FDA Executives Knew About Plan to Spy on Scientists
Top U.S. Food and Drug Administration executives knew about the monitoring of scientists’ emails after they questioned FDA safety standards, The Wall Street Journal reported. And although they didn’t order the surveillance, the agency leaders did tacitly condone the secret actions taken against employees who sought to keep the public safe from defective medical devices. […]
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FDA Limits Use of Stryker Wingspan Brain Stent
The U.S. Food and Drug Administration said Wednesday it has limited the use of a Stryker Corp. (SYK) brain stent used to open narrowed arteries in some patients who have had repeated strokes. The company’s Wingspan Stent System was approved in 2005 to treat patients who have 50% or greater narrowing in arteries in the […]
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Novartis is staying put in UK – but selling 12 acres
One of Horsham’s most prestigious employers Novartis this week confirmed its commitment to remaining in the town but it is to sell a significant part of its town centre campus for redevelopment, the County Times can exclusively reveal. The land – more than 12 acres – is likely to be used to build homes and […]
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Bankrupt KV Pharma Goes After States for Money
Source At the same time that KV Pharmaceutical was preparing long-threatened bankruptcy papers, the besieged drugmaker also filed a pair of lawsuits against two state Medicaid programs for failing to cover their controversial Makena treatment for premature births. The lawsuits, which were filed against Georgia and South Carolina, followed a lawsuit filed last month against […]
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Bapi Fails – New Alzheimer Drug Disappoints in Trials
Source Two weeks after results of a closely watched Alzheimer’s failed to meet two primary endpoints, a related study has similarly disappointed. The topline results from a study in patients with mild-to-moderate Alzheimer’s disease who do not carry the ApoE4 genotype failed to meet the co-primary clinical endpoints – a change in cognitive and functional […]
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FDA Finds Chinese Handwipes Contaminated With Bacteria
Source File this under ‘sad irony.’ A Chinese maker of antiseptic wipes was actually distributing a large amount of product that was contaminated with… bacteria. That, essentially, defeats the purpose, as you can imagine. The problem surfaced during an FDA inspection last September at a Jiangsu Province Jianerkang Medical Dressing facility in China and prompted […]
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A Really Dumb Insider Trading Scheme by BMS Exec
“Stupid Pet Tricks†has always been a favorite David Letterman sketch. The criminal insider trading charges filed against a Bristol-Myers Squibb executive, Robert D. Ramnarine, may well qualify for “Stupid Insider Trading Tricks.†Federal prosecutors charged Mr. Ramnarine with three counts of securities fraud for trading in takeover targets of Bristol-Myers, and the Securities and […]
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Teva Subpoenaed Over Foreign Bribes
Yet another drugmaker has receive a subpoena in connection with a US government investigation into the possibility of foreign bribes. The latest is Teva Pharmaceuticals, which last month received a subpoena from the US Securities and Exchange Commission concerning unspecified activities in Latin America, according to a filing last week with the SEC (see page […]
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ISO Quality Control Director!
Source We normally confine ourselves to pharmaceutical matters on this site, but every so often, an interesting item of some other sort passes by and so we take notice. In this instance, the FDA issued a July 24 warning letter to United Nutrition Labs, which makes several dietary supplements, but had some difficulty, among many […]
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FDA Director Arrested for Soliciting Prostitution
Source Last month, Bill Maisel, the FDA deputy director for science at the Center of Devices and Radiological Health, was arrested for soliciting prostitutes. Specifically, he was charged with four counts of prostitution and one count of disorderly conduct, and is scheduled to go to trial in September, according to the case information. The arrest […]
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