FDA Shoots Down Pfizer's Remoxy - June 24, 2011

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Friday, June 24, 2011  |   |   |  The Bioprocessing Summit August 22-23, 2011 Boston, Massachusetts www.BioprocessingSummit.com CHI's annual "The Bioprocessing Summit" is specially 'formulated' to focus on the most pressing challenges of bioproduction. From cell line selection and transfection, to biopreservation, scale-up and bioreactor design, this event explores the bioprocesses that continually consume time and resources. The six meetings comprising the Summit provide a close-up look at the current strategies and innovations for optimizing bioprocesses while mitigating risk and ensuring bottom-line quality. To view complete details, visit To view complete details, visitwww.BioprocessingSummit.com. •  FDA Shoots Down Pfizer Inc. (PFE)'s Remoxy More... •  FDA Panel Backs Shire plc Drug for Rare Disease More... •  Amsterdam Molecular Therapeutics (AMT) (RHP.DE) Glybera MAA Receives CHMP Negative Opinion, Shares Fall 50 Percent More... •  Amgen (AMGN) Receives Positive CHMP Opinion for Vectibix(R) (Panitumumab) in Combination With Chemotherapy More... •  ViroPharma Incorporated (VPHM) Announces Positive CHMP Opinion for Buccolam® (Midazolam, Oromucosal Solution) in the European Union More... More BLA/NDA/ANDA News More IND News More MAA News •  Singapore Health Sciences Authority Approves Emergent BioSolutions (EBS) Anthrax Vaccine, BioThrax More... •  Lannett Company, Inc. (LCI) Receives FDA Approval for Morphine Sulfate Oral Solution NDA More... •  Mylan Inc. (MYL) Launches First Generic Version of Entocort EC® Capsules More... More Drug Approval News •  ERA-EDTA Congress 2011: Late Breaking Clinical Trials I More... •  Abbott Laboratories (ABT) Release: New Phase 2 Data Published in The New England Journal of Medicine Show Bardoxolone Methyl Sustained Improvement in Measure of Kidney Function (eGFR) Over 52 Weeks in Patients With Moderate to Severe Chronic Kidney Disease and Type 2 Diabetes More... •  InVasc Therapeutics Initiates Phase IIa Proof of Concept Study with INV-144 in Patients with Chronic Kidney Disease More... •  Adocia Launches Phase 2 Clinical Study on Type 1 Diabetic Patients with its Fast-Acting Human Insulin, Hinsbet(R) More... •  BioAlliance Pharma Submits Application for Orphan Medicinal Product Designation for Clonidine Lauriad(TM) in Europe and the United States More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News •  Lithium Profoundly Prevents Brain Damage Associated with Parkinson's, Buck Institute for Age Research Study More... •  Compound May Provide Drug Therapy Approach for Huntington's Disease, UT Southwestern Medical Center Study More... •  Weight Loss Surgery May Cure Obese Diabetics, Vrije Universiteit in Amsterdam Study More... •  Little Progress Seen in Treating Chronic Pain, University of Washington Researchers Say More... •  Rotavirus Vaccine Greatly Reduced Gastroenteritis Hospitalizations in Children, Centers for Disease Control and Prevention (CDC) 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 (Deerfield, Illinois) Astellas Pharma US Associate Director, Clinical Studies Responsible for overseeing the management of multiple clinical development programs that typically involve multiple therapeutic areas or indications. Provides direction to Senior Managers and Study Managers and clinical teams. Etc. • BioForest (Bothell, Washington) OncoGenex Technologies Inc. Clinical Research Associate II Monitor clinical trials or co-monitor with internal and external (e.g. CRO or contractor) staff. Contribute to protocol and case report form development. Ensure appropriate regulatory documents and agreements from investigational sites are obtained and materials are filed in the Clinical Trial Master File. Etc. • Biotech Bay (South San Francisco, California) Exelixis, Inc. Sr. Clinical Trials Manager Accountable for the day-to-day management of operations of 1-4 clinical trials commensurate with complexity, including trial start-up, conduct, and close-out activities. This activity is coordinated in conjunction with one or more CROs. • BioCapital (Rockville, Maryland) Human Genome Sciences, Inc. Clinical Trial Manager Responsible for study start up activities, including assisting with investigator recruitment, site feasibility, vendor selection (CRO, Central Laboratory, etc.), CRF development, edit specifications, procurement of clinical trial insurance, collection of regulatory documents, etc. • Pharm Country (Ridgefield, Connecticut) Boehringer Ingelheim Pharmaceuticals, Inc. Director, Clinical Research (MD) - Diabetes You will ensure that goals and objectives for a drug development program are met. Provides medical/scientific and technical direction to the planning, implementation, conduct, completion, 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 • BioMidwest Career Fair, Chicago, IL October 4, 2011 • Pharm Country Career Fair, Bridgewater, NJ October 5, 2011 • 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 •  Garamycin(R) Ophthalmic Solution Now Available from Fera Pharmaceuticals More... More Drug Product News Hot Company eBioscience, Inc. 10255 Science Center Drive San Diego, California 92121 U.S.A. Phone: 858-642-2058 Fax: 858-642-2046 eBioscience, Inc. provides innovative, high quality reagents to researchers worldwide that empower the process of scientific discovery in the areas of cellular immunity and oncology. 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. 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