safety
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Telormedix’s TMX-101 exhibits high safety in phase I/II for non-muscle invasive bladder cancer
Telormedix announced that it has successfully completed the safety portion of a Phase I/II trial for TMX-101.
safety | 04 May 2012
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Improving drug safety in China
Merck Millipore opened its Biopharmaceutical Technical and Training Center in Shanghai, China, in May this year. Pharma Asia speaks to Jean-Paul Mangeolle, Head of Merck Millipore’s Process Solutions business, about the signifi cance of the facility in the company’s overall strategy for the region.
safety | 01 July 2011
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FDA endorses efficacy but not safety of Novartis drug for gouty arthritis
An advisory committee of the Food and Drug Administration (FDA) has voted in favor of the overall efficacy but not the overall safety of ACZ885 (canakinumab) to treat gouty arthritis attacks in patients who cannot obtain adequate relief with non-ster…
safety | 22 June 2011
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New four year STELARA data show consistent safety profile
New findings showed that rates of adverse events remained consistent and stable over time in adults with moderate to severe plaque psoriasis receiving up to four years of treatment. Investigators also reported findings from an analysis of four placeb…
safety | 26 May 2011
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Kowa reports efficacy and safety of Rho kinase inhibitor
Kowa Company Ltd announced the results of two clinical studies and a non-clinical study of a drug candidate for glaucoma and ocular hypertension (K-115). The results were presented as three posters at The Association for Research in Vision and Ophtha…
safety | 11 May 2011
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Abbott's BVS demonstrates positive one-year safety and efficacy results
Abbott announced positive one-year results from 101 patients enrolled in the second phase of the ABSORB trial evaluating the drug eluting bioresorbable vascular scaffold (BVS) for the treatment of coronary artery disease. These results were presented…
safety | 04 April 2011
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XIENCE V shows safety and efficacy
Late-breaking data were presented from the investigator-initiated Compare trial of 1,800 real-world patients involving Abbott 's XIENCE V everolimus eluting coronary stent system and the TAXUS liberte paclitaxel-eluting coronary stent system. The…
safety | 14 October 2010
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The ticket to quality and safety
A rigorous metal detection system is crucial in ensuring that the highest standard of drug safety is met.
safety | 01 October 2010
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US FDA and NIH Launch Web-based Safety Reporting Portal
US FDA and the National Institutes of Health (NIH) launch the Safety Reporting Portal (SRP) web site allowing increased accessibility to submit reports concerning FDA regulated products. Product Manufacturers, Processors, Packers, Warehouses, Res…
safety | 09 June 2010
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ERT: Suicidality Monitoring in Clinical Trials
ERT has announced its Knowledge Series of educational papers. Each paper discusses issues that are relevant to patient safety in clinical trials today. The paper that is written by Michael Federico, investigates the increased risk of suicidal beh…
safety | 03 March 2010
