Scynexis to recall GSK partnered antifungal pill over cross contamination risk
Scynexis said on Monday it would voluntarily recall its antifungal pill, which it has licensed to GSK, due to risk of cross-contamination with a potential allergy-inducing compound, sending the drugmaker's shares tumbling over 30%.
The drugmaker said it became aware substances used to make drugs that contain beta-lactam are manufactured using equipment also used to make its treatment, called Brexafemme.
The U.S. Food and Drug Administration's guidelines require companies to segregate the manufacturing of beta-lactam compounds from other drugs because they may trigger hypersensitivity or an allergic reaction in some people.
Scynexis said the recall was cautionary and that it had not received any report of any adverse events due to possible beta-lactam cross contamination.
It had also placed a temporary hold on clinical studies of the drug until a mitigation strategy and a resupply plan were determined.
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