NASH Race No More Clear After AASLD Than Before
Genfit joins Intercept in Phase III, but Tobira thinks its Phase IIb study will position it well for registrational studies. Intercept expects to get to market first in primary biliary cholangitis, which could be a significant market opportunity.
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Sponsors in the hotly pursued and yet untapped field of non-alcoholic steatohepatitis think that selection of different primary or co-primary endpoints could help differentiate their programs in the competitive space.
Approved in February as an on-demand remedy, Nurtec will be filed for migraine prevention after success in Phase III. It could be the first oral preventive therapy and first dual purpose migraine drug.
A protocol amendment is not needed to pause enrollment to decrease potential exposure to COVID-19, and virtual visits can be immediately implemented to ensure safety; experts say pandemic is forcing a rethinking in how companies carry out trials and in how regulators ensure patient safety and trial integrity.