Solid Biosciences has secured the US Food and Drug Administration (FDA) rare paediatric disease designation for SGT-212, its investigational gene therapy targeting Friedreich’s ataxia (FA).
IASO Biotechnology has received the Hong Kong Department of Health’s approval for its biologics licence application (BLA) for the fully human anti-B-cell maturation antigen (BCMA) chimeric antigen receptor T-cell (CAR-T) therapy, Fucaso (Equecabtagene Autoleucel), for adults with relapsed or refractory multiple myeloma (R/R MM).
The US Food and Drug Administration (FDA) has accepted the new drug application (NDA) for BeOne Medicines’ B-cell lymphoma 2 (BCL2) inhibitor, sonrotoclax, and granted it priority review for use in treating adults with relapsed or refractory mantle cell lymphoma (R/R MCL).
UNICEF and Gavi, the Global Alliance for Vaccines and Immunisation now known as the Vaccine Alliance, have announced a pricing deal to expand access to the R21/Matrix-M malaria vaccine, aiming to protect almost seven million more children from the disease.
Otsuka Pharmaceutical has secured accelerated approval from the US Food and Drug Administration (FDA) for Voyxact (sibeprenlimab-szsi) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at disease progression risk.
Novartis has received approval from the US Food and Drug Administration (FDA) for the Itvisma (onasemnogene abeparvovec-brve) gene replacement therapy to treat spinal muscular atrophy (SMA).
AstraZeneca has announced a $2bn investment plan to expand its biomanufacturing presence in the US state of Maryland, aiming to support 2,600 jobs at its Frederick and Gaithersburg sites.
OSR Company Vaximm has signed a non-binding term sheet with Swiss-based life sciences investor BCM Europe (BCME) for a potential exclusive worldwide licence for Vaximm’s oral cancer immunotherapy platform, VXM01.
US-based Aspen Neuroscience has closed a Series C funding round, raising $115m to further the clinical development of its lead autologous cell therapy candidate, ANPD001, for moderate-to-advanced Parkinson’s disease.
Alvotech and Advanz Pharma have announced the European Commission’s (EC) marketing authorisations for Gobivaz, a biosimilar to Simponi (golimumab), across the European Economic Area (EEA).
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