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Protalix BioTherapeutics, Inc.

http://www.protalix.com

Latest From Protalix BioTherapeutics, Inc.

Protalix Plans US Resubmission For ERT For Fabry After Positive Phase III Trial Results

Clinical Trials Complete Response Letters

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.

Europe Drug Review

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.

Complete Response Letters Drug Approval Standards

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.

Gene Therapy Rare Diseases
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Company Information

  • Industry
  • Biotechnology
  • Pharmaceuticals
  • Biotechnology
    • Large Molecule
    • Synthesis Technologies, Production Processes
    • Transgenics
  • Other Names / Subsidiaries
    • Protalix Ltd.
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