Reports that Sanofi SA has asked to withdraw its sBLA for Tzield (teplizumab) from the U.S. FDA’s Commissioner’s National Priority Voucher (CNPV) program is once again raising questions about whether leadership skepticism is overruling approval decisions at the agency.
Researchers from Sab Biotherapeutics Inc. presented data generated in the development and validation of a pharmacokinetic (PK) assay for SAB-142 and the evaluation of its toxicology and immunologic effects in a juvenile cynomolgus monkey model.
Newcelx Ltd. has entered into a collaborative research agreement with Eledon Pharmaceuticals Inc. with the aim of advancing its lead program, NCEL-101, for type 1 diabetes.
Ahead Therapeutics SL has been awarded an Industry Discovery and Development Partnership (IDDP) grant from Breakthrough T1D to support progression of the company’s proprietary Mimi-Top (mimicking tolerogenic particles) platform.
Century Therapeutics Inc. has announced its first program for type 1 diabetes, CNTY-813. The program comprises induced pluripotent stem cell (iPSC)-derived β islets engineered with the company’s proprietary Allo-Evasion 5.0 technology, designed to protect from T-cell, NK-cell and humoral immune rejection, with the goal of durable glycemic control without the need for systemic immunosuppression.
Zag Bio Inc. came out of stealth mode with $80 million in funding so far, including a recently closed series A financing, to develop its platform for autoimmune diseases using drugs targeted to the thymus where thymic regulatory cells are produced.
Adocia SA is looking to further apply its Biochaperone formulation technology to metabolic disorders, Olivier Soula, Adocia co-founder and CEO told BioWorld, the firmhaving recently gained positive top-line phase III results of Tonghua Dongbao Pharmaceutical Co. Ltd.’s THDB-0206 injection (Biochaperone Lispro) in diabetes patients in China.
Zag Bio Inc. came out of stealth mode with $80 million in funding so far, including a recently closed series A financing, to develop its platform for autoimmune diseases using drugs targeted to the thymus where thymic regulatory cells are produced.
Adocia SA is looking to further apply its Biochaperone formulation technology to metabolic disorders, Olivier Soula, Adocia co-founder and CEO told BioWorld, the firmhaving recently gained positive top-line phase III results of Tonghua Dongbao Pharmaceutical Co. Ltd.’s THDB-0206 injection (Biochaperone Lispro) in diabetes patients in China.
