FDA Adds New Warnings to Big Pharma's Cancer Drug - Oct. 11, 2011

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Tuesday, October 11, 2011  |   |   |   |  CHI's 11 Annual PepTalk: The Protein Science WeeK January 9-13, 2012 | Hotel Del Coronado | San Diego, CA www.chi-peptalk.com REGISTER BY FRIDAY, October 14 and SAVE UP TO $400! PepTalk 2012 continues the tradition of strong scientific programming centered around protein-based therapeutics. The four distinct protein pipelines focused on formulation, purification, biotherapeutics and expression range from applying protein discovery research, to developing downstream protein products that ultimately lead to clinical applications. Create your own agenda by moving between the tracks and choosing the sessions that best fit your research and networking needs. Please click here for more information. •  FDA Adds New Warnings to Big Pharma's Cancer Drug More... More Discontinuations News More Recalls and Warning News •  Roche (RHHBY)'s Experimental Alzheimer's Drug Gantenerumab Looks Promising in Phase I More... •  BioSante Pharmaceuticals, Inc. (BPAX) Reports Positive LibiGel(R) Safety Data Review in Phase III Program More... •  Alvine Pharmaceuticals, Inc. Announces Positive Results From Phase 2a Trial of ALV003 in Celiac Disease Patients More... •  Sirius Genomics Launches Major International Sepsis Study More... •  Pacira Pharmaceuticals, Inc. Announces Exparel(TM) Data to Be Presented at Upcoming Medical Meetings More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News Social & Scientific Systems, Inc., and panel members, Eleanor Feingold, Gina D'Angelo, and Joan Bailey-Wilson, invite you to join us at a symposium to honor Brad Efron for his many contributions to theoretical and applied statistics. We will be discussing emerging statistical challenges in large-scale inference, with a focus on applications in genetics and biomedical imaging. The goal of the symposium is to stimulate discussion; it will include both formal and informal meeting and discussion time, in addition to the featured speakers. The symposium is limited to 200 people. Please RSVP to: LargeData@s-3.com Please click here for more information. •  Edgemont Pharmaceuticals, LLC Release: U.S. FDA Approves New 60 mg Dosage Strength of Fluoxetine More... More Drug Approval News •  Advaxis, Inc. Granted Pre-IND Meeting with FDA for ADXS-HER2, an Immunotherapy for HER2 Expressing Cancers More... More BLA/NDA/ANDA News More IND News More MAA News •  Dietary Supplements Risky for Older Women, University of Minnesota Study More... •  Karolinska Institute Study: Chocolate Lovers Have Lower Risk of Stroke More... •  Restless Legs Syndrome May Raise High Blood Pressure Risk in Middle-Aged Women, Brigham and Women's Hospital Study More... •  Obese Mothers Put Children At Higher Risk of Asthma, Murdoch Childrens Research Institute and University of Melbourne Study More... •  After Stroke, Crossed Legs a Welcome Sign, University of Munich Study More... More General Clinical Research News The CRO Market Outlook To 2014 • Develop deeper insight into the size and growth of the global CRO industry by utilising the report's unique market forecasts. • Assess outsourcing strategy and understand how drug development costs can be reduced through CRO alliances , and conducting clinical trials offshore. • Identify the differences between full-service and niche CROs and which capabilities best fit the needs of your organisation. Click Here for More Information. • Pharm Country (Radnor, Pennsylvania) PolyMedix, Inc. Clinical Trial Operations Manager/Director Experience in execution of Phase II Phase II pivotal studies, Phase III and small Phase I studies and larger, multi-center trial management. Experience in infectious diseases and/or cardio vascular. Well versed in GCP and applicable FDA/EMEA regulations required. Ability to prepare and present clinical trial updates to senior management. • Biotech Bay (San Francisco, California) FibroGen, Inc. Clinical Research Associate II (CRA II) Will assist with operational activities for two phase two trials in China. The therapeutic area is anemia. May monitor study sites for data collection, source data verification, review of regulatory documents/files and drug accountability. • Genetown (Boston, Massachusetts) On Assignment Clinical Research Clinical Contract Manager Responsible for overseeing large complex contract negotiation and management for CRO and other vendor agreements providing expert consultancy and assisting with difficult negotiations and developing innovative strategies and solutions. • BioMidwest (McGaw Park, Illinois) Baxter International, Inc. Clinical Educator Provides clinical expertise and support primarily to key Baxter accounts and Baxter sales representatives within a specified territory. This includes providing information on key clinical topics and programs that support the clients and clinicians within an assigned territory. Serves as the primary educator and consultant to clients regarding the appropriate use of products and services to achieve business results. • Biotech Beach (San Diego, California) Sequenom Inc. Clinical Laboratory Supervisor Will be responsible for monitoring the production of medical diagnostic testing in the CLIA lab performed by assigned Clinical Lab Scientists. The supervisor will work closely with internal and external contacts including suppliers, physicians and other healthcare providers regarding clinical laboratory testing, operations and development of new tests. • 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 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 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 •  Maxygen, Inc. (MAXY) Announces Final Rejection of All Claims of Amgen (AMGN) '804 Patent in Inter Partes Reexamination Proceeding More... •  PROLOR Biotech (PBTH) Receives Notice of Allowance for New U.S. Patent Covering its Longer-Acting CTP-Modified Interferons More... More Patent News •  Vertex Pharmaceuticals Incorporated (VRTX)'s INCIVEK9(TM) (telaprevir) Now Available in Canada for People with Hepatitis C More... More Drug Product News Hot Company Coldstream Laboratories Inc. 1500 Bull Lea Road, Suite 250 Lexington, Kentucky 40511 U.S.A. Phone: 859-257-6600 Fax: 859-323-5985 At Coldstream Laboratories Inc. (CLI), we're seasoned at turning pharmaceutical development ideas into safe, pure, and effective clinical pharmaceutical dosage forms. Since 1986, we have completed more than 200 formulation development projects that led to clinical trials providing us extensive clinical manufacturing experience with both commercial product development and grant-funded projects from such sources as the National Institutes of Health. 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. 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.