Former Synthes Execs Jailed For Fatal Clinical Trial
Three executives from Synthes, a device maker that was recently purchased by Johnson & Johnson, were sentenced yesterday to prison for their roles in an unapproved trial of a bone-cement drug that led to three patient deaths. A fourth exec will be sentenced later. All four pleaded guilty to one misdemeanor count of shipping an […]
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Bayer Keeps Confidential Documents Under Wraps
A federal judge has denied an effort by a plaintiff in the sprawling litigation involving the Yaz and Yasmin contraceptive pills to provide confidential documents to the FDA in advance of a December 8 advisory committee meeting. The panel will examine the risk of blood clots caused by birth control pills containing drospirenone, and the […]
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FDA Yanks Breast Cancer Indication For Avastin
After more than a year of controversy and anticipation, the FDA has decided to formally yank the breast cancer indication for Avastin after deciding the widely used medication is not safe and effective for that purpose. However, the drug – which is sold by Genentech – will remain on the market to treat cancers that […]
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Did FDA Make The Right Decision About Avastin?
Now that the FDA has formally withdrawn the breast cancer indication for Avastin, still more debate is likely to break out. As you may recall, the agency acted after a handful of trials demonstrated the med was not safe and effective for this use, reversing a decision that was made as part of the controversial […]
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Pfizer To Pay $60M To Settle Bribery Probe
The big drugmaker has reached an agreement in principle with the US Department of Justice and the US Securities and Exchange Commission to pay at least $60 million resolve a foreign bribery investigation, and a final deal could be struck by the end of the year, according to The Wall Street Journal. The disclosure comes […]
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Troubled Boehringer Unit Suspends Manufacturing
Five months after reluctantly acknowledging that quality-control problems had caused severe shortages of several medicines, Ben Venue Laboratories has disclosed plans to “voluntarily and temporarily†suspend production and distribution at its Bedford, Ohio, facility. “A recent internal review of documentation indicated that routine preventive maintenance and requalification of some manufacturing equipment did not occur at […]
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100 Years Ago – Bayer Once Promoted Heroin Use in Children
It’s not news that Bayer, the venerable German drug company, made its first fortunes in the late 1890s when it commercialized both aspirin and heroin as cough, cold and pain remedies. Many people have seen the sepia images of vintage Bayer’s “Heroin” brand medicine bottles. But it’s less widely known that Bayer promoted heroin for […]
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Sex-Pill Makers Jailed as China Plays ‘Whac-a-Mole’ With Phoney Producers
China jailed eight sex-pill makers and raided more than 1,400 drug dens this month as the government stepped up its fight to control an estimated $3 billion of fake drugs in the world’s fastest-growing pharmaceuticals market. China criminalized the manufacture of counterfeit medicines this year and raised maximum penalties to the death sentence to try […]
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Novartis Workers End Their Strike… For Now
Earlier today, about 1,000 Novartis workers in Switzerland held a brief strike to protest the planned closing of a plant in the town of Nyon, where about 320 people are employed. The move came after the drugmaker last month plans to eliminate another 2,000 jobs, including 1,100 in Switzerland, which is a blow to a […]
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Pfizer Strikes A Deal With Feds Over Foreign Bribes
The big drugmaker has reached an agreement in principle with the US Department of Justice and the US Securities and Exchange Commission to resolve a foreign bribery investigation, and a final deal could be struck by the end of the year, according to an SEC filing (see page 34). The disclosure comes three months after […]
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