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December 4, 2006

Is the FDA Approving More Drugs?

by @ 2:26 pm.  Filed under FDA, Drug Development

A recent UPI report focused on the number of FDA approvals.

United Press International - Health Business - Analysis: FDA approving more drugs:

The report states that September and October were strong and there have been 83 approvals putting it in line with 2004 results. However, this may be temporary and not a long term trend. I think the lack of a lead and the possibility of even more legislation regarding drug safety will likely slow down the process.

I personally think the low-lying fruit has been picked over throughly and now there needs to be more validation of potential drug targets in order to facilitate research and allow for more potential drugs to be developed. Until more valid targets are discovered, I think the rate of drug development will continue to be sluggish.

Email Ed Vawter



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    Another biotech merger albeit a smaller one

    by @ 2:06 pm.  Filed under Pharma News

    Commonwealth Biotechnolgies (CBI)of Richmond, VA will buy Mimotopes, an Australian company for $5.8 million.

    TimesDispatch.com | Biotech firm sets major merger:

    The details are interesting in that CBI will issue 2.15 million shares of its stock to PharmAust Chemistry Ltd. who will then own 40% of CBI. According to the article, CBI wants to get into the drug discovery aspect which is valued at ~%7 billion by 2009. It is interesting since several drug discovery based companies have been acquired or gone out of business in recent years. While I think drug discovery will continue to be important, I think it will see major price pressures and that this means more centers in China and India. I see a certain decline in drug discovery houses in the US. I’m not sure where Australia comes out in this discussion but the labor costs are almost certainly higher than in China or India.

    CBI is a biotech drug and diagnostic contract services company and Mimotopes supplies lab quantities of research-grade peptides.

    I’m not really familiar with either of these companies so it is hard to judge the value here. However, since I’ve been focusing on the number and size of mergers in this area, I at least wanted to mention this one.

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    Congress and Imported Drugs

    by @ 1:11 pm.  Filed under Health News, Pharma

    I always get concerned when I see drug imports touted as a way to achieve lower drug prices.

    Congress seen pushing for imported drugs:

    The main point brought up by the pharmaceutical industry and the FDA is safety. While I think safety is a concern, it is something that could be overcome and the proper procedures put into place to ensure safety. The safety concerns are important especially with regard to companies that set up websites that appear to be Canadian based but are really getting the “drugs” from questionable sources.

    The more important point from my perspective is that if even if a low percentage of Americans start this, there simply are not enough drugs in Canada to supply even a small percentage of the US. Also, the Canadian government has considered and are still considering a ban on sales into the US. Also, it is interesting as to how you word the question. If you ask simply about importing cheaper drugs then the majority are for it. If you change the question to be should we have price controls on drugs similar to Canada’s then the majority are not in favor. They are basically the same thing just worded differently.

    Also, not all drugs from Canada are cheaper. Primarily it is the brand name drugs that are cheaper. Generic drugs in general tend to be more expensive when purchased form Canada. The US has chosen a different approach than the rest of the world with regard to generics ever since the Generic Drug Act.

    The main problem is that prescription drugs are like energy, it is something you basically can not do without. With other products, the consumer can decide whether or not to purchase say a car or even how much they want to spend on a car. With energy and medicines, this isn’t the case. The choice of a generic can save money but it is not always the case that generics are available.

    It is a trouble-some issue and the main point to be kept in mind is that on an international scale, the drug and biotech industry are not a free market. In most of the rest of the world, the government is the sole purchaser and the companies must negotiate with the governments. This basically means that the US subsidizes drug costs for the rest of the world.

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