Oncolytics’ Reolysin gets orphan drug designation for malignant gliomas treatment
An ODD has been applied by the company for pediatric high grade gliomas (HGG), however the FDA granted an ODD for the broader indication of malignant glioma in
The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have granted paediatric clinical trial waivers to Shanton Pharma for its lead candidate SAP-001, easing the drug’s regulatory paths to approval.
XMT-1522 is based on the company’s Fleximer immunoconjugate technology that carries an average of 15 proprietary auristatin payload molecules. Optimized for payload delivery, the conjugate uses a new
As part of the deal, BMS has transferred full commercialization and manufacturing operational responsibilities to Lilly. The companies’ decision comes after a 14-year successful collaboration, which includes ImClone,