FDA-&-EMA-New-Drug Approvals(Mid-2020 Recap)-insert
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Find Clinical Drug Pipeline Developments & Deals by Clinigen Group

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            Lead Product(s): Aldesleukin

            Therapeutic Area: Neurology Product Name: Proleukin

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 13, 2020

            Details:

            According to the firm, the ODD recognises the potential therapeutic role of aldesleukin in treating disease, and could provide a number of benefits for Clinigen should it obtain a marketing approval for this indication.

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            Lead Product(s): Interleukin 2,Tumor infiltrating lymphocyte,Nivolumab

            Therapeutic Area: Oncology Product Name: Undisclosed

            Highest Development Status: Phase I Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 04, 2020

            Details:

            Study aimed at evaluating the safety and efficacy of TIL therapy in metastatic NSCLC (mNSCLC) after evidence of progression on nivolumab.

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            Lead Product(s): Asparaginase

            Therapeutic Area: Oncology Product Name: Undisclosed

            Highest Development Status: Approved Product Type: Large molecule

            Recipient: Porton Biopharma

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Licensing Agreement April 16, 2020

            Details:

            Under the terms of the agreement, Clinigen will distribute Erwinase®/ Erwinaze®, the Porton's life-saving treatment for acute lymphoblastic leukaemia.

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            Lead Product(s): Aldesleukin

            Therapeutic Area: Oncology Product Name: Undisclosed

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Iovance Biotherapeutics

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement January 14, 2020

            Details:

            Proleukin will be made available by Clinigen in bulk supply over the course of a two-year period, ensuring that Iovance has uninterrupted access to Proleukin to continue ongoing clinical trials.