Phase III
Selecta Biosciences is eying a Phase III trial for its gout treatment based on expanded positive data from an ongoing mid-stage trial that showed a significant reduction of serum uric acid at 12 weeks.
Bluebird bio’s LentiGlobin gene therapy is increasing hemoglobin levels in anemia patients battling sickle cell disease and beta thalassemia, which reduces the need for blood transfusions in those patients.
While pharma and biotech researchers have been driving forward with therapies aimed at helping Parkinson’s disease patients, medical researchers have identified “unexpected new key players” in the development of early-onset Parkinson’s disease, called Parkinsonism.
ViiV Healthcare, established in November 2009 by GlaxoSmithKline, Pfizer and Shiongi, reported positive results from its Phase III GEMINI-1 and -2 clinical trials.
This year the FDA issued a Refusal to File letter regarding its New Drug Application (NDA) for its multiple sclerosis drug ozanimod. The finger is pointed at its California subsidiary, Receptos for the failure.
vTv Therapeutics reported the second part of its Phase III Alzheimer’s disease study failed to meet co-primary efficacy endpoints.
The U.S. Food and Drug Administration (FDA) granted Boston-based Albireo Pharma’s A4250 rare pediatric disease designation.
Following a meeting with the U.S. Food and Drug Administration Sage Therapeutics is seeing the goal line for potential expedited approval of its major depressive disorder (MDD) and postpartum depression (PPD) treatment, SAGE-217.
Yet another drug for Alzheimer’s has been tossed in the trash. AstraZeneca and Eli Lilly announced they have abandoned two late-stage clinical trials of lanabecestat for Alzheimer’s disease.
Allergan announced positive results from its oral Phase IIb/III CGRP antagonist, atogepant. Allergan said atogepant showed a statistically significant reduction in monthly migraine days.
PRESS RELEASES