How Many Adverse Events Are On The Internet?
There is no debate that the Internet holds many potential riches for drugmakers seeking insights into patients. Consumers always have something to say about effectiveness and marketing. Yet many pharma folks dread combing through blogs, Facebook, forums and Twitter feeds, among other things, because they live in fear of having to file adverse event reports […]
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Bayer, J&J’s Xarelto Wins Key FDA Nod, With Warning
Bayer and Johnson & Johnson ($JNJ) snagged the crucial stroke-prevention indication for their new clot-fighter Xarelto. The FDA approval isn’t without its caveats, however. FDA may have granted the new use despite objections from staffers, who had questioned the usefulness of a key study, but the agency didn’t give Xarelto a snag-free label. J&J, which […]
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The Number Of Drug Recalls Is Rising How Fast?
During the third quarter of this year, the number of pharmaceutical recalls jumped to 150, compared with about 90 recalls during each of the first two quarters of 2011, according to FDA Enforcement Reports. Moreover, the recent tally dwarfs the roughly 65 recalls that were made during the last quarter of 2010 and nearly doubled […]
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U.S. court allows class action suit against Amgen
A U.S. appeals panel upheld the certification of a securities class action accusing biotech company Amgen of failing to disclose safety information about two products used to treat anemia. Amgen allegedly exaggerated the safety of its products for Food and Drug Administration-approved uses, according to court documents. The plaintiff, a state pension fund, also alleged […]
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AstraZeneca Is Indicted By Serbia Over Bribes
Last August, AstraZeneca received a criminal indictment in Belgrade, Serbia, over allegations that local employees offered alleged bribes to physicians at the Institute of Oncology and Radiology, according to a filing made yesterday with the US Securities and Exchange Commission (see this). The indictment, however, had actually been previously disclosed when AstraZeneca reported earnings late […]
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Teva To Axe 1,500 Jobs, Mostly From Cephalon
Now that its $6.8 billion purchase of Cephalon has been completed, Teva Pharmaceuticals is planning to eliminate about 1,500 jobs, mostly from the ranks of the biotech, according to Yediot Aharanot. Such a move is hardly surprising, since acquisitions generally result in layoffs and Teva had already signaled that some $500 million in savings was […]
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Chinese Drug Exec Gets Suspended Death Sentence
While the pharma c-suite ponders stepped up regulatory interest in corruption, consider the penalty for bad behavior in China. A Shanghai court just sentenced the former ceo of Shanghai Pharmaceutical, a state-owned drugmaker, to a suspended death sentence for corrupt activities in which he amassed more than $8 million, the Associated Press reports. Wu Jianwen […]
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FDA Should Warn Smokers of Increased Danger of Chantix, Study Says
Scientists say the U.S. Food and Drug Administration (FDA) should take warnings about the stop-smoking drug Chantix up a notch, citing data showing that the drug increases suicidal behavior and depression far more than other drugs and methods designed to help smokers quit. Chantix, also called varenicline, has been hotly debated since 2007, when experts […]
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How to Create a Pharma Website That Will Get You a Warning Letter
Given the increased scrutiny the FDA is applying toward websites devoted to individual prescription drugs, it may behoove the people who design these sites to include some basic info. Such as? Well, there are always tidbits about safety and efficacy. A helpful rule of thumb, for instance, is to ensure safety info is not minimized […]
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Lilly Wins First Trial Over Zyprexa Marketing
A California state court jury ruled late last week that Eli Lilly was not responsible for the death of a 20-year-old college student, who died from illnessess related to diabetes while taking the Zyprexa antipsychotic for mental illness. The family of Cody Tadai, who died in 2007, filed a lawsuit alleging the drugmaker hid the […]
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