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    [{"orgOrder":0,"company":"Swedish Orphan Biovitrum AB","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"SOBI Announces Results From Pivotal Phase 2\/3 Study of Emapalumab in Patients With Primary HLH Published in New England Journal of Medicine","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase IV","country":"SWEDEN","productType":"Large molecule","productStatus":"Approved","date":"May 2020","url1":"","url2":"","graph1":"Immunology","graph2":"Phase IV"},{"orgOrder":0,"company":"Swedish Orphan Biovitrum AB","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sobi will File for a Re-Examination of Emapalumab in Europe","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase IV","country":"SWEDEN","productType":"Large molecule","productStatus":"Approved","date":"July 2020","url1":"","url2":"","graph1":"Immunology","graph2":"Phase IV"},{"orgOrder":0,"company":"Swedish Orphan Biovitrum AB","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Gamifant (Emapalumab) Recommended for Approval in China for Treatment of Primary Haemophagocytic Lymphohistiocytosis (HLH)","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase IV","country":"SWEDEN","productType":"Large molecule","productStatus":"Approved","date":"February 2022","url1":"","url2":"","graph1":"Immunology","graph2":"Phase IV"},{"orgOrder":0,"company":"Swedish Orphan Biovitrum AB","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sobi's Emapalumab-lzsg Gets FDA Fast Track For Macrophage Activation Syndrome","therapeuticArea":"Immunology","highestDevelopmentStatus":"Preclinical","country":"SWEDEN","productType":"Large molecule","productStatus":"Approved","date":"May 2024","url1":"","url2":"","graph1":"Immunology","graph2":"Preclinical"}]

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              Swedish Orphan Biovitrum AB

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              Sobi's Emapalumab-lzsg Gets FDA Fast Track For Macrophage Activation Syndrome

              Details:

              Gamifant (emapalumab) is an anti-IFNγ monoclonal antibody that binds free and receptor-bound IFNγ, neutralizing its biological activity. Emapalumab is currently in Phase lll development for MAS.

              Lead Product(s): Emapalumab

              Therapeutic Area: Immunology Product Name: Gamifant

              Highest Development Status: Preclinical Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable May 24, 2024

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              Swedish Orphan Biovitrum AB

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              Gamifant (Emapalumab) Recommended for Approval in China for Treatment of Primary Haemophagocytic Lymphohistiocytosis (HLH)

              Details:

              Gamifant (emapalumab) is a mAb that binds to and neutralizes interferon-gamma (IFNy), is the first and only medicine approved in the US and UAE for primary HLH, also has received approval by NMPA of China.

              Lead Product(s): Emapalumab

              Therapeutic Area: Immunology Product Name: Gamifant

              Highest Development Status: Phase IV Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable February 25, 2022

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              Swedish Orphan Biovitrum AB

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              Sobi will File for a Re-Examination of Emapalumab in Europe

              Details:

              Emapalumab has demonstrated a positive benefit/risk profile in primary HLH in a post-approval real life setting in the US since the FDA approval in 2018.

              Lead Product(s): Emapalumab

              Therapeutic Area: Immunology Product Name: Gamifant

              Highest Development Status: Phase IV Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable July 24, 2020

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              Swedish Orphan Biovitrum AB

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              SOBI Announces Results From Pivotal Phase 2/3 Study of Emapalumab in Patients With Primary HLH Published in New England Journal of Medicine

              Details:

              The results with emapalumab in primary HLH published in the New England Journal of Medicine highlight the overall response rate of 63 percent in previously treated patients at the end of up to 8 weeks of treatment (compared to the pre-specified null hypothesis of 40%.

              Lead Product(s): Emapalumab

              Therapeutic Area: Immunology Product Name: Undisclosed

              Highest Development Status: Phase IV Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable May 07, 2020

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              Farmhispania Group, a leading European CDMO in HPAPI Technologies & High Potency Fermentation.
              One Pharma aims to be one of the leading generic companies in Europe.
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