Issues at Italian CDMO leads to US approval delay for Novartis’ inclisiran

he US FDA has issued a complete response letter for Leqvio (inclisiran) due to ‘unresolved facility inspection-related conditions’ at a third-party site run by Corden Pharma. In October 2020, this publication reported the US approval of Novartis’ small interfering RNA (siRNA) therapy for the treatment of adults with hypercholesterolemia or mixed dyslipidemia, Leqvio, was dependent […]

FDA authorizes CPAP machines and more as emergency ventilator alternatives

The FDA issued a wide-ranging emergency policy allowing alternative devices to be used as potentially lifesaving ventilators as shortages begin to impact hospitals’ responses to the coronavirus pandemic. This includes modified anesthesia gas hardware and positive-pressure breathing devices as well as home continuous positive airway pressure machines used to treat sleep apnea, portable oxygen generators […]

Collaboration Formed to Develop New Radiochemicals for Diagnosing, Treating Brain Diseases

A collaborative effort between Fuzionaire Diagnostics, McGill University and The Neuro (Montreal Neurological Institute-Hospital) will foster the development of a new class of radioactive molecules — called radiochemicals — for the diagnosis and treatment of neurodegenerative diseases, including Parkinson’s disease. Radiochemicals are compounds prepared with radioactive elements that are used for medical applications, such as tracers in positron emission tomography (PET) scans. PET scan […]