Fresenius' Leaked Memo Leads to FDA Class I Recall - Aug. 1, 2012

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Wednesday, August 01, 2012  |   |   |   |  CHI's Fourth Annual ADAPT 2012: Accelerating Development & Advancing Personalized Therapy Congress, will be held at the in Washington, DC, September 19-21, 2012. Delegates from pharma and diagnostic companies, clinical organizations, academia, and government, will be provided a unique opportunity to learn and discover actionable strategies bridging drug and diagnostic development. Please click here for more information. •  Fresenius Medical Care's Leaked Memo Leads to FDA Class I Recall More... More Discontinuations News More Recalls and Warning News •  Watson Pharmaceuticals, Inc. (WPI)'s Generic Version of Pulmicort RESPULES® Receives FDA Approval More... More Drug Approval News •  Pfizer Inc. (PFE) CEO: FDA May Need More Time to Review Tofacitinib Application More... •  Depomed, Inc. (DEPO) Announces Submission of Serada® NDA More... •  Hemispherx Biopharma (HEB) Files Complete Response With the FDA Regarding Its Ampligen® New Drug Application for Chronic Fatigue Syndrome More... •  pSivida Corp (PSDV) Reports Alimera Sciences (ALIM)'s Intention to Resubmit Application to FDA for ILUVIEN® in DME Using Data from Completed Trials More... •  Ampio Pharmaceuticals, Inc. (AMPE) Announces Successful Pre-IND Meeting With the Ophthalmology Division of the FDA on Optina™ for the Treatment of Diabetic Macular Edema More... More BLA/NDA/ANDA News More IND News More MAA News •  Array BioPharma, Inc. (ARRY) Pain Drug Fails to Better Existing Treatment More... •  InSite Vision (ISV) Initiates the First Phase 3 Clinical Study of BromSite™ for the Reduction of Pain and Inflammation after Cataract Surgery More... •  Pharmacyclics, Inc. (PCYC) Triggers Significant Milestone Payment and Provides Clinical Program Update More... •  Acetylon Pharmaceuticals Initiates New Phase 1b Clinical Trial of Rocilinostat (ACY-1215) in Combination with Celgene Corporation (CELG)'s Revlimid® (Lenalidomide) and Dexamethasone for Patients with Multiple Myeloma More... •  Bioniche Life Sciences Inc. (BNC) Presents Preliminary Data on the Use of In-Licensed Superagonist Hormone Technology in Cattle More... More Phase III News More Phase II News More Phase I News More Pre-Clinical News More Post-Approval News 8th Annual Bioassays and Bioanalytical Method Development October 1 - 3, 2012 Event Website IIR's 8th Annual Bioassays and Bioanalytical Method Development event (formerly Cell Based Assays and BAMD) gives you access to the know how of the pharmaceutical scientists with the most experience in cell-based and ligand binding assays and bio analytical method development. For more information, please visit: http://www.bioassaysevent.com. •  Sleep Affects Potency of Vaccines, University of California, San Francisco (UCSF) Study More... •  Even Mild Depression, Anxiety Hurts the Heart, University College London Study More... •  Large Waistline Linked to Sexual Dysfunction, New York Presbyterian Hospital and Weill Cornell Medical College Study More... •  Hey, I'm Over Here: Men and Women See Things Differently, University of Southern California Study More... •  Smile! It Might Lower Your Stress Level, University of Kansas Study More... More General Clinical Research News • Southern Pharm (Miami, Florida) Cubist Pharmaceuticals, Inc. Clinical Business Manager Responsible for achieving and maximizing territory and account sales goals through account management, high level clinical proficiency and effective selling. The CBM will be the primary point of contact for Cubist with key hospital influencers and decision makers across key functional areas including but not limited to physicians, pharmacists and formulary committee members. • BioMidwest (Northbrook, Illinois) Astellas Pharma US Associate Clinical Program Director Provide strategic input into clinical development plans, GMAP and other key global project team deliverables through participation on global project team. Deliver and manage the operational plan including budget, resources and timelines to global project team. • BioForest (Lake Oswego, Oregon) Galena Biopharma Global Clinical Project Manager Responsible for the planning, development, implementation and ongoing management of all of the operational aspects of clinical trials including protocol development, defining scope of work, resource planning and allocation, recruitment of clinical investigators, training, planning and execution of investigator meetings, establishment and adherence to timelines, ensuring compliance with protocols and clinical/corporate objectives, adherence to regulations and company Standard Operating Procedures (SOPs), and clinical supply management. • Biotech Bay (Foster City, California) Gilead Sciences Associate Director, Clinical Research Will primarily support the GS-7340 project, a new nucleotide reverse transcriptase inhibitor in development for the treatment of HIV, though work on other HIV development projects may also be required. • Pharm Country (Bedminster, New Jersey) Allergan Inc. Manager, Clinical Data Quality Manages a team of professionals responsible for supporting independent Data Management and Programming quality activities including database, documentation and data trend assessments. Responsible for hiring and managing the performance of these professionals. • Get Noticed! Add your resume to the BioSpace Career Center! • See more than 5,000 job postings in the BioSpace Career Center! 2012 Pharm Country 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 tri-state 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. • Pharm Country Career Fair, Bridgewater, NJ September 13, 2012 • Biotech Beach Career Fair, San Diego, CA September 20, 2012 • Biotech Bay Career Fair, Burlingame, CA October 3, 2012 • BioCapital Career Fair, Bethesda, MD October 9, 2012 • BioMidwest Career Fair, Lincolnshire, IL October 22, 2012 • Bio NC Career Fair, Durham, NC October 25, 2012 • Genetown Career Fair, Cambridge, MA November 5, 2012 More information about BioSpace's Career Fairs BioSpace White Paper Biotech Career Fairs For Job Seekers 101: Control Your Experience •  U.S. Patent Office Allows Laurantis Pharma Oy Application for Treatment of Skin Inflammation More... •  Intellect Neurosciences, Inc. Adds Two New Patent Allowances to Its Global Patent Portfolio More... •  AcelRx Pharmaceuticals Receives Two Additional U.S. Patents for Small-Volume Oral Transmucosal Dosage Forms More... •  Genelex Corporation Receives First Patent on Business Methods for Pharmacogenetics More... More Patent News •  ULURU Inc. Announces First Shipment of Altrazeal® to Australia 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! Biomarkers in Late Stage Clinical Trials • Quantify and analyze revenues of late stage biomarker technology and services in North America, Europe, Asia and the Rest of the World. • Identify the key market drivers and resistors of the biomarker market and evaluate the growth potential of emerging technologies. • Assess biomarker activity at leading companies, including Abbott, AZ, BMS, Eli Lilly, GSK, Merck & Co, Novartis, Pfizer, Roche and Sanofi-Aventis. Click Here for More Information. 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: Lana Ho Editorial & Production Staff: Maysa Darwish, Tammy Liu ClinicaSpace.com - Clinical Trials. Clinical Research. 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