By Barbara Obstoj-Cardwell. Editor
In COVID-19 related news last week, Japan’s Takeda and Australia’s CSL Ltd reported that the project they are leading, dubbed CoVig-19 Plasma Alliance, had failed to meet Phase III goals, and is therefore concluded. AstraZeneca’s COVID-19 vaccine, now called Vaxzevria, came under the spotlight last week regarding possible links to blood clots. On the regulatory front, Acadia Pharmaceuticals had a setback, as the US Food and Drug Administration issued a complete response letter (CRL) relating to its supplementary Biologics License (sBLA) for Nuplazid as a treatment for dementia-related psychosis. FibroGen revealed that some false data had been presented on its drug candidate roxadustat for the treatment of chronic kidney disease-associated anemia. Also, Provention Bio revealed problems with its regulatory filing for diabetes candidate teplizumab.
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