FDA

Perceptive’s survey shows increasing interest in adaptive trial designs

Monday, April 25, 2011 12:55 PM

Perceptive Informatics, an eClinical solutions provider and a subsidiary of the Boston-based company Parexel, has results of a global survey conducted during its recent webinar entitled "Implementing Bayesian Response Adaptive Trials." The webinar was attended by over 300 professionals from the biopharmaceutical industry across a broad range of clinical, statistical and regulatory functions. Perceptive polled these professionals about their plans for the implementation of adaptive clinical trial designs.

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China: a quick and cost-efficient direction for drug development

Monday, April 25, 2011 12:12 PM

U.S. companies seeking to conduct clinical trials of new drugs and medical devices, Dr. R. Stephen Porter of Tennessee says China provides a lower-cost setting in which jobs can be accomplished more quickly, according to The Tennessean.

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Streamlining IRB approval process yields dramatic results in turnaround time for University of Maryland

Monday, April 25, 2011 08:02 AM

Last March it took 35 days for a full Institutional Review Board (IRB) approval for a clinical trial from the University of Maryland’s School of Medicine, which reviews more than 1,000 applications annually. This March, IRB approval time dropped to 21 days, and just 13 days in February.

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New data show number of principal investigators dropping 11% globally, and 20% in U.S.

Monday, April 25, 2011 08:02 AM

The number of principal investigators (P.I.s) filing 1572s worldwide has declined sharply, according to new data from the Tufts Center for the Study of Drug Development (CSDD).

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Biotechs say FDA regulations impede job creation

Friday, April 22, 2011 12:13 PM

Drug and medical device companies are having a hard time creating jobs and delivering innovative new therapies to patients because of tight government regulations, limits in science and research funding and high taxes reported biotech industry leaders at a recent congressional hearing in San Diego, according to The San Diego Union-Tribune.

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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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