Protalix BioTherapeutics, Inc.
http://www.protalix.com
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Latest From Protalix BioTherapeutics, Inc.
New EU Filings Include Tibsovo Resubmission, Pegunigalsidase & Daprodustat
Servier is trying again with Tibsovo in the EU, while Protalix is using June 2021 data to support its filing for pegunigalsidase, which the US regulator turned down last April.
US FDA’s 2022 Novel Agent Actions Suggest Acceleration In Use Of Complete Response Letters
COVID does not appear to be a driving factor, and letters are split almost equally between clinical and quality concerns.
Sangamo's Fabry Gene Therapy May Be A STAAR In The Making
The US biotech has presented interesting preliminary data from the first four patients treated in the Phase I/II STAAR study evaluating isaralgagene civaparvovec for Fabry.
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