Enzo Biochem, Inc. (NYSE: ENZ) announced that their Enzo Therapeutics division is initiating a clinical trial of Optiquel. The decision comes after the filing of an investigational new drug application with the U.S. FDA.
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Optiquel has been awarded
orphan drug status in the European Union and a similar designation may be
applied for in the US.
Optiquel is an oral
therapeutic for chronic non-infectious uveitis.
Dynavax
Technologies Corp. (Nasdaq: DVAX) reported that its novel
hepatitis B vaccine candidate, HEPLISAV, given as two doses over four weeks
demonstrated superior seroprotection in persons with diabetes mellitus compared
to Engerix-B given as three doses over 24 weeks.
The data was presented
in an abstract on the website of the 61st Annual Meeting of the American
Association for the Study of Liver Diseases (AASLD).
Orthovita, Inc. (Nasdaq: VITA) announced that they have received 501(k) clearance for marketing of VITOMATRIX Bone Graft Substitute by the U.S. FDA. The clearance was given for the use of VITOMATRIX in certain dental procedures.
Orthovita is evaluating potential commercial partners to distribute the product or license its underlying technology.
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Celsion
Corporation (Nasdaq: CLSN) announced that they have reached an
agreement with the U.S. Food and Drug Administration (FDA) that the
requirements for non-clinical studies have been met for the New Drug
Application (NDA) of ThermoDox.
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