Phase III
AstraZeneca reported Tuesday that its Phase III MESSINA trial hit one primary endpoint but missed the other. The study was evaluating Fasenra in eosinophilic esophagitis.
Novartis’ positive-third quarter growth report was slightly marred by several clinical setbacks that resulted in the termination of studies in liver transplant and non-small cell lung cancer.
Mirum Pharmaceuticals announced that Livmarli oral solution met its primary endpoint in the Phase III MARCH study in young patients with progressive familial intrahepatic cholestasis.
The FDA greenlit AstraZeneca’s tremelimumab in combination with its checkpoint inhibitor Imfinzi as a treatment for patients with unresectable hepatocellular carcinoma.
Top-line data from Tricida’s VALOR-CKD trial showed veverimer failed to meet its primary endpoint and does not slow progression in patients with metabolic acidosis and CKD.
In a Phase III trial comparing Novartis’ experimental iptacopan against AstraZeneca’s Soliris and Ultomiris in paroxysmal nocturnal hemoglobinuria, iptacopan demonstrated superiority.
After the Data Monitoring Committee reviewed the case based on protocol modifications implemented earlier this year, it was determined that enrollment in the trial and dosing may continue.
BMS’s blockbuster checkpoint inhibitor Opdivo hit the primary endpoint in the Phase III CheckMate -76K trial for a particularly intractable form of melanoma.
An analysis of un-blinded interim data showed fosgonimeton provided clinically meaningful improvements in cognition and function in patients with mild-to-moderate Alzheimer’s disease.
Biogen announced the FDA has extended its review for ALS drug tofersen by three months. The regulator set a new PDUFA action date set of April 25, 2023.
PRESS RELEASES