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    [{"orgOrder":0,"company":"Recordati Rare Diseases","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Recordati Rare Diseases Announces First European Launch of Isturisa\u00ae (osilodrostat)","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2020","url1":"","url2":"","graph1":"Endocrinology","graph2":"Approved"},{"orgOrder":0,"company":"Recordati Rare Diseases","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Recordati Rare Diseases: Isturisa\u00ae (osilodrostat) Phase III LINC-4 Trial Meets Its Primary Endpoint in Cushing\u2019s Disease","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2020","url1":"","url2":"","graph1":"Endocrinology","graph2":"Approved"},{"orgOrder":0,"company":"Recordati Rare Diseases","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"U.S. FDA Approves CYSTADROPS\u00ae 0.37%, A New Practical Treatment Option for the Ocular Manifestations of Cystinosis","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"August 2020","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Approved"},{"orgOrder":0,"company":"Recordati Rare Diseases","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Recordati Rare Diseases: Carbaglu\u00ae Tablets 200mg Gets Approval for A New Indication","therapeuticArea":"Hematology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"January 2021","url1":"","url2":"","graph1":"Hematology","graph2":"Approved"},{"orgOrder":0,"company":"Recordati Rare Diseases","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Recordati Rare Diseases Announce Publication in The Journal of Clinical Endocrinology & Metabolism of the Phase III LINC 4 Study Confirming Efficacy and Safety of ISTURISA\u00ae (osilodrostat) in Patients With Cushing\u2019s Disease","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Endocrinology","graph2":"Approved"},{"orgOrder":0,"company":"Recordati Rare Diseases","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Recordati Rare Diseases Announces Multiple Scientific Abstracts to Be Highlighted at American Association of Clinical Endocrinology","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Endocrinology","graph2":"Approved"},{"orgOrder":0,"company":"Recordati Rare Diseases","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Phase III LINC 3 Study Demonstrates That ISTURISA\u00ae (osilodrostat) Improves Physical Features Associated With Hypercortisolism in Patients With Cushing\u2019s Disease","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Endocrinology","graph2":"Approved"},{"orgOrder":0,"company":"Recordati Rare Diseases","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Recordati Rare Diseases Announces Positive Data From Phase III Linc 4, Phase III Linc 3, and Illustrate ISTURISA\u00ae Studies Presented at ENDO 2022","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2022","url1":"","url2":"","graph1":"Endocrinology","graph2":"Approved"},{"orgOrder":0,"company":"Recordati Rare Diseases","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"U.S. FDA Approves CYSTADROPS\u00ae (Cysteamine Ophthalmic Solution) 0.37%, A New Practical Treatment Option for the Ocular Manifestations of Cystinosis","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"August 2020","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Approved"}]

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              Recordati Rare Diseases Announces Positive Data From Phase III Linc 4, Phase III Linc 3, and Illustrate ISTURISA® Studies Presented at ENDO 2022

              Details:

              ISTURISA® (osilodrostat), a cortisol synthesis inhibitor that works by inhibiting 11-beta-hydroxylase maintained normal mean urinary free cortisol (mUFC) long-term in patients with Cushing’s disease.

              Lead Product(s): Osilodrostat

              Therapeutic Area: Endocrinology Product Name: Isturisa

              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 June 15, 2022

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              Phase III LINC 3 Study Demonstrates That ISTURISA® (osilodrostat) Improves Physical Features Associated With Hypercortisolism in Patients With Cushing’s Disease

              Details:

              LINC 3 study demonstrated that Isturisa (osilodrostat) therapy provided long-term mean urinary free cortisol control and clinical improvements, with decreases inpatient weight and the severity of physical features, including hirsutism, that were maintained through to week 72.

              Lead Product(s): Osilodrostat

              Therapeutic Area: Endocrinology Product Name: Isturisa

              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 13, 2022

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              Recordati Rare Diseases Announces Multiple Scientific Abstracts to Be Highlighted at American Association of Clinical Endocrinology

              Details:

              Isturisa (osilodrostat) is a cortisol synthesis inhibitor indicated for the treatment of adult patients with Cushing’s disease for whom pituitary surgery is not an option or has not been curative.

              Lead Product(s): Osilodrostat

              Therapeutic Area: Endocrinology Product Name: Isturisa

              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 10, 2022

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              Recordati Rare Diseases Announce Publication in The Journal of Clinical Endocrinology & Metabolism of the Phase III LINC 4 Study Confirming Efficacy and Safety of ISTURISAÂ...

              Details:

              The LINC 4 study demonstrated superiority of ISTURISA® (osilodrostat) over placebo in achieving cortisol control during the 12-week, double-blind, randomized phase (77% vs 8%, P<0.0001).

              Lead Product(s): Osilodrostat

              Therapeutic Area: Endocrinology Product Name: Isturisa

              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 29, 2022

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              Recordati Rare Diseases: Carbaglu® Tablets 200mg Gets Approval for A New Indication

              Details:

              U.S. FDA has approved a new indication for CARBAGLU® (carglumic acid) tablets 200mg as adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to propionic acidemia (PA) or methylmalonic acidemia (MMA) in pediatric and adult patients.

              Lead Product(s): Carglumic Acid

              Therapeutic Area: Hematology Product Name: Carbaglu

              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 January 26, 2021

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              U.S. FDA Approves CYSTADROPS® 0.37%, A New Practical Treatment Option for the Ocular Manifestations of Cystinosis

              Details:

              CYSTADROPS demonstrated a significant reduction in cystine crystal deposits in the cornea of the eye and is the first and only FDA-approved cysteamine drop formulation with four times a day dosing.

              Lead Product(s): Cysteamine Hydrochloride

              Therapeutic Area: Genetic Disease Product Name: Cystadrops

              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 August 25, 2020

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              U.S. FDA Approves CYSTADROPS® (Cysteamine Ophthalmic Solution) 0.37%, A New Practical Treatment Option for the Ocular Manifestations of Cystinosis

              Details:

              Cystadrops (cysteamine) ophthalmic solution, acts as a cystine-depleting agent by converting cystine to cysteine and is indicated for the treatment of corneal cystine crystal deposits in adults and children with cystinosis.

              Lead Product(s): Cysteamine Bitartrate

              Therapeutic Area: Genetic Disease Product Name: Cystadrops

              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 August 25, 2020

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              Recordati Rare Diseases: Isturisa® (osilodrostat) Phase III LINC-4 Trial Meets Its Primary Endpoint in Cushing’s Disease

              Details:

              ISTURISA® (osilodrostat) demonstrates significant and sustained benefit over placebo at normalizing mean urinary free cortisol (mUFC) levels in patients with Cushing’s disease.

              Lead Product(s): Osilodrostat

              Therapeutic Area: Endocrinology Product Name: Isturisa

              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 June 17, 2020

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              Recordati Rare Diseases Announces First European Launch of Isturisa® (osilodrostat)

              Details:

              Isturisa® (osilodrostat), a novel treatment for Cushing’s Syndrome, is now commercially available in France, and will be across select other European Union markets over 2020.

              Lead Product(s): Osilodrostat

              Therapeutic Area: Endocrinology 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 June 02, 2020

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