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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And the Winner for Worst Biotech CEO Is….
If you guessed that Mitch Gold, who heads Dendreon, you would be right. He won this sad distinction in the annual reader poll conducted by The Street, where he nabbed 37 percent of the 1,800 votes for stunning investors – and just about everybody else – by scrapping his sales forecast for the year after […]
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The FDA Targets Novartis Manufacturing Plants
If you happen to run a big drugmaker, you know the FDA has its eye on you when a warning letter cites a host of problems at three manufacturing facilities and you are instructed to schedule a meeting within five days to discuss plans to rectify your myriad transgressions. In other words, the heat is […]
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