FDA Approves Astellas' Drug for Leaky Bladders - June 29, 2012

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Friday, June 29, 2012  |   |   |   |  SECOND ASIA PACIFIC PHARMACEUTICAL COMPLIANCE CONGRESS A Hybrid Conference and Internet Event Sponsored by Pharmaceutical Compliance Forum and Asia Pacific Healthcare Industry Compliance Team Media Partners: Life Science Compliance and RX Compliance Report September 11 - 13, 2012 Intercontinental Shanghai Pudong Hotel Shanghai, China Please click here for more information. •  FDA Approves Astellas Pharma Inc. (YPH.BE)'s Drug for Leaky Bladders More... •  Eisai Company, Ltd. (ESALY.PK) and Toyama Chemical Company Receive Approval to Market Anti-rheumatic Agent Iguratimod in Japan More... •  Ipsen's Somatuline Gets Marketing Approval in Japan More... More Drug Approval News •  Bedford Laboratories Issues Voluntary Drug Recall More... More Discontinuations News More Recalls and Warning News •  FDA Approves Actelion Pharmaceuticals US, Inc. (ATLN.VX)'s SNDA for Second Generation VELETRI for Injection More... More BLA/NDA/ANDA News More IND News More MAA News •  BioDelivery Sciences International (BDSI) Announces Positive Results from BEMA Buprenorphine/Naloxone (BNX) Pharmacokinetic Study More... •  A.P. Pharma, Inc. (APPA) Announces Positive APF530 Patient-Satisfaction Data from Phase 3 Study in Patients With Chemotherapy-Induced Nausea and Vomiting More... •  Medivir AB (MVIRb.F) Announces an Interferon-Free Phase II Combination Trial With TMC435 and Daclatasvir to Commence Shortly More... •  Lexicon Pharmaceuticals, Inc. (LXRX) Announces Publication of Results of Two Studies of LX4211 in Patients with Type 2 Diabetes in the Journal Clinical Pharmacology & Therapeutics More... •  PROLOR Biotech (PBTH) to Present Data on Its Long-Acting Clotting Factors at Leading International Scientific Conference More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News Collaborate... Learn... Innovate IBC's BioProcess International Conference & Exhibition October 8 -12, Rhode Island Convention Center, Providence, RI Event Website Download the BioProcess International brochure and see why this is IBC's best program yet! By attending, you expand your knowledge with unparalleled access to new, unpublished data and exclusive case studies from companies of all sizes and perspectives at the most comprehensive event for those directly involved with improving the speed, cost and quality of developing and manufacturing biotherapeutics. Save 20% off the standard rates when you register by June 29th - this is up to a $600 savings! Register today at or call 800-390-4078. Register with priority code BS12EOD. *Discounts are for new registrations only and cannot be used in conjunction with other offers. •  Why a Change in a Bristol-Myers Squibb Company (BMY) Hepatitis C Trial Has Big Implications More... •  Eating Vegetables May Protect Pancreas, Karolinska Institute Study More... •  Smallest, Largest Fetuses at Higher Risk of Stillbirth, St. Michael's Hospital Study More... •  Weill Cornell Medical College Study Affirms Safety and Acceptability of Shang Ring for Reducing HIV Risk Among Men More... •  Nemours Study Shows Fruit and Vegetable Juice Concentrate May Reduce Abdominal Fat Mass and Improve Insulin Resistance in Overweight Boys More... More General Clinical Research News • Pharm Country (Princeton, New Jersey) Otsuka America Pharmaceutical, Inc. Associate Director Clinical Outsourcing Responsible for supporting OPDC Clinical Regulatory Teams (CRT) in selecting, negotiating costs, contracting and providing business oversight of CROs and other ancillary vendors. The position provides leadership in developing internal processes and standards. • Biotech Beach (Carlsbad, California) Genoptix, Inc. Senior Clinical Lab Scientist, Clinical Trials Conduct pre-analytical, analytical, and post-analytical processes associated with specimens, including test performance and reporting test results. Provide technical assistance to testing staff. Ensure adherence to established processes and procedures for proper performance of all laboratory procedures and reporting of test results. • BioMidwest (Indianapolis, Indiana) Synteract, Inc. Clinical Trial Assistant Will provide support to the Clinical Operations and Project Management department in project-specific tasks and the overall management of clinical trials. You will assist with the preparation of clinical/research documentation, receipt, collection, and initial/ongoing review of study regulatory documentation to confirm completeness/track dates, and distribute to appropriate team members for review • Genetown, (Lexington, Massachusetts) Cubist Pharmaceuticals, Inc. Senior Manager, Clinical Risk Management, Pharmacovigilance Serves as Pharmacovigilance lead at cross-functional and/or external meetings including clinical trial team meetings and/or multidisciplinary product teams. Provides input to the product Clinical Development Team on program objectives and deliverables. • Biotech Bay (Walnut Creek, California) Harvest Technical Services, Inc. Senior Clinical Research Associate Participates in and is accountable for the planning and conduct of clinical studies, with a strong focus on enrollment, quality of data, site relationships, and oversight of challenging and/or complex studies with adherence to established timelines. • Get Noticed! Add your resume to the BioSpace Career Center! • See more than 5,000 job postings in the BioSpace Career Center! Job seekers can spend days with HR representatives and Hiring Managers from top biotech, pharma, medical device and diagnostics companies in various regions across the U.S. 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. 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 •  MediStem, Inc. (Formerly known as Medistem Laboratories, Inc.) Receives Notice of Patent Allowance Covering Fat Stem Cell Therapy of Autoimmune Diseases More... •  Osiris Therapeutics, Inc. (OSIR) Bolsters its Stem Cell Intellectual Property Estate More... More Patent News •  InterMune, Inc. (ITMN) Release: Sweden's Dental and Pharmaceutical Benefits Agency (TLV) Authorizes Reimbursement of Esbriet® (pirfenidone) More... More Drug Product News Building Novel Applications with Pipeline Pilot to Drive Next Generation Sequencing This case study shows how scientists are streamlining the process of analyses of DNA sequence information. Enabled by new DNA sequencing technologies, many more scientists and informaticians are interrogating larger and more complex data set. Request Now! Optimizing Clinical Trials Through IT • Examine the trends shaping clinical trials • Learn how social media are being used in patient recruitment. • Analyse the potential of electronic health record data in clinical development. Click Here for More Information. Hot Company MPI Research 54943 North Main Street Mattawan, Michigan 49071-9399 U.S.A. Phone: 269-668-3336 Fax: 269-668-4151 MPI Research with global headquarters in Mattawan, Michigan, provides discovery, safety evaluation, bioanalytical, and analytical services to the biopharmaceutical, medical device, animal health, and chemical industries. Scientific knowledge and experience, integrity, trust, teamwork, and dedication to strong and enduring Sponsor relationships are the defining attributes that characterize MPI Research as a high-performance, high-quality organization that is committed to bringing safer and more effective products to the world. 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: Lana Ho Editorial & Production Staff: Maysa Darwish, Tammy Liu ClinicaSpace.com - Clinical Trials. Clinical Research. 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