Warning Issued for Takeda Top Drug; BMY Gets FDA Nod - June 16, 2011

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Thursday, June 16, 2011  |   |   |  Advancing Oncology. Changing Medicine. Crown Bioscience Inc. is a US-based oncology service company committed to advancing anti-cancer therapeutics through the preclinical and drug development stages. Our multi-disciplinary team of experts, located in two research campuses in Beijing and Shanghai, provides an integrated service solution from your idea to an enabling IND, including: preclinical, translational and clinical capabilities. Crown Bio offers a full range of predictive models; such as HuPrime™ xenografts , OmniPanel™ cell based screens, and SnapShot™ translational research services to provide data to help you select the development candidate with the highest chance of success. To learn more about our unique portfolio and breadth of services, visit www.crownbio.com or call us at 603-686-9330. •  FDA Says Heavy Use of Takeda Pharmaceutical Co. Ltd. (TKDG.DE)'s Actos May Be Tied to Bladder Cancer More... •  FDA: Pfizer Inc. (PFE)'s Chantix (Varenicline) May Increase the Risk of Certain Cardiovascular Adverse Events in Patients with Cardiovascular Disease More... •  GlaxoSmithKline (GSK) Rotavirus Vaccine Linked to Bowel Disorder More... •  American Regent, Inc. Initiates Voluntary Nationwide Recall of Concentrated Sodium Chloride Injection, USP, 23.4%, 30 mL Single Dose Vial Due to Particulates More... More Discontinuations News More Recalls and Warning News •  FDA Approves Bristol-Myers Squibb Company (BMY)'s Drug That Prevents Organ Rejection More... More Drug Approval News •  FDA: Regeneron Pharmaceuticals, Inc. (REGN) Drug Effectively Treats Vision Loss More... •  Seattle Genetics, Inc. (SGEN) Announces FDA Advisory Committee to Review Brentuximab Vedotin for the Treatment of Relapsed or Refractory Hodgkin Lymphoma and Systemic ALCL More... •  Novartis AG Application for Expanded Menveo(R) Indication from 2 Months of Age Accepted for Review by FDA More... •  Aegerion Pharmaceuticals, Inc. Holds Pre-NDA Meeting With FDA for Investigational Lomitapide and is on Track for NDA Submission More... More BLA/NDA/ANDA News More IND News More MAA News •  H. Lundbeck A/S's Alcoholism Drug Does Well in Three Phase III Clinical Studies, to File MAA by end of 2011 More... •  BiondVax Pharmaceuticals Announces Positive Phase IIa Results for Universal Flu Vaccine More... •  Cubist Pharmaceuticals, Inc. (CBST) Announces Positive Results from Two Phase 2 Trials, CXA-201 and CDAD Program More... •  Aradigm Corporation (ARDM) Reports Successful ORBIT-1 Bronchiectasis Study with Inhaled Liposomal Ciprofloxacin More... •  Reata Pharmaceuticals, Inc. and Abbott Laboratories (ABT) Initiate Global Phase 3 Study of Bardoxolone Methyl in Patients With Chronic Kidney Disease and Type 2 Diabetes More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News •  Using Living Cells as an "Invisibility Cloak" to Hide Drugs, American Chemical Society Study More... •  Long-Term Use of Vitamin E May Cut COPD Risk, Cornell University and Brigham and Women's Hospital Study Finds More... •  Probiotic Drinks Help Against Allergies, Wageningen University Study More... •  Billionaire-Led Serum Institute of India, Ltd.'s 50-Cent Vaccine Beats GlaxoSmithKline (GSK)'s Version in Study More... •  Olive Oil Linked to Lower Stroke Risk, University of Bordeaux Study More... More General Clinical Research News Join us for the 40th Annual Meeting of the American College of Clinical Pharmacology, Sept. 11-13, 2011 at the Crowne Plaza Chicago O'Hare Hotel, Chicago (Rosemont), IL, covering a wide range of current, relevant topics as noted below. CME and CPE credits available for registered attendees. • Transdermal Delivery Systems • Opioids and Psychotropic Drugs • First-in-Human Clinical Trials • Model-based Drug Development • Biotherapeutic Dose Selection Strategies • Drug Safety vs. Disease Treatment • Quantitative Clinical Pharmacology in Inflammation & Immunology • Imaging Techniques in Drug Development • Bridging Clinical Trials • Innovations in Pharmacoepideomiology • Hormone Therapy in Menopausal Women Keynote speakers include: Francis S. Collins, MD, PhD, Director of the National Institutes of Health (NIH) on Sunday, Sept 11th and Anne Schuchat, MD, Director of the CDC's National Center for Immunization and Respiratory Diseases (NICRD) on Monday, Sept 12th. Additional information about the ACCP 40th Annual Meeting and the Preliminary Program are available online or contact TStevens@ACCP1.org. 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 • BioMidwest (Indianapolis, Indiana) Eli Lilly and Company Principal Research Scientist, Immunologist - Autoimmune Disease Serve as a source of state-of-the-art scientific knowledge in the field of immuno-inflammation especially as this applies to autoimmune disease; exert influence on research direction and the choice of experimental approaches taken. Etc. • Biotech Bay (South San Francisco, California) Bayside Solutions, Inc. Pre-Clinical Research Associate, In Vivo Pharmacology We are currently seeking an experienced and motivated Research Associate with experience in Pre-Clinical in vivo pharmacology. Experiments will assess both the pharmacodynamic and pharmacokinetic nature of novel variants, utilizing various animal models of disease. • 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. • 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 •  Tioga Pharmaceuticals Issued Key U.S. Patent for the Use of Asimadoline to Treat D-IBS More... More Patent 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. 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