Merck & Co. Eyes Neuroscience Advancement With US FDA’s New Receptivity To Biomarkers
Company is ‘anxious to understand’ how to utilize the agency’s views on importance of biomarkers, exec notes in earnings call. Merck & Co. and Pfizer advance COVID-19 therapeutics into Phase III. Pfizer is awaiting FDA risk-benefit assessment of JAK-1 inhibitors Xeljanz and abrocitinib.
You may also be interested in...
The Coalition for Epidemic Preparedness and Innovations is working with China’s ZerunBio to develop prototype and variant vaccine candidates, and Australia believes MSD’s molnupiravir could be a potential treatment for COVID-19. The European Medicines Agency is looking into more possible side effects with two mRNA vaccines.
Ahead of CDC advisory committee this fall, Merck highlights additional bacteria serotypes its Vaxneuvance protects against while Pfizer touts Prevnar 13’s indication for pneumonia.
After Pfizer saw increased risks in a surveillance study of Xeljanz, three other products have also seen their user fee dates pushed back; if FDA were to convene an expert panel, it could lead to more consistent labeling across the class, as requested in a recent citizen petition.