All Data
Lead Product(s): Capecitabine
Therapeutic Area: Oncology 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 February 17, 2021
Details:
Dr. Reddy’s Capecitabine Tablets, USP are available in 150 mg and 500 mg strengths in bottle count sizes of 60 and 120, respectively.
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Lead Product(s): Olaparib
Therapeutic Area: Oncology Product Name: Lynparza
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: AstraZeneca PLC
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 17, 2021
Details:
Based on the planned interim analysis, the IDMC concluded that the trial crossed the superiority boundary for its primary endpoint of invasive disease-free survival (iDFS) and demonstrated a sustainable, clinically relevant treatment effect for Lynparza versus placebo.
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Lead Product(s): Sunitinib
Therapeutic Area: Oncology Product Name: Sutib
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 16, 2021
Details:
Sunitinib is an oral multi-kinase inhibitor (MKI), works by blocking several enzymes that promote cell growth. It is useful for the treatment of certain patients with gastrointestinal stromal tumors and advanced renal cell carcinoma.
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Lead Product(s): Axitinib
Therapeutic Area: Oncology 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 01, 2020
Details:
Glenmark has received tentative approval by the United States Food & Drug Administration (U.S. FDA) for Axitinib Tablets, 1 mg and 5 mg, the generic version of Inlyta Tablets, 1 mg and 5 mg, of PF Prism C.V.
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Lead Product(s): Palbociclib
Therapeutic Area: Oncology 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 November 09, 2020
Details:
The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), lbrance Capsules, 75 mg, 100 mg, and 125 mg, of Pfizer Inc. (Pfizer).
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Lead Product(s): Doxorubicin HCl
Therapeutic Area: Oncology 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 11, 2020
Details:
Zydus Cadila has received final approval from the USFDA to market Doxorubicin Hydrochloride Liposome Injection in the strengths of 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL) Single-Dose Vials. First approval for a complex injectable which has been developed in-house.
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Lead Product(s): Trastuzumab
Therapeutic Area: Oncology Product Name: Herclon
Highest Development Status: Approved Product Type: Large molecule
Partner/Sponsor/Collaborator: F. Hoffmann-La Roche
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership June 17, 2020
Details:
Cipla entered a distribution agreement with Roche Products to expand scope of the partnership to include, marketing and distribution of Roche’s trademark oncology drugs - Trastuzumab (Herclon), Bevacizumab (Avastin) and Rituximab (Ristova) in India.
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