Astellas Pharma (TSE:4503) has revealed that the FDA has slapped a clinical hold on its Phase 1/2 FORTIS Pompe disease study after observing a serious adverse event (SAE) — peripheral sensory neuropathy — in a trial participant. Peripheral sensory neuropathy results from damage to nerves outside of the central nervous system. The condition can lead…

The Galien Foundation has revealed its latest nominees for the 2021 Prix Galien USA Award highlighting innovations in biotechnology, pharmaceutical agents, medical technology and digital health products. Entrants to the competition must have received FDA approval within the past five years and demonstrate exceptional therapeutic potential. The Galien Foundation does not use financial data to…

Xospata (gilteritinib) from Astellas Pharma is indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia with a FMS-like tyrosine kinase 3 (FLT3) mutation as detected by an FDA-approved test. In March, Astellas announced that the drug met its primary endpoint in a planned interim analysis of a Phase 3 confirmatory…

The Galien Foundation recently announced nominees for most innovative pharmaceutical agents for its 14th Annual Prix Galien USA Awards. The foundation bestows the Prix Galien Award annually to examples of outstanding biomedical, pharmaceutical drugs and medical technology products that are designed to improve the human condition. “As we celebrate 50 years of the Prix Galien…