Phase III
Despite multiple therapeutics approved to treat localized symptoms, there are currently no systemic therapies on the market for Sjogren’s syndrome.
While donanemab showed impressive results in Phase III TRAILBLAZER-ALZ 2, concerns regarding its safety remain compared with Biogen’s and Eisai’s Leqembi.
Data from Phase III confirmatory MIRASOL trial show antibody-drug conjugate boosts survival in platinum-resistant ovarian cancer, setting the stage for full approval by the FDA.
Despite the Phase III failure, Travere and partner CSL Vifor will explore potential regulatory paths for sparsentan as a treatment for focal segmental glomerulosclerosis.
The amyloid plaque targeting therapy met primary endpoint and all secondary endpoints, which Lilly will use in its submission to the FDA this quarter.
In the Phase III SURMOUNT-2 study, Mounjaro reduced body weight by 29.8 lbs. on average in adult type 2 diabetes patients who were overweight or obese.
Longitudinal studies that track patients’ experiences can inform and accelerate the drug approval process for rare diseases.
The joint venture between Walgreens and Prothena to accelerate the approval of an Alzheimer’s treatment is the latest in biotech and retail chain alliances.
The French pharma drops another BTK inhibitor program from Principia and an anti-TNFa from Ablynx.
Merck and AstraZeneca are seeking broad approval for Lynparza in mCRPC regardless of BRCA status.
PRESS RELEASES