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.
GlaxoSmithKline said on Sept. 28 the company would develop an HIV treatment with Japan’s Shionogi for use in regimens with dosing gaps of three months or more, as the drugmaker seeks to build on the success of GSK’s previous long-acting therapies.
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.
The Oncologic Drugs Advisory Committee (ODAC), as part of the U.S. Food and Drug Administration, voted 13-4 that a regulatory decision on Incyte’s PD-1 inhibitor retifanlimab for the treatment of advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) should be deferred until further data are available from the clinical trial POD1UM-303.
GlaxoSmithKline Plc said an injection of the company’s cabotegravir drug given every two months, in combination with Johnson & Johnson’s rilpivirine, was recommended for approval to treat HIV infections by a panel of the European health regulator.
The U.S. Food and Drug Administration approved Switzerland-based pharmaceutical company Roche’s HIV-1/HIV-2 qualitative test for use on the fully automated Cobas 6800/8800 Systems.
Britain’s GSK said an injection of the company’s cabotegravir drug given every two months was found to be 65 percent more effective in preventing HIV infections than Gilead’s Truvada daily oral pills.
The U.S. Food and Drug Administration approved Gilead Sciences Inc.’s Descovy to reduce the risk of sexually acquired HIV infection in men and transgender women who have sex with men.
GlaxoSmithKline’s ViiV Healthcare received European Commission approval for Dovato to treat advanced-stage HIV infections in adults and adolescents above the age of 12 and weighing at least 40 kg.
GlaxoSmithKline’s two-drug treatment for HIV infections won marketing approval from a European Medicines Agency panel. The British drugmaker received U.S. FDA approval in April 2019.