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).
Roche has received conditional marketing authorisation from the European Commission (EC) for Lunsumio (mosunetuzumab) subcutaneous (SC) for adults with relapsed or refractory follicular lymphoma (R/R FL) after at least two systemic therapies.
Insmed has received approval from the European Commission (EC) for Brinsupri (brensocatib 25 mg tablets) to treat non-cystic fibrosis bronchiectasis (NCFB) in patients aged 12 and above with two or more exacerbations in the year preceding treatment.
Sofinnova Partners has closed its latest Sofinnova Capital XI fund, aimed at supporting early-stage healthcare companies in the US and Europe, at €650m ($750m) above its initial target.
Novartis has opened a 10,000ft² radioligand therapy (RLT) manufacturing facility in Carlsbad in the US state of California, as part of its $23bn investment in the country’s infrastructure up to 2030.
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