News
World Health Organization Grants Prequalification to Prevenar 13*, Pfizer's 13-valent Pneumococcal Conjugate Vaccine for Infants and Young Children
August 23, 2010 1:36 pm | by Bio-Medicine.Org | CommentsNEW YORK, Aug. 23 /- The World Health Organization (WHO) has granted prequalification to Prevenar 13* (Pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed])for active immunization of infants and children from 6 weeks through five years of age against invasive disease,...
Alexion's R.I. site approved as second drug manufacturing site
August 23, 2010 1:35 pm | by Mass High Tech: The Journal of New England Technology | CommentsThe U.S. Food and Drug Administration has approved Alexion Pharmaceuticals Inc.'s Smithfield, R.I.-based manufacturing facility as a second source of commercial supply its drug Soliris, a treatment for paroxysmal nocturnal hemoglobinuria.
PRA International to Exhibit at ESC's Annual Conference
August 23, 2010 1:35 pm | by Bio-Medicine.Org | CommentsRALEIGH, N.C., Aug. 23 /PRNewswire/ -- PRA International, a leading Clinical Research Organization, will exhibit our cardiology expertise and experience at the European Society of Cardiology's (ESC) annual conference in Stockholm, Sweden from 28 August to 1 September 2010. At PRA booth...
Quest Diagnostics' Care360â„¢ EHR Module Receives Preliminary ARRA IFR Stage 1 Certification
August 23, 2010 1:35 pm | by Bio-Medicine.Org | CommentsMADISON, N.J., Aug. 23 /- Quest Diagnostics (NYSE: DGX ), the world's leading provider of diagnostic testing, information and services, today announced that its Care360™ Electronic Health Record (EHR), Version 2010.1, has been inspected by the Certification Commission for Health...
Q & A with Nobel laureate Lee Hartwell
August 23, 2010 1:34 pm | by Arizona State University | CommentsLee Hartwell, chief scientist at the ASU Biodesign Institute's Center for Sustainable Health, discusses his recent retirement and new role as director emeritus. read more
Medical device group spent $380,000 on 2Q lobbying
August 23, 2010 12:45 pm | by The Associated Press | CommentsThe medical device industry's chief advocacy group spent nearly $380,000 lobbying the federal government in the second quarter of 2010, according to a recent disclosure form.AdvaMed, or the Advanced Medical Technology Association, lobbied on efforts in Congress to make it easier for patients to...
Harvard Bioscience buys lab tool maker Coulbourn
August 23, 2010 10:45 am | by The Associated Press | CommentsMedical instruments maker Harvard Bioscience Inc. said Monday it has acquired Coulbourn Instruments, a private company that makes lab equipment for assessing learning and memory.Harvard Bioscience did not disclose financial details of the acquisition.It estimates the total market for the...
Alnylam data supports 'silencing' of gene linked to Parkinson's
August 23, 2010 8:31 am | by Mass High Tech: The Journal of New England Technology | CommentsAlnylam Pharmaceuticals Inc. is releasing early data that shows its RNAi therapeutic technology may be able to "silence" a gene associated with Parkinson's disease. It has already happened in a pre-clinical trial, testing the technology on a group of non-human primates.
Extera Partners hires life sciences vet Bernitz
August 23, 2010 8:31 am | by Mass High Tech: The Journal of New England Technology | CommentsSteve Bernitz has taken the role of general partner at Cambridge-based Extera Partners, a life sciences-focused firm specializing in partnerships, acquisitions and new product commercialization.
Public Workshop - Medical Device User Fee Program Public Meeting, September 14, 2010
August 23, 2010 7:37 am | by U.S. Food & Drug Administration | CommentsThe FDA is is announcing a public meeting on the reauthorization of the medical device user fee program. The current legislative authority for the medical device user fee program expires in September 2012 and new legislation will be required for FDA...
Biomerica gets European OK for dog allergy test
August 23, 2010 6:45 am | by The Associated Press | CommentsBiomerica Inc. said Monday it has received European regulatory approval to sell a home test that consumers can use to determine if they are allergic to dogs.The biomedical company will sell the product through drug stores and other retailers in the European Union under the Fortel Dog allergy...
Covalon Technology third-quarter loss tightens as operating expenses fall
August 23, 2010 5:45 am | by The Associated Press | CommentsCovalon Technologies Ltd. (TSXV:COV) says its third-quarter loss was cut in half, as the medical technology developer reduced costs by 40 per cent compared with the same period last year.Covalon's net loss was $647,223 in the three months ended June 30, down from $1.2 million in the...
Federal Register: Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice; Public Workshop
August 23, 2010 5:32 am | by U.S. Food & Drug Administration | CommentsThe public workshop on FDA's clinical trial requirements is designed to aid the clinical research professional's understanding of the mission, responsibilities, and authority of FDA and to facilitate interaction with FDA representatives. The program will
Federal Register: Public Workshop on Medical Devices and Nanotechnology: Manufacturing, Characterization, and Biocompatibility Considerations
August 23, 2010 5:32 am | by U.S. Food & Drug Administration | CommentsThe purpose of this workshop is to obtain information on manufacturing, characterization, and biocompatibility evaluation of medical devices containing or utilizing nanomaterials and nanostructures, including diagnostics. FDA is seeking input on these...
Taligen boosts Series B round by $10M
August 23, 2010 5:32 am | by Mass High Tech: The Journal of New England Technology | CommentsCambridge biotech Taligen Therapeutics Inc. has added on to its Series B Round with an additional $10 million, bringing the amount up to $36 million of a planned $65 million second round.
