Like Candy? Foster Kids Get More Antipsychotics
In the latest reason for concern about prescribing antipsychotics for children, a study finds that foster kids are being prescribed combinations of antipsychotics just as frequently as some of the most mentally disabled youngsters on Medicaid. And the findings underscore a growing trend to prescribe these meds, which are approved only for schizophrenia and bipolard […]
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Those Returns On R&D Are Falling Fast
It is no secret that every big drugmaker is struggling to transform research and development in the wake of the infamous patent cliff and accompany pipeline problems. But how have they been faring? A new report suggests what investors have largely known – not so well. Of a dozen big drugmakers analyzed, 10 showed a […]
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Gilead Is Paying How Much For Pharmasset?
For those keeping close watch on the Hepatitis C market or biotech stocks this morning, the $11 billion deal in which Gilead Sciences agreed to buy Pharmasset is now well known. But does it make sense? And if so, for which side of the table? Gilead shares, for instance, are down nearly 5 percent, although […]
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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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