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Triastek

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MED™ 3D Printed Pharmaceutical Product Receives IND Clearance From the US FDA

Lead Product(s): T19

Therapeutic Area: Immunology Product Name: T19

Highest Development Status: IND Enabling Product Type: Undisclosed

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 09, 2021

Details:

United States Food and Drug Administration (FDA) has approved Triastek's Investigational New Drug (IND) 505(b)(2) application for its first 3D printed drug product – T19, indicated for the treatment of rheumatoid arthritis (RA).

InnoCare Pharma

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InnoCare Announces Clearance by the US FDA of Phase II Clinical Trial Using Orelabrutinib for the Treatment of Multiple Sclerosis

Lead Product(s): Orelabrutinib

Therapeutic Area: Immunology Product Name: ICP-022

Highest Development Status: IND Enabling Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 02, 2020

Details:

This will be a randomized, double-blind, placebo-controlled and multi-center phase II Study in Relapsing-Remitting multiple sclerosis patients (RRMS). Orelabrutinib is a highly selective BTK inhibitor targeting both B-cell lymphomas and autoimmune indications.