Nephrology

Aurinia Pharmaceuticals

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CANADA Canada

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Drug Discovery Chemistry

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Aurinia Announces AURORA Phase 3 Clinical Data for Voclosporin

Lead Product(s): Voclosporin,Mycophenolic Acid,Corticosteroids

Therapeutic Area: Nephrology

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 18, 2020

Details:

Clinical data from its AURORA Phase 3 trial will be highlighted in a late-breaking oral presentation during the National Kidney Foundation 2020 Spring Clinical Meetings.

Mallinckrodt Plc

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United States

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Drug Discovery Chemistry

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Mallinckrodt Completes Rolling Submission of New Drug Application to the FDA

Lead Product(s): Terlipressin

Therapeutic Area: Nephrology

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 17, 2020

Details:

The terlipressin NDA is based, in part, on results from the Phase 3 CONFIRM trial, and the culmination of a sustained, 17-year effort to develop terlipressin for potential use in the U.S. and Canada.

Aurinia Pharmaceuticals

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CANADA Canada

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Drug Discovery Chemistry

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Aurinia Pharmaceuticals Initiates Rolling Submission of a New Drug Application to the FDA for Voclosporin

Lead Product(s): Voclosporin

Therapeutic Area: Nephrology

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 16, 2020

Details:

The rolling NDA allows completed portions of an NDA to be submitted and reviewed by the Agency on an ongoing basis.

Boehringer Ingelheim GmbH

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GERMANY Germany

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Drug Discovery Chemistry

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US FDA grants Fast Track designation to Jardiance®

Lead Product(s): Empagliflozin

Therapeutic Area: Nephrology

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 12, 2020

Details:

The EMPA-KIDNEY clinical study is evaluating Jardiance for the progression of kidney disease and the occurrence of cardiovascular death in adults with established CKD with and without diabetes.

University of Rochester School of Medicine & Dentistry

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United Kingdom

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Drug Discovery Chemistry

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Evgen and Rochester University partner to advance SFX-01 trial

Lead Product(s): Sulforaphane

Therapeutic Area: Nephrology

Highest Development Status: Undisclosed Product Type: Small molecule

Partner/Sponsor/Collaborator: Evgen Pharma

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement February 18, 2020

Details:

Under the agreement, Evgen will supply SFX-01 to support a potential future clinical trial led by University of Rochester Nephrology division chief Thu Le.

Catalent Pharma Solutions

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United States

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Drug Discovery Chemistry

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Catalent to Support DiaMedica Trial Using GPEx Technology

Lead Product(s): DM199

Therapeutic Area: Nephrology

Highest Development Status: Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 23, 2020

Details:

WI facility to support the trial using its GPEx cell line development technology. DiaMedica intends to initiate enrollment in the study in the next few weeks.

AbbVie Inc

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United States

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Drug Discovery Chemistry

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Chinook Therapeutics Obtains Worldwide Rights from AbbVie to Atrasentan with Plans to Develop for the Treatment of Kidney Diseases

Lead Product(s): Atrasentan Hydrochloride

Therapeutic Area: Nephrology

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Chinook Therapeutics

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement January 10, 2020

Details:

Chinook Therapeutics in-license of atrasentan provides a unique opportunity for Chinook to add a potential new drug to its precision medicine portfolio for the treatment of rare CKD conditions.

Novome Biotechnologies

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United States

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Drug Discovery Chemistry

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Novome Biotechnologies Raises $33 Million Series A Financing and Appoints Blake Wise as Chief Executive Officer

Lead Product(s): Undisclosed

Therapeutic Area: Nephrology

Highest Development Status: Discovery Product Type: Large molecule

Partner/Sponsor/Collaborator: DCVC Bio

Deal Size: $33.0 million Upfront Cash: Undisclosed

Deal Type: Series A Financing January 07, 2020

Details:

The financing will be used to advance the company’s lead hyperoxaluria program through Phase 1 clinical proof-of-concept work, as well as to expand its (GEMMs) platform.

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Product Type

Development Status

Aurinia Pharmaceuticals

Aurinia Announces AURORA Phase 3 Clinical Data for Voclosporin

Mallinckrodt Plc

Mallinckrodt Completes Rolling Submission of New Drug Application to the FDA

Aurinia Pharmaceuticals

Aurinia Pharmaceuticals Initiates Rolling Submission of a New Drug Application to the FDA for Voclosporin

Boehringer Ingelheim GmbH

US FDA grants Fast Track designation to Jardiance®

University of Rochester School of Medicine & Dentistry

Evgen and Rochester University partner to advance SFX-01 trial

Catalent Pharma Solutions

Catalent to Support DiaMedica Trial Using GPEx Technology

AbbVie Inc

Chinook Therapeutics Obtains Worldwide Rights from AbbVie to Atrasentan with Plans to Develop for the Treatment of Kidney Diseases

Novome Biotechnologies

Novome Biotechnologies Raises $33 Million Series A Financing and Appoints Blake Wise as Chief Executive Officer