Phase III
Health economics and outcomes research (HEOR) is a critical but sometimes overlooked part of drug development. Decentralized trials now make it easy.
Axsome clinched a late-stage victory for its chronic sleep disorder candidate AXS-12, which demonstrated significant improvement in cataplexy—the sudden loss of muscle tone while a person is awake—after five weeks.
Regeneron’s bispecific antibody odronextamab was hit with Complete Response Letters from the FDA noting issues with the enrollment status of its confirmatory trials.
Despite meeting its primary endpoint in a late-stage generalized myasthenia gravis trial, Roche and Chugai Pharmaceutical’s Enspryng did not demonstrate clinical benefit as expected, the companies announced Thursday.
Imagine testing a really good drug for HER2+ breast cancer in someone with liver cancer. Would it be any surprise when that drug fails?
Keytruda, when used with AstraZeneca’s Lynparza, did not significantly improve overall and progression-free survival in specific patients with metastatic non-squamous non-small cell lung cancer.
The recent FDA decision will likely mean more Medicare patients gain access to the blockbuster weight loss drug, experts say. Meanwhile, results continue to roll in for GLP-1 agonists for conditions beyond diabetes and obesity.
In advance of a March 21 PDUFA date, Italfarmaco on Tuesday reported that its drug candidate givinostat met the primary endpoint for treating Duchenne muscular dystrophy.
Bristol Myers Squibb secured another late-phase immuno-oncology victory Wednesday, showing that the combination of Opdivo and Yervoy improved overall survival in a patient population served by rival checkpoint inhibitors from AstraZeneca and Roche.
Bayer bagged another late-stage victory for its menopause drug candidate Tuesday, setting up a potential showdown with Astellas’ Veozah which was approved last year by the FDA for the treatment of hot flashes.
PRESS RELEASES