- cafead Dec 22, 2021 at 11:02: AM
via The FDA is coming down on yet another therapy over concerns about glass particulates winding up in drug solution.
Regulators have slapped a clinical hold on 10 trials studying injectable versions of Gilead’s experimental HIV treatment lenacapavir, due to concerns that vials made of borosilicate glass could lead to the formation of sub-visible glass particles in the solution.
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Regulators have slapped a clinical hold on 10 trials studying injectable versions of Gilead’s experimental HIV treatment lenacapavir, due to concerns that vials made of borosilicate glass could lead to the formation of sub-visible glass particles in the solution.
article source