines for non-routine clinical data acquisition, quality checking and reporting. • Biotech Beach (Westlake, California) Baxter International, Inc. Clinical Data Analyst II Responsible for supporting clinical data management (CDM) operational activities in one or more therapeutic areas. Support the creation, execution and maintenance of Data Management Plans in support of clinical study deliverables. • BioCapital (Gaithersburg, Maryland) MedImmune, LLC Clinical Supplies Specialist II Coordinates the packaging & labeling activities required to provide Investigational Product (IP) for clinical studies in time for scheduled First-Patient-In (FPI) date. This person is also responsible for participating in the coordination of the IP returns & reconciliation process to provide for appropriate destruction of IP within a defined time period following the close-out of a study. • Southern Pharm (Memphis, Tennessee) St. Jude Children's Research Hospital Coordinator - Clinical Research Contracts Develops, initiates, and negotiates contractual arrangements with industry sponsors and/or collaborating sites (domestic and international) derived from existing clinical research study protocols. Reviews and understands clinical research protocols for Investigational New Drugs (IND) or Investigational Device Exemptions (IDE). • Pharm Country (Cranbury, New Jersey) On Assignment Clinical Research Clinical Project Manager Responsible for the operational oversight of our clinical development programs and management of our CRO. Providing input to our clinical development strategies. He/she is responsible for technical leadership and successful execution of projects involving clinical operations, etc. • Get Noticed! Add your resume to the BioSpace Career Center! • See more than 5,000 job postings in the BioSpace Career Center! Biotech Beach 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 Southern California 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. • Biotech Beach Career Fair, San Diego, CA September 22, 2011 • BioMidwest Career Fair, Chicago, IL October 4, 2011 • Pharm Country Career Fair, Bridgewater, NJ October 5, 2011 • Biotech Bay Career Fair, Burlingame, CA October 11, 2011 • 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) Confirms First-to-File Patent Challenge Relating to FROVA(R) Tablets More... •  Fuisz Pharma Announces Publication of US Patent Pending for a System That Confirms Drug Compliance More... •  Syndax Pharmaceuticals Inc. Announces Issuance of EU Patent for Entinostat More... More Patent News Hot Company SNBL USA, Ltd. 6605 Merrill Creek Parkway Everett, Washington 98203 U.S.A. SNBL USA, Ltd., is a preclinical CRO that specializes in nonhuman primate (NHP) and small animal research. Study programs range from regulatory toxicology to customized study designs and disease models. Specialized programs include reproductive toxicology, safety pharmacology, immunotoxicology and carcinogenicity. SNBL USA’s Laboratory Services division intelligently applies extensive experience, comprehensive scientific capabilities, and modern technology to bring outstanding support to all client research. 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, Matt Thwin, Maysa Darwish ClinicaSpace.com - Clinical Trials. Clinical Research. Community. • ClinicaSpace is a registered trademark of BioSpace, Inc. • Please distribute this e-cast freely. • Credit any excerpts as follows: Copyright 2011 ClinicaSpace http://www.clinicaspace.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. Safely unsubscribe from ClinicaSpace.com e-mail at any time by managing your account here.