How Does The FDA Now Justify Rejecting Plan B?
File this under ‘no swapsies allowed.’ Last week, US Department of Health & Human Secretary Kathleen Sebelius took the unprecedented step of overruling the FDA and thwarted a move to ease access to the Plan B pill, which is also known as the morning after pill. The move quickly generated debate that the White House […]
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Pharma Closed How Many US Plants This Year?
If you guessed that 38 plants are being closed by drugmakers and biotechs this year, you would be right. Given the extent to which the pharmaceutical industry is downsizing, this most likely would not come as a surprise. But while that certainly is a large number, there were 65 facilities closed in 2010, according to […]
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FDA finds serious problems in cancer drug factory
The latest FDA inspection report details lax quality control, failure to follow standard procedures in the Ben Venue Laboratories Inc. facility Federal inspectors say the contract manufacturer for Johnson & Johnson’s cancer drug Doxil hasn’t been maintaining equipment or promptly investigating defective product batches and other serious problems at its Bedford, Ohio, factory. The latest […]
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For Boehringer, A Pot Of Gold Is Now A Can Of Urine
Until a spate of serious manufacturing issues cropped up, Boehringer Ingelheim seemed to be pleased with its Ben Venue Laboratories unit, which had been making a variety of different drugs for other companies. But after the FDA and European Medicines Agency repeatedly found violations, Ben Venue last month “voluntarily and temporarily†suspended operations at its […]
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Former Shionogi Worker Is Sentenced For Hacking
Last year, Jason Cornish resigned from his information tech job at Shionogi offices in Georgia after a dispute with a senior manager. However, he was subsequently retained as a consultant, but later resigned and then a co-worker and friend was laid off. And so this past February, Cornish hacked into the Shionogi network and wiped […]
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J&J Contract Manufacturer Ben Venue Slammed by FDA For Manufacturing Problems
Federal inspectors say the contract manufacturer for Johnson & Johnson’s cancer drug Doxil hasn’t been maintaining equipment or promptly investigating defective product batches and other serious problems at its Bedford, Ohio, factory. The latest Food and Drug Administration inspection report details lax quality control, failure to follow standard procedures and even lack of follow-up about […]
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Nutley’s Roche demolishes La Monte buildings
A symbol of Nutley’s industry has come down. The buildings were owned by Roche, part of its Nutley-Clifton campus, which decided they were no longer necessary. “As a research and early development site, we are continuing to assess our facilities and have determined that several buildings are no longer needed, based on the scope of […]
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State Council approves plan to vouchsafe drug safety
The State Council approved a blueprint on Wednesday to establish a credit rating system and intensify monitoring of pharmaceutical groups to boost the country’s drug safety over the next five years. “Our country’s pharmaceutical companies are experiencing various problems such as the lack of an integrated credit system, inadequate supervision and a weak technical foundation. […]
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Alexza Inhaled Antipsychotic May Pose Fatal Lung Risks, FDA Review Finds
Alexza Pharmaceuticals Inc. (ALXA)’s inhaled antipsychotic drug may put some patients at risk for respiratory failure, according to U.S. regulators considering whether to approve the treatment for sale. While Adasuve is effective as a fast-acting treatment for agitation among patients with schizophrenia and bipolar disorder, it can cause bronchial spasms that may be fatal in […]
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Was HHS Correct To Overrule The FDA On Plan B?
In an unprecedented move, the US Human & Health Secretary Kathleen Sebelius yesterday overruled the FDA and thwarted a move to ease access to the Plan B pill, which is also known as the morning after pill. The contraceptive is available only to women age 17 and older without a prescription, but behind counters. The […]
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