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Biotechnology companies have expressed general support for FDA’s draft guidance defining whether products contain nanomaterials or otherwise involve the application of nanotechnology.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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J&J Mesh Approved by FDA Based on Recalled Device
Johnson & Johnson (JNJ), the world’s second-biggest health-care products maker, is battling lawsuits over a vaginal implant based on a similar device pulled from the market more than a decade ago for safety reasons. The complaints are the latest to implicate the approval process for medical devices at the U.S. Food and Drug Administration, which […]
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Penn faces lawsuit for patent fraud
The pursuit of effective cancer treatments is not only fraught with scientific complexities, but also legal complications. Biotech company Genentech is suing Penn for patent fraud on a cancer treatment that both entities believe to be theirs. At Penn, the treatment was tested on transgenic mice who were engineered to have cancer. When a patent […]
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Bayer, The FDA & Confidential Yaz Documents
As a widely anticipated FDA advisory committee meeting nears, one of the many plaintiffs in the sprawling litigation involving the Yaz and Yasmin contraceptive pills has asked a federal court for permission to provide confidential documents to the agency in the belief that these may help the panel conduct its forthcoming review of risks and […]
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