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Archive for the ‘Pharma’ Category

Well, all sugar is not bad for you. Apparently, when given to you in pill form by someone wearing a white coat with a pleasant demeanour, it can cure all kinds of ills.
It’s not that the old meds are getting weaker, drug developers say. It's as if the placebo effect is somehow getting stronger.The [...]

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Thinking about implanting an RFID microchip under your skin? Don’t do it! Why would the FDA approve something that was linked to cancers in rats?
Chip Implants Linked to Animal Tumors – washingtonpost.com:
When the U.S. Food and Drug Administration approved implanting microchips in humans, the manufacturer said it would save lives, letting doctors scan [...]

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Would have been my headline. Apparently, the New York Times byline writer was more concerned about a multi billion dollar company losing a small amount of money than the fact that a different ruling in this case would have made life saving drugs unaffordable for millions of people. When did American newspapers become shills for [...]

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I mentioned in May that Brazil had introduced compulsory licensing on a Merck AIDs drug Efavirenz, and heartily recommended that Brazil and other third world countries continue to play hardball with big pharma whenever they could. It looks like Merck decided to not bargain, but Abbott did on Kaletra. Note that Abbott got into [...]

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The FDA issues rules that will finally make dietary supplement manufacturers conform to some rules in the manufacturing of the products.
Which ones?

Accurate potency and labeling – 30 mg glucosamine will now contain something close to 30mg
Impurities Testing – All the raw materials will now be tested for impurities/contaminants. They will probably follow USP guidelines. [...]

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Bloomberg.com: Worldwide
Sanofi-Aventis SA’s weight-loss pill may raise the risk of suicide and suicidal thoughts, U.S. regulators said in documents that may help an expert panel decide whether the three-time delayed drug should be approved.
The FDA noted two suicides in clinical trials of volunteers testing the drug. The panel will be asked to discuss whether [...]

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The New York Times has an article on the FDA’s competing needs of safety and speed in drug approval.
Potentially Incompatible Goals at F.D.A. – New York Times
Safety and speed are the yin and yang of drug regulation. Patients want immediate access to breakthrough medicines but also want to believe the drugs are safe.
These goals [...]

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Brazil is positioning itself as a major manufacturer of generics, and offering to build this factory is a very good move because it will provide AIDs treatment options for Mozambique at affordable prices (well, better prices than the pharma giants would provide, at any rate). Is there expertise available in Mozambique to staff this [...]

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China Sentences Former Drug Regulator to Death – New York Times
The former head of China’s top food and drug safety agency was sentenced to death today after pleading guilty to corruption and accepting bribes, according to the state-controlled news media.
That’s barbaric, we may have our problems with the FDA, but kill someone for taking a [...]

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if you have not been following the Avandia story, an article published in the New England Journal of Medicine revealed that Avandia, a popular drug used in diabetes control significantly increased the threat of heart attacks and heart failure. A couple of things to note here, firstly, this fact was known to the FDA in [...]

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