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Why are new drugs failing?

The FDA's recent decision to pull Pfizer Cox-2 inhibitor Bextra from the marketplace clearly jolted both Pfizer and the market. Pfizer was initially caught up in the Merck Vioxx dilemma months ago and its stock has declined from $38 per share a year ago to under $25 per share in February. It has recently moved up to the $27 level.

This activity still represe......

Full article >>> is particularly sensitive to cardiovascular side effects (those affecting the heart). It has mandated in the last few years that drug and biotech companies perform additional pre-clinical (animal) and clinical (human) testing of cardiac effects (particularly those known as "QT interval" testing).

What is QT interval testing? The QT interval is a measure of the heartbeat as seen in ......

Full article >>> s that have already been marketed by other companies and are already successful.

During its early years, Sepracor would approach the company already marketing the successful chiral drug and offer its services to create a second-generation-approved product with new patent life. This strategy was successful with companies like Schering-Plough and the anti-histamine Clarinex (anti-histamines......

Full article >>> is in the right place at the right time to hit the FDA's "sweet spot". The company has already successfully obtained biotech and pharma companies as clients from both coasts and is mining Europe for further business.

CorDynamics uses what's called the "isolated heart model," which has a series of benefits for a drug company partner in evaluating its drug candidate. These include:

Full article >>> a/Searle. Before that, he was director of experimental toxicology and pathology at Astra Pharmaceuticals. He also had a similar role at Ciba-Geigy Pharmaceuticals. He is backed up by an experienced toxicology group that all came from Pfizer/Pharmacia/Searle.

The message here for any up-and-coming biotech company (or even Big Pharma) is that it's more cost effective to thoroughly test your......

Full article >>> untries. More recently, the company has moved into designing its own prodrugs that are free of cardio toxicity.

This whole area will become increasingly important with the increased FDA vigilance of drug side effects and in particular cardio toxic side effects. It appears that a number of Midwest-based companies are poised to take advantage of this situation. See you next week!

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Full article >>>
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Source:wistechnology.com By Michael Rosen 04/18/05


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