Prostate-specific antigen (PSA) screening may be complicated by aspirin and other pain relievers. So says Reuters. A recent study of 1,319 men suggests men taking painkillers had 10 percent lower PSA levels.
With eyes wide, the Wall Street Journal medical blog has discovered ... electronic data capture (EDC). Which is great, ten years or so into the development of the technology. Trouble is, one reader comment below the article suggests the industry has not won over every doubter. That WSJ reader says: “It is the most cumbersome program. Their servers are overloaded, the program often shuts off in the middle of entry or takes minutes to load the next page. In the time it takes to do one electronic page I could have done 4-5 paper ones.”
Ranbaxy, the Indian generic drug maker, has had good news of late but now faces a major inquiry. The company was recently acquired for $8.5 billion by a major Japanese pharma, Daiichi Sankyo, and won the right to sell a generic version of Lipitor. But Business Week says FDA officials raided the New Jersey offices of Ranbaxy in 2007. The allegation: selling fake or adulterated HIV medicine in Africa.
The journal Nature Review Drug Discovery (NRDD) has a subscription-only article on European guidance for hepatoxicity. The central issue: whether animal or in silico models for hepatoxicity are sufficiently robust to accurately predict what happens in humans. “At this time point, not all models mentioned in the draft guidance are accepted as fit for use to screen our compounds,” says Steven Spanhaak, chair of an ad-hoc safety working group and principal scientist in toxicology at a Belgium Johnson & Johnson facility.
This article on the Zacks website recommends contract research organizations as investments, specifically Kendle and ICON.
The National Institutes of Health (NIH) announced a new, $38 million research program to investigate chronic pelvic pain. “The launch of this novel research effort is an excellent example of NIH’s commitment to encouraging translational research,” said NIH director Elias Zerhouni. “It also illustrates NIH’s leadership in furthering innovative approaches to discovering effective new therapies to help our patients.”
The University of North Carolina at Chapel Hill set up a new Center for Drug Safety Sciences. The $10 million effort does not appear to have its own website yet. It will be lead by Paul Watkins and include a 14,000-square foot laboratory. Here’s an article and a release.
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