FDA Releases St. Jude Warning Letter
The FDA on Tuesday released the full text of a warning letter sent last week to St. Jude Medical. The company had previously disclosed the existence of the letter in an SEC filing but did not make clear the full extent of the FDA warning. The letter from the FDA is the latest in a series of setbacks and challenges […]
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Pharma Corporate Reputation Takes a Dive
Source Anyone who pays attention to the pharmaceutical industry is probably aware that corporate reputation has been stuck in the ‘damaged goods’ file. Chalk that up to years of controversy over safety, pricing and transparency. And the problem persists – in a big way, according to a new survey of patient groups around the world […]
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Pfizer’s Possible Unit Shuffle Triggers Breakup Concern
Pfizer Inc. (PFE)’s four business units may be combined into two, a top company official said, triggering speculation by analysts that the world’s biggest drugmaker is preparing to split in half. Pfizer’s units cover oncology, primary care, specialty drugs, and so-called established products, which are medicines that have lost patent protection and are sold against […]
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Roche and Astrazeneca Shake Up R&D Operations
Source The meager pipelines and R&D setbacks plaguing the pharmaceutical industry have prompted two of the largest drugmakers to shake up their operations today. Roche hired John Reed (pictured left), who heads the Sanford-Burnham Medical Research Institute in California, to take over as head of its Pharma Research and Early Development unit, replacing Mike Burgess. […]
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Plenty of Spin and Bias in Cancer Drug Clinical Trials
source File this under ‘sweep it under the rug.’ It may be human nature to downplay unwanted or negative developments, but it is not considered to be good science. Nonetheless, some investigators have masked disappointing clinical trial results, such as missing primary endpoints and reporting toxicity, with selective and biased reporting for breast cancer treatments, […]
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Difficulties With Clinical Trial Enrollment
Source There is good news and bad news about enrolling patients in clincal trials. First, the good news – 89 percent of all trials meet their enrollment goals. Now, the bad news – 48 percent of the trial sites miss enrollment targets and study timelines often slip, causing extensions that are nearly double the original […]
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FDA Issues Orders Drugmakers To Decrease Sleeping Pill Dosages
source The FDA is requiring drugmakers that sell sleeping pills that contain the zolpidem active ingredient – a list that includes Ambien – to lower current recommended doses by half. Why? New data show that zolpidem blood levels in some patients may be high enough the morning after usage to impair activities that require alertness. […]
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Monkeys No Longer Flying the Friendly Skies
source After more than a year of pressure from animal-rights activists, United Airlines has agreed to halt shipments of primates to or from medical research laboratories anywhere in the world. The decision means there are no longer any North American carriers that will transport primates for research purposes into the US or Canada. In fact, […]
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HHS Accused of Lax Trial Oversight
Source In a strongly worded missive, a consumer watchdog group is accusing the US Department of Health & Human Services of “dangerously lax oversight†of a clinical trial that is being sponsored by the National Institutes of Health, because children are being exposed to risks and these are not properly disclosed to their parents or […]
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Gilead Sciences No Longer Using Chimps for Research
Source After pressure from The Humane Society of the United States, Gilead Sciences has agreed to end the use of chimpanzees in research. The move comes after the animal-rights organization two months ago submitted a shareholder proposal urging the biotech to phase out the use of the primates in its medical research (back story). At […]
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