Multi-drug resistant HIV-1 infection Archives

FDA Action Alert: Immunocore, Reata, CTI, Gilead and Legend/Janssen

Biologics License Application (BLA), Chronic Kidney Disease, Clinical Trials, FDA/Regulatory, Genetic Mutations, Gilead, Kinase Inhibitors, Multi-drug resistant HIV-1 infection, Multiple Myeloma, Myelofibrosis, PDUFA, Priority Review Status, R&D, Uveal Melanoma

Legend Biotech has a target action date of February 28 for the company’s BLA for ciltacabtagene autoleucel (cilta-cel) for adults with relapsed and/or refractory multiple myeloma. The BLA was submitted by Legend’s collaboration partner, Janssen Biotech Inc., a Johnson & Johnson company.

February 21, 2022/by Andrew Humphreys

New Phase 3 Data Support the Sustained, Long-Acting Efficacy of Lenacapavir, Gilead’s Investigational HIV-1 Capsid Inhibitor

Antiretrovirals, Capsid inhibitors, Clinical Data, Clinical Trials, Gilead, HIV infections, Multi-drug resistant HIV-1 infection, R&D

Gilead Sciences Inc. announced new results from the Phase 2/3 CAPELLA trial evaluating lenacapavir, the company’s investigational, long-acting HIV-1 capsid inhibitor, in heavily treatment-experienced people living with multi-drug resistant HIV.

July 17, 2021/by Andrew Humphreys