Merck & Co. Pauses Enrollment Of Oral Islatravir In PrEP Studies As Bad News Mounts
Merck has already paused other studies testing the potential first-in-class NRTTI and is adding additional monitoring of lymphocyte and CD4+ T-cell assessments.
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After a nine-month US FDA-imposed pause, Merck is relaunching its studies of islatravir with a lower dose, while also abandoning its use in PrEP studies.
The US FDA issued a complete response letter for the P2X3 receptor antagonist for the treatment of refractory chronic cough, requesting more efficacy data.
Biopharma will outline its growth goals for 2022 over the coming weeks, with J&J, Novartis, AbbVie, Merck, Roche, Biogen and Lilly among the first to report.