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AZ gets CRL asking for REMS changes to rare disease sBLA

While the U.S. FDA didn’t ask for more study data or have safety or efficacy concerns, it does want modifications to Alexion, Astrazeneca Rare Disease’s sBLA for Ultomiris (ravulizumab-cwvz) to treat adults with the rare central nervous system disease neuromyelitis optica spectrum disorder. The agency has issued a complete response letter (CRL) requesting changes to Ultomiris’ Risk Evaluation and Mitigation Strategy (REMS) to better validate patients’ meningococcal vaccination status or prophylactic administration of antibiotics before being treated. ....

Astrazeneca Rare Disease , Ultomiri Risk Evaluation , Mitigation Strategy , Astrazeneca Plc , Astrazeneca Rare Disease , Neuromyelitis Optica Spectrum Disorder , Complete Response Letter , Rare Disease , Alexion Pharmaceuticals Inc ,

Evolution of Schizophrenia Treatment Shaped by the COVID-19 Pandemic

Panelists discuss the impact of pandemic-influenced process changes and shifting standards of care for the treatment of schizophrenia. ....

Carolinep Carney , Sandy Dimiterchik , Nev Jones , Johnj Miller , Whati D , Covid 19 Pandemic , Support System , Access To Care ,