Food and Drug Administration regulators turned down a request from Johnson & Johnson to expand the approved uses for Risperdal, a treatment for bipolar disorder. J&J received a not approvable letter from the FDA to use Risperdal in Alzheimer’s-related psychoses. This is after last weeks announcement that the FDA rejected J&J’s application to market Risperdal […]
Barr Pharmaceuticals Inc. announced that it dropped its lawsuit against the Food and Drug Administration (FDA) over exclusive marketing rights to a generic version of the Allegra allergy drug made by France’s Sanofi-Aventis. In February, Barr sued the FDA to challenge its decision to make the company share a 6-month exclusive selling period. The company […]
I am glad right now that the only thing I am suffering from is a common head cold, thanks to my two toddlers wanting to “share.” If I had arthritis like my grandmother did, I would really be starting to worry. It seems that even after the talk of using “black box warnings” from this […]
Just when you thought it was safe to say “FDA”, and things seemed to be calming down ever so slightly with the uproar over COX-2 inhibitors and scrutiny over the FDA approval processes, the issue of suspect drugs plaguing the pharmaceutical industry has now spread to the biotech sector, with one of its best performing […]
Ten members of the Food and Drug Administration advisory panel who voted that a group of COX-2 inhibitors should continue to be sold had ties to the drug makers, a new analysis shows. A study by the Center for Science in the Public Interest indicates that 10 of the 32 panel members had ties to […]
As if the waters at the FDA needed further muddying, a special panel of the US Food and Drug Administration voted last Thursday to allow Pfizer’s pain killer Celebrex to remain on the market, despite a finding that it can cause heart problems in some patients. The panelists voted 31-1 to keep Pfizer’s Celebrex on […]
Well, somehow I managed to miss the next round of American Idol this past Wednesday night and found myself watching 60 Minutes Wednesday night edition, with their interview of Dr. David Graham. Dr. Graham is a senior scientist within the FDA’s Office of Drug Safety and now a whistleblower at the FDA. Graham blames the […]
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Editor-in-Chief Barista Stephen Jenei is a patent attorney and Owner of Jenei LLC. When not serving up patent chat over a steaming cup of java, he's handling a diverse intellectual property practice in the biotechnology, pharmaceutical and chemical fields. More info @ Jenei LLC
