Phase III
It seems that the primary news surrounding Alzheimer’s disease research has been nothing but negative for years.
The company is now waiting for the FDA to determine a path forward in resuming clinical studies.
The FDA’s Breakthrough Therapy Designation for balovaptan was primarily based on efficacy findings in the VANILLA study, a Phase II trial of balovaptan in adults with ASD.
Amgen’s migraine drug Aimovig continues to impress with its efficacy in late-stage studies.
Another experimental Alzheimer’s disease treatment has failed in a late-stage study.
Lilly finally revealed the data in the New England Journal of Medicine.
The negative trend vote from the CHMP will likely mean the EMA will not authorize neratanib for extended adjuvant treatment of early-stage HER2-positive breast cancer.
In the study, 246 patients were randomized to receive Aimovig or placebo over a 12-week treatment phase.
On Jan. 8, Alder BioPharma announced that its eptinezumab met its primary endpoint in its Phase III PROMISE 2 clinical trial for preventing migraine.
Merck’s Keytruda has done it again.
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