Phase III
Karuna Therapeutics released results from the Phase III EMERGENT-2 trial showing that KarXT, its lead candidate, can strongly reduce symptom severity in schizophrenia patients.
With Monkeypox, COVID-19, Long COVID symptoms and persistent diseases like cancer and Alzheimer’s, the world is dealing with a lot right now. Here’s a look at the latest in clinical trial news.
Lackluster initial results forces Pfizer to discontinue Phase III trial on a potential drug for symptomatic dilated cardiomyopathy (DCM).
Alnylam revealed its Phase III APOLLO-B study, which showed that patisiran improves both functional capacity and quality of life in patients with ATTR amyloidosis with cardiomyopathy.
Although no new safety concerns were observed, Merck’s Keytruda did not demonstrate significant improvements based on the pre-specified statistical plan.
Ipsen said that Onivyde did not show greater benefit than topotecan used in patients with SCLC who have progressed on or after platinum-based first-line therapy treatment.
The FDA granted Priority Review for omidubicel with a target action date of January 30, 2023. Omidubicel is a first-in-class, advanced NAM (nicotinamide)-enabled stem cell therapy.
The BLA is for the use of the drug N-803 with BCG to treat patients with BCG-unresponsive non-muscle-invasive bladder cancer carcinoma with or without Ta or T1 disease.
Bristol Myers Squibb’s Opdivo (nivolumab) and Yervoy (ipilimumab) as an adjuvant treatment for localized renal cell carcinoma (RCC) failed to hit the primary endpoint.
The end of July is busy for the FDA, with Coherus, Sanofi, Acadia, Myovant and Pfizer having PDUFA dates filling the calendar. Here’s a look.
PRESS RELEASES