INDUSTRY NEWS Cryo-Cell Announces Célle(SM) Research and Development Collaboration with Department of Medicine, Monash University Cryo-Cell International, Inc. announced a research and development collaboration agreement with Monash University in Australia. [Cryo-Cell International, Inc. Press Release] Cryo-Cell International to Explore Strategic Acquisition Opportunities Cryo-Cell International, Inc. announced that it has engaged Morgan Joseph LLC to evaluate strategic acquisition opportunities available to enhance value for Cryo-Cell’s shareholders. [Cryo-Cell International, Inc. Press Release] International Society for Cellular Therapy (ISCT) Joins Forces with Roche and Genzyme to Launch Cell Therapy Industry Partnership Many companies in the cell therapy regenerative medicine market including Roche, Genzyme, Athersys, Miltenyi Biotec, Hospira, Lonza and Life Technologies will join ISCT to launch a series of new initiatives that will create greater strategic alignment within the industry and drive late stage clinical development. [International Society for Cellular Therapy Press Release] ASH Recommends Cross-Disciplinary Engagement to Advance Regenerative Medicine The American Society of Hematology (ASH) has developed specific recommendations to the scientific community and federal agencies to help propel collaborative research in regenerative medicine in order to make real strides in improving patient care. These recommendations were released in Blood. [American Society of Hematology Press Release] Proteonomix, Inc. Announces Joint Venture in the United Arab Emirates Proteonomix, Inc. announced that it has executed a joint venture agreement with a group of investors that will create a new stem cell treatment and research facility in the United Arab Emirates. [Proteonomix, Inc. Press Release] Emerging Healthcare Solutions Inks Option for Breakthrough Stem Cell Technology Emerging Healthcare Solutions, Inc. announced that the Company has signed an option with Regenevita, owner of the right to license Neo Natal Progenitor Cell Expansion Technology in Latin America. [Business Wire] NSF Awards $3 Million Stem Cell Bio-Manufacturing Program to Georgia Tech The National Science Foundation (NSF) has awarded $3 million to the Georgia Institute of Technology to fund a unique research program on stem cell bio-manufacturing. [Georgia Institute of Technology Press Release] Mesoblast on Track for Phase III Bone Marrow Transplant Trial Following Positive Meeting with FDA Australian regenerative medicine company, Mesoblast Limited provided market guidance on its Phase III bone marrow transplant program following a formal meeting with the United States Food and Drug Administration (FDA). [Mesoblast Limited Press Release] Genmab Announces Top-Line Interim Results for Ofatumumab in Diffuse Large B-Cell Lymphoma Genmab A/S announced top-line interim results from an initial Phase II single arm open label study of ofatumumab to evaluate the treatment of relapsed Diffuse Large B-Cell Lymphoma in patients ineligible for or relapsed following a stem cell transplant. [Genmab A/S Press Release] Sanofi Seeks Efficiencies with New Model Sanofi-aventis is dividing its vast resources into decentralized disease-based units, each with its own departments for research and development, regulatory affairs, marketing, and sales — a plan designed to identify promising drugs more quickly and weed out failures before spending billions on unsuccessful clinical trials. [The Boston Globe]
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POLICY NEWS Enhancing Research in Regenerative Medicine The American Society of Hematology (ASH) convened a working group of experts from the fields of hematopoietic stem cell biology, embryonic stem cells, transplantation biology, and gene therapy at the urging of the Committee on Government Affairs with the goal of developing a “white paper” to inform recommendations to ASH and appropriate parties at the National Institutes of Health about the need for additional research in the area of regenerative medicine. [Blood] EMA and U.S. FDA Seek Potential Candidate Companies for Joint GMP Inspection Program The European Medicines Agency (EMA) and the Food and Drug Administration of the United States of America (U.S. FDA) continue to seek potential candidate companies for a joint GMP inspection pilot programmed for manufacturers of medicinal products. [European Medicines Agency, European Union] Exceptional, Unconventional Research Enabling Knowledge Acceleration (EUREKA) (R01) (RFA-GM-11-003) [National Institutes of Health, United States] National Heart, Lung, and Blood Institute; Notice of Closed Meetings (FR Doc. 2010-20291) [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] Clarification of Eligible Institutions for PAR-10-221 (R01) and PAR-10-222 (R21): Biophysical and Biomechanical Aspects of Embryonic Development (NOT-HD-10-020) [National Institutes of Health, United States] Proposed Collection; Comment Request; NIH NCI Central Institutional Review Board (CIRB) Initiative (NCI) (FR Doc. 2010-20167) [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. 2010-20021) [National Institutes of Health, United States] National Human Genome Research Institute; Notice of Closed Meeting (FR Doc. 2010-19939) [National Institutes of Health, United States] Basic Research on Self-Regulation (R21) (RFA-AG-11-010) [National Institutes of Health, United States] National Center for Research Resources; Notice of Meeting (FR Doc. 2010-20014) [National Institutes of Health, United States] Limited Pilot for National Institute of General Medical Sciences Legacy Community-Wide Scientific Resources (R24) (PAR-10-261) [National Institute of General Medical Sciences, United States] 7342.007 Addendum – Imported Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) [Center for Biologics Evaluation and Research, 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]
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EVENTS (Listed by Date) Select Biosciences 3rd Annual Stem Cells Europe Conference August 24-25, 2010 Edinburgh, Scotland Select Biosciences World Biobanking Summit August 24-25, 2010 Edinburgh, Scotland Select Biosciences Inaugural Cellular Therapy Summit August 24-25, 2010 Edinburgh, Scotland International Society for Cellular Therapy – Europe 2nd Regional Meeting September 11-14, 2010 Belgirate, Italy Stem Cells USA & Regenerative Medicine Congress 2010 September 13-15, 2010 Philadelphia, United States Tissue Engineering & Regenerative Medicine International Society (TERMIS) – Asia Pacific 2010 September 15-17, 2010 Sydney, Australia International Society for Hematology and Stem Cells (ISEH) 2010 Meeting September 15-18, 2010 Melbourne, Australia Cellular Therapy of Cancer Symposium – ATTACK Project Meeting September 24-27, 2010 Montpellier, France International Society for Cell and Gene Therapy of Cancer (ISCGT) Congress September 27-29, 2010 Doha, Qatar 5th Annual Meeting of the German Society for Stem Cell Research September 30-October 2, 2010 Lübeck, Germany AABB (formerly known as the American Association of Blood Banks) Annual Meeting & Cellular Therapy and Transfusion Medicine Expo (CTTXPO) 2010 October 9-12, 2010 Baltimore, United States Institute for Genomic Medicine Inaugural Symposium October 11-12, 2010 San Diego, United States 5th Annual Translational Stem Cell Research Conference October 12-13, 2010 New York City, United States Fraunhofer Life Science Symposium Leipzig 2010 October 29-30, 2010 Leipzig, Germany NEW BioMalaysia 2010 Conference and Exhibition November 2-4, 2010 Kuala Lumpur, Malaysia World Cord Blood Congress November 4-7, 2010 Marseille, France Cambridge Healthtech Institute’s Inaugural Stem Cells in Drug Discovery and Development November 8-9, 2010 San Diego, United States Select Biosciences 2nd International Forum on Stem Cells (2010 IFSC) November 12-13, 2010 Tianjin, China The 16th International Conference of the International Society of Differentiation: From Stem Cells to Organisms November 15-18, 2010 Nara, Japan Stem Cell Network’s 10th Annual Scientific Meeting November, 22-24, 2010 Calgary, Alberta 52nd American Society of Hematology (ASH) Annual Meeting and Exposition December 4-7, 2010 Orlando, United States Select Biosciences 5th Annual Stem Cells World Congress January 24-25, 2011 San Diego, 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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