FDA

Tissue Genesis begins trials for PVD using ASCs

Wednesday, April 20, 2011 12:15 PM

Tissue Genesis, a company focused on adult stem cell and regenerative medicine, has begun clinical trials for peripheral vascular disease (PVD) with adipose-derived adult stem cell-coated vascular grafts at the University of Louisville hospital.  Tissue Genesis is the first to initiate a FDA-approved trial using the patient's own adipose-derived adult stem cells (ASCs) prepared at the point-of-care. 

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Anulex Techonologies will layoff workers

Wednesday, April 20, 2011 11:28 AM

Minnesota-based Anulex Techonologies will layoff workers after receiving a warning letter from the FDA in February, 2011, according to Fierce Medical Devices. 

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Durect reports Eladur phase II results in back pain

Wednesday, April 13, 2011 12:51 PM

Durect has released results from a phase II clinical trial in chronic low back pain for Eladur (Transdurr-Bupivacaine), Durect's investigational transdermal bupivacaine pain patch. This study was conducted by Durect's collaborator, King Pharmaceuticals, which is now owned by Pfizer. In this study of 263 patients suffering from chronic low back pain, the primary efficacy endpoint of demonstrating a positive treatment difference for the mean change in pain intensity scores from baseline to the mean of weeks 11 and 12 between Eladur as compared to placebo was not met.  Complete data analysis is ongoing.

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Durect reports Eladur phase II results in back pain

Tuesday, April 12, 2011 12:30 PM

Durect has released results from a phase II clinical trial in chronic low back pain for Eladur (Transdurr-Bupivacaine), Durect's investigational transdermal bupivacaine pain patch. This study was conducted by Durect's collaborator, King Pharmaceuticals, which is now owned by Pfizer. In this study of 263 patients suffering from chronic low back pain, the primary efficacy endpoint of demonstrating a positive treatment difference for the mean change in pain intensity scores from baseline to the mean of weeks 11 and 12 between Eladur as compared to placebo was not met.  Complete data analysis is ongoing.

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Government shutdown could force FDA to cut staff

Friday, April 8, 2011 11:16 AM

Officials working with the FDA warned that the looming government shutdown will severely restrict food and drug inspections, according to a CNN Money report.

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Salix expands partnership with Lupin

Friday, April 8, 2011 10:31 AM

Morrisville, North Carolina-based Salix Pharmaceuticals licensed a drug delivery technology from Mumbai, India-based Lupin Pharmaceuticals in 2009. Salix uses that technology in its gastrointestinal drug rifaximin, marketed as Xifaxan. Lupin recently granted Salix exclusive worldwide rights, outside India, to use that technology and any technology jointly developed by the companies for all rifaximin products for human use, according to MedCity News. 

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AstraZeneca's vandetanib approved for MTC

Thursday, April 7, 2011 11:35 AM

The FDA has approved AstraZeneca’s vandetanib, which is a kinase inhibitor and has no brand name yet, to treat adult patients with late-stage medullary thyroid cancer (MTC) who are ineligible for surgery and who have disease that is growing or causing symptoms. The once-daily oral treatment is the first agency-approved drug for MTC, which is estimated to represent 3%-5% of all thyroid cancer.

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Pharmas eagerly await FDA guidance on social media

Thursday, April 7, 2011 11:01 AM

As the FDA further delays its eagerly-awaited draft guidance on social media, U.S. drugmakers have pointed to the "incredible potential public health benefits" of using electronic media in health care, according to Pharma Times.

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Health Research Bus takes clinical trials on the road to boost recruitment, retention in U.K. cities

Monday, April 4, 2011 10:25 AM

With recruitment for clinical trials being tough and retention being even tougher, some are taking recruitment efforts and patient visits directly to the community, instead of waiting for volunteers to come to them.

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Novotech expands into Taiwan

Wednesday, March 30, 2011 12:08 PM

Novotech, an Australia-based Asia Pacific CRO, has opened a Taiwan office as part of its ongoing Asian expansion. 

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