Medtronic, Inc. (NYSE: MDT), announced today that it has received 510(k) marketing clearance from the U.S. Food and Drug Administration for the Complete SE (self-expanding) Biliary Stent System, which is indicated for use in the palliative treatment of malignant neoplasms in the biliary tree – cancerous tumors in the bile duct that can compromise digestion by restricting the flow of digestive fluids.
U.S. commercial sales of the new biliary stent will begin immediately in a wide size range, with diameters of 4 – 10 mm and lengths of 20 – 150 mm.
Bench testing has shown the Complete SE Biliary Stent System to be extremely accurate in terms of stent placement. Accurate stent placement can decrease the likelihood that additional stents are necessary to cover the entire narrowing of the bile duct.
The safety and effectiveness of this device in the vascular system have not been established.
About Medtronic
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.
Thursday, November 15, 2007
Wednesday, November 14, 2007
Invitrogen and CytRx Subsidiary RXi Pharmaceuticals Collaborate to Enhance RNAi Technologies for Therapeutic Applications
Invitrogen Corporation (NASDAQ:IVGN), a provider of essential life science technologies for research, production and diagnostics, and CytRx Corporation's (NASDAQ:CYTR) majority-owned subsidiary RXi Pharmaceuticals Corporation (RXi) today announced that they have entered into an agreement whereby RXi will exclusively license second generation RNA interference (RNAi) technology from Invitrogen for designated target genes in all human therapeutic categories.
Invitrogen's patent applications that are part of this agreement cover Stealth™ and other proprietary technologies related to enhanced configurations of chemically modified double-stranded RNA. Terms of the agreement were not disclosed.
“Licensing this broad technology from Invitrogen is part of our strategy to continually enhance our proprietary rxRNA™ compounds for therapeutic applications,” said Dr. Tod Woolf, President and Chief Executive Officer of RXi.
“Currently Invitrogen Stealth™ RNAi synthetic duplexes are widely used for RNAi research across both in vitro and in vivo applications due to their specificity, efficacy and stability,“ said Amy Butler, Invitrogen vice president of gene expression profiling.“We see the use of our Stealth™ RNAi technology in therapeutics as a natural next step in Invitrogen's efforts to be at the cutting edge of in vivo gene regulation.“
About Invitrogen
Invitrogen Corporation provides products and services that support academic and government research institutions and pharmaceutical and biotech companies worldwide in their efforts to improve the human condition. The company provides essential life science technologies for disease research, drug discovery, and commercial bioproduction. Invitrogen's own research and development efforts are focused on breakthrough innovation in all major areas of biological discovery including functional genomics, proteomics, bioinformatics and cell biology -- placing Invitrogen's products in nearly every major laboratory in the world. Founded in 1987, Invitrogen is headquartered in Carlsbad, California, and conducts business in more than 70 countries around the world. The company is celebrating 20 years of accelerating scientific discovery. Invitrogen globally employs approximately 4,700 scientists and other professionals and had revenues of approximately $1.15 billion in 2006. For more information, visit www.invitrogen.com.
About CytRx Corporation
CytRx Corporation is a biopharmaceutical research and development company engaged in the development of high-value human therapeutics. The Company owns three clinical-stage compounds based on its small molecule "molecular chaperone" co-induction technology. In September 2006, CytRx announced that arimoclomol was shown to be safe and well tolerated at all three doses tested in its Phase IIa clinical trial in patients with ALS. The Company plans to enter a Phase IIb clinical trial with arimoclomol in ALS in 2007, subject to U.S. Food and Drug Administration (FDA) clearance. The FDA has granted Fast Track designation and Orphan Drug status to arimoclomol for the treatment of ALS, which has also been granted orphan medicinal product status for the treatment of ALS by the European Commission. The Company has announced plans to commence a Phase II clinical trial for arimoclomol in stroke recovery in the first half of 2008, subject to FDA clearance. The Company has also announced plans to commence a Phase II clinical trial with its next drug candidate, iroxanadine, for diabetic foot ulcers in the first half of 2008, subject to FDA clearance. CytRx has recently opened a research and development facility in San Diego. For more information on the Company, visit www.cytrx.com.
About RXi Pharmaceuticals Corporation
RXi a discovery-stage biopharmaceutical company pursuing the development and commercialization of proprietary therapeutics based on RNA interference (RNAi) for the treatment of human diseases. RXi's initial focus is on the treatment of neurological diseases, metabolic diseases and cancer. RXi has secured exclusive and non-exclusive licenses under certain issued and pending patents and patent applications covering therapeutic targets, chemistry and configurations of RNAi and delivery of RNAi within the body. The Company was founded by RNAi pioneers Craig Mello, Ph.D., 2006 Nobel Laureate for co-discovering RNAi and co-inventing RNAi therapeutics; Tariq M. Rana, Ph.D., inventor of fundamental technology for stabilizing RNAi and of RNAi nanotransporters; Greg Hannon, Ph.D., discoverer of short hairpin RNAi (shRNA); and Michael Czech, Ph.D., a leader in the application of RNAi to diabetes and obesity. RXi's CEO, Tod Woolf, Ph.D., previously co-invented and commercialized STEALTH™ RNAi, one of the most widely used second-generation RNAi research products. The Company currently operates as a privately held subsidiary of CytRx Corporation (NASDAQ: CYTR) and is located in Worcester, MA.
Invitrogen's patent applications that are part of this agreement cover Stealth™ and other proprietary technologies related to enhanced configurations of chemically modified double-stranded RNA. Terms of the agreement were not disclosed.
“Licensing this broad technology from Invitrogen is part of our strategy to continually enhance our proprietary rxRNA™ compounds for therapeutic applications,” said Dr. Tod Woolf, President and Chief Executive Officer of RXi.
“Currently Invitrogen Stealth™ RNAi synthetic duplexes are widely used for RNAi research across both in vitro and in vivo applications due to their specificity, efficacy and stability,“ said Amy Butler, Invitrogen vice president of gene expression profiling.“We see the use of our Stealth™ RNAi technology in therapeutics as a natural next step in Invitrogen's efforts to be at the cutting edge of in vivo gene regulation.“
About Invitrogen
Invitrogen Corporation provides products and services that support academic and government research institutions and pharmaceutical and biotech companies worldwide in their efforts to improve the human condition. The company provides essential life science technologies for disease research, drug discovery, and commercial bioproduction. Invitrogen's own research and development efforts are focused on breakthrough innovation in all major areas of biological discovery including functional genomics, proteomics, bioinformatics and cell biology -- placing Invitrogen's products in nearly every major laboratory in the world. Founded in 1987, Invitrogen is headquartered in Carlsbad, California, and conducts business in more than 70 countries around the world. The company is celebrating 20 years of accelerating scientific discovery. Invitrogen globally employs approximately 4,700 scientists and other professionals and had revenues of approximately $1.15 billion in 2006. For more information, visit www.invitrogen.com.
About CytRx Corporation
CytRx Corporation is a biopharmaceutical research and development company engaged in the development of high-value human therapeutics. The Company owns three clinical-stage compounds based on its small molecule "molecular chaperone" co-induction technology. In September 2006, CytRx announced that arimoclomol was shown to be safe and well tolerated at all three doses tested in its Phase IIa clinical trial in patients with ALS. The Company plans to enter a Phase IIb clinical trial with arimoclomol in ALS in 2007, subject to U.S. Food and Drug Administration (FDA) clearance. The FDA has granted Fast Track designation and Orphan Drug status to arimoclomol for the treatment of ALS, which has also been granted orphan medicinal product status for the treatment of ALS by the European Commission. The Company has announced plans to commence a Phase II clinical trial for arimoclomol in stroke recovery in the first half of 2008, subject to FDA clearance. The Company has also announced plans to commence a Phase II clinical trial with its next drug candidate, iroxanadine, for diabetic foot ulcers in the first half of 2008, subject to FDA clearance. CytRx has recently opened a research and development facility in San Diego. For more information on the Company, visit www.cytrx.com.
About RXi Pharmaceuticals Corporation
RXi a discovery-stage biopharmaceutical company pursuing the development and commercialization of proprietary therapeutics based on RNA interference (RNAi) for the treatment of human diseases. RXi's initial focus is on the treatment of neurological diseases, metabolic diseases and cancer. RXi has secured exclusive and non-exclusive licenses under certain issued and pending patents and patent applications covering therapeutic targets, chemistry and configurations of RNAi and delivery of RNAi within the body. The Company was founded by RNAi pioneers Craig Mello, Ph.D., 2006 Nobel Laureate for co-discovering RNAi and co-inventing RNAi therapeutics; Tariq M. Rana, Ph.D., inventor of fundamental technology for stabilizing RNAi and of RNAi nanotransporters; Greg Hannon, Ph.D., discoverer of short hairpin RNAi (shRNA); and Michael Czech, Ph.D., a leader in the application of RNAi to diabetes and obesity. RXi's CEO, Tod Woolf, Ph.D., previously co-invented and commercialized STEALTH™ RNAi, one of the most widely used second-generation RNAi research products. The Company currently operates as a privately held subsidiary of CytRx Corporation (NASDAQ: CYTR) and is located in Worcester, MA.
Monday, November 12, 2007
New Phase III Trial Results for Rivaroxaban to be Presented at the 49th Annual Meeting of the American Society of Hematology
Findings from three phase III clinical trials of rivaroxaban will be presented in the plenary session and during oral presentations at the American Society of Hematology (ASH) Annual Meeting in Atlanta, Georgia, from December 8 to 11, 2007. Rivaroxaban is being jointly developed by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. and Bayer HealthCare, AG.
The studies evaluated rivaroxaban in head-to-head comparison with enoxaparin, the current standard of care, for the prevention of venous thromboembolism (VTE) in patients undergoing major orthopaedic surgery. The presentations will highlight results from the recently-completed RECORD1 (Regulation of Coagulation in major Orthopaedic surgery reducing the Risk of DVT and PE) and RECORD2 studies in total hip replacement surgery as well as additional data from the RECORD3 trial, which evaluated rivaroxaban in total knee replacement surgery. Copies of the following abstracts can be viewed online at the ASH website: www.hematology.org/meetings/abstracts.cfm.
Oral Rivaroxaban Compared with Subcutaneous Enoxaparin for Extended Thromboprophylaxis after Total Hip Arthroplasty: The RECORD1 Trial Abstract# 6. Plenary presentation: Sunday, Dec. 9, 3:10 p.m., Hall A1, Georgia World Congress Center
Extended Thromboprophylaxis with Rivaroxaban Compared with Short-Term Thromboprophylaxis with Enoxaparin After Total Hip Arthroplasty: The RECORD2 Trial
Abstract# 307. Oral presentation: Monday, Dec. 10, 11:00 a.m., Rooms B312-B313a
Rivaroxaban – an Oral, Direct Factor Xa Inhibitor – for Thromboprophylaxis After Total Knee Arthroplasty: The RECORD3 Trial
Abstract# 308. Oral presentation: Monday, Dec. 10, 11:15 a.m., Rooms B312-B313a
Four additional abstracts will be presented as poster presentations on Saturday, December 8 and Sunday, December 9, 2007.
Johnson & Johnson Pharmaceutical Research and Development
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), is part of Johnson & Johnson, the world's most broadly based producer of healthcare products. J&JPRD is headquartered in Raritan, NJ, and has facilities throughout Europe and the United States. J&JPRD is leveraging drug discovery and drug development in a variety of therapeutic areas to address unmet medical needs worldwide.
The studies evaluated rivaroxaban in head-to-head comparison with enoxaparin, the current standard of care, for the prevention of venous thromboembolism (VTE) in patients undergoing major orthopaedic surgery. The presentations will highlight results from the recently-completed RECORD1 (Regulation of Coagulation in major Orthopaedic surgery reducing the Risk of DVT and PE) and RECORD2 studies in total hip replacement surgery as well as additional data from the RECORD3 trial, which evaluated rivaroxaban in total knee replacement surgery. Copies of the following abstracts can be viewed online at the ASH website: www.hematology.org/meetings/abstracts.cfm.
Oral Rivaroxaban Compared with Subcutaneous Enoxaparin for Extended Thromboprophylaxis after Total Hip Arthroplasty: The RECORD1 Trial Abstract# 6. Plenary presentation: Sunday, Dec. 9, 3:10 p.m., Hall A1, Georgia World Congress Center
Extended Thromboprophylaxis with Rivaroxaban Compared with Short-Term Thromboprophylaxis with Enoxaparin After Total Hip Arthroplasty: The RECORD2 Trial
Abstract# 307. Oral presentation: Monday, Dec. 10, 11:00 a.m., Rooms B312-B313a
Rivaroxaban – an Oral, Direct Factor Xa Inhibitor – for Thromboprophylaxis After Total Knee Arthroplasty: The RECORD3 Trial
Abstract# 308. Oral presentation: Monday, Dec. 10, 11:15 a.m., Rooms B312-B313a
Four additional abstracts will be presented as poster presentations on Saturday, December 8 and Sunday, December 9, 2007.
Johnson & Johnson Pharmaceutical Research and Development
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), is part of Johnson & Johnson, the world's most broadly based producer of healthcare products. J&JPRD is headquartered in Raritan, NJ, and has facilities throughout Europe and the United States. J&JPRD is leveraging drug discovery and drug development in a variety of therapeutic areas to address unmet medical needs worldwide.
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