INDUSTRY NEWS Celgene/Abraxis Receive Verbal Confirmation of Early Termination of Hart-Scott-Rodino (HSR) 30-Day Waiting Period Celgene Corporation announced that it has received verbal confirmation of early termination of the Hart-Scott-Rodino Act 30-day waiting period without the United States Federal Trade Commission requesting additional information with regard to Celgene’s pending acquisition of Abraxis Bioscience, Inc. [Celgene Corporation Press Release] GlaxoSmithKline and Amplimmune Form Global Strategic Collaboration Amplimmune, Inc. announced that it has entered into a broad strategic alliance with GlaxoSmithKline (GSK) to further develop PD-1 targeting therapies that may be effective in the treatment of cancer and other diseases. GSK will obtain exclusive worldwide rights to AMP-224 as well as other potential next generation fusion proteins that target PD-1. [Amplimmune, Inc. Press Release] Living Cell Technologies Receives Approval to Expand DIABECELL® New Zealand Trial Living Cell Technologies Limited reported that the Minister of Health has approved an addition to the New Zealand Phase II clinical trial of DIABECELL® to include more patients. [Living Cell Technologies Limited Press Release] Mixtard 30 — Going, Going, Gone? The drug company Novo Nordisk announced that its only conventional human biphasic insulin, human Mixtard 30, would no longer be available in the UK from January 2011, a decision that affects an estimated 90,000 patients. [Drug and Therapeutics Bulletin] Panel Recommends Defining Select Agents by DNA Sequence The way to bring synthetically designed genomes that could be potentially as deadly as known pathogens under regulation, according to a new National Academies report, is to develop a new system of defining select agents based on DNA sequences. [ScienceInsider] Free Access to U.S. Research Papers Could Yield $1 Billion in Benefits A new economic analysis finds that making taxpayer-funded scientific papers freely available would yield more than $1 billion in benefits to the U.S. economy over 30 years–five times the costs of archiving the papers. [ScienceInsider]
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POLICY NEWS Scientists Decry Proposed Ban on Chimp Research In the latest twist in the protracted debate over the use of chimpanzees in biomedical research, U.S. senators introduced the Great Ape Protection Act, an identical bill to one that has been stuck in a House of Representatives committee for more than a year. [Senate, United States] Senate Bill Would Encourage Drugs Targeting Rare Kids’ Diseases A group of bipartisan senators introduced legislation to entice drug makers to focus more intently on cures for uncommon children’s diseases. [Senate, United States] FDA Issues Assessments of the 510(k) Program and Use of Science in Decision-Making The U.S. Food and Drug Administration issued two comprehensive evaluations containing recommendations that address three key objectives of the agency’s public health mission as it relates to medical devices — foster device innovation, create a more predictable regulatory environment, and enhance device safety. [Food and Drug Administration, United States] Solicitation for Nominations: New Clinical Preventive Health for the United States Preventive Services Task Force (2010-19117) [Agency for Healthcare Research and Quality, United States] National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting (2010-19210) [National Institute of Diabetes and Digestive and Kidney Diseases, United States] Coordinating and Bioinformatics Unit for the Mouse Metabolic Phenotyping Centers and the Diabetic Complications Consortium (U24) (RFA-DK-10-007) [National Institute of Diabetes and Digestive and Kidney Diseases, United States] NIH Common Fund Transformative Research Projects Program (R01) (RFA-RM-10-010) [National Institutes of Health, United States] Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01) [Docket No. FDA-2010-N-0394] [Food and Drug Administration, United States] Comprehensive List of Guidance Documents at the Food and Drug Administration [Docket No. FDA-1998-N-0050] (formerly Docket No. 1998N-0046) [Food and Drug Administration, United States] Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting [Docket No. FDA-2010-N-0001] [Food and Drug Administration, United States] 2010 Biological License Application Supplement Noteworthy Approvals [Center for Biologics Evaluation and Research, United States]
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EVENTS (Listed by Date) 2010 World Cancer Congress August 18-21, 2010 Shenzhen, China Select Biosciences Inaugural Cellular Therapy Summit August 24-25, 2010 Edinburgh, Scotland Select Biosciences 3rd Annual Stem Cells Europe Conference August 24-25, 2010 Edinburgh, Scotland Select Biosciences 2nd Annual World Biobanking Summit August 24-25, 2010 Edinburgh, Scotland The European Molecular Biology Organization (EMBO) Meeting – Advancing the Life Sciences September 4-7, 2010 Barcelona, Spain The Association of Upper Gastrointestinal Surgeons of Great Britain and Ireland (AUGIS) 2010 Scientific Meeting September 9-10, 2010 Oxford, United Kingdom Stem Cells USA & Regenerative Medicine Congress 2010 September 13-15, 2010 Philadelphia, United States Annual Human Proteome Organization (HUPO) World Congress September 19-23, 2010 Sydney, Australia Institute of Medicine – University of Illinois at Chicago Midwest Conference on Diabetes and Obesity September 21, 2010 Chicago, United States 35th European Society for Medical Oncology (ESMO) Congress October 8-12, 2010 Milan, Italy Fraunhofer Life Science Symposium 2010 October 29-30, 2010 Leipzig, Germany 2010 American Pancreatic Association (APA) Annual Meeting November 3-6, 2010 Chicago, United States Select Biosciences International Forum on Stem Cells November 12-13, 2010 Tianjin, China Type 2 Diabetes, Insulin Resistance and Metabolic Dysfunction January 12-17, 2011 Dillon, United States Epithelial Plasticity and Epithelial to Mesenchymal Transition January 21-26, 2011 Vancouver, Canada Select Biosciences 5th Annual Stem Cells and Regenerative Medicine World Congress January 24-25, 2011 San Diego, United States Phacilitate 7th Annual Cell & Gene Therapy Forum 2011 January 24-26, 2011 Washington, DC, 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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