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2009 NOV 23 ... development prior to initiating clinical trials. Aduro anticipates filing an investigationalnewdrug (IND) application with the FDA in fourth quarter of 2010 to begin Phase 1 ...
2009 NOV 16 ... with second-line PTCL. Completed patient enrollment in the Company's investigational Phase 2b, randomized, international, multi-center clinical trial comparing pralatrexate ... is the first and only drug approved by the FDA for this indication and represents a new treatment option for patients with relapsed or refractory PTCL. Announced ... agreement for FOLOTYN paid upon FDA acceptance and approval of the Company's New Drug Application, respectively, during the nine months ended September 30, 2009. The $5.8 million ...
2009 NOV 16 ... Following completion of preclinical studies, AllTranz expects to submit an InvestigationalNewDrug (IND) application and initiate a Phase I clinical trial to examine the safety ...
2009 NOV 16 ... have no additional requests for information, the Company expects within 30 days that the InvestigationalNewDrug (IND) application for its lead drug candidate will be released. Bio-Path ...
2009 NOV 16 ... laboratory-confirmed H1N1 patients and activating their cells with the LEAPS H1N1 investigational therapy in order to assess the cells' response as the basis for the planned future ... Oncology, Pandemics, Swine Flu, Swine Influenza, Therapy, Treatment, U.S. Food and Drug Administration, Vaccines, Virology, CEL-SCI Corporation. This article was ... autoimmune diseases and allergies, are potential therapeutic or preventive sites for the application of L.E.A.P.S. technology. Keywords: Biotechnology, Clinical Trial Research, ...
2009 NOV 23 ... to prevent and treat human disease, has announced that it has filed its first IND (investigationalnewdrug) application with the U.S. Food and Drug Administration (FDA). CEQ508, an ...
2009 NOV 23 ... Inc. announced that it has initiated a Phase 1b clinical study with CTP-518, its investigational oral HIV protease inhibitor for the treatment of HIV infection. In connection with the ... once-daily therapy without the side effects, inconvenience and expense of an additional drug." The initial Phase 1 clinical trial is designed to evaluate the safety, ... Concert Concert Pharmaceuticals is a clinical stage biotechnology company focused on the application of deuterium chemistry to create novel and differentiated small molecule drugs. ...
2009 NOV 16 ... Biologics License Application (BLA) for PROVENGE=AE (sipuleucel-T), the Company's lead investigational product, to the U.S. Food and Drug Administration (FDA). Dendreon is seeking licensure ... cancer (CRPC). If approved by the FDA, PROVENGE would represent the first product in the new therapeutic class known as active cellular immunotherapies. The amended BLA ...
2009 NOV 16 ... will be available following completion of the full 76-week study period. Belimumab is an investigationaldrug and the first in a new class of drugs called BLyS-specific inhibitors. Belimumab is ... 52 weeks, in accord with the study protocol, in support of a potential Biologics License Application in the United States and Marketing Authorization Applications in Europe and other ...
2009 NOV 28 ... to the successful completion of ongoing GLP studies, believe we are on track to file an investigational new drug application and initiate a Phase I clinical trial of INX-189 in the first half of 2010." Third ...
2009 NOV 16 ... Artificial Heart, announced it has submitted an application to the FDA to conduct an Investigational Device Exemption (IDE) clinical study of the Freedom™ discharge driver, designed ... FDA, Artificial Heart, Clinical Trial Research, FDA, Medical Device, U.S. Food and Drug Administration, SynCardia Systems Inc. This article was prepared by Biotech ...
2009 NOV 16 ... in chemotherapy-induced gastrointestinal mucositis or CIGIM and recently completed a pre-investigational new drug application (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) about the path ...
2009 NOV 16 ... MDVN) announced the initiation of CONTACT and CONSTELLATION, two Phase 3 trials of the investigationaldrug dimebon (latrepirdine)* in patients with moderate-to-severe Alzheimer's disease ... in partnership to advance the Phase 3 development program with the goal of submitting a new drug application to the FDA and bringing dimebon to market in the United States. In ...
2009 NOV 23 ... that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of Sol-Gel's Investigational New Drug Application (IND) for DER45-EV Gel for the topical treatment of rosacea. This IND allows Sol-Gel to ...
2009 NOV 23 ... SpinalMotion, developer of the investigational Kineflex® lumbar and Kineflex/C® cervical disc implants for treating patients ... Trial Research, Degenerative Disc Disease, FDA, Regulatory Actions, U.S. Food and Drug Administration, SpinalMotion. This article was prepared by Pain & Central ... plans to use the additional funds for completing its Kineflex/C cervical disc PMA application and developing its next-generation artificial discs. It total, the company has enrolled ...
2009 NOV 16 ... Tolera Therapeutics, Inc., announced it has filed an InvestigationalNewDrug (IND) application with the United States Food and Drug Administration (FDA) for ...
2009 NOV 16 ... and the University of Pennsylvania School of Medicine, announced the approval of an InvestigationalNewDrug (IND) application from the US Food and Drug Administration (FDA) and opening ...
2009 NOV 23 ... half of 2010. An oral form of palifosfamide has been developed preclinically to the investigational new drug application stage. Darinaparsin (ZinaparTM or ZIO-101) is a novel organic arsenic being ...
2009 NOV 23 ... half of 2010. An oral form of palifosfamide has been developed preclinically to the investigational new drug application stage. Darinaparsin (ZinaparTM or ZIO-101) is a novel organic arsenic being ...
