FDA-&-EMA-New-Drug Approvals(Mid-2020 Recap)-insert
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Find Novel Endocrinology Drugs in Clinical Development

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            Lead Product(s): Glargine

            Therapeutic Area: Endocrinology Product Name: Undisclosed

            Highest Development Status: Undisclosed Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 11, 2020

            Details:

            At the Biosimilar Biological Product Development Type II meeting the FDA provided positive feedback on the clinical and Chemistry, Manufacturing and Controls advancement of company's biosimilar insulin glargine that was consistent with our expectations.

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            Lead Product(s): Recombinant pluripotent stem cell-derived pancreatic islet beta cells

            Therapeutic Area: Endocrinology Product Name: Undisclosed

            Highest Development Status: Undisclosed Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Sernova

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Collaboration May 29, 2020

            Details:

            Sernova to utilize AgeX’s UniverCyteTM gene technology to generate transplantable, universal immune-protected therapeutic cells for Sernova’s Cell PouchTM Platform.

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            Lead Product(s): KT-A112

            Therapeutic Area: Endocrinology Product Name: Undisclosed

            Highest Development Status: Undisclosed Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: QVT

            Deal Size: $80.5 million Upfront Cash: Undisclosed

            Deal Type: Series A Financing May 12, 2020

            Details:

            Financing proceeds will support the development of Kriya's pipeline, internal discovery engine, and proprietary GMP manufacturing infrastructure. Kriya's initial pipeline includes multiple AAV-based gene therapies for the treatment of metabolic diseases.

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            Lead Product(s): IDG-16177

            Therapeutic Area: Endocrinology Product Name: Undisclosed

            Highest Development Status: Undisclosed Product Type: Undisclosed

            Partner/Sponsor/Collaborator: ILDONG Pharmaceutical Co. Ltd

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Collaboration March 31, 2020

            Details:

            Under the terms of the agreement, Evotec's experts in Integrated development solutions will accelerate the development of Ildong's projects with services from Evotec's comprehensive INDiGO platform.

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            Lead Product(s): Gene Therapy-AAV8

            Therapeutic Area: Endocrinology Product Name: Undisclosed

            Highest Development Status: Undisclosed Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Ultragenyx Pharmaceutical

            Deal Size: Undisclosed Upfront Cash: $7.0 million

            Deal Type: Licensing Agreement March 31, 2020

            Details:

            Ultragenyx has been granted an exclusive, worldwide license, with rights to sublicense REGENXBIO's NAV AAV8 and AAV9 Vectors for the development and commercialization of gene therapy treatments.

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            Lead Product(s): Undisclosed

            Therapeutic Area: Endocrinology Product Name: Undisclosed

            Highest Development Status: Undisclosed Product Type: Undisclosed

            Partner/Sponsor/Collaborator: JDRF T1D

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Financing March 25, 2020

            Details:

            The investment from the JDRF T1D Fund wil help company to utilize its core platforms to discover new antigens and T cell receptors in hopes of advancing the development of treatments for T1D.

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            Lead Product(s): Gut microbiome based therapeutics

            Therapeutic Area: Endocrinology Product Name: Undisclosed

            Highest Development Status: Undisclosed Product Type: Large molecule

            Partner/Sponsor/Collaborator: Dupont Nutrition & Health

            Deal Size: $15.1 million Upfront Cash: Undisclosed

            Deal Type: Collaboration February 19, 2020

            Details:

            In collaboration, proprietary MRM Health technology platform and some selected DuPont strains will be combined to develop novel therapeutics based on live bacterial strain combinations.

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            Lead Product(s): saRNA

            Therapeutic Area: Endocrinology Product Name: Undisclosed

            Highest Development Status: Undisclosed Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: AstraZeneca PLC

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Collaboration January 07, 2020

            Details:

            The collaboration combines MiNA's expertise in the discovery & development of saRNA therapeutics with AstraZeneca's experience in bringing breakthrough treatments to patients with metabolic diseases.