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News and Press Releases

June 2021
02/06/2021
Protalix Biotherapeutics and Chiesi Global Rare Diseases Provide Update Regarding Clinical Development of PRX-102 for Treatment of Fabry Disease
Protalix management to host conference call and live webcast today at 8:30 am EDT   CARMIEL, Israel and BOSTON, Mass. – June 2, 2021 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American:PLX) (TASE:PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant...
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May 2021
01/05/2021
Chiesi Global Rare Diseases Announces FDA Approval of FERRIPROX® (deferiprone) for Treatment of Transfusional Iron Overload due to Sickle Cell Disease
- Approval is based on demonstrated reduction in liver iron concentration – - Expanded indications for patients with sickle cell disease or other anemias, as well as thalassemia -   BOSTON, Mass. – May 1, 2021 - Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an international research-focused...
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April 2021
28/04/2021
Protalix BioTherapeutics and Chiesi Global Rare Diseases Receive Complete Response Letter for Pegunigalsidase Alfa from FDA
  CARMIEL, Israel and BOSTON, April 28, 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...
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February 2021
26/02/2021
Chiesi Global Rare Diseases Recognizes Rare Disease Day Highlighting Importance of Staying Connected for Information and Support
Company sponsors #wewearstripes social media campaign calling on participants to share photos to express support for people affected by rare diseases   Company to light up offices around the world including Italy, the United States, and Canada   BOSTON, Mass. - February 26, 2021 - Chiesi Global Rare Diseases, a business unit of...
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23/02/2021
Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Positive Topline Results from BRIGHT Phase III Open-Label, Switch-Over Clinical Trial Evaluating Pegunigalsidase Alfa 2 mg/kg every Four Weeks for Treatment of Fabry Disease
Study achieved key objectives for safety, efficacy and pharmacokinetics   After completion of the study, all patients enrolled in an extension study   pegunigalsidase alfa (PRX-102) provided coverage to patients for the entire 4-week period in treated patients   No new patients developed treatment-induced anti-drug antibodies...
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10/02/2021
Protalix BioTherapeutics and Chiesi Global Rare Diseases Present Key Clinical Data of Pegunigalsidase Alfa for the Treatment of Fabry Disease at the 17th Annual WORLDSymposium™ 2021
Phase III BRIDGE open-label, switch-over clinical trial met key objectives for safety and efficacy Mean overall annualized change in estimated Glomerular Filtration Rate (eGFR slope) improved from -5.9 to -1.2 mL/min/1.73 m2/year 12-months on-treatment Phase III BRIDGE study final results suggest a potential benefit of pegunigalsidase alfa...
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December 2020
30/12/2020
Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Final Results of BRIDGE Phase III Open-Label, Switch-Over Clinical Trial Evaluating Pegunigalsidase Alfa for the Treatment of Fabry Disease
Phase III BRIDGE open-label, switch-over clinical trial met key objectives for safety and efficacy   Final analysis confirmed substantial improvement in renal function as measured by mean annualized estimated Glomerular Filtration Rate (eGFR slope) in patients switched from agalsidase alfa to pegunigalsidase alfa (PRX-102)   A...
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23/12/2020
Chiesi Global Rare Diseases Announces First Patient Treated in Expanded Access Program for Pegunigalsidase Alfa for Proposed Treatment of Fabry Disease
Program grants access to investigational therapy for Fabry disease patients in the United States who cannot be adequately treated with currently available FDA-approved drugs -   Boston, MA, (December 23, 2020) – Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an international research-focused healthcare...
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November 2020
27/11/2020
Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Extension of PDUFA Date for Pegunigalsidase Alfa for the Proposed Treatment of Fabry Disease
CARMIEL, Israel, November 27, 2020 /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 Global Rare...
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24/11/2020
Chiesi Group Acquires Unikeris Limited and Adds Revcovi® (elapegademase-lvlr) Injection to Product Portfolio
Addition of approved therapy for treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID)expands Chiesi commitment to addressing significant areas of unmet need in treatment of rare diseases Under terms of the agreement Chiesi Group has acquired all rights to Revcovi, which will continue to be available to patients through...
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October 2020
13/10/2020
Chiesi Global Rare Diseases Launches “Rethink Fabry” Campaign to Bring Important Information to Fabry Disease Community and Support Patients and Caregivers
Disease education program aims to help patients, caregivers and families affected by Fabry disease to make informed healthcare decisions Program includes new resources for healthcare professionals to support strategies in diagnosis and disease management   Boston, MA (October 13, 2020) – Chiesi Global Rare Diseases, a business unit...
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02/10/2020
Chiesi Global Rare Diseases and Protalix BioTherapeutics Announce Launch of Expanded Access Program in the United States for Pegunigalsidase Alfa for the Proposed Treatment of Fabry Disease
Program grants access to investigational treatment for Fabry disease patients that cannot be adequately treated with any FDA-approved drugs and provides guidance to treating physicians   Boston, MA and Carmiel, Israel, (02/10/2020) – Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an international...
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August 2020
24/08/2020
Protalix BioTherapeutics Announces Completion of the Treatment Period for its Phase III BRIGHT Clinical Trial of Pegunigalsidase Alfa (PRX-102) for the Proposed Treatment of Fabry Disease
Top-line data anticipated in 4Q2020 upon completion of final monitoring visits CARMIEL, Israel, August 24, 2020 /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...
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11/08/2020
Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce U.S. Food and Drug Administration Acceptance of Biologics License Application (BLA) for Pegunigalsidase Alfa for the Proposed Treatment of Fabry Disease and Grants Priority Review
CARMIEL, Israel, Aug. 11, 2020 /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, or the Company,...
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July 2020
10/07/2020
Bioasis and Chiesi Group to Host Webcast on July 16, 2020
GUILFORD, CONN., U.S.A. and PARMA, ITALY – BIOASIS TECHNOLOGIES INC. (“Bioasis”) (TSXV:BTI.V; OTCQB:BIOAF), a pre-clinical, research-stage biopharmaceutical company developing its proprietary xB3 TMplatform technology for the delivery of therapeutics across the blood-brain barrier (“BBB”) and...
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June 2020
29/06/2020
Bioasis and Chiesi Group Announce Rare Diseases Strategic Alliance
Deal provides Chiesi Group with worldwide, exclusive license to use Bioasis xB3 TM platform for delivery of undisclosed enzymes in treatment of four lysosomal storage disorders.   Under terms of the agreement, Bioasis will receive an upfront payment of US$3 million, additional potential milestone payments of up to US$138 million and...
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May 2020
20/05/2020
Chiesi Group Receives FDA Approval for Ferriprox® (deferiprone) twice-a-day tablets
BOSTON, May 21, 2020 (GLOBE NEWSWIRE) -- Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group (Chiesi Group), today announced that the U.S. Food and Drug Administration (FDA) has approved Ferriprox® (deferiprone) twice-a-day tablets for the treatment of patients...
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February 2020
06/02/2020
Chiesi Group Announces Establishment of New Global Rare Diseases Division
Specialized division focused on research and product development for rare and ultra-rare diseases highlights Chiesi’s commitment to building a brighter future for patients Chiesi Global Rare Diseases unit will harness the full resources of Chiesi Group to support rare disease communities, with initial focus on lysosomal storage disorders,...
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