Glaxo To Pay $3B To Settle Marketing Probes
In the largest settlement of its kind involving a drugmaker, GlaxoSmithKline has agreed to pay $3 billion to resolve a trio of US investigations into its sales, marketing and pricing practices dating back more than a decade. The deal, which is expected to be finalized, some time next year, would settle both civil and criminal […]
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The FDA Approved How Many New Drugs?
Why not take an opportunity to crow when the numbers are going your way? That is what the FDA is doing today with a new report that trumpets that 35 new medicines were approved over the past 12 months, which is nearly the highest number of approvals in the past decade. The only year in […]
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Former Pfizer Rep Won’t Return $411K Severance
Nearly two years ago, Janet Rodriguez was told by Pfizer that her services as a sales rep – a position she held since 1993 – were no longer needed. And so the ensuing paperwork for termination indicated that she was entitled to receive a lump sum payment of $105,851.75. But instead, Pfizer mistakenly sent a […]
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J&J Faces A Boycott Over Baby Shampoo Chemicals
Two years after several advocacy groups complained about the use of two potentially harmful chemicals in Johnson & Johnson’s Baby Shampoo, the healthcare giant continues to sell the venerable product in the US with traces of those ingredients, but does not do so in several other countries. And the ongoing discrepancy threatens to give J&J […]
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Genzyme Charged With Double Standard, Again
Throughout the controversial shortage of Genzyme medicines, the biotech has upset Fabry disease patients with rationing of its Fabryzyme med in the US. The official reason given has been there simply is not enough to go around, although patients in Europe were offered full dosages, fueling perception of an inexplicable double standard (back story). Genzyme, […]
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And The World’s Largest Drug Maker Will Be…
Pretty soon, it will no longer be Pfizer. Instead, Sanofi is expected to become the No. 1 drugmaker next year and stay on top until at least 2016, by which time Pfizer will slide to third place, behind Novartis, according to the latest calculation by EvaluatePharma. The fall from grace is, of course, largely attributed […]
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FDA Evaluating Input from Industry on Nanotech Guidance
Biotechnology companies have expressed general support for FDA’s draft guidance defining whether products contain nanomaterials or otherwise involve the application of nanotechnology. But the sector also made its case for less red tape and more leeway, raising issue with some specifics and asking for clarity on other topics. Questions and suggestions were sent to FDA […]
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Jazz Pharmaceuticals shares fall after FDA warning
Shares of Jazz Pharmaceuticals Inc. fell Tuesday after the Food and Drug Administration released a warning letter issued to the company over violations at a California plant. Company shares ended down $2.68, or 6.2 percent, to $40.34. The FDA warning letter, dated Oct 11, cites the company for failing to report 74 reports of serious […]
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FDA approves high-tech screening device to help spot early-stage skin cancer
Dermatologists will soon get some high-tech help deciding which suspicious-looking moles should be removed and checked for melanoma, the deadliest form of skin cancer. The Food and Drug Administration on Wednesday approved a first-of-its-kind device, called MelaFind, that makes detailed, digital images of skin growths and uses a computer to analyze them for signs of […]
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FDA tightens standards to prove generics can be swapped
Generic-drug makers such as Mylan Inc. will have to meet tighter standards to prove their blood- thinners and anti-seizure treatments work as well brand-name products, U.S. regulators said. The Food and Drug Administration, responding to complaints that some copies don’t work as well as the originals, is writing guidelines for limits companies must follow that […]
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