Industry & Policy News

[Kymera Therapeutics, Inc.] Kymera Therapeutics, Inc. announced that the US FDA has granted Fast Track designation to KT-333 for the treatment of R/R Cutaneous T cell Lymphoma and R/R Peripheral T cell Lymphoma.

[Diabetes UK] The National Institute for Health and Care Excellence (NICE) have published draft guidance approving the use of tirzepatide (brand name Mounjaro) for treating type 2 diabetes in England and Wales.

[Almirall, S.A.] Almirall S.A. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a positive opinion recommending the marketing authorization of EBGLYSS for the treatment of adult and adolescent patients with moderate-to-severe atopic dermatitis, who are candidates for systemic therapy.

[Medigene AG] Medigene AG announced that it has selected its lead candidate for MDG2011, a T cell receptor engineered T cell (TCR-T) therapy targeting KRAS G12V with HLA-A*11 and being developed in combination with the Company’s PD1-41BB costimulatory switch protein technology.

[Nature News] Researchers at the Children’s Hospital of Philadelphia are seeking approval for the first human clinical trials of the device they’ve been testing, named the Extra-uterine Environment for Newborn Development, or EXTEND. The team has emphasized that the technology is not intended — or able — to support development from conception to birth.

[NeuroBo Pharmaceuticals] NeuroBo Pharmaceuticals, Inc. announced dosing of the first patient in its two-part, Phase IIa clinical trial of DA-1241, a novel G-Protein-Coupled Receptor 119 agonist, for the treatment of nonalcoholic steatohepatitis (NASH).