Shire will submit additional Fosrenol (lanthanum) data and analysis prior to approval of the non-calcium binder to address issues outlined in FDA "approvable" letter, company says March 3. "Shire is initiating a dialogue with the FDA to agree [to] the balance between pre and post approval commitments which will resolve the questions" The European Union also requested additional data (1"The Pink Sheet" March 3, In Brief)...

The risk of inadvertently growing SARS-CoV-2 virus in cell and gene therapies and possibly infecting patients and workers should be assessed and mitigated, the agency advises.

Move was meant to preempt others’ efforts to secure the next six months of Regeneron’s COVID-19 antibody therapeutic.