Tag: Phase III Trial
FDA Authorizes Moderna Vaccine, Another Pfizer Vaccine Recipient Has Allergic Reaction
PEG compound possible culprit in allergic reactions.
Dupixent (dupilumab) Study Shows Significant Improvement in Eosinophilic Esophagitis Signs and...
Phase 3 trial in (EoE) to show a significantly improved structural and histologic measures, while rapidly improving ability to swallow in patients 12 years and older
Recruitment of Infants Begins for Phase 3 Trial of Cream to...
The trial needs 760 babies aged three weeks or younger whose parents or siblings suffer from either eczema, asthma or food allergies.
Phase 3 Trial Data Demonstrates Consistent Safety and Efficacy of AR101...
“Results of the European ARTEMIS trial provide further clinical validation of the safety and efficacy of AR101 for children and adolescents with peanut allergy.”
Viaskin Peanut Completes Phase III Part A Study of Toddlers With...
Part B expected to commence in 2018Q4 with Viaskin Peanut 250 µg.
Aimmune to Submit FDA Application for Peanut OIT Candidate by End...
If approved, AR101 could be offered as the first FDA approved OIT therapy for peanut allergy.
Results of Phase III Trial of Aimmune's Peanut OIT Therapy
After one year, 3/4 of patients ages 4-17 who received the therapy were able to consume a minimum of 300mg of peanut. Results for adults were less clear.
Aimmune Issues Update on AR101 Peanut Oral Immunotherapy Candidate
The company announces their timeline for continued progress toward an FDA approved standardized therapy.
Positive Safety Results Reported for Viaskin Peanut Phase III Trial
The trial met its primary objective, demonstrating that Viaskin Peanut was well-tolerated with no new or unexpected adverse events.
Viaskin Peanut Phase III Trial Falls Short, Still Chance for FDA...
The Viaskin Peanut patch therapy still has 50:50 chance of approval according to research note.
