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    [{"orgOrder":0,"company":"Fresenius Kabi AB Brunna","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Fresenius Kabi Issues Voluntary Recall of Sodium Acetate Injection, USP Due to the Presence of Particulate Matter","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Approved","country":"SWEDEN","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Nephrology","graph2":"Approved"},{"orgOrder":0,"company":"Fresenius Kabi AB Brunna","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Fresenius Kabi Receives European Commission Approval for its Pegfilgrastim Biosimilar Stimufend\u00ae - Fresenius Kabi Global","therapeuticArea":"Hematology","highestDevelopmentStatus":"Approved","country":"SWEDEN","productType":"Large molecule","productStatus":"Biosimilar","date":"March 2022","url1":"","url2":"","graph1":"Hematology","graph2":"Approved"},{"orgOrder":0,"company":"Fresenius Kabi AB Brunna","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Fresenius Kabi Receives U.S. FDA Approval for Biosimilar Stimufend\u00ae (pegfilgrastim-fpgk)","therapeuticArea":"Hematology","highestDevelopmentStatus":"Approved","country":"SWEDEN","productType":"Large molecule","productStatus":"Biosimilar","date":"September 2022","url1":"","url2":"","graph1":"Hematology","graph2":"Approved"},{"orgOrder":0,"company":"Fresenius Kabi AB Brunna","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Fresenius Kabi Introduces Pralatrexate Injection for the Treatment of Relapsed or Refractory Peripheral T-cell Lymphoma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"SWEDEN","productType":"Small molecule","productStatus":"Approved","date":"December 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Fresenius Kabi AB Brunna","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Fresenius Kabi Receives U.S. FDA Approval for Biosimilar Idacio\u00ae (adalimumab)","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Approved","country":"SWEDEN","productType":"Large molecule","productStatus":"Biosimilar","date":"December 2022","url1":"","url2":"","graph1":"Dermatology","graph2":"Approved"},{"orgOrder":0,"company":"Fresenius Kabi AB Brunna","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Fresenius Kabi Targets Treatment of Certain Seizures with Launch of Generic Lacosamide Injection, USP","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"SWEDEN","productType":"Small molecule","productStatus":"Approved","date":"December 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Fresenius Kabi AB Brunna","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Fresenius Kabi Expands Ready-to-Administer Portfolio with Diazepam Injection, USP in Simplist\u00ae Prefilled Syringe","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Approved","country":"SWEDEN","productType":"Small molecule","productStatus":"Approved","date":"May 2023","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Approved"},{"orgOrder":0,"company":"Fresenius Kabi AB Brunna","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Expanding Access to Women\u2019s Health Fresenius Kabi Launches Generic Fertility Treatment","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Approved","country":"SWEDEN","productType":"Peptide","productStatus":"Approved","date":"July 2023","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Approved"},{"orgOrder":0,"company":"Fresenius Kabi AB Brunna","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Tyenne\u00ae*, Fresenius Kabi\u2019s Tocilizumab Biosimilar, Receives European Commission Approval","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"SWEDEN","productType":"Large molecule","productStatus":"Biosimilar","date":"September 2023","url1":"","url2":"","graph1":"Immunology","graph2":"Approved"}]

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              Fresenius Kabi AB Brunna

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              Tyenne®*, Fresenius Kabi’s Tocilizumab Biosimilar, Receives European Commission Approval

              Details:

              Tyenne (tocilizumab biosimilar) is a recombinant humanized monoclonal antibody targeting IL-6R, which specifically binds to sIL-6R and mIL-6R and inhibits signaling mediated by sIL-6R or mIL-6R. It is approved for the treatment of RA, sJIA, and CRS.

              Lead Product(s): Tocilizumab

              Therapeutic Area: Immunology Product Name: Tyenne

              Highest Development Status: Approved Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable September 19, 2023

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              Fresenius Kabi AB Brunna

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              Expanding Access to Women’s Health Fresenius Kabi Launches Generic Fertility Treatment

              Details:

              Ganirelix Acetate Injection is indicated for the inhibition of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation.

              Lead Product(s): Ganirelix

              Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Antagonä-Generic

              Highest Development Status: Approved Product Type: Peptide

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable July 10, 2023

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              Fresenius Kabi AB Brunna

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              Fresenius Kabi Expands Ready-to-Administer Portfolio with Diazepam Injection, USP in Simplist® Prefilled Syringe

              Details:

              Diazepam Injection is a ready-to-administer prefilled syringes which is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety.

              Lead Product(s): Diazepam

              Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

              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 May 31, 2023

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              Fresenius Kabi AB Brunna

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              Fresenius Kabi Targets Treatment of Certain Seizures with Launch of Generic Lacosamide Injection, USP

              Details:

              Fresenius Kabi Lacosamide Injection, USP is an approved treatment option for partial-onset seizures in patients 17 years of age and older and is available in 200 mg per 20 mL single-dose vials.

              Lead Product(s): Lacosamide

              Therapeutic Area: Neurology Product Name: Lacosamide-Generic

              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 15, 2022

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              Fresenius Kabi AB Brunna

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              Fresenius Kabi Receives U.S. FDA Approval for Biosimilar Idacio® (adalimumab)

              Details:

              Idacio® (adalimumab), is a tumor necrosis factor (TNF) blocker and a biosimilar to Humira®. Adalimumab is a monoclonal antibody that binds TNFα and blocks its general cytokine effects.

              Lead Product(s): Adalimumab

              Therapeutic Area: Dermatology Product Name: Idacio

              Highest Development Status: Approved Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable December 14, 2022

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              Fresenius Kabi AB Brunna

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              Fresenius Kabi Introduces Pralatrexate Injection for the Treatment of Relapsed or Refractory Peripheral T-cell Lymphoma

              Details:

              Pralatrexate injection is a dihydrofolate reductase inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).

              Lead Product(s): Pralatrexate

              Therapeutic Area: Oncology Product Name: Pralatrexate-Generic

              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 08, 2022

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              Fresenius Kabi AB Brunna

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              Fresenius Kabi Receives U.S. FDA Approval for Biosimilar Stimufend® (pegfilgrastim-fpgk)

              Details:

              U.S.FDA has approved its biosimilar, Stimufend® (pegfilgrastim-fpgk), for use in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

              Lead Product(s): Pegfilgrastim

              Therapeutic Area: Hematology Product Name: Stimufend

              Highest Development Status: Approved Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable September 06, 2022

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              Fresenius Kabi AB Brunna

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              Fresenius Kabi Receives European Commission Approval for its Pegfilgrastim Biosimilar Stimufend® - Fresenius Kabi Global

              Details:

              Stimufend (pegfilgrastim) is a long-acting form of filgrastim (recombinant human granulocyte colony-stimulating factor or G-CSF) which serves to stimulate the production of white blood cells (neutrophils).

              Lead Product(s): Pegfilgrastim

              Therapeutic Area: Hematology Product Name: Stimufend

              Highest Development Status: Approved Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable March 30, 2022

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              Fresenius Kabi AB Brunna

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              Fresenius Kabi Issues Voluntary Recall of Sodium Acetate Injection, USP Due to the Presence of Particulate Matter

              Details:

              Microscopic and elemental analyses determined the presence of particulates in Maxivial (sodium acetate) injection that is composed of carbon and oxygen with varying amounts of iron and trace amounts of sodium, silicon, chromium, aluminum and cellulose.

              Lead Product(s): Sodium Acetate

              Therapeutic Area: Nephrology Product Name: Maxivial

              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 07, 2022

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