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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
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