Cephalon Warning Letter – June 28, 2011
SILVER SPRING, Md., Jun 28 2011—The FDA has posted on its website a letter sent to Cephalon regarding its website for Trisenox reviewing a number of problems. The letter is below. Franklin Vairinhos, Ph.D. Director, Regulatory Affairs Cephalon, Inc. 41 Moores Road Frazer, PA 19355 USA Dear Dr. Vairinhos: The Division of Drug Marketing, Advertising, […]
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R&D Spending In India Is Projected To Mushroom
Last year, the pharmaceutical industry spent about $2 billion on assorted R&D activities in India, but that figure is expected to reach a whopping $25 billion by 2025. The reasons are varied, but can be traced to expanding activities by Indian companies, additional government investment and a growing pool of qualified researchers, according to a […]
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Spinal Tap: Medtronic Studies Are Repudiated
In a highly unusual move, a medical journal has devoted an entire issue to dissecting a mushrooming controversy over Infuse, a genetically engineered protein that is made by Medtronic and has been widely used in spinal surgeries. But the Spine Journal reviewed 13 studies previously published elsewhere and discovered that side effects were downplayed or […]
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France Decides Sanofi’s Multaq Is ‘Insufficient’
Once again, Sanofi is facing trouble with Multaq. The latest difficulty comes from French regulators that have reevaluated the effectiveness of the drug, which is used to treat atrial fibrillation, after two patients developed severe liver damage. The move comes just nine months after Multaq, which The High Authority for Health determined that Multaq is […]
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FDA To Cephalon: How Not To Build A Website
With concerns about social media front and center, drugmakers can clearly use some guidance when it comes to creating a product web site. Then again, a degree of common sense should already be in place, yes? Cephalon, however, committed a few avoidable blunders with a web site for Trisenox, which was approved to treat acute […]
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Doing Deals With Biotechs Fails To Yield Results?
Here are some sobering numbers, especially for those wandering the halls of the annual BIO gathering that gets under way today in Washington, DC. The pharmaceutical industry spent an estimated $68 million less on drug R&D in 2010, a 3 percent drop from spending during the previous two years, according to data compiled by CMR […]
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Supreme Court Strikes Down Data Mining Law
In a 6-to-3 ruling, the US Supreme Court has struck down a highly controversial Vermont law that restricts the sale of prescription drug info identifying prescribers and patients for commercial marketing purposes. The practice is known in the pharma world as data mining and has been growing for the past two decades, ever since data […]
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GSK Pays $41 Million To States For Manufacturing Fraud
As an outgrowth of manufacturing fraud to which GlaxoSmithKline pled guilty last year, the drugmaker has now agreed to pay $40.8 million to 37 US states and the District of Columbia. This comes on top of a $750 million payment to settle criminal and civil charges related to numerous production problems – contaminated meds, mislabeled […]
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CSL Warning Letter Summary
Flu vaccine maker CSL has been cited by the FDA for GMP failures spanning a lack of follow-through on raw material test failures to half-hearted investigations into adverse reactions suffered by hundreds of Australian children after they received the Fluvax shot last year. Twenty-three of those children landed in the hospital with seizures and fever. […]
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FDA stands by silicone breast implants
Five years after allowing silicone breast implants back on the market, the Food and Drug Administration said further studies showed the decision was sound. The FDA was criticized by consumer groups in 2006 for approving the implants after a 14-year hiatus because of widespread fear that they caused a range of illnesses. During that period, […]
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