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Lead Product(s): Ethacrynic Acid
Therapeutic Area: Cardiology/Vascular Diseases 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 October 20, 2020
Details:
Strides Pharma Global Pte. Limited, Singapore, has received approval for Ethacrynic Acid Tablets USP, 25 mg from the United States Food & Drug Administration (USFDA). The product is a generic version of Edecrin® Tablets, 25 mg, of Bausch Health Americas, Inc.
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Lead Product(s): Apixaban
Therapeutic Area: Cardiology/Vascular Diseases 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 September 14, 2020
Details:
Apixaban is an anticoagulant, or blood thinner. It is used for patients with health problems caused by a blood clot.
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Lead Product(s): Ivabradine
Therapeutic Area: Cardiology/Vascular Diseases 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 September 02, 2020
Details:
Approval marks the first once-a-day formulation for Ivabradine in India, which will help increase adherence to therapy for chronic heart failure and chronic stable angina.
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Lead Product(s): Midodrine
Therapeutic Area: Cardiology/Vascular Diseases 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 September 02, 2020
Details:
Zydus Cadila has received final approval from the USFDA to market Cisatracurium Besylate Injection USP (US RLD: Nimbex ®) in the strength of 20 mg (base)/10 mL (2 mg/mL) Multiple-Dose Vial.
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Lead Product(s): Bone marrow-derived allogeneic mesenchymal stromal cells
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Stempeucel
Highest Development Status: Approved Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Stempeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration August 20, 2020
Details:
Stempeucel® has been developed by Stempeutics and is the first allogeneic cell therapy product to be approved for commercial use in India and the first stem cell product to be approved globally for CLI treatment. Cipla will market and distribute in Stempeucel® India.
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Lead Product(s): Bone marrow-derived allogeneic mesenchymal stromal cells
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed
Highest Development Status: Approved Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Novumcella
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement May 28, 2020
Details:
As per the agreement, Novumcella will initially provide regulatory support services to Stempeutics for getting approval from PMDA, Japan for conduct of bridge study in Japan for commercializing Stempeucel® product for Buerger’s Disease.
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