CAR-T & Other Cell Therapy Testing

23 08, 2023

First IND clearance for an allogeneic, off-the-shelf NK or CAR-T cell therapy candidate in autoimmune disease

2023-08-23T12:54:17+00:00

Artiva Biotherapeutics announced today that the U.S. Food and Drug Administration has cleared the company’s Investigational New Drug application for AlloNK®, in combination with rituximab for treatment of systemic lupus erythematosus in patients with active lupus nephritis...

First IND clearance for an allogeneic, off-the-shelf NK or CAR-T cell therapy candidate in autoimmune disease2023-08-23T12:54:17+00:00
18 07, 2023

FDA Approves First Cellular Therapy to Treat Patients with Type 1 Diabetes

2023-07-18T13:27:31+00:00

The U.S. Food and Drug Administration approved Lantidra, the first allogeneic (donor) pancreatic islet cellular therapy made from deceased donor pancreatic cells for the treatment of type 1 diabetes. Lantidra is approved for the treatment of adults with type 1 diabetes who are unable to approach target glycated hemoglobin (average blood glucose levels) because of current...

FDA Approves First Cellular Therapy to Treat Patients with Type 1 Diabetes2023-07-18T13:27:31+00:00
27 06, 2023

A historic first for gene therapy

2023-06-27T12:46:28+00:00

Sarepta Therapeutics announces FDA approval of ELEVIDYS, the first gene therapy to treat Duchenne Muscular Dystrophy. ELEVIDYS addresses the root genetic cause of Duchenne – mutations in the dystrophin gene that result in the lack of dystrophin protein – by delivering a gene that codes for a shortened form of dystrophin to muscle cells known as ELEVIDYS micro-dystrophin...

A historic first for gene therapy2023-06-27T12:46:28+00:00
13 06, 2023

2seventy bio presents broad range of new data highlighting novel approaches across its cell therapies portfolio

2023-06-13T14:36:57+00:00

2seventy bio announced new data featuring novel approaches combining the company’s platform CAR T cell and T cell receptor technology and unique cell therapy engineering capabilities to potentially enhance treatment potency in a range of cancers...

2seventy bio presents broad range of new data highlighting novel approaches across its cell therapies portfolio2023-06-13T14:36:57+00:00
2 03, 2023

Avance Biosciences™ licenses SeQure Dx’s GUIDE-seq off-target NGS analysis technology

2023-04-11T14:21:43+00:00

Avance Biosciences™ (Avance), a leading CRO that provides GLP/CGMP-compliant biological testing services that aid drug development and manufacturing, announced today that it has signed a licensing agreement with SeQure Dx, a cutting-edge gene-editing diagnostics company...

Avance Biosciences™ licenses SeQure Dx’s GUIDE-seq off-target NGS analysis technology2023-04-11T14:21:43+00:00
2 08, 2022

ARM and NIIMBL Release Project A-Cell to Bring Quality by Design Principles to Cell-Based Therapy Manufacturing

2022-08-02T18:20:11+00:00

Effort to address challenges to the manufacturing scale-up of cell-based therapies follows release of Project A-Gene for gene therapy in 2021 The Alliance for Regenerative Medicine (ARM) and the National Institute for Innovation in Manufacturing BioPharmaceuticals (NIIMBL) today released Project A-Cell, a multistakeholder collaboration to incorporate Quality by Design (QbD) principles into a manufacturing case [...]

ARM and NIIMBL Release Project A-Cell to Bring Quality by Design Principles to Cell-Based Therapy Manufacturing2022-08-02T18:20:11+00:00