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DewDiligence

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DewDiligence

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Re: DewDiligence post# 211849

Monday, 10/23/2017 8:20:35 PM

Monday, October 23, 2017 8:20:35 PM

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FDA approves ALXN’s Soliris for gMG:

http://www.businesswire.com/news/home/20171023006539/en/

Alexion Pharmaceuticals…announced today that the U.S. Food and Drug Administration has approved Soliris (eculizumab) as a treatment for adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody-positive. In the Phase 3 REGAIN study and its ongoing open-label extension study, Soliris demonstrated treatment benefits for patients with anti-AchR antibody-positive gMG who had previously failed immunosuppressive treatment and continued to suffer from significant unresolved disease symptoms…

Today was the PDUFA date.

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

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