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    [{"orgOrder":0,"company":"Chiesi Global Rare Diseases","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Chiesi Global Rare Diseases Announces Approval of FERRIPROX\u2122 MR Deferiprone Extended-Release Tablets in Canada","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"ITALY","productType":"Small molecule","productStatus":"Approved","date":"March 2023","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Approved"},{"orgOrder":0,"company":"Chiesi Global Rare Diseases","sponsor":"Protalix BioTherapeutics","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Chiesi Global Rare Diseases and Protalix BioTherapeutics Announce European Commission Authorization of PRX-102 (pegunigalsidase alfa) for the Treatment of Fabry Disease","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"ITALY","productType":"Large molecule","productStatus":"Approved","date":"May 2023","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Approved"},{"orgOrder":0,"company":"Chiesi Global Rare Diseases","sponsor":"Protalix BioTherapeutics","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Chiesi Global Rare Diseases and Protalix BioTherapeutics Announce FDA Approval of ELFABRIO\u00ae (pegunigalsidase alfa-iwxj) for the Treatment of Fabry Disease","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"ITALY","productType":"Large molecule","productStatus":"Approved","date":"May 2023","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Approved"},{"orgOrder":0,"company":"Chiesi Global Rare Diseases","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Chiesi Global Rare Diseases Announces Health Canada Approval of MYALEPTA\u2122 (metreleptin for injection) for the Treatment of Patients with Lipodystrophy","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"ITALY","productType":"Peptide","productStatus":"Approved","date":"February 2024","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Approved"},{"orgOrder":0,"company":"Chiesi Global Rare Diseases","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Chiesi Global Rare Diseases Receives FDA Approval for FILSUVEZ\u00ae (birch triterpenes) Topical Gel for the Treatment of Epidermolysis Bullosa","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"ITALY","productType":"Small molecule","productStatus":"Approved","date":"December 2023","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Approved"}]

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              Chiesi Global Rare Diseases

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              Chiesi Global Rare Diseases Announces Health Canada Approval of MYALEPTA™ (metreleptin for injection) for the Treatment of Patients with Lipodystrophy

              Details:

              Myalepta (metreleptin) is a USFDA approved leptin receptor activator, which is now approved by Health Canada for the treatment of congenital or acquired generalized lipodystrophy.

              Lead Product(s): Metreleptin

              Therapeutic Area: Genetic Disease Product Name: Myalepta

              Highest Development Status: Approved Product Type: Peptide

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable February 05, 2024

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              Chiesi Global Rare Diseases

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              Chiesi Global Rare Diseases Receives FDA Approval for FILSUVEZ® (birch triterpenes) Topical Gel for the Treatment of Epidermolysis Bullosa

              Details:

              Filsuvez (birch triterpenes) is a topical gel which is approved for the treatment of wounds associated with dystrophic and junctional epidermolysis bullosa.

              Lead Product(s): Birch Triterpenes

              Therapeutic Area: Genetic Disease Product Name: Filsuvez

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable December 19, 2023

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              Chiesi Global Rare Diseases

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              Chiesi Global Rare Diseases and Protalix BioTherapeutics Announce FDA Approval of ELFABRIO® (pegunigalsidase alfa-iwxj) for the Treatment of Fabry Disease

              Details:

              Elfabrio (pegunigalsidase alfa-iwxj) is a PEGylated enzyme replacement therapy (ERT) for the treatment of adult patients with Fabry disease. It is a recombinant human α–Galactosidase–A enzyme expressed in plant-cell culture that is designed to provide a long half-life.

              Lead Product(s): Pegunigalsidase alfa-iwxj

              Therapeutic Area: Genetic Disease Product Name: Elfabrio

              Highest Development Status: Approved Product Type: Large molecule

              Recipient: Protalix BioTherapeutics

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable May 10, 2023

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              Chiesi Global Rare Diseases

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              Chiesi Global Rare Diseases and Protalix BioTherapeutics Announce European Commission Authorization of PRX-102 (pegunigalsidase alfa) for the Treatment of Fabry Disease

              Details:

              PRX-102 (pegunigalsidase alfa), EC authorized, is a novel PEGylated, covalently crosslinked form of α-galactosidase-A developed as enzyme replacement therapy for fabry disease, was designed to increase plasma half-life and reduce immunogenicity, thereby enhancing efficacy.

              Lead Product(s): Pegunigalsidase alfa

              Therapeutic Area: Genetic Disease Product Name: PRX-102

              Highest Development Status: Approved Product Type: Large molecule

              Recipient: Protalix BioTherapeutics

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable May 05, 2023

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              Chiesi Global Rare Diseases

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              Chiesi Global Rare Diseases Announces Approval of FERRIPROX™ MR Deferiprone Extended-Release Tablets in Canada

              Details:

              Ferriprox™ (deferiprone) is a chelating agent with an affinity for ferric ion (iron III), being developed for the treatment of patients with transfusional iron overload due to thalassemia syndromes.

              Lead Product(s): Deferiprone

              Therapeutic Area: Genetic Disease Product Name: Ferriprox

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable March 31, 2023

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              Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.
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