Tuesday, July 28, 2015

Other Q2 2015 Release Updates: Hep C Candidate Grazoprevir/Elbasvir Granted Priority FDA Review -- Decision By January 2016


So as not to be lost in the shuffles -- of revised guidance, Venezuelan charges and the smallish Israeli oncology candidate acquisition. . .

I will separately post on the next gen, once daily combo tab for Hep C Merck is advancing through Phase III, now. FDA has received the packet, and will likely make a decision on it early in 2016. However, Kenilworth already faces some daunting competitors in this space. Just the same, this is moderately good news:

. . . .Separately, Merck said, the U.S. Food and Drug Administration has accepted for review the company’s new drug application for grazoprevir/elbasvir, a once-daily, single-tablet therapy for hepatitis C. The agency granted priority review for the treatment with a decision expected by Jan. 28 [2016]. . . .


And, just as expected Remicade tok a hit from biosim introductions this quarter. That will accelerate in future quarters. Onward. . . .

1 comment:

Anonymous said...

And so. . . knowing that so much of science is mystical, too. . . the stars shine and glisten, for like one's skin -- in a night rain, under a waning moon -- it is science. . . that makes it so. . . . But only if we. . . notice, is it so.