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Biotechnology companies have expressed general support for FDA’s draft guidance defining whether products contain nanomaterials or otherwise involve the application of nanotechnology.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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Rats On Antidepressants Showed Signs Of Autism
Yet another study suggests the possibility of a link between antidepressant use and autism. This time, rats given Celexa just before and after birth showed what researchers describe as substantial brain abnormalities and behaviors. Celexa is an SSRI, or serotonin selective reuptake inhibitor, a popular class of antidepressants that includes Prozac, Zoloft, Paxil and Lexapro. […]
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Congress Blasts FDA Over Heparin Scandal, Again
In their latest clash with the FDA over the four-year-old heparin scandal, several Republicans on the House Energy and Commerce Committee have blasted the agency for failing to pursue a pair of so-called workshops in China that allegedly sold tainted supplies that led to more than 80 deaths in the US back in 2007 and […]
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Occupy Novartis? Protesters Target Job Cuts
First, it was Occupy Wall Street. Then came, Occupy Pfizer. Now, we have Occupy Novartis. Thanks to an ongoing stream of job cuts by the Swiss drugmaker – including 2,000 announced earlier this week (see here) – a trade union and the youth faction of the Socialist Party are planning a demonstration outside the comfy […]
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