INmune Bio announced that the UK Medicines & Healthcare products Regulatory Agency (MHRA) approved the Pediatric Investigation Plan (PIP) for its cell therapy Ebstrocel™, part of the CORDStrom™ platform, targeting Recessive Dystrophic Epidermolysis Bullosa (RDEB). This approval is a key regulatory step toward marketing authorization in the UK, aligning with the company's plan to file for conditional approval in 2026 and accelerated US approval in 2027. The MHRA's quick review endorses the clinical data and supports the ongoing phase 3 trial, addressing a critical unmet need for about 300 children in the UK suffering from RDEB, a severe systemic disease causing chronic wounds and pain. INmune Bio is now preparing for final regulatory submissions and manufacturing to bring this first systemic therapy for RDEB closer to market.
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CHARBONE Corporation has increased its helium delivery fleet from one to five units to meet rising demand caused by global helium supply disruptions, notably from Qatar. This expansion supports North American customers in sectors like semiconductors ...
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Xenon Pharmaceuticals is evolving into a late-stage, cash-rich neuroscience company with a validated Kv7 potassium channel platform. Its lead drug candidate, azetukalner, has shown strong effectiveness in treating refractory focal onset seizures and ...
