Vertex's HCV Drug Might Gain Advantage Over Merck's From FDA Draft Guidance
FDA’s draft guidance on chronic hepatitis C drug development inspired one analyst to predict an advantage for Vertex Pharmaceuticals’ telaprevir over Merck & Co.’s boceprevir.
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Collective top-line data from the Phase III program testing Vertex Pharmaceuticals' protease inhibitor telaprevir in treatment-naïve and treatment-experienced hepatitis C patients set a high bar for competitors, particularly for Merck & Co.'s boceprevir, with which telaprevir is dueling to be the first approved specifically targeted antiviral therapy for hepatitis C (STAT-C).
No stroke risk has been identified, but FDA and CDC officials want to investigate whether concomitant administration of influenza and COVID-19 vaccines are related to the issue.
In an interview, OND Deputy Director of Operations Kevin Bugin describes how FDA might be able to "accelerate" the transition back to in-person meetings if the initial phase with Type A and BPD Type 1 meetings goes well. But there is still no plan to return to in-person advisory committees.