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Mundipharma

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GERMANY Germany

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Mundipharma Gets E.C Approval for Extended Invokana® (Canagliflozin) Indication to Cover Diabetic KD in Type 2 Diabetes

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.

Napp Pharmaceuticals

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United Kingdom

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Napp Pharmaceuticals Announces European Commission Approval of Invokana® (canagliflozin) Label Update to Reflect Improved Renal Outcomes in...

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.

Emcure Pharmaceuticals

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INDIA India

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Emcure Pharma Launches Generic Drug for Hyperphosphatemia in Chronic Kidney Disease Patients

Lead Product(s): Sucroferric Oxyhydroxide

Therapeutic Area: Nephrology Product Name: Dynulta

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 01, 2020

Details:

The company launched generic version of sucroferric oxyhydroxide tablets, indicated for the control of increased serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis.

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Mundipharma

Mundipharma Gets E.C Approval for Extended Invokana® (Canagliflozin) Indication to Cover Diabetic KD in Type 2 Diabetes

Napp Pharmaceuticals

Napp Pharmaceuticals Announces European Commission Approval of Invokana® (canagliflozin) Label Update to Reflect Improved Renal Outcomes in...

Emcure Pharmaceuticals

Emcure Pharma Launches Generic Drug for Hyperphosphatemia in Chronic Kidney Disease Patients