INDUSTRY NEWS CSL Behring Receives FDA Approval to Extend Shelf Life of Hizentra® from 18 Months to 24 Months CSL Behring announced that the U.S. Food and Drug Administration has approved a supplemental Biologics License Application to extend the shelf life of Hizentra®, Immune Globulin Subcutaneous (Human), 20% Liquid, from 18 months to 24 months. [CSL Behring Press Release] Stem Cell Agency Commits $243 Million, Expands Team Approach to Developing New Therapies The Governing Board of the California Institute for Regenerative Medicine, the state stem cell agency created by proposition 71, approved the concept for up to $243 million round of funding to move stem cell-based therapies to clinical trial. [California Institute for Regenerative Medicine Press Release] Taligen Granted Patent for Lead Product Candidate, TT30, and Other Compounds Targeting the Complement System Taligen Therapeutics announced that the U.S. Patent and Trademark Office has issued U.S. Patent No. 7,759,304, entitled “Targeting Complement Factor H For Treatment of Diseases”, covering the composition of matter for its lead product candidate, TT30, a novel fusion protein that selectively binds to complement activated cells to locally regulate the complement system, as well as other complement receptor 2-Factor H (CR2-FH) fusion compounds. [Businesswire]
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POLICY NEWS NIH Launches Effort to Define Markers of Human Immune Responses to Infection and Vaccination A new nationwide research initiative has been launched to define changes in the human immune system, using human and not animal studies, in response to infection or to vaccination. [National Institutes of Health, United States] Lawrence A. Tabak Named Principal Deputy Director NIH National Institutes of Health Director Francis S. Collins, M.D., Ph.D., announced the appointment of Lawrence A. Tabak, D.D.S., Ph.D., as principal deputy director of the National Institutes of Health. [National Institutes of Health, United States] GlaxoSmithKline and Human Genome Sciences Announce FDA Priority Review Designation for Benlysta® (Belimumab) as a Potential Treatment for Systemic Lupus Erythematosus GlaxoSmithKline PLC and Human Genome Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted a priority review designation to Benlysta® (belimumab) as a potential treatment for systemic lupus erythematosus. [Food and Drug Administration, United States] Exceptional, Unconventional Research Enabling Knowledge Acceleration (EUREKA) (R01) (RFA-GM-11-003) [National Institutes of Health, United States] Proposed Collection; Comment Request; STAR METRICS–Science and Technology in America’s Reinvestment: Measuring the Effects of Research on Innovation, Competitiveness and Science (FR Doc. 2010-20614) [National Institutes of Health, United States] Center for Scientific Review; Notice of Closed Meeting (FR Doc. 2010-20287) [National Institutes of Health, United States] Office of the Director, National Institutes of Health; Notice of Meeting (FR Doc. 2010-20675) [National Institutes of Health, United States] NIH-RAID Updates on Program Scope and Procedures: Biologics Manufacture, Lead Selection, and Product Development Plans (NOT-RM-10-012) [National Institutes of Health, United States] Support of National Institute of General Medical Sciences Program Project Grants (P01) (PAR-10-266) [National Institutes of Health, United States] Complete List of Currently Approved NDA and ANDA Application Submissions (PDF – 62KB) [Food and Drug Administration, United States]
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EVENTS (Listed by Date) Select Biosciences 7th Annual RNAi & miRNA Europe September 14-15, 2010 Dublin, Ireland Immunology & Microbiology, Genetics & Genomics, Development, Other September 18-22, 2010 Barcelona, Spain Cell Symposia: Inflammation and Disease September 26-28, 2010 Lisbon, Portugal 11th International Symposium on Dendritic Cells in Fundamental and Clinical Immunology – DC2010: Forum on Vaccine Science September 26-30, 2010 Lugano, Switzerland 5th International Conference on Gene Regulation in Lymphocyte Development October 9-14, 2010 Chania, Greece Autumn Immunology Conference 2010 November 19-22, 2010 Chicago, United States Cell Symposia: Influenza – Translating Basic Insights December 2-4, 2010 Washington, D.C., United States Visit our events page to stay up to date with the latest events in the cell, gene and immunotherapy community.
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