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Details:
FDA has approved the NDA for alkylating agent, TEPYLUTE (thiotepa), a ready-to-dilute infusion formulation to treat breast and ovarian cancer.
Lead Product(s): Thiotepa
Therapeutic Area: Oncology Product Name: Tepylute
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 28, 2024
Details:
SH-201 is the first palatable oral liquid of the related chemotherapeutic agent in the U.S. SH-201 is an oral liquid treatment that slows or stops the growth of certain forms of leukemia (such as acute lymphoblastic leukemia and chronic myeloid leukemia) and other cancers.
Lead Product(s): SH-201
Therapeutic Area: Oncology Product Name: SH-201
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 08, 2024
Details:
SH-105 is a ready-to-dilute form of a well-established drug that has been used as a freeze-dried powder. It is being evaluated for the treatment of breast and ovarian cancer.
Lead Product(s): SH-105
Therapeutic Area: Oncology Product Name: SH-105
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 09, 2024
Details:
Jylamvo (methotrexate) is a DHFR inhibitor small molecule drug candidate, which is currently being evaluated for the treatment of acute lymphoblastic leukemia in adults.
Lead Product(s): Methotrexate
Therapeutic Area: Oncology Product Name: Jylamvo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 19, 2023
Details:
Through the acquisition, Shorla gains Jylamvo, an oncology and autoimmune drug and easy-to-administer, sweet tasting oral methotrexate solution that eliminates the need for crushing or splitting pills, or compounding into a liquid formulation, for the US market.
Lead Product(s): Methotrexate
Therapeutic Area: Immunology Product Name: Jylamvo
Highest Development Status: ApprovedProduct Type: Small molecule
Recipient: Therakind
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition October 31, 2023
Details:
The financing will be used to accelerate the growth of its oncology portfolio by advancing its pipeline, including SH-105, bringing therapies to market that will address drug shortages, and improving the preparation and application of oncology medication.
Lead Product(s): SH-105
Therapeutic Area: Oncology Product Name: SH-105
Highest Development Status: Phase IIIProduct Type: Undisclosed
Partner/Sponsor/Collaborator: Kurma Partners’ Growth Opportunities Fund
Deal Size: $35.0 million Upfront Cash: Undisclosed
Deal Type: Series B Financing October 04, 2023
Details:
Under the agreement, Shorla will obtain an exclusive license from the developer to register and commercialize PIP-101, the first palatable oral solution of the related chemotherapeutic agent in the U.S. that slows or stops the growth of certain forms of leukemia.
Lead Product(s): PIP-101
Therapeutic Area: Oncology Product Name: PIP-101
Highest Development Status: Phase IIIProduct Type: Undisclosed
Recipient: Undisclosed
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement July 06, 2023
Details:
Nelarabine Injection is a nucleoside metabolic inhibitor indicated for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma in adult and pediatric patients age 1 year and older.
Lead Product(s): Nelarabine
Therapeutic Area: Oncology Product Name: Nelarabine-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Eversana
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 16, 2023
Details:
The funding will support the advancement of the product pipeline, along with expansion of technical and commercial operations in both Ireland and the US.
Lead Product(s): SH-105
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Undisclosed
Partner/Sponsor/Collaborator: Seroba Life Sciences
Deal Size: $8.3 million Upfront Cash: Undisclosed
Deal Type: Series A Financing June 06, 2020