Dallas 5/5/2010 10:11:47 PM
News / Business

NASDAQ Stock Volume Buzzers after FDA Decision (SVA, OSIR, ITMN, ARIA)

NASDAQ Stocks

 

Sinovac Biotech Ltd. (Nasdaq: SVA) announced today that its 30%-owned joint venture, Sinovac Dalian, has submitted an application to China's State Food and Drug Administration (SFDA) to commence human clinical trials for its mumps vaccine. The proprietary mumps vaccine developed by Sinovac Dalian represents not only the first live attenuated vaccine for which Sinovac has filed a clinical trial application, but also the first candidate from the joint venture's pipeline for which a clinical trial application has been submitted to and accepted by the SFDA since the formation of the joint venture in January 2010.

 

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Osiris Therapeutics, Inc. (Nasdaq: OSIR) today announced that it has been granted Orphan Drug designation from the U.S. Food and Drug Administration (FDA) for Prochymal as a treatment for type 1 diabetes mellitus. The FDA instituted the Orphan Drug Act to promote the development of treatments for underserved patient populations. To be eligible for Orphan Drug designation, the treatment must target a disease that affects fewer than 200,000 new patients per year in the United States.

 

InterMune Inc. (NASDAQ: ITMN) failed to receive approval from U.S. health regulators for its drug designed to treat lung scarring and was asked to conduct a new clinical trial to prove its effectiveness.

 

ARIAD Pharmaceuticals, Inc. (Nasdaq: ARIA) today announced that it has restructured its July 2007 collaboration with Merck, Sharpe & Dohme Corp. (NYSE: MRK) for the development, manufacture, and commercialization of ridaforolimus – ARIAD’s investigational mTOR inhibitor. The Company will host an investor conference call this morning at 9:00 a.m. ET to discuss the revised transaction and financial guidance.

 

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