Daiichi Unit Warned By FDA Over Manufacturing
Yet another unit of Daiichi Sankyo has elicited the wrath of the FDA. The agency issued a warning letter to its Luitpold Pharmaceuticals subsidiary for “significant†and repeated violations at a Long Island, New York, manufacturing plant. The facility was inspected last winter and was shut down for a month in April to address the […]
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Merck Is On The Defensive Over Gardasil, Again
These are trying times for the Merck c-suite. For the past week, their Gardasil vaccine has been in the news every day, but not for very good reasons. First, Texas Governor Rick Perry is attacked by his rivals for the Republican presidential nomination for accepting Merck donations leading up to his controversial decision to unilaterally […]
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J&J Pays $85M Fine Over Natrecor Marketing
The Scios unit of Johnson & Johnson Scios has agreed to pay an $85 million fine and pleaded guilty to a msidemeanor for misbranding the Natrecor acute heart failure drug. The drugmaker was accused of providing labeling that “lacked adequate directions for use†between 2001 and 2005. The move comes two years after prosecutors began […]
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FDA advisers wary of time limit on bone drugs
U.S. health advisers declined to suggest how long women should take a class of drugs used by millions to prevent bone fractures, but agreed the labels should be changed to reflect uncertainty about the risks and benefits of long-term use. The Food and Drug Administration had asked two of its advisory panels to recommend whether […]
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FDA cites Medtronic drug pump’s severe flaw
Federal health officials said Monday that an implantable drug pump that Medtronic Inc. recalled this year had a potentially life-threatening design problem. The pump, called the SynchroMed II, delivers drugs directly into the spinal fluid to treat chronic pain and spasticity. The problem relates to the formation of a film within the pump’s battery that […]
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FDA Reorganizes Its Office Of Cancer Drugs
The controversial FDA Office of Oncology Drug Products is being reorganized and renamed, although Richard Pazdur (see photo) remains in charge. The move comes amid increasing pressure on the agency to speed reviews and, in particular, cope with concerns over the application of the accelerated approval process (see this). And so the oncology office is […]
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Pradaxa Causes A Side Effect Flap In New Zealand
Three months after New Zealand’s pharmaceutical management agency agreed to place the new Pradaxa bloodthinner on its formuarly, the Boehringer Ingelheim drug is being linked to two deaths and reports of dozens of elderly patients suffering bleeds. And some doctors say the Pharmac agency may have put lives at risk by funding Pradaxa before more […]
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Offshore Manufacturing Is More Dangerous: Study
Is making pharmaceuticals offshore more problematic than in the US? A new study suggests the answer is resoundingly ‘yes.’ Even drugs made in offshore plants run by US drugmakers pose a greater quality risk than those manufactured on the mainland, according to the study in the Journal of Operations Management. New Webinar Sept. 13! Avoid […]
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Genzyme Apologizes For Fabrazyme Screw Up
Early last month, Genzyme infuriated patients who take its Fabrazyme drug with the surprise news that unspecified quality control problems had disrupted supplies. This was disclosed just one week after letters were sent saying August meds, although in limited supply, would be available. Instead, Genzyme expressed uncertainty about when Fabrazyme would become available at all. […]
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Drunken Spending Orgy? What The Boardroom Looks Like At Harbin Pharma
There is considerable anger sometimes directed at ceo pay in the pharmaceutical industry. Last week, for instance, a Johnson & Johnson shareholder filed a lawsuit to demand that ceo Bill Weldon relinquish part of his salary for overseeing an embarrassing array of manufacturing problems, product recalls, illegal marketing and government probes. But how about drugmakers […]
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