Novartis: Patient Died After Starting Gilenya - Dec. 13, 2011

Having trouble viewing this email? View in Browser.

Tuesday, December 13, 2011  |   |   |   |  Online Auction January 11 at 9 AM ET Featuring lab equipment from Elan and other leading global firms! Register and bid online. •  Novartis AG (NVS): Patient Died After Starting Gilenya More... More Discontinuations News More Recalls and Warning News •  Lannett Company, Inc. (LCI) Receives FDA Approval for Triamterene with Hydrochlorothiazide 37.5/25mg Capsules More... More Drug Approval News •  Alexza Pharmaceuticals, Inc. (ALXA) Surges After FDA Panel Backs Inhaled Antipsychotic Drug More... •  Eisai Company, Ltd. (ESALY.PK) Submits Application in Japan for New Dry Syrup Formulation of its Alzheimer's Disease Treatment Aricept More... •  Tarsa Therapeutics Targets 2012 NDA Submission for its OSTORA(TM) Oral Calcitonin More... •  Results From Gentium S.p.A.'s Treatment IND for Defibrotide Presented at the American Society of Hematology Annual Meeting More... More BLA/NDA/ANDA News More IND News More MAA News •  Takeda Pharmaceutical Co. Ltd. (TKDG.DE) Drug Cuts Myeloma Death Risk in 5-Year Study More... •  Anacor Pharmaceuticals, Inc. Announces Positive Preliminary Results from Phase 2a Trial of AN2728 and AN2898 in Atopic Dermatitis More... •  Symphogen A/S Presents Positive Rozrolimupab (SYM001) Phase 2 Trial Results in ITP at American Society of Hematology More... •  Cell Therapeutics, Inc. (CTIC) and Chroma Therapeutics Final OPAL Phase II Results of Tosedostat Demonstrate Significant Response Rates in Elderly Patients with Treatment Refractory or Relapsed Primary or Secondary Acute Myeloid Leukemia (AML) More... •  Top-Line Phase 2 Data Indicate Repros Therapeutics Inc. (RPRX)'s Androxal(R) Normalizes Testicular Function in Men With Type 2 Diabetes More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News Quantifying the Value of Pipeline Pilot, the Accelrys Scientific Enterprise Platform This white paper outlines the methodology, sources of value, and quantifiable results from bringing products to market faster, avoiding unproductive experiments, saving developer time, and more. Request Now! •  ADHD Drugs Don't Raise Risk of Heart Problems, Kaiser Permanente Study More... •  Blink Patterns May be a Window into Autistic Mind, Emory University School of Medicine Study More... •  Friends and Loved Ones Yawn Together, University of Pisa Study More... •  Cancer Outpatients at Greater Risk for Blood Clots, University of Rochester Medical Center Study More... •  People With DFNA2 Hearing Loss Show Increased Touch Sensitivity, Max Delbruck Center Study More... More General Clinical Research News SafeBridge Consultants, Inc. announces two Potent Compound Safety Training offerings (may be taken separately or consecutively) The SafeBridge original Potent Compound Safety "Boot Camp"® (Boot Camp I) is a comprehensive two-day course in pharmaceutical potent compound safety focused on training EH&S and related professionals in critical technical concepts and proactive safety programs in pharmaceutical industrial hygiene, occupational and environmental toxicology, analytical chemistry, and risk communication. The SafeBridge Advanced Concepts to Support Drug Development of Potent Compounds from R&D through Manufacturing (Boot Camp II) is a one-day advanced course focused on case studies and problem-solving to address potent compound safety issues in discovery, development, contract manufacturing and commercialization. COURSE SEATING IS LIMITED AND USUALLY SELLS OUT! San Diego, CA Boot Camp I May 15-16, 2012 Boot Camp II May 17, 2012 Contact: Susan Custer: susan.custer@safebridge.com or or 650-961-4820 X 231 orhttp://www.safebridge.com. Innovative Clinical Trial Design and Management • Use detailed case studies of recent adaptive trials featuring companies including Merck, Pfizer, Novartis, GSK, Eli Lilly, and AstraZeneca. • Measure the potential cost savings offered by the reduced development times and improved decision-making associated with adaptive trials. • Assess the logistics of adaptive trial implementations. Click Here for More Information. • BioForest (Bothell, Washington) Seattle Genetics, Inc. Clinical Data Associate II/ Senior Clinical Data Associate Responsible for all aspects of the data management process throughout a clinical trial. Specific responsibilities will include: creating a Data Management Plan, designing online Case Report Forms for an EDC data management system, defining the edit checks required per study, coordinate medical coding, SAE reconciliation, and identifying and resolving data discrepancies. • Pharm Country (Bridgewater, New Jersey) Sanofi Senior Clinical Trial Manager Responsible for the overall operational planning and activities for the implementation and conduct of clinical exploratory pharmacology clinical trials in compliance with ICH, GCP's, SOPs, local requirements, internal/departmental guidelines, and established timelines. • Biotech Bay (Sunnyvale, California) Pharmacyclics, Inc. Clinical Trial Assistant Ensure studies are completed, on time, within budget and in compliance with SOPs, FDA regulations and ICH/GCP guidelines. Set up CTMS system, as appropriate. Assist in preparation of documents including regulatory document templates, study binders, study communications and presentations. • Genetown (Cambridge, Massachusetts) Millennium: The Takeda Oncology Company Global Medical Affairs (GMA) Clinical Research Manager I Lead provides oversight and management of Investigator Initiated Studies (IIS) for one or more molecule (s), either in development or post approval, within the IIS Program. The IIS Program includes studies submitted from US academic institutions, NCI CTEP/COOP, and Ex-US Investigators and/or COOPs. • Biotech Beach (San Diego, California) Ardea Biosciences, Inc. Clinical Trials Assistant Will support the efforts of a Phase 1, 2 or 3 clinical operations team (special emphasis on Phase 1's). Responsibilities include, but are not limited to maintaining clinical master files, making investigator payments. • Get Noticed! Add your resume to the BioSpace Career Center! • See more than 5,000 job postings in the BioSpace Career Center! BioSpace Life Science Career Fairs are the biotech industry's premier career events. Featuring well-respected employers from around the nation, our job fairs attract top candidates in the biotech, pharmaceutical, life science and medical device industries. With such a great number of recruiters and hiring managers from top biotech companies attending our career fairs, there are an abundance of opportunities available for job seekers. Many different disciplines within the industry are represented bringing a diversity of candidates to our job fairs. Companies seeking pharmaceutical sales representatives and marketing jobs regularly attend our job fairs. Engineering and technical jobs can be found, as well as regulatory jobs and positions in QA/QC. Individuals desiring a science job or a research job will find many opportunities at our job fairs. In addition, hiring managers seeking candidates for clinical research jobs also attend our events. 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 •  Aegis Therapeutics, LLC Awarded Patent for Parathyroid Hormone (PTH) Peptide Drug Formulations Suitable for Metered Nasal Spray and Oral Delivery More... •  Avaxia Biologics, Inc. is Awarded Patent for its Proprietary Orally Active Antibody for Celiac Disease More... More Patent 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, Maysa Darwish, Tammy Liu, Michelle Wong 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.