Industry & Policy News

[Atea Pharmaceuticals, Inc.] Atea Pharmaceuticals, Inc. announced the initiation of a first-in-human Phase I clinical trial evaluating AT-587, for the treatment of hepatitis E virus infection.

[Fate Therapeutics, Inc.] Fate Therapeutics, Inc. announced that the US FDA has cleared its Investigational New Drug application for FT839, the Company’s next-generation, off-the-shelf CAR T cell product candidate uniquely engineered to co-target CD19 and CD38.

[] EMA’s human medicines committee (CHMP) has started a phased review of data on daraxonrasib, a medicine intended for the treatment of metastatic pancreatic cancer. A phased review aims to accelerate the assessment of a medicine by evaluating the data in phases, as they become available.

[STEMCELL Technologies] STEMCELL Technologies and the Centre for Commercialization of Regenerative Medicine (CCRM) announced a partnership to expand access to high-quality hiPSC starting materials, giving cell therapy developers worldwide a faster, lower-risk path from research to the clinic.

[Epicrispr Biotechnologies] Epicrispr Biotechnologies announced the completion of enrollment and dosing in the dose-escalation portion of its first-in-human clinical trial evaluating EPI-321 for facioscapulohumeral muscular dystrophy.

[Emmecell (Businesswire)] Emmecell announced that the US FDA has granted Regenerative Medicine Advanced Therapy designation to EO2002, the Company’s lead investigational magnetic human corneal endothelial cell therapy for the treatment of corneal edema secondary to corneal endothelial dysfunction.