FDA Warns of Risks for Novo Nordisk's Victoza - June 14, 2011

Having trouble viewing this email? View in Browser.

Tuesday, June 14, 2011  |   |   |  Reduce Risk and Maximize Potential in Ophthalmology Development: Ophthalmic study design and execution can be quite different than other therapeutic areas. Pharm-Olam's team has a proven track record of excellence in achieving trial objectives and can provide strategic, operational and consulting to sponsors for phase I to phase IV development. The majority of our clinical staff in emerging markets are MDs or PhDs, including Ophthalmologists in strategic areas for clinical trials. The incidence of disorders and standards of treatment can vary widely, so let Pharm-Olam conduct a complimentary feasibility study specific to your protocol and study budgets to use in your resource planning. Contact us at www.pharm-olam.com, info@pharm-olam.com, USA +1-713-559-7900, UK +44-0-1344-891121. •  FDA Warns of Serious Risks Associated With Novo Nordisk A/S (NVO)'s Victoza More... •  Dr. Reddy's Laboratories, Inc. (RDY)'s Mexican Arm Receives FDA Warning Letter More... •  Bedford Laboratories Initiates Voluntary Recall of Indomethacin for Injection More... More Discontinuations News More Recalls and Warning News •  Abbott Laboratories (ABT) Receives FDA Approval for CREON® (Pancrelipase) Infant-Specific Dosage for Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis More... •  FDA Approves New Test To Help Determine if Breast Cancer Patients Are Candidates for Herceptin Treatment More... More Drug Approval News •  FDA Delays Decision on Pacira Pharmaceuticals, Inc.'s Exparelf More... •  IntelGenx Corp. Announces New PDUFA Date for Its Single Dose 450 mg Bupropion Hydrochloride Tablet More... More PDUFA News •  Cell Technology, Inc. Completes Type A Meeting With FDA's Division of Oncology Drug Products: Guidance Provided for Resubmission of Pixantrone NDA for Consideration of Accelerated Approval More... •  Meda AB (MDABF.PK): FDA Finds the NDA for Dymista Sufficiently Complete More... More BLA/NDA/ANDA News More IND News More MAA News •  Positive Results from Phase IIa Study Pave Way for Phase IIb Trial of AC-201 for the Treatment of Type II Diabetes, TWi Biotechnology, Inc. Study More... •  D-Pharm Ltd. Release: DP-b99 Phase III MACSI Study Protocol Published in International Journal of Stroke More... •  QRxPharma Pty Ltd. Completes Comparative Safety Study More... •  Tengion Inc. Provides Update on Neo-Urinary Conduit Clinical Trial More... •  Sangart, Inc. Initiates Phase 2b Study of Oxygen Therapeutic Agent MP4OX in Severe Trauma Patients With Hemorrhagic Shock More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News •  Bipolar Patients Need Highly Targeted Treatments, University of Toledo Medical Center Study More... •  Could a Diet Help Prevent Alzheimer's? - Feinstein Institute Study More... •  Fresh Hope for Thousands of Scots Men with a Low Sex Drive, The Andropause Society Reveals More... •  Cell Science Systems Corp. Release: Studies Affirm Role of Food Sensitivity in Skin and GI Disorders More... •  Pamlab LLC Release: Randomized Study Combining L-Methylfolate with Antidepressant Shows Significant Boost in Patient Response More... More General Clinical Research News BioSurplus Announces TWO GIANT AUCTIONS BioSurplus will be hosting two large public auctions, one for Roche in Palo Alto / San Francisco Bay and the second a campus-wide auction of a global biotech located in San Diego. Details of the auctions can be found atauctions.biosurplus.com Roche Palo Alto / San Francisco Bay Area Auction Details Over 1200 items are available in this auction. Viewing will be held on June 2, 3 and 7, 2011 from 9 am to 5 pm each day. The items are located at 3431 Hillview Ave., Bldg R3, Palo Alto, CA 94304 Global Biotech - San Diego Campus Liquidation The San Diego campus liquidation will have over 1500 pristine laboratory equipment items. Auction viewing dates are June 13-17, 2011 from 10 am to 6 pm by appointment only. Please call 858-550-0800 x222. An open viewing will be held on June 22, 2011 from 10 am to 6 pm. Items are being added to the online auction site daily. Please click here for more information. Advances in Drug-Diagnostic Co-Development • Understand the current regulatory environment for both diagnostics and drugs within the EU and the US and how these relate to their co-development. • Understand the biomarker discovery and validation process. • Using case studies discover how drugs and their companion diagnostics have already received approval in the US and EU. Click Here for More Information • BioCapital (College Park, Maryland) Takeda Pharmaceuticals Manager/Sr. Manager, Clinical Science & Outcomes Addresses unsolicited requests for scientific and pharmacoeconomic data concerning Takeda Pharmaceuticals products to health care professionals and relevant thought leaders of, but not limited to, regionally based managed care organizations, pharmacy benefit management companies, etc. • Biotech Beach (San Diego, California) Ardea Biosciences, Inc. Associate Director/Senior Manager, Clinical Operations The overall responsibility will be to direct and manage a portion of the people and function of the Clinical Operations group. Additionally, this incumbent may be responsible for Phase 1, 2 and/or 3 planning, with an emphasis on Phase 1 studies. • Genetown (Waltham, Massachusetts) Biogen Idec Sr Clinical Program Leader As a key member of the clinical operations team at Biogen Idec Hemophilia, this individual will play a critical role in advancing our hemophilia programs on a global basis with the overall goal of significantly improving treatment options for patients and their families. • BioTechxus (Houston, Texas) Cyberonics, Inc. Clinical Study Manager Responsible for the management and oversight of company-sponsored domestic and international trials as directed by the Study Director and Manager of Clinical Operations. Etc. • BioCapital (Gaithersburg, Maryland) MedImmune, LLC Senior Clinical Scientist As a member of and in collaboration with a multifunctional team create and maintain the CDP for assigned programs ensuring alignment with the Target Product Profile (TPP), accounting for feasibility and regional requirements, capturing health outcomes, epidemiology, and pharmacogenetic considerations. Etc. • Get Noticed! Add your resume to the BioSpace Career Center! • See more than 5,000 job postings in the BioSpace Career Center! BIO 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 Washington, DC 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. • BIO Career Fair, Washington DC, June 27, 2011 • Biotech Beach Career Fair, San Diego, CA September 22, 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 •  Galectin Therapeutics Expands European Patent Coverage More... More Patent News •  Dry Eye Therapy Utilizing Cationic Novasorb® Technology Available Soon From OCuSOFT More... More Drug Product News Hot Company Tolerx, Inc. 300 Technology Square, 3rd Floor Cambridge, Massachusetts 02139 U.S.A. Phone: 269-668-3336 Fax: 269-668-4151 Tolerx, Inc. is a biopharmaceutical company engaged in discovering and developing new therapies designed to treat patients with immune related diseases. 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 join the ClinicaSpace Focus here. Safely unsubscribe from ClinicaSpace.com e-mail at any time by managing your account here.