J&J Recalls Keep On Coming, And So Does A Lawsuit
How is this for irony? On the same day that a federal judge allows a lawsuit to proceed over charges that Johnson & Johnson misled investors about quality control-failures at manufacturing plants that led to massive recalls, the healthcare giant announces that retailers are being asked to return 12 million bottles of Motrin because the […]
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FDA Declares An Exhibit Booth False & Misleading
Generally, drugmakers that run afoul of the FDA for violating regulations about marketing will be scolded for their advertisements or handouts to doctors. But how about an entire exhibit booth at a medical convention? This is what happened to NeurogesX, which last June was promoting its Qutenza treament for neuropathic pain associated with postherpetic neuralgia. […]
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From Hot To Cold: A Female Sex Drug Goes Limp
Yet another effort to bolster the female libido has failed. This time, BioSante Pharmaceuticals reports that its LibiGel form of testosterone failed two studies. Compared with placebo, women treated with LibiGel did not have more frequent sexual encounters or experience them more often, and they did not have a significantly greater increase in sexual desire. […]
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A Lost Decade? Sharer To Retire As Amgen CEO
After a tumultuous decade running one of the biggest biotechs in the land, Kevin Sharer will retire as ceo in May and leave his post as chairman at the end of next year. He will be replaced by Robert Bradway, 48, who is currently president and chief operating officer. The move comes earlier than some […]
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How The FDA Could Mitigate Drug Shortages
The ongoing crisis of prescription drug shortages – notably, generic injectables that are used to treat various cancers – remains a vexing problem. But to gain insight into what the FDA could do to address the issue, the US Government Accountability Office reports that a couple of key steps should be taken in order to […]
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Sloan-Kettering CEO And ‘Unscrupulous’ Behavior
Is the ceo and president of Memorial Sloan-Kettering Cancer Center, which is one of the most prominent cancer institutions in the world, actually an unscrupulous doctor who surreptitiously made off with valuable research that belongs to a University of Pennsylvania cancer institute and helped form a drugmaker in order to cash in on the work? […]
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FDA says billboards and advertisements promoting Lap-Band downplay risks
Federal health officials have issued warning letters to eight surgical centers and a marketing firm in California for misleading advertisements promoting the Lap-Band, a stomach-restricting device used to treat obesity. The Food and Drug Administration said Tuesday that advertisements by the centers and a marketing firm, 1-800-GET-THIN, do not provide mandatory information about the risks […]
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Novartis Probes Death Tied To New MS Pill
One year after Novartis won FDA approval for a new type of drug to treat relapsing forms of multiple sclerosis and delay the progression of physical disabilities, the drugmaker is now investigating a death tied to its pill, which is called Gilenya. The disclosure, which was made by a Wall Street analyst, has the potential […]
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SEC Charges Glaxo Unit & Former CEO With Fraud
You never know what can happen after you buy a company. But the US Securities and Exchange Commission has charged Stiefel Laboratories, which GlaxoSmithKline bought two years ago, with using low valuations for stock buybacks between November 2006 and April 2009, according to a complaint filed today in federal court. Employees allegedly lost more than […]
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Medtronic Pays $23.5M To Settle Kickback Charges
In the latest instance in which a medical products company has bellied up to the bar to resolve kickback charges, Medtronic has agreed to pay $23.5 million to settle whistleblower claims that doctors were paid off through post-marketing studies and device registries to implant pacemakers and defibrillators. The kickbacks led to fraudulent Medicare and Medicaid […]
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