Clinical research
The decision to allow the release of Adbry follows positive results from the Phase III ECZTRA trials, which covered almost 2,000 patients living with moderate to severe atopic dermatitis.
BridgeBio Pharma reported topline data from Part A (Month 12) of its Phase III study of acoramidis for symptomatic transthyretin amyloid cardiomyopathy. The drug failed the study arm.
The company was assessing mavrilimumab as a potential therapeutic for COVID-19-related acute respiratory syndrome.
The FDA has greenlit Merck and Ridgeback’s molnupiravir under EUA to treat mild to moderate COVID-19 infections in adults at high risk of progression to severe disease.
The latest approvals mark the first time a biologic has been approved for ERA. Cosentyx is also the only biologic approved in the United States for both ERA and PsA in pediatric patients.
PhaseBio’s move to suspend its Phase IIb trial of pemziviptadil is due to the effect of COVID-19 on manufacturing, associated drug supply, and the rate of enrollment in the study.
Takeda hoped that its experimental therapy could become the first FDA-approved treatment for EoE. However, the FDA wants the company to initiate another clinical study with TAK-721.
The new Phase III study will include an enhanced version of the Viaskin Peanut patch, approximately 50% larger than the patch initially rejected by the FDA.
Allakos reported mixed results on two clinical trials, the Phase II ENIGMA 2 and Phase II/III KRYPTOS trials of lirentelimab.
Novartis believes Gyroscope’s investigational Phase II gene therapy for geographic atrophy has the potential to become the first therapy that demonstrates sustained efficacy for GA patients.
PRESS RELEASES
