08/01/2023

Chiesi Farmaceutici S.p.A. to Acquire Amryt Pharma Plc

Parma Italy, Boston MA and Dublin, Ireland, January 8, 2023 Chiesi Farmaceutici S.p.A. (“Chiesi”), an international, research-focused biopharmaceuticals and healthcare group, and Amryt Pharma Plc (“Amryt”) (Nasdaq: AMYT), a global, commercial-stage biopharmaceutical company dedicated to acquiring, developing, and commercializing novel treatments for rare...

5/12/2022

Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce U.S. Food and Drug Administration Acceptance of a Resubmitted Biologics License Application for Pegunigalsidase Alfa for the Proposed Treatment of Fabry Disease

CARMIEL, Israel and BOSTON, December 5, 2022 /PRNewswire/ - Protalix BioTherapeutics, Inc. (NYSE American:PLX) (TASE:PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx^® plant cell based protein expression system, and Chiesi...

14/11/2022

Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Resubmission of Biologics License Application to U.S. Food and Drug Administration for Pegunigalsidase Alfa for the Treatment of Fabry Disease

CARMIEL, Israel and BOSTON, November 14, 2022 2022 /PRNewswire/Protalix BioTherapeutics, Inc. (NYSE American:PLX) (TASE:PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell based protein expression system ...

09/12/2022

Chiesi Global Rare Diseases Announces FDA Acceptance of BLA Filing for Velmanase Alfa for the Proposed Treatment of Alpha-Mannosidosis

- FDA grants Priority Review designation with PDUFA date in the first half of 2023 -

BOSTON, September 12, 2022 – Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group (Chiesi Group), announced today that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License...

04/04/2022

Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Topline Results from the 24-Month Phase III BALANCE Clinical Trial of PRX-102 for the Treatment of Fabry Disease

PRX-102 successfully met the primary endpoint on kidney function in active control, non-inferiority study vs. agalsidase beta

Topline results demonstrated a favorable tolerability and immunogenicity profile for PRX-102 BLA resubmission planned for the second half of 2022

22/02/2022

Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce the Submission of a Marketing Authorization Application to the European Medicines Agency for PRX-102 for the Treatment of Fabry Disease

CARMIEL, Israel and BOSTON, February [22], 2022 -- Protalix BioTherapeutics, Inc. (NYSE American:PLX) (TASE:PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based...

03/12/2021

Chiesi Global Rare Diseases Announces Updated U.S. Prescribing Information for FERRIPROX® (deferiprone)

BOSTON, Dec. 3, 2021 /PRNewswire/ – Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group (Chiesi Group), announced today that the FERRIPROX® (deferiprone) Prescribing Information in the U.S. has been updated in the treatment of transfusional iron overload...

15/10/2021

Chiesi Global Rare Diseases Announces Approval of FERRIPROX® (deferiprone) in Canada for the Treatment of Iron Overload in Sickle Cell Disease

BOSTON, Mass. – October 15, 2021 – Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group (Chiesi Group), announced today that Health Canada has approved FERRIPROX® (deferiprone) for the treatment of iron overload in patients with sickle cell disease (SCD)...

15/10/2021

Protalix Biotherapeutics and Chiesi Global Rare Diseases Announce Final Dosing of Last Patient in Phase III BALANCE Clinical Trial PRX-102 for the Treatment of Fabry Disease

CARMIEL, Israel and BOSTON, October 15, 2021 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American:PLX) (TASE:PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, and Chiesi...