Biotech Values

[DewDiligence]

FDA Rejects Jerini’s NDA for Icatibant in HAE

[Good news for LEVP, Pharming, DYAX, and CSL Behring.]

http://biz.yahoo.com/pz/080424/140863.html

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Thursday April 24, 8:50 am ET

Jerini Expects CHMP Opinion for European Marketing Authorization Later Today

BERLIN, April 24, 2008 (PRIME NEWSWIRE) -- Jerini AG (FSE:JI4) has received a not approvable letter from the FDA for its New Drug Application (NDA) for Icatibant in the treatment of hereditary angioedema (HAE). The not approvable letter outlines areas of concern that the company is now going to review with the agency.

Jerini is expecting an opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) for Icatibant in the treatment of HAE later today.
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