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The drug, ATryn has already been approved in Europe. Up until now the drug has been created from blood from human donors. The drug is used to prevent blood clots and would be used during surgery given via an IV, and would not replace normal prescribed blood thinners taken as a normal treatment...
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Can’t get your LDL down, even with statins, one more drug to the rescue if needed, and can be taken with or without statin use and it should also raise the HDL, but there’s nothing related to prevent heart disease. BD The FDA approved the new drug application of a new formulation of fenofibric...
Posted to
The Medical Quack .... by Barbara Duck
by
The Medical Quack
on
01-06-2009
Filed under:
Filed under: Medically Related, Pharma/FDA News, drugs, healthcare, Pharma, FDA, Statins, Lipids, HDL, LDL, fenofibric acid
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This is the second approval this week for a generic version of Wellbutrin, earlier this week Watson Pharmaceuticals announced it’s new version. BD The Food and Drug Administration approved a generic copy of an antidepressant made by Impax Laboratories Inc. Regulators gave the drug — a copy of GlaxoSmithKline...
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I will once more mention a potential change of paradigms here with educating the public. Each patient who took the drug is unique. Do we have any information on other drugs they were taking at the same time? Groups will continue to advise against the use until the full facts are known...
Posted to
The Medical Quack .... by Barbara Duck
by
The Medical Quack
on
10-31-2008
Filed under:
Filed under: Medically Related, Pharma/FDA News, Other Items of Interest, drugs, healthcare, Pharma, PHR, FDA, Marketing, paradigms, personal heatlh records
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Reports of four experimental drugs held up at the FDA emerged in the first two days of this week. “ There’s almost certainly a bit of coincidence at work here, but it also seems to be one more sign of the tough safety climate at the agency these days .” Below are the 4 drugs. No doubt the...
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Whistle blowers today seem to be playing a role in the move towards transparency in more ways than one, not to mention the bounty that could be there if a case goes to court and wrongdoing is found to be the case. BD A New Jersey arbitrator ruled that a former Amgen sales rep can proceed with a...
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It seems not a week goes by without a warning being issued from the FDA, so this looks to be a sign of the times, not to put anyone out of business, but to create an awareness. This is transparency folks and the warnings will keep on coming, so get used to it. Who knows, perhaps the competition...
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The drug evaluation department has the largest increase, and oncologists were difficult to find as most make more money on the outside. I wonder if they can find enough for the drug side of the business, as it is changing every day with new applications and with more information to review, it's...
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Interesting article with some good background information about drugs that are close to or are related to the "street drugs" as we know them. There are definitely a number of researchers who want to delve into this further, but with bad raps and being illegal in their "street drug"...
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More marketing and potential hidden information seems to be making it's way to front, and interesting now on who wants to be reimbursed, insurance companies among the group. This appears to be an all out battle ground here. Weight gain and diabetes as side effects? Class action...
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I spent a little time looking around today and there are many "red stars" on this page, which indicate a safety alert from the FDA. Safety alerts come in all shapes and sizes and a red start does not mean to stop taking medications by any means, just an awareness to help both the clinicians...
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Many of the generic manufacturers started years back with knock off drugs to sell locally in India, but now the game is changing to where US Pharma is using some of the talent, which costs less than R and D individuals here in the states, to further develop existing work, in other words somewhat continue...
Posted to
The Medical Quack .... by Barbara Duck
by
The Medical Quack
on
09-05-2008
Filed under:
Filed under: Medically Related, Pharma/FDA News, Genomics, drugs, Pharma, Biotech, Cancer, FDA, Budgets, R and D, Alzheimers, Outsourcing
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Well back to the drawing board to gather up some additional data. We live in a world of data today, overloaded data for that matter, and decisions just are not as simple as they used to be. With all the additional side effects coming to light the FDA appears to be taking the same stance as...
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The patent is stated not to expire until 2010 and this will put a 30 hold at the FDA to grant approval. This one should prove interesting to follow and see where the infringement occurs. BD LONDON -(Dow Jones)- Sanofi-Aventis SA (SNY) has launched a legal action against Canadian generic drugmaker...