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Lead Product(s): Canagliflozin
Therapeutic Area: Nephrology Product Name: Canaglu
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 February 26, 2021
Details:
Tai Tien Pharmaceuticals has obtained the regulatory approval of CANAGLU® (CANAGLU)(INN: canagliflozin; Japan names: CANAGLU® Tablets 100mg) for a treatment agent for diabetic nephropathy in Taiwan FDA.
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Lead Product(s): Sucroferric Oxyhydroxide
Therapeutic Area: Nephrology Product Name: Velphoro
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 February 15, 2021
Details:
Clinical Kidney Journal published results from a real-world setting study, the VELREAL multicenter study, which showed a 20% decrease in serum phosphorus in addition to reduced parathyroid hormone level using Vifor Pharma’s Velphoro in CKD patients on dialysis.
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Lead Product(s): Sevelamer Carbonate
Therapeutic Area: Nephrology 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 January 25, 2021
Details:
Sevelamer Carbonate Tablets, 800 mg, are indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease on dialysis.
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Lead Product(s): Metolazone
Therapeutic Area: Nephrology 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 December 03, 2020
Details:
The approved ANDA is therapeutically equivalent to the reference listed drug product, Zaroxolyn Tablets 2.5 mg, 5 mg, and 1 O mg, of Lannett Company. Metolazone Tablets are indicated for the treatment of salt and water retention caused by heart failure or kidney disease.
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Lead Product(s): Sodium Zirconium Cyclosilicate
Therapeutic Area: Nephrology Product Name: Lokelma
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 November 24, 2020
Details:
The approval by the NMPA was based on data from the Phase IIIb DIALIZE trial. The trial showed sustained potassium control pre-dialysis for more patients receiving Lokelma, compared with placebo.
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Lead Product(s): Patiromer
Therapeutic Area: Nephrology Product Name: Veltassa
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Fresenius Kabi AG
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration November 19, 2020
Details:
Fresenius Kabi will have the exclusive right to distribute and sell Veltassa® across China. By bringing Veltassa® to China, VFMCRP and Fresenius Kabi will deliver a treatment that will enable patients to remain on RAASi therapy by managing their chronic hyperkalemia.
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Lead Product(s): Alfacalcidol
Therapeutic Area: Nephrology Product Name: One-Alpha
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Cheplapharm Arzneimittel Gmbh
Deal Size: $357.0 million Upfront Cash: Undisclosed
Deal Type: Divestment August 31, 2020
Details:
The divested portfolio comprises four products within bone disorders/nephrology, dermatology and gynecology: One-Alpha©, Locoid©, Pimafucin©, and Zineryt©.
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Lead Product(s): Vadadustat
Therapeutic Area: Nephrology Product Name: Vafseo
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 26, 2020
Details:
Vadadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), is now commercially available in Japan as a treatment for anemia due to chronic kidney disease (CKD) under the trade name VAFSEO™.
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Lead Product(s): Canagliflozin
Therapeutic Area: Nephrology Product Name: Invokana
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 July 03, 2020
Details:
The EC approval is based on the Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation Phase III renal outcomes trial, which achieved pre-specified efficacy criterion.
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Lead Product(s): Canagliflozin
Therapeutic Area: Nephrology Product Name: Invokana
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 July 02, 2020
Details:
The European Commission approval is based on the Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation Phase III renal outcomes trial, which was stopped early based on the achievement of a pre-specified efficacy criterion.
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