Food and Drug Administration
Wyeth and Elan in a World of Pain
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A little over a month ago, I wrote a post detailing how I thought the Bapineuzumab trial (which had just released phase 2 results) was a total loser.
It was, and still is, my contention that mAbs targeting APP, Tau, gamma secretase or the protein du jour in brain soup will not be effective [...]
AutoGenomics Files for IPO
Mmmmm. I love a hot IPO market.
I especially love an integrated diagnostic testing systems company.
AutoGenomics announced it has filed an S-1 with the SEC. The price and number of shares have not yet been determined.
The company is based in Carlsbad and according to the S-1, has developed the first automated, microarray based multiplexing diagnostic [...]
Shire Ponies Up For Jerini
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Shire and its well known acquisition strategy are at it again, this time buying Berlin-based, Jerini for $521.2M (a 71% premium).
The rationale for the deal was the addition of Firazyr, an orphan drug treatment for hereditary angioedema (HAE), which received a not approvable letter from the FDA in April but has an EU [...]
Drug Development: From Discovery to NDA
Introduction
The time it takes from starting a program to selling a product can vary but is usually estimated to be around 10 years and the total cost associated with bringing a drug to market is widely cited to be at least $850 million. These numbers outline high stakes and whether you are an [...]
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